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Weight Bearing for Fibular Fractures

Primary Purpose

Fibula Fracture

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Controlled Ankle Motion (CAM) boot
Physical Therapy
Sponsored by
Rothman Institute Orthopaedics
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Fibula Fracture

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts 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)

Sites / Locations

  • Rothman Orthopaedic Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Early weight bearing

Postponed weight bearing

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
May 3, 2021
Last Updated
May 3, 2021
Sponsor
Rothman Institute Orthopaedics
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1. Study Identification

Unique Protocol Identification Number
NCT04872296
Brief Title
Weight Bearing for Fibular Fractures
Official Title
Early Weight Bearing for Isolated Fibular Fractures: A Prospective Randomized Study
Study Type
Interventional

2. Study Status

Record Verification Date
May 2021
Overall Recruitment Status
Unknown status
Study Start Date
December 20, 2018 (Actual)
Primary Completion Date
December 20, 2021 (Anticipated)
Study Completion Date
December 20, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Rothman Institute Orthopaedics

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fibula Fracture

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
64 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Early weight bearing
Arm Type
Active Comparator
Arm Description
Participants treated for an ankle fracture will be allowed to weight bear early after surgery starting at 2 weeks post operatively
Arm Title
Postponed weight bearing
Arm Type
Active Comparator
Arm Description
Participants treated for an ankle fracture will be treated with standard protocol of non-weight bearing for 6 weeks post operatively.
Intervention Type
Device
Intervention Name(s)
Controlled Ankle Motion (CAM) boot
Intervention Description
A CAM boot will be worn on the affected ankle to allow weight bearing
Intervention Type
Procedure
Intervention Name(s)
Physical Therapy
Intervention Description
Standard physical therapy protocol will be started at 6 weeks after surgery
Primary Outcome Measure Information:
Title
Participant Satisfaction with treatment #1
Description
Participant satisfaction will be measured using the Short Form-12 survey (SF-12)
Time Frame
24 weeks
Title
Participant Satisfaction with treatment #2
Description
Participant satisfaction will be measured using the Foot and Ankle Ability Measure (FAAM) scores
Time Frame
24 weeks
Title
Participant Pain after surgery
Description
Participant Pain will be measured using the Visual Analog Scale for Pain (VAS) score
Time Frame
24 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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)
Facility Information:
Facility Name
Rothman Orthopaedic Institute
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Weight Bearing for Fibular Fractures

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