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临床试验/NCT06553508
NCT06553508已完成不适用

Trochanteric Bursal Repair After a Total Hip Replacement - Are There Benefits During the First 90 Days

Ankara City Hospital Bilkent2 个研究点 分布在 2 个国家目标入组 104 人开始时间: 2022年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
104
试验地点
2
主要终点
Rate of posterior gluteal pain

研究概览

简要总结

During total hip arthroplasty surgery, the trochanteric bursa is routinely excised. This anatomical structure, which functions as a soft tissue barrier, is generally recommended for removal as it facilitates the surgical approach. However, recent studies have suggested that the trochanteric bursa is an important soft tissue barrier and may protect against infections. The aim of this study is to evaluate the differences in infection rates, wound complications, deep gluteal syndrome presence, pain, and clinical scores within the first 90 days between patients in whom the trochanteric bursa was repaired and those in whom it was not, and to provide recommendations regarding bursal repair.

详细描述

During total hip arthroplasty surgery, the trochanteric bursa is routinely excised. This anatomical structure, which functions as a soft tissue barrier, is typically recommended for removal as it facilitates the surgical approach. However, recent studies have suggested that the trochanteric bursa is an important soft tissue barrier and may provide protection against infections. The aim of this study is to evaluate the differences in infection rates, wound complications, deep gluteal syndrome presence, pain, and clinical scores within the first 90 days between patients in whom the trochanteric bursa was repaired and those in whom it was not, and to provide recommendations regarding bursal repair.

This research will be a prospective randomized controlled trial with patients subjected to sequential randomization. One group of patients will undergo the routine excision of the bursa during surgery, referred to as Group 1. In the other group, the trochanteric bursa will be carefully retracted and subsequently repaired in its anatomical location beneath the fascia after the surgical procedure. Wound closure will be performed routinely, with subcutaneous and skin closure. All patients will have a Hemovac drain placed, and they will follow the same rehabilitation protocol.

Patients will be evaluated on postoperative days15, 30, and 90 using Visual Analog Scale scores, and on days 30 and 90 using the Harris Hip Score. Additionally, patients will be assessed for tenderness on palpation, the presence of hip snapping (a sensation of the hip catching), hemoglobin drop, 90-day infection rates, and the presence of deep gluteal syndrome.

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
None

入排标准

年龄范围
18 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients between 18 to 90 years of age
  • With a diagnosis of primary hip osteoarthritis
  • Willing to be included in the study

排除标准

  • Patients who had a known history of trochanteric bursitis, deep gluteal syndrome, sciatica, vertebral fracture, hip fracture, hip arthroscopy, and core decompression surgery
  • Patients who had a history of bursal injection within 6 months
  • Patients undergoing hip arthroplasty with a shortening osteotomy

结局指标

主要结局

Rate of posterior gluteal pain

时间窗: First postoperative 90 days

The condition is also refered to as Deep Gluteal Syndrome - Recorded as Yes / No

Rate of superficial wound problems

时间窗: First postoperative 90 days

Wound leakage, superficial infection, wound dehiscence - Recorded as Yes / No

Rate of painful trochanteric bursitis

时间窗: First postoperative 90 days

Recorded as pain on the trochanteric region on palpation - Recorded as Yes / No

次要结局

  • Range of motion (ROM)(First postoperative 90 days)
  • Visual Analog Scale (VAS)(First postoperative 90 days)
  • Harris Hip Score (HHS)(First postoperative 90 days)

研究者

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

Enejd Veizi, MD

Assistant Professor

Ankara City Hospital Bilkent

研究点 (2)

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