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NCT Number: NCT06553508

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

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Trochanteric bursa repaired

Procedure

As a routine procedure in our centre, the trochanteric bursa is left unrepaired after a hip arthroplasty.

Trochanteric bursa unrepaired

Procedure

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.

Primary outcomes

  1. Rate of superficial wound problems

    Time frame: First postoperative 90 days

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

  2. Rate of posterior gluteal pain

    Time frame: First postoperative 90 days

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

  3. Rate of painful trochanteric bursitis

    Time frame: First postoperative 90 days

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

Secondary outcomes

  1. Range of motion (ROM)

    Time frame: First postoperative 90 days

    Angular measurement of hip joint motion - minimum value:0, maximum value 130, higher values mean better outcome

  2. Visual Analog Scale (VAS)

    Time frame: First postoperative 90 days

    minimum value:0, maximum value 10, higher values mean worse outcome

  3. Harris Hip Score (HHS)

    Time frame: First postoperative 90 days

    minimum value:0, maximum value 100, higher values mean better outcome

Sponsors and collaborators

Lead sponsor

Ankara City Hospital Bilkent

Other

Registry information

Important dates

Study start
2022
Primary completion
2022
Study completion
2023
First posted
Aug 14, 2024
Registry last updated
Aug 16, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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