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Gluteus Maximus Transfer Following THA Does Not Improve Abductor Strength

Primary Purpose

Hip Arthropathy

Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Gluteus maximus transfer
Sponsored by
Göteborg University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hip Arthropathy

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • Patients with hip abductor deficiency of the gluteus medius following total hip arthroplasty (THA)

Exclusion Criteria:

  • THA prior to the muscle transfer

Sites / Locations

  • Roland Zügner

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Gait performance preop vs postop

Gait performance postop vs controls

Arm Description

Pre and postop

Postop vs controls

Outcomes

Primary Outcome Measures

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
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.
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
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.

Secondary Outcome Measures

Full Information

First Posted
February 24, 2021
Last Updated
July 2, 2021
Sponsor
Göteborg University
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1. Study Identification

Unique Protocol Identification Number
NCT04798742
Brief Title
Gluteus Maximus Transfer Following THA Does Not Improve Abductor Strength
Official Title
Gluteus Maximus Transfer Following THA Does Not Improve Abductor Strength - a Case-control Gait Analysis Study of 15 Patients With Gluteus Medius Disruption
Study Type
Interventional

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Completed
Study Start Date
February 1, 2012 (Actual)
Primary Completion Date
September 17, 2018 (Actual)
Study Completion Date
September 17, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Göteborg University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hip Arthropathy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Non-Randomized
Enrollment
15 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Gait performance preop vs postop
Arm Type
Experimental
Arm Description
Pre and postop
Arm Title
Gait performance postop vs controls
Arm Type
Experimental
Arm Description
Postop vs controls
Intervention Type
Procedure
Intervention Name(s)
Gluteus maximus transfer
Intervention Description
Gait analysis study of 15 patients with gluteus medius disruption
Primary Outcome Measure Information:
Title
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
Description
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.
Time Frame
Preop
Title
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
Description
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.
Time Frame
Postop 2 year

10. Eligibility

Sex
Female
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Patients with hip abductor deficiency of the gluteus medius following total hip arthroplasty (THA) Exclusion Criteria: THA prior to the muscle transfer
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Roland Zügner
Organizational Affiliation
Göteborg University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Roland Zügner
City
Gothenburg
ZIP/Postal Code
SE 41310
Country
Sweden

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
After publication, all available data will be available by appointment and within a reasonable time.
IPD Sharing Time Frame
After publication and 2 years after publication
Citations:
PubMed Identifier
21796476
Citation
Whiteside LA. Surgical technique: Transfer of the anterior portion of the gluteus maximus muscle for abductor deficiency of the hip. Clin Orthop Relat Res. 2012 Feb;470(2):503-10. doi: 10.1007/s11999-011-1975-y.
Results Reference
result

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Gluteus Maximus Transfer Following THA Does Not Improve Abductor Strength

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