NCT04872296

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
64

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 20, 2018

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

May 3, 2021

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 4, 2021

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 20, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 20, 2021

Completed
Last Updated

May 4, 2021

Status Verified

May 1, 2021

Enrollment Period

3 years

First QC Date

May 3, 2021

Last Update Submit

May 3, 2021

Conditions

Fibula Fracture

Outcome Measures

Primary Outcomes (3)

  • Participant Satisfaction with treatment #1

    Participant satisfaction will be measured using the Short Form-12 survey (SF-12)

    24 weeks

  • Participant Satisfaction with treatment #2

    Participant satisfaction will be measured using the Foot and Ankle Ability Measure (FAAM) scores

    24 weeks

  • Participant Pain after surgery

    Participant Pain will be measured using the Visual Analog Scale for Pain (VAS) score

    24 weeks

Study Arms (2)

Early weight bearing

ACTIVE COMPARATOR

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

Device: Controlled Ankle Motion (CAM) bootProcedure: Physical Therapy

Postponed weight bearing

ACTIVE COMPARATOR

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

Device: Controlled Ankle Motion (CAM) bootProcedure: Physical Therapy

Interventions

Controlled Ankle Motion (CAM) bootDEVICE

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

Early weight bearingPostponed weight bearing
Physical TherapyPROCEDURE

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

Early weight bearingPostponed weight bearing

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rothman Orthopaedic Institute

Philadelphia, Pennsylvania, 19107, United States

Location

MeSH Terms

Conditions

Fibula Fractures

Interventions

Complementary TherapiesPhysical Therapy Modalities

Condition Hierarchy (Ancestors)

Fractures, BoneWounds and Injuries

Intervention Hierarchy (Ancestors)

TherapeuticsRehabilitation

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 3, 2021

First Posted

May 4, 2021

Study Start

December 20, 2018

Primary Completion

December 20, 2021

Study Completion

December 20, 2021

Last Updated

May 4, 2021

Record last verified: 2021-05

Locations

US(1)