Back to resultsEarly Protected Full Weight-bearing vs. Partial Weight-bearing After Surgical Fixation of Unstable Ankle Fractures, Monitored With Bio-feedback Insoles.
Primary Purpose
Post Operative Treatment After Unstable Malleolar Fractures
Status
Not yet recruiting
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Full weight bearing
Partial weight bearing
Sponsored by
About this trial
This is an interventional treatment trial for Post Operative Treatment After Unstable Malleolar Fractures focused on measuring malleolar fractures, postoperative treatment protocol, full weight bearing, partial weight bearing, bio-feedback insoles
Eligibility Criteria
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
Sites / Locations
- Canton Hospital St. Gallen
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Full weight bearing
Partial weight bearing
Arm Description
After 2 weeks after surgery the arm will begin full weight bearing
The arm will perform partial weight bearing for 6 weeks after surgery
Outcomes
Primary Outcome Measures
Manchester Oxford Foot and Ankle Questionnaire
Patient reported Outcome measure
Secondary Outcome Measures
other PROMs (patient reported outcome measures)
Range of Motion
Secondary dislocation of fracture
Full Information
NCT ID
NCT06023979
First Posted
August 29, 2023
Last Updated
August 29, 2023
Sponsor
Cantonal Hospital of St. Gallen
1. Study Identification
Unique Protocol Identification Number
NCT06023979
Brief Title
Early Protected Full Weight-bearing vs. Partial Weight-bearing After Surgical Fixation of Unstable Ankle Fractures, Monitored With Bio-feedback Insoles.
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
September 1, 2023 (Anticipated)
Primary Completion Date
October 31, 2025 (Anticipated)
Study Completion Date
October 31, 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cantonal Hospital of St. Gallen
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post Operative Treatment After Unstable Malleolar Fractures
Keywords
malleolar fractures, postoperative treatment protocol, full weight bearing, partial weight bearing, bio-feedback insoles
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
110 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Full weight bearing
Arm Type
Experimental
Arm Description
After 2 weeks after surgery the arm will begin full weight bearing
Arm Title
Partial weight bearing
Arm Type
Active Comparator
Arm Description
The arm will perform partial weight bearing for 6 weeks after surgery
Intervention Type
Other
Intervention Name(s)
Full weight bearing
Intervention Description
Full weight bearing monitored with a bio-feedback insole
Intervention Type
Other
Intervention Name(s)
Partial weight bearing
Intervention Description
Partial weight bearing monitored with a bio-feedback insole
Primary Outcome Measure Information:
Title
Manchester Oxford Foot and Ankle Questionnaire
Description
Patient reported Outcome measure
Time Frame
1 year
Secondary Outcome Measure Information:
Title
other PROMs (patient reported outcome measures)
Time Frame
1 year
Title
Range of Motion
Time Frame
1 year
Title
Secondary dislocation of fracture
Time Frame
6 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Primoz Potocnik, MD
Phone
0041714941111
Email
primoz.potocnik@kssg.ch
Facility Information:
Facility Name
Canton Hospital St. Gallen
City
Saint Gallen
ZIP/Postal Code
9007
Country
Switzerland
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Primoz Potocnik, MD
Email
primoz.potocnik@kssg.ch
First Name & Middle Initial & Last Name & Degree
Andreas Toepfer, MD
Email
andreas.toepfer@kssg.ch
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Early Protected Full Weight-bearing vs. Partial Weight-bearing After Surgical Fixation of Unstable Ankle Fractures, Monitored With Bio-feedback Insoles.
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