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临床试验/NCT06850155
NCT06850155已完成不适用

Impact of Gluteal Sling Release on Gluteal Dysfunction and Functional Outcomes in Primary Total Hip Arthroplasty

Ankara City Hospital Bilkent1 个研究点 分布在 1 个国家目标入组 144 人开始时间: 2023年9月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
144
试验地点
1
主要终点
Muscle atrophy

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Investigator)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

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

排除标准

  • •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

研究组 & 干预措施

Released Gluteal Sling

Experimental

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

干预措施: Sling release (Procedure)

Released&Repaired Gluteal Sling

Experimental

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

干预措施: Sling release and repair (Procedure)

Control Gluteal Sling

No Intervention

The Gluteal sling was left untouched during the whole procedure

结局指标

主要结局

Muscle atrophy

时间窗: Preoperative & Postoperative 6th month

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

Muscle density

时间窗: Preoperative & Postoperative 6th month

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

Kinematic assesment

时间窗: Postoperative 6th month

Muscle strength through kinematic assesment (Nm)

次要结局

  • 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)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Enejd Veizi, MD

MD

Ankara City Hospital Bilkent

研究点 (1)

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