- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06850155
Gluteal Sling Release on Gluteal Dysfunction After in Primary Total Hip Arthroplasty
Impact of Gluteal Sling Release on Gluteal Dysfunction and Functional Outcomes in Primary Total Hip Arthroplasty
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Ankara, Turkey, 06800
- Ankara Bilkent City Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Patients diagnosed with unilateral coxarthrosis
- Scheduled for primary total hip arthroplasty (THA)
- Age between 18 and 90 years
Exclusion Criteria:
Coxarthrosis secondary to:
- Developmental hip dysplasia
- Fracture-related pathology
Conditions requiring revision surgery, including:
- Periprosthetic fractures
- Current or previous hip joint infections
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: Control Gluteal Sling
The Gluteal sling was left untouched during the whole procedure
|
|
|
Experimental: Released Gluteal Sling
The Gluteal sling was released and left unrepaired at the end of the procedure
|
The gluteal sling was released and left unrepaired at the end of the procedure
|
|
Experimental: Released&Repaired Gluteal Sling
The Gluteal sling was released and then repaired at the end of the procedure
|
The gluteal sling was released and then repaired at the end of the procedure
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Muscle density
Time Frame: Preoperative & Postoperative 6th month
|
Muscle density measurements on CT scans (Hounsfield units - HU)
|
Preoperative & Postoperative 6th month
|
|
Kinematic assesment
Time Frame: Postoperative 6th month
|
Muscle strength through kinematic assesment (Nm)
|
Postoperative 6th month
|
|
Muscle atrophy
Time Frame: Preoperative & Postoperative 6th month
|
Muscle atrophy through cross-sectional area measurement on CT scans (number, cm^2)
|
Preoperative & Postoperative 6th month
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Visual Analog Scale (VAS)
Time Frame: Preoperative & Postoperative 6th month
|
minimum value:0, maximum value 10, higher values mean worse outcome
|
Preoperative & Postoperative 6th month
|
|
Harris Hip Score (HHS)
Time Frame: Preoperative & Postoperative 6th month
|
minimum value:0, maximum value 100, higher values mean better outcome
|
Preoperative & Postoperative 6th month
|
|
Western Ontario and McMaster Universities Arthritis Index (WOMAC)
Time Frame: Preoperative & Postoperative 6th month
|
minimum value:0, maximum value 100, higher values mean worse outcome
|
Preoperative & Postoperative 6th month
|
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Enejd Veizi, Ankara City Hospital Bilkent
Publications and helpful links
General 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.
- Uemura 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.
- Homma 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.
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
- E2-23-4913
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
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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