Covering Letter for Research Protocol

The director,
Research, Training and Monitoring Cell,
College Of Physicians and Surgeons, Pakistan
7th Central street, DHA
Phase 11, Karachi-75500

Dear Sir,

Enclosed herewith the copy of synopsis, the title is,

“Functional outcome following open reduction and internal

fixation of unstable ankle fracture”

Prepared by: Dr. Zeeshan Siddique

As a pre-requisite for FCPS-11 in subject of orthopaedics
Copy submitted on : 23-11-2020
RTMC Registration Number: 75202-P
FCPS-1 Roll Number: 62225
Session: 05-09-2016
Trainee’ Signature:
Name of Supervisor: Col. SHAHID MUNIR
Name of Training Institution: Combined Military Hospital, Lahore
Department: Orthopaedics

Yours Sincerely,

Col. SHAHID MUNIR

MBBS, FCPS, FCPS

Department of Orthopedics

Combined Military Hospital, Lahore

The Director,

Research, Training and Monitoring Cell,

College of Physicians and Surgeons, Pakistan

Subject: Ethical Issue Regarding Synopsis

Respected Sir,

It is stated that Synopsis titled: “Functional outcome following open reduction

and internal fixation of unstable ankle fracture” is being submitted to Synopsis

Review Committee for reviews. Regarding ethical issue, I want to state that this study will
not increase morbidity or mortality in patients.

Yours Sincerely,

Col. SHAHID MUNIR

MBBS, FCPS, FCPS

Department of Orthopedics

Combined Military Hospital, Lahore

The Director,

Research, Training and Monitoring Cell,

College Of Physicians and Surgeons, Pakistan

Subject:- Ethical Issue Regarding Synopsis

Dear Sir,

It is stated that Synopsis titled: “Comparison of Dynamic Compression Plate and

Interlocking nail for humerus shaft fracture” is being submitted to Synopsis

Review Committee for reviews. Regarding ethical issue, I want to state that this study will
not have any additional harm to the patients.

Yours Sincerely,

DR. Zeeshan Siddique

FCPS II Trainee
DEPARTMENT OF ORTHOPAEDICS
ITTEFAQ HOSPITAL TRUST LAHORE
The director,
Research, Training and Monitoring Cell,
College Of Physicians and Surgeons, Pakistan
7th Central street, DHA
Phase 11, Karachi-75500

Dear sir,

It is stated that study “Functional outcome following open reduction

and internal fixation of unstable ankle fracture” has not been performed in
Combined Military Hospital, Lahore before. I assure that it is not being duplicated in
Combined Military Hospital, Lahore.

Yours Sincerely,

Col. SHAHID MUNIR

MBBS, FCPS, FCPS

Department of Orthopedics

Combined Military Hospital, Lahore

INTRODUCTION
Fracture of the shaft of humerus is commonly encountered in road traffic accidents,

playgrounds, factory and assault. In past, all low velocity trauma were treated conservatively.

However, with increasing numbers of high velocity trauma and varied complex fracture

patterns, and also the growing expectations of patients, more of them are being managed

surgically now . Contrary to popular ideas, the operative treatment of fractures is much
(1, 2)

simpler than non-operative. Internal fixation of fracture of the shaft of humerus by either

dynamic compression plating (DCP) or interlocking nails (ILN) allows for full, active, pain

free mobilization with rapid return of function preventing fracture disease . Although both
(3-5)

of these treatment options are being used widely globally, however, increased interest about

the use of interlocking intramedullary nails is based on the theoretical advantages like less

invasive surgery, fracture hematoma is not disturbed and the advantage of a load sharing

device. However, there have been concerns about the reports of shoulder dysfunction due to

invasion of rotator cuff, and increased incidence of delayed union and nonunion (6, 7).

In a previous study, the mean duration of union in patients undergoing ILN was 13.60

± 4.32 weeks and in those undergoing DCP was 15.2 ± 5.65 weeks (p value 0.376) (8).

The rationale of the study is that humerus fractures due to any reason is a major

concern as it has a longstanding effects on health and social life of the patient. Following all

kinds of trauma and fractures, patient’s most common concern is earliest recovery and best

functional outcome. In case of humerus fractures, two modalities of treatment are being

frequently used, however, no consensus on best one has been established yet. Therefore, it is

important to assess the outcome of patients following this treatment. If one modality shows a

better outcome, we may use it regularly for humerus fractures in our patients. Although

previous studies over the topic have been conducted but minimal data is available from our

country over the topic.

OBJECTIVES

 To compare mean duration of union in patients undergoing interlocking nails and

dynamic compression plating for humerus shaft fractures

OPERATIONAL DEFINITIONS

Union: Union will be defined if all of these are present:

 the presence of bridging callus in two planes (On X-ray of arm in AP and

Lateral View) (viewed as radio-opaque new bone formation on X-rays)

 the absence of pain (pain <3 using Visual Analog Scale) (Annexure)

 movement at fracture site (full range of movement as a normal person) (on

clinical examination)

o They will be assessed at 2, 6, 12, 24 and 36 week for Union

Humerus shaft fracture: If a patient presents with history of trauma (of any mode of

trauma with duration <3 weeks) at arm with tenderness (determined on clinical

examination) or palpable fracture of humerus (determined on clinical examination),

further confirmed by X-ray of the arm (Anteroposterior and lateral views)

Hypothesis: There is difference in mean duration of union in patients undergoing

interlocking nails and dynamic compression plating for humerus shaft fractures

MATERIAL AND METHODS

STUDY DESIGN: This will be a randomized controlled trial

SETTING: Study will be conducted in Orthopedics department, Ittefaq Hospital,

Lahore.

DURATION OF STUDY: Six months after the approval of synopsis.

SAMPLE SIZE: A sample size of 250 patients (125 in each group) was calculated taking level

of significance as 5%, power of test as 90%, and mean duration of union in patients

undergoing ILN as 13.60 ± 4.32 weeks and in those undergoing DCP as 15.2 ± 5.65

weeks (8).

SAMPLING TECHNIQUE: Non-probability, consecutive sampling.

SAMPLE SELECTION

Inclusion Criteria:

 All the male and female patients of age 18-50 years with fractures of shaft of humerus

Exclusion Criteria:
 Patients with Pathological fractures (Medical records) (as healing may be different

than normal population in these patients)

 Patients with Compound fractures (On X-rays) (as these patients will be needing more

time for union which may alter our outcome)

DATA COLLECTION

After approval from ethical review board and CPSP, all patients fulfilling the criteria will be

enrolled in the study. Written informed consent for inclusion in the study will be taken from

each patient. Appropriate pre-operative evaluation will be done in all the cases and name,

age, gender, Bod mass index (BMI), laterality will be noted. Patients will be divided into two

groups using lottery method: group A (interlocking nails) and group B (dynamic compression

plating). All patients will be operated under general anaesthesia. In group A (ILN),

commercially available reamed antegrade interlocking nails will be used. The nail having two

screws proximally and two distally. One proximal screw will be oriented transversely and the

other obliquely, while one distal screw will be directed anteroposteriorly and the other
transversely. A 4–5 cm incision, lateral to the acromion, will be made to facilitate the

splitting of the deltoid muscle. The posterior margin of the greater tuberosity will be exposed

by retracting the supraspinatus tendon. The entry hole will be made with an awl. The canal

will be gradually enlarged by reaming after insertion of a guide pin. During reaming, cortical

contact at fracture site will be ensured to prevent radial nerve injury. After passing the nail in

the canal, fracture site will be inspected under image intensifier to avoid distraction at the

fracture site. The distal screws will be fixed by the freehand technique. To prevent damage to

the neurovascular structures, the entry holes were visualized by image intensifier followed by

stab incision and blunt dissection to the bone. The proximal screws will be fixed by the target

device. In the plating group (group B), fixation will be done with 4.5-mm dynamic

compression plates using appropriate surgical techniques, depending on the fracture

configuration. Transverse or short oblique fractures will be stabilized by axial compression,

while in the spiral or oblique fractures interfragmentary lag screw fixation will be done,

followed by application of plate in the neutralization mode. Anterolateral or posterior

approach will be used, depending upon the fracture configuration and the surgeon preference.

Fixation of at least six cortices, preferably eight cortices, both proximal and distal to the

fracture will be obtained in every patient. All patients in both groups will be given same post-

operative care as per departmental protocol. All patients will be followed up at 2, 6, 12, 24

and 36 week for assessment of Union. All data will be recorded on the proforma (attached).

DATA ANALYSIS PROCEDURE

The collected data will be analyzed using SPSS version 20. Mean and standard deviation will

be calculated for quantitative values like age, BMI. Frequencies and percentages will be

calculated for qualitative variables like gender and side. Mean time for union in both groups

will be compared using student’s t-test. Data will be stratified for effect modifiers including
age, gender, BMI and side in both groups. Post-stratification student’s t-test will be applied

and P < 0.05 will be considered significant.

REFERENCES
1. Bisaccia M, Meccariello L, Rinonapoli G, Rollo G, Pellegrino M, Schiavone A, et al.

Comparison of plate, nail and external fixation in the management of diaphyseal fractures of

the humerus. Med Arch. 2017;71(2):97-102.

2. Mohamed O, Bousbaa H, Bennani M, Cherrad T, Zejjari H, Louste J, et al. Treatment

of humerus diaphyseal fractures using Hackethal's retrograde centro-medullary bundle

nailing: about 54 cases. Pan Afr Med J. 2018;30:38.

3. Saha MK, Alam MJ, Kabir SJ, Karim MR, Kamruzzaman M, Rahman MM, et al.

Management of distal third comminuted humerus shaft fracture by LCP using posterior

approach. Mymensingh Med J. 2019;28(2):291-7.

4. Schumaier A, Grawe B. Proximal humerus fractures: Evaluation and management in

the elderly patient. Geriatr Orthop Surg Rehabil. 2018;9:2151458517750516.

5. Updegrove GF, Mourad W, Abboud JA. Humeral shaft fractures. J Shoulder Elbow

Surg. 2018;27(4):e87-e97.

6. Khan MK, Khan MS. Frequency of radial nerve injury in patients with closed fracture

of humerus shaft. Ophthalmol Update 2014;12(1):83-5.

7. Lal K, Chachar MB, Chohan MH, Baig MA, Khoso JA. Gartland type III

supracondylar fracture humerus. Professional Med J. 2015;22(12):1629-33.

8. Wali MG, Baba AN, Latoo IA, Bhat NA, Baba OK, Sharma S. Internal fixation of

shaft humerus fractures by dynamic compression plate or interlocking intramedullary nail: a

prospective, randomised study. Strategies Trauma Limb Reconstr. 2014;9(3):133-40.

 PROFORMA
Comparison of Dynamic Compression Plate and Interlocking nail for
humerus shaft fracture
Patient’s Name: _________________

Age: _______________ Hosp. Reg. # _______________

Address: ______________________________________________________________

Contact number: _______________________________

Gender:

Male

Female

BMI: __________________________________

Side:

Right

Left

Group: Group A

Group B

Time taken for Union: ___________________________

 ANNEXURE

 Patient will be asked for pain and will be asked to rate his pain during movement.
Lower the pain, lower the scale