Weight Bearing for Fibular Fractures

Fibula Fracture Clinical Trial

Official title:

Early Weight Bearing for Isolated Fibular Fractures: A Prospective Randomized Study

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04872296
• Other study ID #: RSHA18D.798
• Status: Enrolling by invitation
• Phase: N/A
• Start date: December 20, 2018
• Est. completion date: December 20, 2021

Study information

• Verified date: May 2021
• Source: Rothman Institute Orthopaedics
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 64
• Est. completion date: December 20, 2021
• Est. primary completion date: December 20, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Fibula Fracture
• Fractures, Bone

Intervention

Device:
• Controlled Ankle Motion (CAM) boot
A CAM boot will be worn on the affected ankle to allow weight bearing

Procedure:
• Physical Therapy
Standard physical therapy protocol will be started at 6 weeks after surgery

Locations

Country	Name	City	State
United States	Rothman Orthopaedic Institute	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Rothman Institute Orthopaedics

Country where clinical trial is conducted

United States, 

Outcome

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