- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04798742
Gluteus Maximus Transfer Following THA Does Not Improve Abductor Strength
Gluteus Maximus Transfer Following THA Does Not Improve Abductor Strength - a Case-control Gait Analysis Study of 15 Patients With Gluteus Medius Disruption
Gluteus maximus transfer following THA does not improve abductor strength - a case-control gait analysis study of 15 patients with gluteus medius disruption
The investigators have compared 15 gluteus maximus transferred patients with the use of a gait analysis system based on reflective markers and force plates to objectively evaluate the gait performance pre- and postoperatively.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The gluteus maximus flap transfer (GMT) is a surgical technique to improve gait kinematics and kinetics as well as reduce pain and ameliorate functional outcome in patients with hip abductor deficiency of the gluteus medius following total hip arthroplasty (THA). The investigators used a gait analysis system based on reflective markers and force plates to objectively evaluate gait performance pre- and postoperatively.
Methods Gait analysis was performed in 15 patients who underwent GMT and were examined with an optical tracking system before and at a minimum of 13 months after the operation. Mean age was 69 years (SD=11), all were females. Median follow-up time was 24 (13-60) months. The primary outcome was hip abduction moment (Nm/kg) during gait. The control group consisted of 66 subjects without any gait pathology.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Gothenburg, Sweden, SE 41310
- Roland Zügner
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Patients with hip abductor deficiency of the gluteus medius following total hip arthroplasty (THA)
Exclusion Criteria:
- THA prior to the muscle transfer
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Gait performance preop vs postop
Pre and postop
|
Gait analysis study of 15 patients with gluteus medius disruption
|
|
Experimental: Gait performance postop vs controls
Postop vs controls
|
Gait analysis study of 15 patients with gluteus medius disruption
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Abductor strength measurement with use of an optical tracking system after Gluteus maximus transfer - a case-control gait analysis study of 15 patients pre- and postoperative with gluteus medius disruption
Time Frame: Preop
|
Gait analysis examination/measure will be performed preoperative with an optical tracking system in a gait laboratory using reflective markers and integrated force plates in order to record kinetics (Nm/kg) of abductor muscles moment in the frontal plane.
|
Preop
|
|
Abductor strength measurement with use of an optical tracking system after Gluteus maximus transfer- a case-control gait analysis study of 15 patients pre- and postoperative with gluteus medius disruption
Time Frame: Postop 2 year
|
Gait analysis examination/measure will be performed 2 year postoperative with an optical tracking system in a gait laboratory using reflective markers and integrated force plates in order to record kinetics (Nm/kg) of abductor muscles moment in the frontal plane.
|
Postop 2 year
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Roland Zügner, Göteborg University
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Gluteus maximus transfer
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
- CSR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.
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