Weight Bearing for Fibular Fractures

Rothman Institute Orthopaedics

Status: Unknown

Conditions: Fibula Fracture

Treatments: Device: Controlled Ankle Motion (CAM) boot; Procedure: Physical Therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT04872296

RSHA18D.798

Details and patient eligibility

About

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

Enrollment: 64 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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64 participants in 2 patient groups

Early weight bearing

Active Comparator group

Description:

Participants treated for an ankle fracture will be allowed to weight bear early after surgery starting at 2 weeks post operatively

Treatment:

Device: Controlled Ankle Motion (CAM) boot

Procedure: Physical Therapy

Postponed weight bearing

Active Comparator group

Description:

Participants treated for an ankle fracture will be treated with standard protocol of non-weight bearing for 6 weeks post operatively.

Treatment:

Device: Controlled Ankle Motion (CAM) boot

Procedure: Physical Therapy