Gluteal Sling Release on Gluteal Dysfunction After in Primary Total Hip Arthroplasty

NCT ID: NCT06850155

Last Updated: 2025-02-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 144 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-09-01
• Study Completion Date: 2025-02-04

Brief 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 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.

Conditions

Hip Osteoarthritis; Osteoarthritis, Hip; Gluteus Maximus Muscle Atrophy; Muscle Weakness Condition; Fatty Degeneration

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Control Gluteal Sling

The Gluteal sling was left untouched during the whole procedure

Group Type: NO_INTERVENTION

No interventions assigned to this group

Released Gluteal Sling

The Gluteal sling was released and left unrepaired at the end of the procedure

Group Type: EXPERIMENTAL

Sling release

Intervention Type: PROCEDURE

The gluteal sling was released and left unrepaired at the end of the procedure

Released&Repaired Gluteal Sling

The Gluteal sling was released and then repaired at the end of the procedure

Group Type: EXPERIMENTAL

Sling release and repair

Intervention Type: PROCEDURE

The gluteal sling was released and then repaired at the end of the procedure

Interventions

Sling release

The gluteal sling was released and left unrepaired at the end of the procedure

Intervention Type: PROCEDURE

Sling release and repair

The gluteal sling was released and then repaired at the end of the procedure

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ankara City Hospital Bilkent

OTHER

Sponsor Role: lead

Responsible Party

Enejd Veizi, MD

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Enejd Veizi

Role: STUDY_CHAIR

Ankara City Hospital Bilkent

Locations

Ankara Bilkent City Hospital

Ankara, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

References

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.

Reference Type: RESULT

PMID: 33779410 (View on PubMed)

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.

Reference Type: RESULT

PMID: 26652475 (View on PubMed)

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.

Reference Type: RESULT

PMID: 30191287 (View on PubMed)

Other Identifiers

E2-23-4913

Identifier Type: -

Identifier Source: org_study_id