Hip ArthropathyNCT04798742
Gluteus Maximus Transfer Following THA Does Not Improve Abductor Strength
A study testing Gluteus maximus transfer in people with Hip Arthropathy, run by Göteborg University at 1 site in Sweden.
Trial 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… Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Hip Arthropathy
- What is being tested?
- Gluteus maximus transfer
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteSweden
- Study dates
- 1 Feb 2012to 17 Sep 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Patients with hip abductor deficiency of the gluteus medius following total hip arthroplasty (THA)
Who cannot join
- THA prior to the muscle transfer
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Hip Arthropathy
- Being tested
- Gluteus maximus transfer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gluteus maximus transferProcedure or surgery
Gait analysis study of 15 patients with gluteus medius disruption
| Study group | Role | What they receive |
|---|---|---|
| Gait performance preop vs postop | Experimental | Pre and postop Receives: Procedure: Gluteus maximus transfer |
| Gait performance postop vs controls | Experimental | Postop vs controls Receives: Procedure: Gluteus maximus transfer |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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.
Measured: Postop 2 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2021
- Study start1 Feb 2012
- Primary completion17 Sep 2018
- Study completion17 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hip ArthropathyStudies of the same condition, open and under way.
- More trials run by Göteborg UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Göteborg University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Roland Zügner, Principal investigator, Göteborg University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04798742
- Sponsor's protocol ID
- Gluteus maximus transfer
- Status last verified
- Jul 2021
- First submitted
- 24 Feb 2021
- Last updated
- 7 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: After publication, all available data will be available by appointment and within a reasonable time.
Publications
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.
PubMed 21796476
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04798742
- Acronym / sponsor ID
- Gluteus maximus transfer
- Conditions
- Hip Arthropathy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Göteborg UniversityUniversity, hospital or other
- Study start
- 1 Feb 2012 (actual)
- Primary completion
- 17 Sep 2018 (actual)
- Study completion
- 17 Sep 2018 (actual)
- First posted
- 15 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Gait performance preop vs postop | Experimental | Procedure: Gluteus maximus transferPre and postop |
| Gait performance postop vs controls | Experimental | Procedure: Gluteus maximus transferPostop vs controls |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with hip abductor deficiency of the gluteus medius following total hip arthroplasty (THA)
Key exclusion criteria (1 listed)
- THA prior to the muscle transfer
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Gluteus maximus transferGait analysis study of 15 patients with gluteus medius disruption | Procedure or surgery | Gait performance postop vs controls, Gait performance preop vs postop |
Primary outcome
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2021.
- Results publication: PubMed 21796476Whiteside 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.
- Individual participant dataSharing planned: Yes. After publication, all available data will be available by appointment and within a reasonable time.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Roland Zügner principal investigator
Göteborg University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Gluteus maximus transfer in people with Hip Arthropathy, run by Göteborg University at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04798742, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jul 2021.