Clinical trial NCT06553508: Trochanteric Bursal Repair After a Total Hip Replacement - Are There Benefits During the First 90 Days
Official title: Trochanteric Bursal Repair After a Total Hip Replacement - Are There Benefits During the First 90 Days
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bursa; Tuberculous
Hip Bursitis
Deep Gluteal Syndrome
Hip Disease
Keywords: bursa
greater trochanter
hip arthroplasty
deep gluteal syndrome
piriformis syndrome
Lead sponsor: Ankara City Hospital Bilkent
Sponsor class: OTHER
First posted: 2024-08-14
Enrollment: 104
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled trial
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Rate of superficial wound problems
timeFrame: First postoperative 90 days
measure: Rate of posterior gluteal pain
timeFrame: First postoperative 90 days
measure: Rate of painful trochanteric bursitis
timeFrame: First postoperative 90 days
Secondary outcomes:
measure: Range of motion (ROM)
timeFrame: First postoperative 90 days
measure: Visual Analog Scale (VAS)
timeFrame: First postoperative 90 days
measure: Harris Hip Score (HHS)
timeFrame: First postoperative 90 days
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Ankara Bilkent City Hospital
Study officials:
affiliation: Ankara City Hospital Bilkent
name: Enejd Veizi, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Schwartsmann CR, Loss F, de Freitas Spinelli L, Furian R, Silva MF, Zanatta JM, Boschin LC, Goncalves RZ, Yepez AK. Association between trochanteric bursitis, osteoarthrosis and total hip arthroplasty. Rev Bras Ortop. 2014 Apr 25;49(3):267-70. doi: 10.1016/j.rboe.2014.04.009. eCollection 2014 May-Jun.
citation: Shemesh SS, Moucha CS, Keswani A, Maher NA, Chen D, Bronson MJ. Trochanteric Bursitis Following Primary Total Hip Arthroplasty: Incidence, Predictors, and Treatment. J Arthroplasty. 2018 Apr;33(4):1205-1209. doi: 10.1016/j.arth.2017.11.016. Epub 2017 Nov 13.
citation: Moerenhout K, Benoit B, Gaspard HS, Rouleau DM, Laflamme GY. Greater trochanteric pain after primary total hip replacement, comparing the anterior and posterior approach: A secondary analysis of a randomized trial. Orthop Traumatol Surg Res. 2021 Dec;107(8):102709. doi: 10.1016/j.otsr.2020.08.011. Epub 2020 Oct 31.