Weight Bearing for Fibular Fractures

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

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04872296

Enrollment

Registered

2021-05-04

Start date

2018-12-20

Completion date

2021-12-20

Last updated

2021-05-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fibula Fracture

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

Interventions

DEVICEControlled Ankle Motion (CAM) boot

A CAM boot will be worn on the affected ankle to allow weight bearing

PROCEDUREPhysical Therapy

Standard physical therapy protocol will be started at 6 weeks after surgery

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SUPPORTIVE_CARE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

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)

Design outcomes

Primary

Measure	Time frame	Description
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
Participant Pain after surgery	24 weeks	Participant Pain will be measured using the Visual Analog Scale for Pain (VAS) score

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026