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

Not Applicable

Completed

• Conditions: Hip Bursitis; Bursa; Tuberculous; Deep Gluteal Syndrome; Hip Disease
• Interventions: Procedure: Trochanteric bursa unrepaired; Procedure: Trochanteric bursa repaired

• Registration Number: NCT06553508
• Lead Sponsor: Ankara City Hospital Bilkent

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2022-01-01
• Primary Completion: 2022-12-31
• Study Completion: 2023-01-01
• Status Verified: 2024-08
• Study First Submitted: 2024-08-12
• Study First Submitted QC: 2024-08-13
• Study First Posted: 2024-08-14
• Last Update Submitted: 2024-08-14
• Last Update Posted: 2024-08-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 104

Inclusion Criteria

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

Exclusion Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Unrepaired bursa group	Trochanteric bursa unrepaired	As a routine procedure in our centre, the trochanteric bursa is left unrepaired after a hip arthroplasty. The conventional joint closure is performed after reduction and the layers are closed in a routine fashion.
Repaired Bursa group	Trochanteric bursa repaired	For the experimental arm, the trochanteric bursa is repaired after a hip arthroplasty. The conventional joint closure is performed after reduction and then the bursa is retrieved and repaired. Layers are then closed in a routine fashion.

Primary Outcome Measures

Name	Time	Method
Rate of posterior gluteal pain	First postoperative 90 days	The condition is also refered to as Deep Gluteal Syndrome - Recorded as Yes / No
Rate of superficial wound problems	First postoperative 90 days	Wound leakage, superficial infection, wound dehiscence - Recorded as Yes / No
Rate of painful trochanteric bursitis	First postoperative 90 days	Recorded as pain on the trochanteric region on palpation - Recorded as Yes / No

Secondary Outcome Measures

Name	Time	Method
Range of motion (ROM)	First postoperative 90 days	Angular measurement of hip joint motion - minimum value:0, maximum value 130, higher values mean better outcome
Visual Analog Scale (VAS)	First postoperative 90 days	minimum value:0, maximum value 10, higher values mean worse outcome
Harris Hip Score (HHS)	First postoperative 90 days	minimum value:0, maximum value 100, higher values mean better outcome

Trial Locations

Locations (1)

Ankara Bilkent City Hospital; 🇹🇷 Ankara, Turkey