Early Protected Full Weight-bearing vs. Partial Weight-bearing After Surgical Fixation of Unstable Ankle Fractures, Monitored With Bio-feedback Insoles.

August 29, 2023 updated by: Primoz Potocnik, Cantonal Hospital of St. Gallen

Early Protected Full Weight-bearing vs. Partial Weight-bearing After Surgical Fixation of Unstable Ankle Fractures, Monitored With Bio-feedback Insoles. A Single Blinded Randomized Controlled Study

The purpose of this study is to compare the postoperative results after ORIF (Open Reduction Inner Fixation) with a partial weight-bearing protocol versus an early full weight-bearing protocol. But in addition, we will measure every patient's actual load by the means of walker integrated bio-feedback insoles for the first six postoperative weeks to record the adherence to the protocol.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

This study aims to compare the postoperative results after PWB (partial weight bearing) and early FWB (full weight bearing) and to show, that documented early protected weight-bearing after surgical fixation of unstable ankle fractures leads to an improved early clinical outcome and a faster return to work compared to PWB. It also aims to show, that an early FWB is safe in terms of complication rate.

Study Type

Interventional

Enrollment (Estimated)

110

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • patients with surgically stabilized unstable ankle fractures
  • signed informed consent
  • closed tibial and fibular epiphysis
  • age 18 or older

Exclusion Criteria:

  • dementia and other known cognitive impairment or incapacity of judgement
  • polytrauma
  • bilateral injury of the lower extremities
  • additional injury of the ipsilateral lower extremity which prevents full weight bearing
  • associated injury of one or both upper extremities
  • open fractures grade II° and III°
  • chronic loss of sensation on plantar aspect of the feet due to known distal neuropathy
  • open epiphysis
  • pregnancy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Full weight bearing
After 2 weeks after surgery the arm will begin full weight bearing
Other: Full weight bearing
Full weight bearing monitored with a bio-feedback insole
Active Comparator: Partial weight bearing
The arm will perform partial weight bearing for 6 weeks after surgery
Other: Partial weight bearing
Partial weight bearing monitored with a bio-feedback insole

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Manchester Oxford Foot and Ankle Questionnaire
Time Frame: 1 year
Patient reported Outcome measure
1 year

Secondary Outcome Measures

Outcome Measure
Time Frame
other PROMs (patient reported outcome measures)
Time Frame: 1 year
1 year
Range of Motion
Time Frame: 1 year
1 year
Secondary dislocation of fracture
Time Frame: 6 weeks
6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cantonal Hospital of St. Gallen

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

September 1, 2023

Primary Completion (Estimated)

October 31, 2025

Study Completion (Estimated)

October 31, 2026

Study Registration Dates

First Submitted

August 29, 2023

First Submitted That Met QC Criteria

August 29, 2023

First Posted (Actual)

September 5, 2023

Study Record Updates

Last Update Posted (Actual)

September 5, 2023

Last Update Submitted That Met QC Criteria

August 29, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BASEC Nr. 2023-01242

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Post Operative Treatment After Unstable Malleolar Fractures

Clinical Trials on Full weight bearing

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Finland

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe