Original Investigation | Orthopedics

Topology-Optimized Splints vs Casts for Distal Radius Fractures

A Randomized Clinical Trial
Honghong Ma, MS; Beite Ruan, MS; Jian Li, PhD; Jiahui Zhang, MS; Changgui Wu, MS; Hao Tian, MS; Yichen Zhao, MS; Debing Feng, MS; Wei Yan, MS; Xiaobing Xi, MS

Abstract Key Points

Question Is a topology-optimized splint
IMPORTANCE To date, there is currently no evidence-based medical support for the efficacy of
more effective than traditional cast
topology-optimized splints in treating distal radius fractures.
therapy in reducing wrist pain and
enhancing wrist function for patients
OBJECTIVE To assess the clinical efficacy and complication rates of topology-optimized splints in
with distal radius fractures, including
the treatment of distal radius fractures after closed manual reduction.
those who did and did not undergo
closed manual reduction?
DESIGN, SETTING, AND PARTICIPANTS This 12-week, multicenter, open-label, analyst-blinded
randomized clinical trial (comprising a 6-week intervention followed by a 6-week observational Findings In this randomized clinical trial
phase) was carried out from December 3, 2021, to March 10, 2023, among 110 participants with distal involving 110 participants with distal
radius fractures. Statistical analysis was performed on an intention-to-treat basis between June 3 radius fractures, the intervention group
and 30, 2023. received topology-optimized splint
immobilization and the control group
INTERVENTION Participants were randomly assigned to 2 groups: the intervention group received received cast immobilization after
topology-optimized splint immobilization and the control group received cast immobilization after closed manual reduction for 6 weeks.
closed manual reduction for 6weeks. After this period, immobilization was removed, and wrist The topology-optimized splint group
rehabilitation activities commenced. exhibited better wrist functional
outcomes than the traditional cast
MAIN OUTCOMES AND MEASURES The primary outcome was the Gartland-Werley (G-W) wrist group for the treatment of distal radius
score at 6 weeks (where higher scores indicate more severe wrist dysfunction). Secondary outcomes fractures, with no clinically significant
encompassed radiographic parameters, visual analog scale scores, swelling degree grade, difference at 12 weeks of follow-up.
complication rates, and 3 dimensions of G-W wrist scores.
Meaning The results suggest that the
topology-optimized splint provides early
RESULTS A total of 110 patients (mean [SD] age, 64.1 [12.7] years; 89 women [81%]) enrolled in the
relief from pain and improved function
clinical trial, and complete outcome measurements were obtained for 101 patients (92%). Median
for patients, offering effective treatment
G-W scores at 6 weeks were 15 (IQR, 13-18) for the splint group and 17 (IQR, 13-18) for the cast group
while mitigating the risks associated
(mean difference, −2.0 [95% CI, −3.4 to −0.6]; P = .03), indicating a statistically significant advantage
with surgery.
for the splint group. At 12 weeks, no clinically significant differences in G-W scores between the 2
groups were observed. Complication rates, including shoulder-elbow pain and dysfunction and skin
irritation, were less common in the splint group (shoulder-elbow pain and dysfunction: risk ratio, + Supplemental content
0.28 [95% CI, 0.08-0.93]; P = .03; skin irritation: risk ratio, 0.30 [95% CI, 0.10-0.89]; P = .02). Author affiliations and article information are
listed at the end of this article.

CONCLUSIONS AND RELEVANCE Findings of this randomized clinical trial suggest that patients
with distal radius fractures that were managed with topology-optimized splints had better wrist
functional outcomes and fewer complications at 6 weeks compared with those who received casting,
with no difference at week 12. Therefore, topology-optimized splints with improved performance
have the potential to be an advisable approach in the management of distal radius fractures.

TRIAL REGISTRATION Chinese Clinical Trial Registry: ChiCTR2000036480

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Open Access. This is an open access article distributed under the terms of the CC-BY License.

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 JAMA Network Open | Orthopedics Topology-Optimized Splints vs Casts for Distal Radius Fractures

Introduction
Distal radius fractures (DRFs) are among the most common fracture injuries in emergency trauma
departments, accounting for approximately 20% of all emergency fractures and 75% of forearm
fractures.1 Predominantly resulting from indirect injuries such as falls, sports accidents, or traffic
accidents,2,3 DRFs affect both young individuals and those older than 65 years. Younger patients
typically experience high-energy injuries, whereas older adults experience low-energy incidents.4,5
The population of older adults in China is projected to exceed 200 million by 2025.6 Osteoporotic
fractures, with DRFs being prominent among older adults, are becoming a major public
health concern.7
Treatments for DRFs comprise surgical and conservative approaches. Several trials have shown
that surgical treatment effectively achieves anatomical reduction and improves early mobility and
quality of life vs conservative treatment.8-10 However, follow-up studies found no significant
differences in pain or functional improvement between these approaches,11-15 sparking debate on the
best strategy.16 British guidelines recommend closed reduction and cast immobilization as primary
treatments.17 However, drawbacks of the conventional cast, such as bulkiness, have spurred
treatment innovations.18-21 The rise of 3-dimensional (3D) printing in orthopedics has led to bespoke
splints with superior clinical efficacy, lightweight design, and better ventilation.22-24 These splints
could reduce patient pain, lessen risks of joint stiffness, and hasten wrist recovery.25
Topology optimization from engineering26 is used to make orthotic devices lighter. It
mathematically models optimal structures and materials, maximizing strength and minimizing
material use. This approach is beneficial, exemplified by Liao et al,27 who reduced a brace’s weight by
12.4% without efficacy loss. Similarly, Mian et al28 and Yan et al29 demonstrated topology-optimized
splints’ potential in enhancing patient comfort and reducing splint weight. Despite advances, clinical
studies on topology-optimized splints remain scarce. Recognizing this, we used topology
optimization with 3D printing to develop a novel polyamide30,31 splint. We conducted preliminary
safety evaluations of our splint using finite element simulations.
Given the absence of clinical trials on splints designed via topology optimization, our study
initiates a 12-week randomized clinical trial. We aim to compare outcomes (Gartland-Werley [G-W]
scores, radiographic parameters, visual analog scale [VAS] scores, swelling grade, complications)
between patients treated with topology-optimized splints and those treated with conventional casts
over 6 weeks. Our hypothesis posits that topology-optimized splints will be more effective than
traditional casts in enhancing function, alleviating pain, and minimizing complications.

Methods
Study Design
The clinical trial protocol (Supplement 1) was approved by the ethics committee of Ruijin Hospital
Affiliated to Shanghai Jiao Tong University School of Medicine and registered in the Chinese Clinical
Trial Registry (2020 Clinical Ethics Review [238]). During the eligibility screening of patients with
DRFs in the outpatient and emergency department of Shanghai Ruijin Hospital and Shanghai Yangpu
District Hospital of Traditional Chinese Medicine from December 3, 2021 to March 10, 2023, all
participants provided written informed consent. This study followed the Consolidated Standards of
Reporting Trials (CONSORT) reporting32 reporting guideline, and the CONSORT flowchart is shown
in the Figure.

Eligibility Criteria
In this study, potential participants with a diagnosis of DRF who met the following criteria were
eligible: acute DRF, age 18 to 85 years, DRFs classified as type A and type B fractures according to AO
Foundation/Orthopaedic Trauma Association (AO/OTA) classification,33 fractures both with and
without displacement, displaced fractures requiring closed manual reduction, fresh closed fractures

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 JAMA Network Open | Orthopedics Topology-Optimized Splints vs Casts for Distal Radius Fractures

that have not been combined with other parts of the fracture and have not received other treatment
methods, willing to sign informed consent, and willing to cooperate with the physician for voluntary
follow-up. Exclusion criteria were as follows: acute open fracture or pathological fracture; inability to
achieve functional reduction after closed reduction of fracture (radiographic criteria after
reduction34: dorsal angulation >10°, radial inclination <15°, or radial shortening >3 mm); rheumatic
diseases requiring hormone therapy for >6 months; serious cardiovascular and cerebrovascular
diseases, diabetes, or neurologic or psychiatric diseases; and wrist skin damage, infection, and
ulceration.

Randomization, Allocation Concealment, and Blinding

Randomization was implemented by an independent statistician. A stratified block randomization
was applied and stratified by center. A block randomization was applied within each center. The block
size in our study was accessible only to the statistician who performed the randomization and
generated the allocation sequence. Patients were randomly assigned to the topology-optimized
splint group or the cast group in a 1:1 ratio. Random sequence lists generated by SAS, version 9.4 (SAS
Institute Inc), were sealed in opaque envelopes and distributed to each center. The envelope was
opened in front of the patient in chronological order of the patient’s visit. The statisticians and data
analysts were blinded to the group assignments, which was implemented to ensure the impartiality
of the analysis. Patients were screened and followed up by surgeons and clinical research
coordinators (CRCs) to whom the interventions were clearly visible. Surgeons and CRCs were not
involved in the data analysis process.

Interventions
All surgeons involved in this study were trained in the treatment of DRFs and the application of
splints and casts. In accordance with routine clinical practice, the fracture was reduced by closed
manipulation under local anesthesia (nondisplaced fractures do not require closed reduction).
Radiographic films were used to assess the success of reduction after closed manual reduction
(eAppendix 3 in Supplement 2). External immobilization was achieved using splints and casts,
according to the assigned group. After immobilization, participants were encouraged to engage in
finger activity.

Figure. Study Flowchart

172 Participants assessed for eligibility

62 Excluded
22 Did not meet inclusion criteria
30 Declined to participate
10 Opted for surgery

110 Randomized

54 Randomized to topology-optimized 56 Randomized to casts group

splint group

54 Received treatment as 56 Received treatment as

randomized randomized
6 Lost to follow-up 3 Lost to follow-up
3 Could not be contacted 1 Could not be contacted
2 Opted for surgery 2 Opted for surgery
1 Relocated

54 Analyzed 56 Analyzed

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In the cast group, the cast was applied directly over the skin to immobilize the fracture,
extending from below the elbow to the metacarpals. Conversely, in the splint group, prefabricated
topology-optimized splints (eAppendix 3 in Supplement 2), which were crafted by combining
topology optimization technology with 3D printing technology, were used to immobilize the fracture.
For patients presenting unique anatomical considerations, customized topology-optimized splints
were made available. The detailed technical methods for both the splints and casts are described in
eAppendix 2 in Supplement 2. Swelling degree and pain were observed during follow-up
appointments at 3 days, 1 week, and 2 weeks. If severe swelling and discomfort were present,
adjustments to the splint or cast may have been necessary. External immobilization was typically
removed after a mean (SD) of 6.0 (0.2) weeks for both groups. Participants in both groups were
provided with the same detailed home exercise program (eAppendix 1 in Supplement 2), and any
additional rehabilitation exercise (including physical therapy) beyond the program was at the
discretion of the clinician or patient.

Outcome Measures
Participants were followed up and data were collected by the CRCs at 3 days, 1 week, 2 weeks, 6
weeks, and 12 weeks. Baseline data included age, sex, fracture type (AO [Arbeitsgemeinschaft für
Osteosynthesefragen] classification), fractured wrist, VAS score, grading of swelling degree,
radiographic parameters of fracture, radiographic parameters after reduction of fracture, and
comorbidities.
The primary outcome was the G-W wrist score (range, 0-38; higher scores indicate worse pain)
evaluated at 6 weeks. This score integrates 4 key dimensions: residual deformities (presence of
residual radial or dorsal deformity), subjective evaluation (patient’s self-assessment of pain, limited
mobility, and loss of function), objective evaluation (surgeon’s assessment of wrist range of motion,
distal radioulnar joint pain, and grip strength), and complications (arthritis, neuropathy, and poor
finger function). In addition, we examined 3 dimensions of the G-W score as secondary outcomes to
thoroughly understand patients’ recovery trajectories under different treatment modalities.
Secondary outcomes included changes in fracture displacement (radius height, volar angle, or
radius inclination) and fracture healing at 2, 6, and 12 weeks after reduction using radiographs; VAS
score changes at 3 days, 7 days, 2 weeks, 6 weeks, and 12 weeks (range, 0-10 points, with 0
indicating no pain and 10 indicating the most severe pain); degree of swelling in the wrist joint at 3
days, 7 days, 2 weeks, 6 weeks, and 12 weeks (with 0 degrees indicating no swelling, 1 degree
indicating mild swelling with visible skin lines, 2 degrees indicating obvious skin swelling with
disappearing lines, and 3 degrees indicating skin depression and tension blisters); and complications
such as arthritis, complex regional pain syndrome, carpal tunnel syndrome, shoulder-elbow pain and
dysfunction, tension blisters, skin irritation syndrome (redness, swelling, itching, allergies,
dermatitis, and odor), and poor finger function.

Statistical Analysis
Statistical analysis was performed between June 3 and 30, 2023. The sample size was calculated
using PASS software, version 11 (NCSS), with reference to a previous randomized clinical trial
(n = 94)35 that compared splint and cast treatments for DRFs. The findings revealed that after 3
months, the splint group had an rate of 96% on the G-W score, while the cast group had a rate of
77%. Assuming a 19% difference in G-W score between the 2 groups, with a 2-sided 5% probability
of type I error and 80% power, the sample size was determined to be 100 patients (50 per group).
Considering a potential dropout rate of 10%, a total of 110 patients were ultimately required for
enrollment.
Data analysis was consistent with the principle of intention-to-treat, with data incorporated
from all enrolled participants. To address the issue of missing data, we used multiple imputation
methods to estimate both primary and secondary outcomes for all follow-up periods. Considering
the nonmonotonic nature of the missing data, we used the fully conditional specification method

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within the canonical multiple imputation framework. Continuous data that followed a normal
distribution were presented as mean (SD), while data that did not follow a normal distribution were
presented as median (IQR). Disaggregated data were expressed as a percentage. Comparisons
between the groups used the t test or the Mann-Whitney test for continuous variables and the χ2 test
or Fisher exact test for categorical variables. For repeatedly measured data, a linear mixture model
was used for statistical analysis, with participants as random effects, and time and group as fixed
effects. Multiple comparisons of repeatedly measured data were Bonferroni corrected.
Complications were analyzed by calculating the risk ratios and 95% CIs. All tests were 2-sided, and
P < .05 was considered statistically significant. SPSS software, version 24.0 (IBM Corp), was used for
all statistical analyses.

Results
Participant Characteristics
From December 3, 2021, to March 10, 2023, a total of 172 eligible patients were screened and 110
participants (mean [SD] age, 64.1 [12.7] years; 89 women [81%]) were recruited, with 54 assigned to
the splint group and 56 to the cast group. Nine participants withdrew from the study. In the splint
group, 6 participants dropped out for the following reasons: 2 chose surgery, 1 relocated, and 3 could
not be contacted. In the cast group, 3 participants withdrew: 2 opted for surgery, while 1 was lost
during follow-up. Ultimately, 101 participants completed the study (Figure). The baseline
characteristics of the participants were found to be similar in both the splint and cast groups
(Table 1). Throughout the clinical trial, the surgeon and the CRC consistently supervised and
managed the follow-up of the patients.

Table 1. Baseline Characteristics of Participants

Characteristic Splint group (n = 54) Cast group (n = 56)

Age, median (IQR) [range], y 67 (59 to 70) [24 to 85] 66 (57 to 72) [29 to 85]
Sex, No. (%)
Male 13 (24) 8 (14)
Female 41 (75) 48 (86)
Fractured wrist, No. (%)
Left wrist 27 (50) 31 (55)
Right wrist 27 (50) 25 (45)
AO classification, No. (%)a
A type 38 (70) 35 (63)
B type 16 (30) 21 (38)
VAS score, median (IQR)a 6 (4 to 7) 6 (4 to 7)
Grading of swelling degree, median (IQR)b 1 (1 to 2) 1 (1 to 2)
Radiographic parameters of fracture, median (IQR)c
Radial height, mm 9 (8 to 11) 9 (7 to 11)
Volar angulation, ° 3 (−10 to 10) 2 (−11 to 10)
Radial inclination, ° 20.5 (17 to 23) 20 (15 to 23)
Reduction of fracture, median (IQR)
Radial height, mm 10 (9 to 11) 10 (9 to 11)
Abbreviations: AO, Arbeitsgemeinschaft für
Volar angulation, ° 7 (4 to 11) 8 (4 to 11)
Osteosynthesefragen class; VAS, visual analog scale.
Radial inclination, ° 22 (20 to 23) 21 (19 to 24) a
On the VAS score, higher scores indicate worse pain.
Comorbidities, No. (%) b
On the grading of swelling degree, higher scores
Diabetes 12 (22) 7 (13)
indicate worse pain.
Smoking 6 (11) 5 (9) c
Measured by computer imaging system.

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Participant-Reported Outcomes
Table 2 presents a detailed overview of the G-W scores. After 6 weeks, the splint group had a
significantly lower overall median G-W score compared with the cast group (15 [IQR, 13-18] vs 17 [IQR,
13-18]; mean difference, −2.0 [95% CI, −3.4 to −0.6]; P = .03). The splint group also reported a lower
subjective score than the cast group. Both groups showed limited wrist range of motion, but the
splint group had advantages in dorsal flexions, with a mean difference of 10.1 (95% CI, 5.2-14.9;
P < .001). Furthermore, the splint group experienced a lower incidence of distal radioulnar joint pain
compared with the cast group (35 of 48 [73%] vs 47 of 53 [89%]; P = .04). At 12 weeks, after 6 weeks
of rehabilitation training, both groups demonstrated significant improvements in wrist range of
motion and grip strength, reaching approximately 70% of the strength of their uninjured hand.
However, wrist functions had not yet returned to preinjury levels, and no significant differences were
observed between the 2 groups.
Radiographic parameters, VAS scores, and wrist swelling levels were compared between groups
(Table 3). Throughout 12 weeks of follow-up, no noticeable differences in radiographic parameters
after closed reduction were observed between the 2 groups, although both groups exhibited varying
degrees of fracture displacements. Analysis of VAS score changes from baseline to 12 weeks revealed
that the splint group experienced more significant pain reduction compared with the cast group at
both the 2- and 6-week intervals. Specifically, the adjusted mean difference in VAS score from
baseline reduction favored the splint group by −0.52 (95% CI, −1.05 to 0.02; P = .03) at 2 weeks and
−0.55 (95% CI, −1.09 to −0.01; P = .03) at 6 weeks. At 2 weeks, the splint group (–0.26; 95% CI,
−0.48 to −0.05, P = .02) also showcased superior reductions in swelling compared with the
cast group.

Table 2. Primary Outcomes at 6 and 12 Weeks

At 6 wk Splint vs cast, At 12 wk Splint vs cast,

Splint group mean difference P Splint group Cast group mean difference P
Clinical outcome (n = 54) Cast group (n = 56) (95% CI) value (n = 54) (n = 56) (95% CI) value
G-W score, median (IQR), pointsa 15 (13 to 18) 17 (13 to 18) −2.0 (−3.4 to .03 0.5 (0 to 2) 0 (0 to 2) −0.05 (−0.6 to .84
−0.6) 0.5)
Residual deformity, No. (%)b 2 (4) 3 (6) NA >.99 NA NA NA NA
Subjective rating, No. (%)c
Optimal 1 (2) 1 (2) 37 (69) 41 (73)
Good 1 (2) 3 (5) 17 (31) 15 (27)
NA .03 NA .59
Average 30 (56) 16 (29) 0 0
Poor 22 (40) 36 (64) 0 0
Objective evaluation, median
(IQR), % of uninjured sided,e
Dorsal flexion, ° 30 (24 to 45), 41f 22 (18 to 30), 30 10.1 (5.2 to 14.9) <.001 70 (65 to 74), 84 70 (63 to 75), 84 0.6 (−1.5 to 2.7) .49
Volar flexion, ° 31 (24 to 38), 40 32 (21 to 40), 39 0.7 (−3.7 to 5.2) .74 68 (60 to 75), 82 65 (60 to 70), 81 0.9 (−1.7 to 3.5) .54
Pronation, ° 72 (62 to 81), 85 69.5 (58 to 78), 84 1.3 (−2.3 to 4.8) .45 85 (80 to 85), 99 85 (80 to 85), 99 0.1 (−0.9 to 1.1) .61
Supination, ° 49 (43 to 52), 66 48 (44 to 50), 65 1.2 (−0.5 to 2.9) .25 65 (60 to 69), 89 64.5 (60 to 70), 90 −0.2 (−2.2 to 1.8) .86
Radial deviation, ° 6 (4 to 9), 30 6 (5 to 8), 31 −0.1 (−1.0 to 0.8) .66 20 (18 to 20), 93 19.5 (17 to 20), 91 0.4 (−0.2 to 1.0) .33
Ulnar deviation, ° 20 (17 to 22), 65 20 (18 to 21), 64 0.1 (−1.3 to 1.5) .74 28 (27 to 28), 91 27 (27 to 28), 91 0.08 (−0.4 to 0.5) .84
Grip strength, kgg 5 (4 to 7), 25 5 (3 to 7), 23 0.5 (−0.5 to 1.4) .44 16 (12 to 18), 73 15 (13 to 17), 71 0.8 (−0.9 to 2.4) .52
Ring motion defect, No. (%) 46 (85) 49 (88) NA .72 8 (15) 7 (13) NA .72
Distal radioulnar joint pain, 39 (76) 50 (89) NA .02 9 (17) 12 (21) NA .53
No. (%)
d
Abbreviations: G-W, Gartland-Werley; NA, not applicable. Measure by electronic protractor.
a e
G-W score range, 0 to 38; higher scores indicate worse pain. The G-W score was the Percentage compared with uninjured side.
main results and all other results were secondary. f
Mean of percentage.
b
Ulnar styloid protrusion, residual radial or dorsal deformity (according to imaging g
Measure by electronic grip strengthener.
assessment).
c
Assessment by the patient of pain, limitation of movement, or loss of function.

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Complications
Table 4 provides an overview of the adverse events reported by both groups. These events
encompassed arthritis, complex regional pain syndrome, carpal tunnel syndrome, tension blister, and
finger dysfunction. However, there was no statistically significant difference observed between the
groups in relation to these complications. The splint group exhibited a lower occurrence of shoulder-
elbow pain and dysfunction (risk ratio, 0.28 [95% CI, 0.08-0.93]; P = .03) as well as skin irritation
(risk ratio, 0.30 [95% CI, 0.10-0.89]; P = .02) compared with the cast group.

Discussion
In this randomized clinical trial, most patients saw positive outcomes, effective treatment, reduced
disability, and enhanced functional activity, leading to an elevated quality of life. At 6 weeks, G-W

Table 3. Secondary Outcomes

Median (IQR) Mean change from reduction baseline (95% CI)

Radiographic Splint group Cast group Splint vs cast, mean difference
parametera (n = 54) (n = 56) Splint group (n = 54) Cast group (n = 56) (95% CI) P value
Radial height, mmb
Reduction baseline 10 (9 to 11) 10 (9 to 11) NA NA NA NA
At 2 wk 10 (9 to 11) 10 (9 to 11) –0.13 (–0.26 to –0.04) –0.23 (–0.41 to –0.07) 0.10 (−0.10 to 0.31) .40
At 6 wk 9.5 (9 to 11) 10 (8 to 11) –0.24 (−0.41 to –0.09) –0.48 (–0.73 to –0.27) 0.24 (−0.05 to 0.53) .12
At 12 wk 9.5 (9 to 11) 10 (8 to 11) –0.26 (0.43 to –0.11) –0.48 (0.73 to –0.25) 0.22 (−0.07 to 0.51) .18
Volar angulation, °c
Reduction baseline 7 (4 to 11) 8 (4 to 11) NA NA NA NA
At 2 wk 7 (3.5 to 11) 7.5 (4 to 11) –0.22 (−0.44 to –0.04) –0.73 (–1.59 to –0.11) 0.51 (−0.27 to 1.29) .95
At 6 wk 7 (2.75 to 11) 7.5 (4 to 11) –0.57 (–0.91 to –0.28) –0.93 (–1.77 to –0.34) 0.35 (−0.45 to 1.16) .63
At 12 wk 7 (3.5 to 11) 7.5 (4 to 11) –0.46 (–0.80 to –0.17) –0.94 (–1.75 to –0.32) 0.47 (−0.34 to 1.27) .78
Radial inclination, °d
Reduction baseline 22 (20 to 24) 21 (19 to 24) NA NA NA NA
At 2 wk 21 (19 to 24) 21 (18 to 24) –0.52 (–1.03 to –0.13) –0.79 (–1.23 to –0.38) 0.26 (−0.38 to 0.91) .19
At 6 wk 21 (19 to 23) 21 (17 to 23.75) –0.72 (–1.24 to –0.31) –1.05 (–1.54 to –0.57) 0.33 (−0.36 to 1.02) .16
At 12 wk 21 (19 to 23) 21 (17 to 23.75) –0.80 (–1.30 to –0.39) −1.05 (−1.55 to −0.57) 0.26 (−0.42 to 0.94) .42
VAS scorese,f
Baseline 6 (4 to 7) 6 (4 to 7) NA NA NA NA
At 3 d 5 (3 to 6) 5 (3 to 6) –0.98 (–1.31 to –0.67) –0.89 (–1.18 to –0.61) 0.09 (−0.52 to 0.34) .92
At 7 d 4 (3 to 5) 4 (3 to 4.75) –2.06 (–2.41 to –1.72) –2.09 (–2.39 to –1.80) 0.03 (−0.42 to 0.49) .83
At 2 wk 2 (2 to 3) 3 (2 to 4) –3.44 (–3.83 to –3.07) –2.93 (–3.27 to –2.61) –0.52 (–1.05 to 0.02) .03
At 6 wk 1 (1 to 2) 2 (1 to 3) –4.43 (–4.81 to –4.04) –3.88 (–4.21 to –3.54) –0.55 (–1.09 to –0.01) .03
At 12 wk 0 (0 to 1) 0 (0 to 1) –5.35 (–5.74 to –4.94) –5.30 (–5.73 to –4.88) –0.05 (−0.65 to 0.55) .84
Grading of swelling degree, %g,h
Baseline 1 (1 to 2) 1 (1 to 2) NA NA NA NA
At 3 d 1 (1 to 2) 1 (1 to 2) 0.24 (0.13 to 0.37) 0.34 (−0.21 to 0.50) –0.10 (−0.28 to 0.08) .24
At 7 d 1 (1 to 2) 1 (1 to 2) −0.02 (−0.19 to 0.15) 0.05 (−0.05 to 0.16) –0.07 (−0.27 to 0.13) .57
At 2 wk 1 (0 to 1) 1 (1 to 2) –0.48 (–0.65 to –0.33) –0.22 (–0.36 to 0.07) –0.26 (–0.48 to –0.05) .02
At 6 wk 0 (0 to 1) 1 (0 to 1) –0.81 (–0.98 to –0.65) –0.66 (–0.82 to 0.50) –0.15 (−0.39 to 0.08) .19
At 12 wk 0 (0 to 0) 0 (0 to 0) –1.15 (–1.31 to –1.00) –1.20 (–1.36 to –1.04) 0.05 (−0.28 to 0.19) .75
e
Abbreviations: NA, not applicable; VAS, visual analog scale. On the VAS score, higher scores indicate worse pain.
a f
Measured by computer imaging system. VAS scores: group × time interaction risk ratio is 0.94 (95% CI, 0.87-1.01); group risk
b
Radial height, mm: group × time interaction risk ratio is 1.08 (95% CI, 1.01-1.16); group ratio is 1.05 (95% CI, 0.66-1.66); time risk ratio is 0.35 (95% CI, 0.34-0.37).
g
risk ratio is 1.01 (95% CI, 0.52-1.96); time risk ratio is 0.84 (95% CI, 0.80-0.89). On the grading of swelling degree, higher scores indicate worse pain.
c h
Volar angulation,°: group × time interaction risk ratio is 1.13 (95% CI, 0.94-1.37); group Grading of swelling degree, %: group × time interaction risk ratio is 1.00 (95% CI, 0.96-
risk ratio is 0.63 (95% CI, 0.05-8.33); time risk ratio is 0.74 (95% CI, 0.65-0.85). 1.04); group risk ratio is 0.85 (95% CI, 0.69-1.06); time risk ratio is 0.77 (95% CI, 0.75-
d
Radial inclination,°: group × time interaction risk ratio is 1.09 (95% CI, 0.93-1.27); group 0.79).
risk ratio is 1.14 (95% CI, 0.28-4.66); time risk ratio is 0.71 (95% CI, 0.63-0.79).

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 JAMA Network Open | Orthopedics Topology-Optimized Splints vs Casts for Distal Radius Fractures

scores were more favorable among the splint group than the cast group. Participants who received
topology-optimized splints reported better ability and satisfaction with daily living, but by 3 months,
any differences had disappeared and all participants showed satisfactory results. Topology-
optimized splints demonstrated advantages in alleviating wrist pain, enhancing functional activity,
and boosting patient comfort in early period. Although both groups exhibited some fracture
displacement after closed reduction, it may have been due to the limitations of external
immobilization methods.36,37 Similar results have been demonstrated by other researchers. For
displaced fractures, palmar plate fixation has been found to provide better stability and radiologic
results compared with cast immobilization for DRFs. Unfortunately, these issues cannot be
addressed with current conservative treatment. However, recent studies38 have introduced a new
angle, suggesting that for older patients with DRFs, functional outcomes are not significantly
correlated with the radiographic measures of reduction. This insight highlights that factors beyond
exact wrist anatomical alignment play a role in realizing satisfactory outcomes. It broadens our
approach to treatment strategies and emphasizes the importance of focusing on overall patient
functionality and quality of life. The splint group outperformed the cast group in reducing VAS scores
at 2 and 6 weeks, as well as in reducing wrist swelling at 2 weeks. Rehabilitation showed
improvement in complications such as intra-articular fracture–induced arthritis. The cast group
reported more shoulder-elbow complications, which could be attributed to adverse shoulder-elbow
motion after cast immobilization, resulting in joint adhesion, pain, and dysfunction. Complications
were less common among the splint group. In addition, the cast group experienced more skin
irritation symptoms, possibly due to the lack of ventilation provided by the cast. In contrast, the
ventilated structure of the splint led to fewer such symptoms among the splint group.
Traditional casts, often used for DRFs, are prone to complications such as arthritis, carpal tunnel
syndrome, and skin issues,21,39 mainly from uneven pressure, excessive strength, and poor
ventilation. 3D printing technology offers personalized, rapid solutions. Chen et al40,41 used this
technology in designing external fixation tools for DRFs, incorporating perforations for enhanced
ventilation, and subsequently conducted clinical trials for validation. The outcomes revealed that
patients in the 3D printed cast group achieved superior therapeutic effects. Moreover, patient
satisfaction surveys indicated a preference for the 3D printed casts compared with their traditional
counterparts. Despite the evident clinical efficacy of the lightweight, breathable 3D printed casts,
issues arose, including blisters near the ulnar bone and perforated skin indentations. Various
researchers have opted for a uniform distribution of perforations,42,43 but this design has
occasionally compromised fracture stability, caused skin to be pinched by the holes,40 and resulted
in pressure ulcers due to high pressure points.44
This research used topology optimization technology in splint design,29 where the pressure
distribution across the forearm was gauged using sensors. The resultant design ensured a balanced
pressure distribution, optimizing structural integrity and material usage. The biocompatible material,
polyamide—compliant with United States Pharmacopeia and National Formulary class I to VI and US
Food and Drug Administration guidelines for skin surface devices,45 and noted for its rigidity and
pliability30,31—was used in the 3D printing process, making it a popular choice in medical

Table 4. Adverse Events

Splint group, No. Cast group, No.
Adverse event (%) (n = 54) (%) (n = 56) Risk ratio (95% CI)a P value
Arthritis 9 (17) 10 (18) 0.92 (0.34-2.48) .87
Complex regional pain syndrome 2 (4) 5 (9) 0.39 (0.07-2.12) .44
Carpal tunnel syndrome 3 (6) 5 (9) 0.60 (0.14-2.64) .72
a
Risk ratios are expressed as splint vs cast.
Shoulder-elbow pain and dysfunctionb 5 (9) 14 (25) 0.31 (0.10-0.94) .03
b
The surgeon checks for pain and range of motion in
Tension blister 5 (9) 7 (13) 0.71 (0.21-2.41) .59
c
the shoulder and elbow joints.
Skin irritation symptom 5 (9) 15 (27) 0.28 (0.09-0.83) .02
c
Redness, swelling, itching, allergies, dermatitis, and
Poor finger function 7 (13) 9 (16) 0.78 (0.27-2.26) .64
odor on the skin.

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 JAMA Network Open | Orthopedics Topology-Optimized Splints vs Casts for Distal Radius Fractures

application.46,47 In addition, the inclusion of a porous sponge within the splint aids in preventing skin
indentations and augments patient comfort.
Currently, there is a paucity of data regarding the treatment of DRFs using topology-optimized
splints. This study introduces the use of 3D printed topology-optimized splints in the clinical realm of
DRFs. Our findings underscore the potential of topology-optimized splints in effectively managing
DRFs, marking a novel approach to external fixation techniques.

Limitations
Our study has some limitations. First, both the surgeon and CRCs were exposed to treatment groups,
eliminating blinding. Second, we excluded C3 fractures (AO/OTA classification), deeming them
unsuitable for nonsurgical treatment, which limits the generalizability of our results. Third, while we
excluded patients with certain chronic conditions, we acknowledge the potential benefits of
nonoperative treatments. Future studies may focus on the specific patient population to explore the
efficacy and safety of nonoperative methods in managing DRFs. Furthermore, the follow-up period
in our study extended to 12 weeks, which may not have been sufficient to observe long-term results.
We plan to continue tracking patient outcomes over an extended period to evaluate treatment
efficacy and identify any long-term disparities more effectively. Fourth, the sample size was a study
constraint.

Conclusions
In this randomized clinical trial, patients with DRFs who received topology optimized splints showed
greater improvements functional activity, pain, swelling, and complication rates than those who
received casts in the early period. These findings indicate that topologically optimized splints are
appropriate for the treatment of DRFs. Future larger multicenter randomized clinical trials are
warranted.

ARTICLE INFORMATION
Accepted for Publication: December 11, 2023.
Published: February 2, 2024. doi:10.1001/jamanetworkopen.2023.54359
Open Access: This is an open access article distributed under the terms of the CC-BY License. © 2024 Ma H et al.
JAMA Network Open.
Corresponding Authors: Xiaobing Xi, MS (skxixiaobing@163.com), and Wei Yan, MS (yw12554@rjh.com.cn),
Department of Orthopaedics, Shanghai Key Laboratory for Prevention and Treatment of Bone and Joint Diseases,
Shanghai Institute of Traumatology and Orthopaedics, Ruijin Hospital, Shanghai Jiao Tong University School of
Medicine, 197 Ruijin 2nd Road, Huangpu District, Shanghai, China.
Author Affiliations: Department of Orthopaedics, Shanghai Key Laboratory for Prevention and Treatment of Bone
and Joint Diseases, Shanghai Institute of Traumatology and Orthopaedics, Ruijin Hospital, Shanghai Jiao Tong
University School of Medicine, Shanghai, China (Ma, Ruan, Zhang, Wu, Tian, Zhao, Feng, Yan, Xi); Graduate School,
Shanghai University of Traditional Chinese Medicine, Shanghai, China (Ma, Xi); Clinical Research Center, Ruijin
Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China (Li).
Author Contributions: Drs Xi and Ma had full access to all of the data in the study and take responsibility for the
integrity of the data and the accuracy of the data analysis. Drs Ma, Ruan, and Li are co–first authors and contributed
equally to this work.
Concept and design: Ruan, Zhang, Tian, Li, Yan, Xi.
Acquisition, analysis, or interpretation of data: Ma, Ruan, Wu, Zhao, Feng.
Drafting of the manuscript: Ma, Ruan, Wu, Tian.
Critical review of the manuscript for important intellectual content: Ruan, Zhang, Zhao, Feng, Li, Yan, Xi.
Statistical analysis: Ruan, Li, Xi.
Administrative, technical, or material support: All authors.

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 JAMA Network Open | Orthopedics Topology-Optimized Splints vs Casts for Distal Radius Fractures

Supervision: Zhang.
Conflict of Interest Disclosures: None reported.
Funding/Support: This study was supported by the Shanghai Hospital Development Center Promotes Clinical
Skills and Clinical Innovation in Municipal Hospitals Three-Year Action Plan Project (SHDC2020CR3016A);
Shanghai’s Three Year Action Plan for Further Accelerating the Inheritance, Innovation and Development of
Traditional Chinese Medicine (2021-2023) (ZY(2021-2023)-0208 and ZY(2021-2023)-0209-03); Shanghai
Integrated Traditional Chinese and Western Medicine Flagship Hospital Construction Project ((ZY
2021-2023)-0205-01); Construction Project of Shanghai Style Traditional Chinese Medicine School Inheritance and
Innovation Team (2021LPTD-003); and Shanghai Sailing Program (20YF1427400).
Role of the Funder/Sponsor: The funding sources had no role in the design and conduct of the study; collection,
management, analysis, and interpretation of the data; preparation, review, or approval of the manuscript; and
decision to submit the manuscript for publication.
Data Sharing Statement: See Supplement 3.

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SUPPLEMENT 1.
Trial Protocol

SUPPLEMENT 2.
eAppendix 1. Rehabilitation Exercise Program
eAppendix 2. Splint and Cast Technique Methods
eAppendix 3. Clinical Photos and Radiographs

SUPPLEMENT 3.
Data Sharing Statement

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