Hip OsteoarthritisNCT06850155
Gluteal Sling Release on Gluteal Dysfunction After in Primary Total Hip Arthroplasty
A study testing Sling release and Sling release and repair in people with Hip Osteoarthritis and Osteoarthritis, Hip, run by Ankara City Hospital Bilkent at 1 site in Turkey (Türkiye).
Trial summary
This study investigates the effects of gluteal sling release during total hip arthroplasty (THA) on gluteal muscle function and hip joint performance. The gluteal sling release technique is used to improve surgical visualization and reduce the risk of sciatic nerve compression, but its impact on postoperative muscle… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hip Osteoarthritis, Osteoarthritis, Hip, Gluteus Maximus Muscle Atrophy
- What is being tested?
- Sling release and Sling release and repair
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 144 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Sep 2023to 4 Feb 2025
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients diagnosed with unilateral coxarthrosis
- Scheduled for primary total hip arthroplasty (THA)
- Age between 18 and 90 years
Who cannot join
- Coxarthrosis secondary to:
- Developmental hip dysplasia
- Fracture-related pathology
- Conditions requiring revision surgery, including:
- Periprosthetic fractures
- Current or previous hip joint infections
Show all 14Show fewer
- Rotational or malalignment issues requiring revision
- Neuromuscular diseases
- History of prior hip surgeries, such as:
- Hip arthroscopy
- Core decompression
- Mobility-limiting conditions in the contralateral hip (e.g., osteoarthritis)
- Patients lost to follow-up or with incomplete data
- Patients who developed complications (e.g., infection, dislocation) within six months of follow-up
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of Gluteal Sling Release on Gluteal Dysfunction and Functional Outcomes in Primary Total Hip Arthroplasty
This study investigates the effects of gluteal sling release during total hip arthroplasty (THA) on gluteal muscle function and hip joint performance. The gluteal sling release technique is used to improve surgical visualization and reduce the risk of sciatic nerve compression, but its impact on postoperative muscle function remains unclear. A prospective randomized controlled trial was conducted on 144 patients with unilateral coxarthrosis undergoing THA, divided into three groups: gluteal sling preserved, released, and released with repair. Clinical outcomes were assessed preoperatively and at six months postoperatively using VAS, HHS, and WOMAC scores, alongside hip CT scans and isokinetic strength testing. While all groups showed significant functional improvement, muscle density in the released gluteal sling group decreased significantly, suggesting potential fatty degeneration. However, no significant differences were found in gluteus maximus surface area or hip extensor strength between the groups. The findings suggest that while gluteal sling release enhances intraoperative visualization and may reduce sciatic nerve injury risk, it could contribute to muscle degeneration. Therefore, preserving or repairing the sling when possible and implementing structured rehabilitation may optimize postoperative outcomes.
Read the detailed description
This study aimed to assess the impact of gluteal sling release during total hip arthroplasty (THA) on gluteal muscle function and hip joint outcomes. A prospective randomized controlled trial was conducted between September 2023 and August 2024, including 144 patients diagnosed with unilateral coxarthrosis who underwent THA. Patients were divided into three groups: gluteal sling preserved (n=47), released (n=52), and released and repaired (n=45). Preoperative and postoperative evaluations at six months included clinical scoring (VAS, HHS, and WOMAC), hip computed tomography (CT) scans for muscle cross-sectional area and density, and isokinetic testing to measure hip extensor strength. Surgical and rehabilitative procedures were standardized across all groups, with a focus on evaluating the functional and radiological effects of gluteal sling release.
The results demonstrated that all groups experienced significant postoperative improvements in pain scores (VAS), hip function (HHS), and joint-related disability (WOMAC) (p<0.001). No significant differences were observed between the groups in terms of gluteus maximus muscle cross-sectional area (p>0.05). However, muscle density significantly decreased in the gluteal sling release group (p=0.022), suggesting fatty degeneration, while no significant changes were observed in the other groups. Hip extensor strength showed a decline in the gluteal sling release group and an increase in the other groups, but these differences were not statistically significant (p>0.05). Sciatic nerve injury was recorded in one patient (2.1%) from the preserved group but was absent in the other groups. No significant differences were found in sciatic nerve injury rates across the groups.
In conclusion, the gluteal sling release technique provides better intraoperative visualization and may reduce the risk of iatrogenic sciatic nerve injury by alleviating nerve compression. However, while it does not significantly affect hip extensor strength, it may contribute to muscle fatty degeneration. Given these findings, preserving or repairing the gluteal sling whenever feasible is recommended. Additionally, a well-structured rehabilitation program following surgery is crucial to optimize patient recovery and functional outcomes.
- Conditions
- Hip Osteoarthritis, Osteoarthritis, Hip, Gluteus Maximus Muscle Atrophy, Muscle Weakness Condition, Fatty Degeneration
- Being tested
- Sling release, Sling release and repair
- Keywords
- hip arthroplasty, gluteal sling, muscle atrophy, gluteus maximus
- Medical subject headings
- Osteoarthritis, Hip, Fatty Liver, Muscular Atrophy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sling releaseProcedure or surgery
The gluteal sling was released and left unrepaired at the end of the procedure
Sling release and repairProcedure or surgery
The gluteal sling was released and then repaired at the end of the procedure
| Study group | Role | What they receive |
|---|---|---|
| Control Gluteal Sling | No intervention | The Gluteal sling was left untouched during the whole procedure |
| Released Gluteal Sling | Experimental | The Gluteal sling was released and left unrepaired at the end of the procedure Receives: Procedure: Sling release |
| Released&Repaired Gluteal Sling | Experimental | The Gluteal sling was released and then repaired at the end of the procedure Receives: Procedure: Sling release and repair |
What is being measured
The primary outcome is the main question the study is designed to answer.
Muscle atrophy
Muscle atrophy through cross-sectional area measurement on CT scans (number, cm^2)
Measured: Preoperative & Postoperative 6th month
Muscle density
Muscle density measurements on CT scans (Hounsfield units - HU)
Measured: Preoperative & Postoperative 6th month
Kinematic assesment
Muscle strength through kinematic assesment (Nm)
Measured: Postoperative 6th month
Secondary outcomes (3)
Visual Analog Scale (VAS)
minimum value:0, maximum value 10, higher values mean worse outcome
Measured: Preoperative & Postoperative 6th month
Harris Hip Score (HHS)
minimum value:0, maximum value 100, higher values mean better outcome
Measured: Preoperative & Postoperative 6th month
Western Ontario and McMaster Universities Arthritis Index (WOMAC)
minimum value:0, maximum value 100, higher values mean worse outcome
Measured: Preoperative & Postoperative 6th month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2025
- Study start1 Sep 2023
- Primary completion1 Aug 2024
- Study completion4 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Hip OsteoarthritisStudies of the same condition, open and under way.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 144 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ankara City Hospital Bilkent
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Enejd Veizi, MD, Ankara City Hospital Bilkent
- Investigators
- Enejd Veizi, Study chair, Ankara City Hospital Bilkent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06850155
- Sponsor's protocol ID
- E2-23-4913
- Status last verified
- Feb 2025
- First submitted
- 23 Feb 2025
- Last updated
- 28 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No individual participant data (IPD) will be publicly shared but the data will be made available upon request.
Publications
Imren Y, Karslioglu B, Dedeoglu SS, Cabuk H, Atar S, Gurbuz S, Gurbuz H. The effect of gluteus maximus tenotomy in primary total hip arthroplasty with posterior approach: Kinematic analysis of hip extensor strength. J Orthop Surg (Hong Kong). 2021 Jan-Apr;29(1):23094990211003349. doi: 10.1177/23094990211003349.
PubMed 33779410Uemura K, Takao M, Sakai T, Nishii T, Sugano N. Volume Increases of the Gluteus Maximus, Gluteus Medius, and Thigh Muscles After Hip Arthroplasty. J Arthroplasty. 2016 Apr;31(4):906-912.e1. doi: 10.1016/j.arth.2015.10.036. Epub 2015 Nov 10.
PubMed 26652475Homma D, Minato I, Imai N, Miyasaka D, Sakai Y, Horigome Y, Suzuki H, Dohmae Y, Endo N. Investigation on the measurement sites of the cross-sectional areas of the gluteus maximus and gluteus medius. Surg Radiol Anat. 2019 Jan;41(1):109-115. doi: 10.1007/s00276-018-2099-9. Epub 2018 Sep 6.
PubMed 30191287
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Gluteal Sling Release on Gluteal Dysfunction and Functional Outcomes in Primary Total Hip Arthroplasty
- ClinicalTrials.gov ID
- NCT06850155
- Acronym / sponsor ID
- E2-23-4913
- Conditions
- Hip Osteoarthritis, Osteoarthritis, Hip, Gluteus Maximus Muscle Atrophy, Muscle Weakness Condition, Fatty Degeneration
- Keywords
- hip arthroplasty, gluteal sling, muscle atrophy, gluteus maximus
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 144 participants (actual)
- Lead sponsor
- Ankara City Hospital BilkentUniversity, hospital or other
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- 1 Aug 2024 (actual)
- Study completion
- 4 Feb 2025 (actual)
- First posted
- 27 Feb 2025 (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.
This study investigates the effects of gluteal sling release during total hip arthroplasty (THA) on gluteal muscle function and hip joint performance. The gluteal sling release technique is used to improve surgical visualization and reduce the risk of sciatic nerve compression, but its impact on postoperative muscle function remains unclear. A prospective randomized controlled trial was conducted on 144 patients with unilateral coxarthrosis undergoing THA, divided into three groups: gluteal sling preserved, released, and released with repair. Clinical outcomes were assessed preoperatively and at six months postoperatively using VAS, HHS, and WOMAC scores, alongside hip CT scans and isokinetic strength testing. While all groups showed significant functional improvement, muscle density in the released gluteal sling group decreased significantly, suggesting potential fatty degeneration. However, no significant differences were found in gluteus maximus surface area or hip extensor strength between the groups. The findings suggest that while gluteal sling release enhances intraoperative visualization and may reduce sciatic nerve injury risk, it could contribute to muscle degeneration. Therefore, preserving or repairing the sling when possible and implementing structured rehabilitation may optimize postoperative outcomes.
Detailed description
This study aimed to assess the impact of gluteal sling release during total hip arthroplasty (THA) on gluteal muscle function and hip joint outcomes. A prospective randomized controlled trial was conducted between September 2023 and August 2024, including 144 patients diagnosed with unilateral coxarthrosis who underwent THA. Patients were divided into three groups: gluteal sling preserved (n=47), released (n=52), and released and repaired (n=45). Preoperative and postoperative evaluations at six months included clinical scoring (VAS, HHS, and WOMAC), hip computed tomography (CT) scans for muscle cross-sectional area and density, and isokinetic testing to measure hip extensor strength. Surgical and rehabilitative procedures were standardized across all groups, with a focus on evaluating the functional and radiological effects of gluteal sling release.
The results demonstrated that all groups experienced significant postoperative improvements in pain scores (VAS), hip function (HHS), and joint-related disability (WOMAC) (p<0.001). No significant differences were observed between the groups in terms of gluteus maximus muscle cross-sectional area (p>0.05). However, muscle density significantly decreased in the gluteal sling release group (p=0.022), suggesting fatty degeneration, while no significant changes were observed in the other groups. Hip extensor strength showed a decline in the gluteal sling release group and an increase in the other groups, but these differences were not statistically significant (p>0.05). Sciatic nerve injury was recorded in one patient (2.1%) from the preserved group but was absent in the other groups. No significant differences were found in sciatic nerve injury rates across the groups.
In conclusion, the gluteal sling release technique provides better intraoperative visualization and may reduce the risk of iatrogenic sciatic nerve injury by alleviating nerve compression. However, while it does not significantly affect hip extensor strength, it may contribute to muscle fatty degeneration. Given these findings, preserving or repairing the gluteal sling whenever feasible is recommended. Additionally, a well-structured rehabilitation program following surgery is crucial to optimize patient recovery and functional outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control Gluteal Sling | No intervention | –The Gluteal sling was left untouched during the whole procedure |
| Released Gluteal Sling | Experimental | Procedure: Sling releaseThe Gluteal sling was released and left unrepaired at the end of the procedure |
| Released&Repaired Gluteal Sling | Experimental | Procedure: Sling release and repairThe Gluteal sling was released and then repaired at the end of the procedure |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients diagnosed with unilateral coxarthrosis
- Scheduled for primary total hip arthroplasty (THA)
- Age between 18 and 90 years
Key exclusion criteria (14 listed)
- Coxarthrosis secondary to:
- Conditions requiring revision surgery, including:
- Neuromuscular diseases
- History of prior hip surgeries, such as:
- Mobility-limiting conditions in the contralateral hip (e.g., osteoarthritis)
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 |
|---|---|---|
| Sling releaseThe gluteal sling was released and left unrepaired at the end of the procedure | Procedure or surgery | Released Gluteal Sling |
| Sling release and repairThe gluteal sling was released and then repaired at the end of the procedure | Procedure or surgery | Released&Repaired Gluteal Sling |
Primary outcome
Muscle atrophy
Time frame: Preoperative & Postoperative 6th month
Muscle atrophy through cross-sectional area measurement on CT scans (number, cm^2)
Muscle density
Time frame: Preoperative & Postoperative 6th month
Muscle density measurements on CT scans (Hounsfield units - HU)
Kinematic assesment
Time frame: Postoperative 6th month
Muscle strength through kinematic assesment (Nm)
3 secondary outcomes
Visual Analog Scale (VAS)
Time frame: Preoperative & Postoperative 6th month
Harris Hip Score (HHS)
Time frame: Preoperative & Postoperative 6th month
Western Ontario and McMaster Universities Arthritis Index (WOMAC)
Time frame: Preoperative & Postoperative 6th month
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 28 Feb 2025.
- Results publication: PubMed 33779410Imren Y, Karslioglu B, Dedeoglu SS, Cabuk H, Atar S, Gurbuz S, Gurbuz H. The effect of gluteus maximus tenotomy in primary total hip arthroplasty with posterior approach: Kinematic analysis of hip extensor strength. J Orthop Surg (Hong Kong). 2021 Jan-Apr;29(1):23094990211003349. doi: 10.1177/23094990211003349.
- Results publication: PubMed 26652475Uemura K, Takao M, Sakai T, Nishii T, Sugano N. Volume Increases of the Gluteus Maximus, Gluteus Medius, and Thigh Muscles After Hip Arthroplasty. J Arthroplasty. 2016 Apr;31(4):906-912.e1. doi: 10.1016/j.arth.2015.10.036. Epub 2015 Nov 10.
- Results publication: PubMed 30191287Homma D, Minato I, Imai N, Miyasaka D, Sakai Y, Horigome Y, Suzuki H, Dohmae Y, Endo N. Investigation on the measurement sites of the cross-sectional areas of the gluteus maximus and gluteus medius. Surg Radiol Anat. 2019 Jan;41(1):109-115. doi: 10.1007/s00276-018-2099-9. Epub 2018 Sep 6.
- Individual participant dataSharing planned: No. No individual participant data (IPD) will be publicly shared but the data will be made available upon request.
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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.
Enejd Veizi study chair
Ankara City Hospital Bilkent
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sling release and Sling release and repair in people with Hip Osteoarthritis and Osteoarthritis, Hip, run by Ankara City Hospital Bilkent at 1 site in Turkey (Türkiye).
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 3 inclusion and 14 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 28 Feb 2025. 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 Turkey (Türkiye). 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?
Muscle atrophy (time frame: Preoperative & Postoperative 6th month). The study lists 3 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 NCT06850155, which also lists 3 linked publications.
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 28 Feb 2025.