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

A

Ankara City Hospital

Status

Completed

Conditions

Bursa; Tuberculous
Hip Disease
Deep Gluteal Syndrome
Hip Bursitis

Treatments

Procedure: Trochanteric bursa repaired
Procedure: Trochanteric bursa unrepaired

Study type

Interventional

Funder types

Other

Identifiers

NCT06553508
E2-21-1124

Details and patient eligibility

About

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.

Full 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.

Enrollment

104 patients

Sex

All

Ages

18 to 90 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

104 participants in 2 patient groups

Unrepaired bursa group
Active Comparator group
Description:
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.
Treatment:
Procedure: Trochanteric bursa unrepaired
Repaired Bursa group
Experimental group
Description:
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.
Treatment:
Procedure: Trochanteric bursa repaired

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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