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

NCT06850155 | Completed

• 1 other identifier: E2-23-4913
• Study Type: interventional
• Target: 144
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

hip arthroplasty; gluteal sling; muscle atrophy; gluteus maximus

Outcome Measures

Primary Outcomes (3)

• Muscle atrophy

  Muscle atrophy through cross-sectional area measurement on CT scans (number, cm\^2)

  Preoperative & Postoperative 6th month

• Muscle density

  Muscle density measurements on CT scans (Hounsfield units - HU)

  Preoperative & Postoperative 6th month

• Kinematic assesment

  Muscle strength through kinematic assesment (Nm)

  Postoperative 6th month

Secondary Outcomes (3)

• Visual Analog Scale (VAS)

  Preoperative & Postoperative 6th month

• Harris Hip Score (HHS)

  Preoperative & Postoperative 6th month

• Western Ontario and McMaster Universities Arthritis Index (WOMAC)

  Preoperative & Postoperative 6th month

Study Arms (3)

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

Procedure: Sling release

Released&Repaired Gluteal Sling

EXPERIMENTAL

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

Procedure: Sling release and repair

Interventions

Sling release PROCEDURE

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

Released Gluteal Sling

Sling release and repair PROCEDURE

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

Released&Repaired Gluteal Sling

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients diagnosed with unilateral coxarthrosis
• Scheduled for primary total hip arthroplasty (THA)
• Age between 18 and 90 years

You may not qualify if:

• 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

Sponsors & Collaborators

• Ankara City Hospital Bilkent: lead

Study Sites (1)

Ankara Bilkent City Hospital

Ankara, 06800, Turkey (Türkiye)

Location

Related Publications (3)

• 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.

  PMID: 33779410 RESULT

• 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.

  PMID: 26652475 RESULT

• 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.

  PMID: 30191287 RESULT

MeSH Terms

Conditions

Osteoarthritis, Hip; Fatty Liver; Muscular Atrophy

Interventions

Wound Healing

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Liver Diseases; Digestive System Diseases; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Regeneration; Biological Phenomena

Study Officials

• Enejd Veizi

  Ankara City Hospital Bilkent

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: February 23, 2025
• First Posted: February 27, 2025
• Study Start: September 1, 2023
• Primary Completion: August 1, 2024
• Study Completion: February 4, 2025
• Last Updated: February 28, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)