Weight Bearing for Fibular Fractures

Not Applicable

• Conditions: Fibula Fracture
• Interventions: Device: Controlled Ankle Motion (CAM) boot; Procedure: Physical Therapy

• Registration Number: NCT04872296
• Lead Sponsor: Rothman Institute Orthopaedics

Brief Summary

It is common practice to restrict weight bearing after ankle fracture open reduction and internal fixation (ORIF) until week 6 postoperatively. However, controversy exists surrounding the optimal postoperative protocol. At our institution, all ankle fractures are made non-weight bearing for 6 weeks across the board. Isolated lateral malleolar fractures after ORIF may benefit from earlier weight bearing in terms of patient satisfaction, short-term functionality, and return to work. The purpose of this study is to determine if early weight bearing at 2 weeks postoperatively for isolated lateral malleolar fractures leads to a higher satisfaction with surgery as compared to standard protocol for postoperative ankle fractures and better functional outcomes

Detailed Description

Not available

Study Timeline

• Study Start: 2018-12-20
• Status Verified: 2021-05
• Study First Submitted: 2021-05-03
• Study First Submitted QC: 2021-05-03
• Last Update Submitted: 2021-05-03
• Study First Posted: 2021-05-04
• Last Update Posted: 2021-05-04
• Primary Completion: 2021-12-20
• Study Completion: 2021-12-20

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 64

Inclusion Criteria

• Adult patients (age>18) undergoing surgical treatment for isolated lateral malleolar fracture with foot and ankle surgeons at the Rothman Orthopaedic Institute

Exclusion Criteria

• Patients requiring other fracture fixation, deltoid ligament repair, or syndesmosis fixation
• Revision ankle fracture cases
• Pre-existing impaired mobility,
• Pre-existing cognitive disability,
• Open fractures,
• BMI >40,
• Diabetes mellitus (DM)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Early weight bearing	Physical Therapy	Participants treated for an ankle fracture will be allowed to weight bear early after surgery starting at 2 weeks post operatively
Postponed weight bearing	Controlled Ankle Motion (CAM) boot	Participants treated for an ankle fracture will be treated with standard protocol of non-weight bearing for 6 weeks post operatively.
Postponed weight bearing	Physical Therapy	Participants treated for an ankle fracture will be treated with standard protocol of non-weight bearing for 6 weeks post operatively.
Early weight bearing	Controlled Ankle Motion (CAM) boot	Participants treated for an ankle fracture will be allowed to weight bear early after surgery starting at 2 weeks post operatively

Primary Outcome Measures

Name	Time	Method
Participant Pain after surgery	24 weeks	Participant Pain will be measured using the Visual Analog Scale for Pain (VAS) score
Participant Satisfaction with treatment #1	24 weeks	Participant satisfaction will be measured using the Short Form-12 survey (SF-12)
Participant Satisfaction with treatment #2	24 weeks	Participant satisfaction will be measured using the Foot and Ankle Ability Measure (FAAM) scores

Trial Locations

Locations (1)

Rothman Orthopaedic Institute; 🇺🇸 Philadelphia, Pennsylvania, United States