Partial Controlled Early Postoperative

Weightbearing Versus Nonweightbearing

After Reconstruction of the Fibular
(Lateral) Collateral Ligament
A Randomized Controlled Trial and Equivalence Analysis
Robert F. LaPrade,*yz MD, PhD, Nicholas N. DePhillipo,y MS, ATC, OTC, CSCS,
Tyler R. Cram,y MA, ATC, OTC, Mark E. Cinque,z MD, Mitchell I. Kennedy,z BS,
Grant J. Dornan,z MSc, and Luke T. O’Brien,§ PT, M.Phty (Sports), SCS
Investigation performed at the Steadman Clinic, Vail, Colorado, USA

Background: While early weightbearing protocols have been advocated after anterior cruciate ligament (ACL) reconstruction,
early weightbearing after fibular (lateral) collateral ligament reconstruction has not been well defined.
Purpose: (1) To determine if early partial controlled weightbearing after fibular collateral ligament (FCL) reconstruction resulted in
an objective difference in laxity on varus stress radiographs at postoperative 6 months as compared with nonweightbearing, and
(2) to determine if there was a difference in pain, edema, range of motion, and subjective patient-reported outcomes between
these groups at 3 time points.
Study Design: Randomized controlled trial; Level of evidence, 1.
Methods: Patients were prospectively enrolled from January 2014 to April 2017. Patients who underwent isolated FCL recon-
struction or combined ACL and FCL reconstructions were included in this study. Patients were randomly assigned to either a con-
trol group (nonweightbearing for 6 weeks) or a treatment group (partial controlled weightbearing at 40% body weight with
crutches for 6 weeks). Patient-related data, including knee pain, edema, and range of motion, were collected for all patients at
postoperative day 1, 6 weeks, and 6 months. Subjective outcomes were collected preoperatively and at 6 months postopera-
tively. The primary objective endpoint was varus stability, evaluated by bilateral varus stress radiographs obtained preoperatively
and at 6 months postoperatively.
Results: Thirty-nine patients were enrolled in the study, with 6-month follow-up obtained for 36 (92%). There was a significant
improvement between the preoperative side-to-side difference (SSD) (2.4 6 1.0) and postoperative SSD (0.2 6 1.0) for lateral
compartment laxity on varus stress radiographs among all patients (P \ .001). Clinical and statistical equivalence was found
between groups in terms of SSD on varus stress radiographs (P \ .001). The SSD in knee edema was significantly lower in
the partial early weightbearing group (beta = 20.6 cm, P = .001), but there were no significant group differences in knee pain,
flexion, or extension. All patients demonstrated significant improvements in subjective outcome scores between the preoperative
and 6-month postoperative conditions (P \ .001 for every score measured).
Conclusion: Clinical and statistical equivalence was found at postoperative 6 months between the early partial weightbearing and
nonweightbearing groups among patients undergoing either an isolated FCL reconstruction or a combined ACL and FCL recon-
struction. There were no significant differences observed between the groups regarding knee stability, pain, swelling, range of
motion, or subjective outcomes. Given these findings, the authors recommend early partial weightbearing after isolated FCL
reconstruction or combined ACL and FCL reconstruction.
Keywords: fibular collateral ligament; lateral collateral ligament; postoperative protocol; outcomes

There is increasing evidence supporting reconstruction of

the fibular collateral ligament (FCL) and posterolateral
The American Journal of Sports Medicine
corner structures when torn.14,29,30,39 Most authors recom-
1–11
DOI: 10.1177/0363546518784301 mend surgical treatment of grade 3 FCL tears; however,
Ó 2018 The Author(s) there is no consensus on the rehabilitation protocol after

1
2 LaPrade et al
FCL reconstruction or combined anterior cruciate ligament
(ACL) and FCL reconstruction. These injuries rarely occur
in isolation; therefore, the rehabilitation protocol depends
on concurrent surgical procedures. Most of the available
literature on rehabilitation after knee ligament surgery
is on ACL and multiligament knee injuries.5,7,14,33,38 In
the postoperative phase, it is important to regain full
knee range of motion (ROM) and initiate muscular
strength programs to resist atrophy and restore preinjury
levels of strength. These goals should be balanced with
the potential risk of graft failure if the reconstruction is
not protected. Most authors recommend a period of non-
weightbearing (4-6 weeks).5,8,13,14 However, some authors
recommend weightbearing as tolerated,15 while others rec-
ommend protected partial early weightbearing after knee
ligament reconstruction.9,39
Early weightbearing protocols have been validated for
ACL and other ligament reconstructions about the
knee35,37,38; however, to our knowledge, limited studies
have reported on the outcomes after early weightbearing
after FCL reconstruction. Therefore, the primary purposes
of this randomized controlled trial were (1) to determine if
early partial controlled weightbearing after an FCL recon-
struction resulted in an objective difference in laxity on
varus stress radiographs at postoperative 6 months as
compared with nonweightbearing and (2) to determine if
there was a difference in pain, edema, ROM, and subjective
patient-reported outcomes between these groups at 3 time
points. The primary hypothesis was that there would be no
difference in varus stress radiographs between groups at
postoperative 6 months. Secondarily, we hypothesized
that pain, edema, ROM, and subjective outcome scales
would be similar between the groups of patients.
METHODS
Study Design
Before patient enrollment, the study protocol was approved
by an external institutional review board (Vail Valley Medi-
cal Center No. 2013-07). Patients were prospectively enrolled
from January 2014 to April 2017 from a single orthopaedic
surgeon’s practice (R.F.L.). Inclusion criteria were isolated
FCL reconstruction or combined ACL and FCL reconstruc-
tions in patients with grade 3 FCL tears. Patients were
also included if they had repairable meniscal tears, including
vertical, horizontal, and bucket-handle tear patterns, who
would have been allowed full weightbearing with a concur-
rent ACL reconstruction. Exclusion criteria were \18 years
of age, pregnancy, revision ACL reconstruction, revision
*Address correspondence to Robert F. LaPrade, MD, PhD, Steadman Philippon Research Institute, The Steadman Clinic, 181 West Meadow Drive,
Suite 400, Vail, CO 81657, USA (email: drlaprade@sprivail.org).
y
The Steadman Clinic, Vail, Colorado, USA.
z
Steadman Philippon Research Institute, Vail, Colorado, USA.
§
Howard Head Sports Medicine, Vail, Colorado, USA.
Presented at the annual meeting of the AOSSM, San Diego, California, July 2018.
One or more of the authors has declared the following potential conflict of interest or source of funding: R.F.L. is a consultant and receives royalties from
Arthrex, Ossur, and Smith & Nephew.
The American Journal of Sports Medicine
FCL reconstruction, concurrent medial collateral and/or pos-
terior cruciate ligament reconstruction, concurrent radial or
root meniscal repairs, a required microfracture or articular
cartilage resurfacing procedure, genu varus alignment (for
patients with chronic FCL tears),1 or a body mass index
35 kg/m2. Patients with meniscal radial and root tear pat-
terns were excluded because they would have been on
restricted weightbearing for 6 weeks. Knee alignment was
determined via long-standing radiographs, which were
obtained for all patients, and alignment was calculated
accordingly. Patients with chronic injuries (.6 weeks) and
varus malalignment were excluded given the potential for
unwanted stress on the FCL and/or ACL reconstruction
graft, thus increasing risk of graft failure. Patients with
acute injuries (\6 weeks) and varus alignment are not at
the same risk for graft rupture as those with chronic injuries
with varus alignment; thus, patients with chronic injuries
and malalignment would be candidates for an osteotomy to
correct alignment before any ligament reconstruction.3,11
Any patient with or requiring an osteotomy was excluded
from the study.
Patients were randomly assigned to either a control
group, which was nonweightbearing for 6 weeks, or a treat-
ment group with partial controlled weightbearing at 40%
body weight and crutches for 6 weeks. This percentage
was chosen after experimental pilot testing as a low-enough
number that patients could use to limit their weightbearing
to ‘‘partial’’ and differentiated them from being ‘‘full.’’ Com-
pliance was recorded as pass or fail, meaning that a patient
continued with the partial weightbearing protocol (pass)
versus withdrawing from the study (fail). The specific
amount of weightbearing placed through a patient’s injured
limb was not routinely measured throughout the partial
weightbearing phase, because it was not possible to monitor
patients daily. However, initial recordings were made with
a body weight scale, with total body weight and 40% con-
verted into a physical amount (in lb). Participants were
allowed sufficient practice trials to ensure that they were
ambulating at 40% of their body weight. This study was
designed with the guidelines for randomized controlled tri-
als developed by Audige et al.4
Block randomization was used to minimize a risk of
selection bias with a 1:1 allocation ratio and a central com-
puter-generated binary random number sequence. Ran-
dom allocation was performed by a research assistant
(N.N.D.) and known only to the research assistant. Inves-
tigators were blinded to establishment of the randomized
order. The senior author (R.F.L.) enrolled patients in the
study in clinic before surgery. Assignments to treatment
groups were placed in sequentially numbered sealed opa-
que envelopes that were opened by the physical therapist
AJSM Vol. XX, No. X, XXXX
Figure 1. Flow diagram of study design utilizing intention-to-treat analysis and randomization for treatment allocation.
in numeric order just before the patients began rehabilita-
tion. The physical therapist opened the envelopes with the
random allocation to a treatment and initiated the treat-
ment assigned to that patient through the random alloca-
tion on postoperative day 1. An intention-to-treat analysis
was performed, and 39 patients were randomly allocated
to treatment groups: partial weightbearing versus non-
weightbearing (Figure 1).
Varus Stress Radiographs
The primary objective endpoint was varus stability evalu-
ated by bilateral varus stress radiographs at postoperative
6 months. Varus stress radiographs were obtained preop-
eratively and at postoperative 6 months with the patient
lying supine and the knee flexed at 20° with physician-
applied varus stress as described according to LaPrade
et al.26 This technique has been shown to be highly reli-
able, with intraclass correlation coefficients (ICCs) of 0.99
(intraobserver) and 0.97 (interobserver).25,26 The 6-month
period was chosen because the FCL reconstruction graft
is expected to be healed at that time, based on previous
studies that reported no difference in varus laxity on stress
radiographs between postoperative 6 months and 2.4
years,27-29 therefore any changes after 6 months cannot
be attributed to the rehabilitation protocol. All measure-
ments for side-to-side difference (SSD) were performed
with a picture archiving and communication system
(Stryker), which allowed for linear measurement of the
Early Postoperative Weightbearing vs Nonweightbearing 3
Figure 2. Preoperative varus stress radiographs and mea-
surement technique. (A) Fibular collateral ligament–injured
knee with 11.9 mm of increased lateral compartment gap-
ping as compared with (B) the uninjured knee with a side-
to-side difference of 2.4 mm of increased lateral compart-
ment gapping, indicative of a complete (grade 3) fibular col-
lateral ligament tear.26
amount of lateral compartment gapping. Varus compart-
ment gapping was defined as the absolute perpendicular
distance in millimeters between the subchondral bone of
the most distal aspect of the lateral femoral condyle and
the most proximal corresponding point on the tibial pla-
teau (Figure 2). To assess measurement reliability, 2 exam-
iners performed all measurements, and 1 examiner made 2
rounds of measurement separated by 2 weeks. The exam-
iners were blinded for treatment. Interrater agreement
was assessed for stress radiograph measurements with
4 LaPrade et al
a 2-way random-effects model to calculate the absolute
agreement definition of the single-measure ICC. ICC val-
ues were interpreted as follows: ICC  0.40, poor agree-
ment; 0.40 \ ICC \ 0.75, fair to good agreement; ICC 
0.75, excellent agreement.23
Outcome Measures
Patient-related data, including knee pain, edema, and
ROM, were collected for all patients at postoperative day
1, 6 weeks, and 6 months. Pain was reported on a 10-point
Likert scale, with 0 being no pain and 10 being extremely
painful. Edema was recorded in centimeters of circumfer-
ence at the level of the knee joint line with the knee fully
extended. Passive ROM was measured with a goniometer
with the patient supine and was recorded in degrees. For
edema and ROM assessments, SSDs were calculated to
assess the degree of change between knees for pairwise
comparisons between the control and treatment groups.
Questionnaires were electronically administered preop-
eratively, at 6-month intervals, and at final follow-up to
evaluate the subjective outcomes between groups. Subjec-
tive outcomes questionnaires included the International
Knee Documentation Committee score; Western Ontario
and McMaster Universities Osteoarthritis Index—pain,
stiffness, physical function, and total scores; Lysholm knee
scoring scale; Tegner activity scale; and patient satisfaction.
Surgical Technique
An anatomic FCL reconstruction was performed for all
patients with either a semitendinosus autograft or allo-
graft (Figure 3).3,24 Allograft was considered only for
patients with previous surgery that harvested their semi-
tendinosus tendons. Indications for surgery were clinical
instability with a minimum 2-mm SSD on preoperative
varus stress radiographs, indicating a grade 3 (complete)
FCL injury. All patients underwent an examination under
anesthesia to evaluate the integrity of the FCL, which fur-
ther included/excluded participants. In addition, arthro-
scopic exploration of the popliteus tendon was performed
in all patients at the time of surgery, which helped confirm
or deny the presence of a complete posterolateral corner
injury. All patients with injuries to the popliteus tendon
were excluded. Dial testing was performed in clinic during
the physical examination and repeated during the exami-
nation under anesthesia. All included patients had nega-
tive dial testing at 30° and 90° on physical examination
in the clinic and at the time of examination under anesthe-
sia. A lateral hockey stick incision was made proximally
over the iliotibial band, which extended distally, centered
between the fibular head and Gerdy tubercle. A common
peroneal neurolysis was routinely performed in all cases
undergoing an FCL reconstruction to minimize the risk
of a postoperative foot drop attributed to swelling. Next,
a horizontal incision was made in the biceps bursa,25 and
a tag stitch was placed in the distal FCL remnant (if pres-
ent), which allowed for later identification of the femoral
and fibular FCL attachment site. The FCL fibular attach-
ment was identified, and a 6-mm tunnel was then reamed,
The American Journal of Sports Medicine
Figure 3. (A) Posterior and (B) lateral illustrations of an ana-
tomic fibular collateral ligament reconstruction (right knee)
with a semitendinosus graft.
entering at the FCL footprint center on the lateral aspect
of the fibular head, which exited on the posteromedial
aspect of the fibular head and distal to the popliteofibular
ligament.28 The FCL femoral attachment was then identi-
fied via a horizontal splitting incision along the fibers of
the superficial layer of the iliotibial band over the FCL
femoral attachment while traction was applied to the tag
stitch. Next, a 6-mm femoral tunnel was reamed over
a guide pin, which was drilled with an anterior and proxi-
mal trajectory to avoid convergence with a concurrent ACL
reconstruction tunnel.3 A 7-mm diameter tap was then
used to enlarge the tunnel to facilitate later interference
screw placement, and a passing suture was placed. A semi-
tendinosus tendon autograft or allograft was then whip-
stitched on each end with No. 2 nonabsorbable sutures
for the FCL reconstruction graft.
After any intra-articular work was completed and any
concurrent ACL reconstruction graft was fixed in its femoral
tunnel, the FCL graft was fixed in the femoral tunnel with
a 7 3 23–mm bioabsorbable interference screw, and the
graft was then passed deep to the iliotibial band and
through the fibular head tunnel with the help of previously
placed passing sutures. The FCL graft was then fixed in the
fibular head tunnel with a 7 3 23–mm bioabsorbable screw
with the knee in 20° of knee flexion, the foot in neutral rota-
tion, and a slight valgus reduction force. An examination
under anesthesia to confirm restoration of varus stability
was then performed, and any concurrent ACL reconstruc-
tion graft was then secured in the tibial tunnel.27
Postoperative Rehabilitation Protocol
All patients initiated rehabilitation on the day after sur-
gery. The control group remained nonweightbearing on
crutches for the first 6 weeks, whereas the treatment
AJSM Vol. XX, No. X, XXXX
group was allowed to ambulate with crutches using partial
weightbearing at 40% of their body weight once the femo-
ral nerve block was removed, typically at postoperative
day 3. Regardless of the weightbearing status, all patients
initially remained in a knee immobilizer to protect the
knee during ambulation. Once patients in the partial
weightbearing group could perform a straight-leg raise
without an extension lag, they were placed into a CTi brace
(Ossur). A transition was made from the knee immobilizer
to the CTi brace, which was at postoperative 2 weeks for
the experimental group and 6 weeks for the control group.
Initial exercises for the first 6 weeks focused on restora-
tion of knee ROM, edema control, patellofemoral mobility,
and quadriceps activation. Both groups began ROM exer-
cises on postoperative day 1, limited to 0° to 90° for 2
weeks, and then progressed to full ROM as tolerated. Fur-
thermore, no open kinetic chain isolated hamstring exer-
cises were permitted in either group for 16 weeks after
surgery.31 At postoperative 2 weeks, after the lifting of
ROM restrictions, the early weightbearing group was
allowed to begin spinning on a stationary bike. The non-
weightbearing group began spinning on a stationary bike
at 6 weeks, when it also began to progressively wean off
crutches. Both groups completed periodized strength pro-
grams that focused on restoring components of muscular
endurance, strength, and power, with the duration of
each phase dependent on the patient’s athletic needs. After
confirmation of restoration of lateral compartment stabil-
ity (\2-mm SSD) on varus stress radiographs at 6 months
postoperatively, a return-to-play progression was initiated
with the expectation to return to full activities/sports
between 7 and 9 months (Figure 4).
Power and Sample Size
Sample size was determined via an a priori power analysis
for the primary hypothesis of group equivalence of varus
laxity measured on stress radiograph at 6 months postsur-
gery. According to Jacobsen,19 the minimal clinically impor-
tant difference in varus laxity was defined as 2 mm, which
represents the difference between groups that is not clini-
cally significant. The SD of varus laxity was taken from
Geeslin and LaPrade,14 who reported a mean 0.1-mm gap-
ping (range, 21.5 to 5 mm). From this, the SD was conser-
vatively estimated to be 61.75 mm (SD = 1/4 3 [5 1 1.5] \
1.75). Statistical equivalence was tested with the two 1-sided
t test (TOST).17 Based on the TOST procedure and an alpha
of 0.05, an observed group difference of 60.5 mm, and a clin-
ically irrelevant threshold of 62 mm, 18 patients per group
were sufficient to achieve 80% statistical power. Thirty-
nine patients were approved to be enrolled in the study to
account for potential patient dropout.
Statistical Analysis
To address the primary hypothesis of statistical and clini-
cal equivalence in varus stress radiographs between the
nonweightbearing (control) and partial early weightbear-
ing (treatment) groups, the TOST was used.17 To aid in
Early Postoperative Weightbearing vs Nonweightbearing 5
interpretation of the TOST, a 90% CI for the mean differ-
ence is presented graphically. Secondarily, comparisons
were made between pre- and postoperative time points
and between groups with respect to mean pain, edema,
ROM, and subjective outcome scores. For variables that
were measured at 6 weeks in addition to 6 months, 2-factor
linear mixed effects models were used to compare time
points and groups while controlling for the time zero mea-
surement as a baseline covariate. Random intercepts were
allowed for each subject to account for the repeated mea-
sures nature of the design. When the interaction between
time and group was nonsignificant, modeled main effects
were reported.
For subjective outcome scores, which were measured at
the furthest postoperative follow-up, Wilcoxon signed-rank
tests were used to compare time points, and Mann-Whit-
ney U tests were used to compare groups. The Fisher exact
test was used to test associations between dichotomous
variables. Interrater agreement for the SSD between varus
stress radiographs was assessed with the 2-way random-
effects absolute agreement definition of the ICC, and
a 95% bootstrap CI was reported. All graphs and analyses
were completed with the statistical package R (R Founda-
tion for Statistical Computing).6,35,36
RESULTS
Patient Characteristics
Thirty-nine patients were enrolled in the study, with 6-
month follow-up obtained for 36 (92%), 18 in each group.
Three patients failed to follow up for their 6-month visit
and were not included in the final analysis. Twenty-five
patients (69.4%) had an acute injury (6 weeks), and 11
(30.6%) had a chronic injury (.6 weeks). There were no
significant differences in patient age (P = .159), sex (P =
1.0), or body mass index (P = .534) between the control
and treatment groups. Thirty-two (89%) patients under-
went an FCL reconstruction with a hamstring autograft
(15 controls and 17 treatment), while 4 (11%) underwent
an FCL reconstruction with a hamstring allograft (3 con-
trols and 1 treatment). Despite random group assign-
ments, the control group was significantly more likely to
have an isolated FCL reconstruction (P = .045). Postopera-
tively (0-6 months), there were no complications reported
and no surgical reinterventions for ligamentous recon-
struction failure or arthrofibrosis in either group. Table 1
reports patient demographics and clinical characteristics.
Bilateral Varus Stress Radiograph Assessment
There was a significant difference between the preopera-
tive SSD (2.4 6 1.0 mm) and the postoperative SSD
(20.3 6 1.0 mm) for lateral compartment gapping on varus
stress radiographs of all patients (P \ .001). For the control
group, the lateral compartment SSD on varus stress radio-
graphs improved from 2.5 6 1.2 mm preoperatively to 20.2
6 1.2 mm at 6 months (P \ .001). For the treatment group,
6 LaPrade et al The American Journal of Sports Medicine

Figure 4. Postoperative physical therapy protocol for all included patients undergoing fibular collateral ligament reconstruction.
The only difference in rehabilitation between the control and treatment groups was the weightbearing status (nonweightbearing
for 6 weeks vs partial weightbearing at 40% body weight for 6 weeks). FPROM, full passive range of motion; NWB, nonweight-
bearing; OKC, open kinetic chain; POD, postoperative day; ROM, range of motion.
AJSM Vol. XX, No. X, XXXX
TABLE 1
Demographics and Clinical Characteristics of All Patients: Control vs Treatment (Early Partial Weightbearing)a
Total (N = 36)
Sex, male:female 21:15
Age, y 30.1 6 9.4
Body mass index, kg/m2 24.4 6 2.8
Reconstruction
Isolated FCL 5 (14)
Combined ACL-FCL 31 (86)
a
Values are presented as mean 6 SD or n (%). ACL, anterior cruciate ligament; FCL, fibular collateral ligament; FET, Fisher exact test.
TABLE 2
Mean Varus Stress Radiographic Values
at Preoperative and 6-Month Time Points:
Control vs Treatment (Early Partial Weightbearing)a
Preoperative Postoperative
SSD SSD P Value
Control group (n = 18) 2.5 6 1.2 20.2 6 1.2 \.001
Treatment group (n = 18) 2.4 6 0.9 20.3 6 0.8 \.001
a
All values are reported in millimeters (mean 6 SD). SSD, side-
to-side difference.
the SSD on varus stress radiographs reduced from 2.4 6 0.9
mm (preoperative) to 20.3 6 0.8 mm (6 months; P \ .001)
(Table 2). Based on the 2-mm clinically relevant threshold,
clinical and statistical equivalence was found between the
groups (mean difference \0.1 mm, 90% CI = 20.6 to
0.6 mm, TOST P \ .001) (Figure 5). Additionally, in consid-
eration of 61/2 the minimal clinically important difference
(1 mm) as the clinically irrelevant range in SSD, statistical
equivalence was achieved (TOST P = .003). Interrater mea-
surement agreement for the varus radiographic measure-
ment technique was excellent (ICC = 0.832, 95% CI =
0.746-0.892). The stress radiograph technique was previously
validated in multiple studies, in vivo and in vitro.20,21,26 This
technique was shown to be reliable with maximal physician-
applied stress and various raters using the same software
system (picture archiving and communication system) for
measurement calibration as in the current study.20,21
Clinical Outcome Evaluation
Knee pain, edema at the joint line, and ROM were compared
among 3 measurement time points and between the control
and treatment groups with 2-factor linear mixed-effects
models. Pain significantly decreased between time zero
and 6 weeks among all patients (mean = 23 points, 95%
CI = 24 to 2, P \ .001). When controlling for baseline
pain and treatment group, pain reduction between 6 weeks
and 6 months was clinically minimal but also statistically
significant (beta = 20.5 points, 95% CI = 20.8 to 20.2,
P = .003) (Figure 6). There was no significant difference in
pain between the control and treatment groups (beta = 0.0
points, 95% CI = 20.3 to 0.3, P = .998).
Early Postoperative Weightbearing vs Nonweightbearing 7
Control (n = 18) Treatment (n = 18) P Value
11:7 10:8 .999 (FET)
27.8 6 7.0 32.3 6 11.0 .254 (t test)
24.7 6 2.7 24.1 6 3.0 .351 (t test)
.045 (FET)
5 0
13 18
Figure 5. Representation of statistical equivalence testing
between treatment and control groups in side-to-side differ-
ence (SSD) of varus gapping measured on stress radiograph.
Dot indicates observed mean group difference, while error
bars represent 90% CI. Statistical and clinical equivalence
was found for 1 minimal clinically important difference
(2-mm SSD) and 1/2 minimal clinically important difference
(1-mm SSD), as defined by Jacobsen.19
Overall, the SSD in knee edema significantly reduced
from time zero to 6 weeks (mean = 22.0 cm, 95% CI =
22.5 to 21.0, P \ .001). When controlling for baseline
edema and group assignment with the linear mixed-effects
model, SSD in knee edema was reduced again from 6
weeks to 6 months (beta = 22.0 cm, 95% CI = 22.5 to
22.0, P \ .001) (Figure 7). There was a significant treat-
ment group effect with the partial early weightbearing
group exhibiting less SSD in knee edema (beta = 20.6
cm, 95% CI = 21.0 to 20.3, P = .001).
Knee flexion significantly increased from time zero to 6
weeks (mean = 66°, 95% CI,12 P \ .001) and from 6 weeks
to 6 months (beta = 16°, 95% CI = 11-20, P \ .001). There
was no significant group effect in knee flexion (beta = 1°,
95% CI = 25 to 6, P = .771). Small but statistically signif-
icant changes in knee extension were found between time
0 and 6 weeks (mean = 21°, 95% CI = 21.5 to 21.0, P \
.001) and from 6 weeks to 6 months (beta = 20.5°, 95%
CI = 21.0 to 20.2, P \ .001). There was no significant
group effect in knee extension (beta = 0°, 95% CI = 20.3
to 0.3, P = .845) (Figure 8).
Patient-Reported Outcomes
Patients demonstrated significant improvements in subjec-
tive outcome scores between the preoperative condition
8 LaPrade et al
Figure 6. Box plot of self-reported knee pain (0 = no pain, 10
= extreme pain) at 3 time points for the nonweightbearing (n =
18) and partial early weightbearing (n = 18) groups. Thick hor-
izontal line represents group median; box height shows inter-
quartile range; and dots represent extreme values (beyond
1.5 times interquartile range from nearest quartile).
and postoperative (6 months) condition (P \ .001 for every
score measured). Significant improvements were also
found in the control group and the treatment group, indi-
vidually. There were no significant differences between
the control and treatment groups for any pre- and postop-
erative subjective outcome scores (Table 3).
DISCUSSION
The most important finding of this randomized controlled
study was that an early partial weightbearing program
after an isolated FCL reconstruction or a combined FCL
and ACL reconstruction had comparable objective and sub-
jective outcomes as a nonweightbearing protocol. At 6-
month follow-up, varus stability was restored in both
groups, and there was no objective sign of graft elongation
or failure based on stress radiographs. This finding sup-
ports early partial weightbearing programs for patients
with isolated or combined FCL and ACL injuries.
Most authors agree on early motion to restore ROM
because joint stiffness is associated with poor functional out-
comes. Early ROM and weightbearing were previously theo-
rized to have a negative effect on graft healing and could thus
affect joint stability. Recent studies reported good outcomes
after FCL reconstruction, followed by early ROM.29,34 Early
postoperative weightbearing after ligament reconstruction
is believed to decrease the incidence or severity of disuse
osteopenia, muscle atrophy, loss of ankle ROM, and deep
The American Journal of Sports Medicine
Figure 7. Box plot of side-to-side difference (SSD) in edema
(cm) at 3 time points for the nonweightbearing (n = 18) and
partial early weightbearing (n = 18) groups. Thick horizontal
line represents group median; box height shows interquartile
range; and dots represent extreme values (beyond 1.5 times
interquartile range from nearest quartile).
vein thrombosis.1,5,16,22,32 In the 1980s, several groups evalu-
ated outcomes of early weightbearing and ROM after an
ACLR and were able to show improvements in these param-
eters and a quicker return to preinjury function.37
In light of the success achieved with early protected
weightbearing for rehabilitation of ACL reconstructions,7
we theorized that similar safety and efficacy would be found
in this randomized controlled trial for patients undergoing
FCL reconstruction. In 2005, Beynnon et al8 conducted
a randomized controlled trial with 25 patients who under-
went ACL reconstruction with bone–patellar tendon–bone
grafts. Patients were randomized to an accelerated rehabil-
itation or nonaccelerated rehabilitation protocol. At the 2-
year follow-up, there was no difference in the increase of
anterior knee laxity relative to the baseline values that
were obtained immediately after surgery between the
groups. The authors concluded that (1) ACL reconstruction
followed by either an accelerated or nonaccelerated rehabil-
itation protocol produced the same increase in anterior knee
laxity and (2) both rehabilitation programs had the same
effect in terms of clinical assessment, patient satisfaction,
functional performance, and the biomarkers of articular car-
tilage metabolism. Similarly, Hiemstra et al18 performed
a randomized controlled trial with 88 patients that com-
pared knee immobilization with no bracing after ACL recon-
struction with hamstring tendons. Patients were permitted
full weightbearing while wearing a knee immobilizer
(except during ROM exercises). There were no differences
in pain, analgesic use, ROM, or effusion at postoperative 2
AJSM Vol. XX, No. X, XXXX Early Postoperative Weightbearing vs Nonweightbearing 9

Figure 8. Box plot of extension and flexion range of motion (degrees) at 3 time points for the nonweightbearing (n = 18) and par-
tial early weightbearing (n = 18) groups. Thick horizontal line represents group median; box height shows interquartile range; and
dots represent extreme values (beyond 1.5 times interquartile range from nearest quartile).

TABLE 3
Comparison of Subjective Outcome Measures Collected Preoperatively and at Postoperative Follow-up:
Control vs Treatment (Early Partial Weightbearing)a

Measure (Range) Control Group (n = 18) Treatment Group (n = 18) P Valueb

IKDC (0-100)
Preoperative 61 6 8 62 6 9 .515
Postoperative 74 6 5 74 6 4 .874
WOMAC: pain (0-20)
Preoperative 864 763 .176
Postoperative 263 161 .946
WOMAC: stiffness (0-8)
Preoperative 3.8 6 1.8 362 .200
Postoperative 1.6 6 1.6 161 .194
WOMAC: function (0-68)
Preoperative 26 6 15 20 6 10 .159
Postoperative 769 563 .987
WOMAC: total
Preoperative 38 6 19 30 6 13 .106
Postoperative 11 6 13 764 .949
Lysholm (0-100)
Preoperative 43 6 22 52 6 14 .133
Postoperative 75 6 18 82 6 10 .438
Tegner (0-10)
Preoperative 2 [1, 4] 3 [2, 4] .179
Postoperative 5 [3, 9] 6 [4, 9] .284
Satisfaction (0-10) 8 [6, 10] 9 [7, 10] .069

a
All values are reported as mean 6 SD or median [minimum, maximum]. IKDC, International Knee Documentation Committee; WOMAC,
Western Ontario and McMaster Universities Osteoarthritis Index.
b
P values for group comparisons derived from Mann-Whitney U tests.

or 14 days, and no adverse effects were reported with early
full weightbearing. Conversely, Vadala et al40 noted a signifi-
cant increase in tunnel osteolysis among patients in an accel-
erated rehabilitation program as compared with patients
who underwent a standard rehabilitation protocol. Although
these differences were significant, tunnel enlargement was
not correlated with clinical outcomes in a previous study,10
and recent research indicated that tunnel osteolysis is a nat-
ural process that occurs after ACL reconstruction.2 These
prior studies support the efficacy of the early weightbearing
principle in some ligament reconstructions, which this study
sought to demonstrate for the FCL.
10 LaPrade et al
Limitations
This study is not without limitations. One limitation was
that we chose to limit weightbearing to partial weightbear-
ing (40% body weight) rather than allow full weightbearing
postoperatively. However, to decrease the subjectivity
involved with weightbearing at 40%, the physical therapist
instructed each patient on how to bear partial weight by
calculating 40% of a patient’s total body weight and con-
verting this number into a unit of mass (lb). Utilizing
a standard body weight scale, patients could practice
applying the same amount of pressure through the limb
onto the scale to receive objective feedback on what exactly
40% of their body weight felt like and then replicate this
during normal walking outside of physical therapy.
Another limitation of our study was the diagnostic utility
of stress radiographs, as performed with maximal physi-
cian-applied stress by the treating surgeon for all patients.
However, this technique is highly reliable and consistent,
with ICCs of 0.97 to 0.99.26 Another limitation of our study
was the maximal follow-up time of 6 months; however, the
purpose of the study was to evaluate if early weightbearing
was safe after an FCL reconstruction. Thus, reporting
long-term follow-up was not necessary because the treat-
ment occurred during the first 6 weeks after surgery, and
if graft elongation were to occur because of weightbearing
status, most likely this would not be the cause at long-term
follow-up. Further studies are planned to compare partial
versus complete weightbearing in the immediate postoper-
ative period.
CONCLUSION
Clinical and statistical equivalence was found at postoper-
ative 6 months between the early partial weightbearing
and nonweightbearing groups among patients undergoing
either an isolated FCL reconstruction or an ACL and
FCL combined reconstruction. There were no significant
differences observed between the groups regarding knee
stability, pain, swelling, ROM, or subjective outcomes.
Given these findings, we recommend early partial weight-
bearing after an isolated FCL reconstruction or combined
ACL and FCL reconstructions.
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