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.

Study Overview

• Status: Completed
• Conditions: Hip Disease; Deep Gluteal Syndrome; Hip Bursitis; Bursa; Tuberculous
• Intervention / Treatment: Procedure: Trochanteric bursa unrepaired; Procedure: Trochanteric bursa repaired

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 Type: Interventional
• Enrollment (Actual): 104
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Ankara, Turkey, 06800
    • Ankara Bilkent City Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Unrepaired bursa group; 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.	Procedure: Trochanteric bursa unrepaired; 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.
Experimental: Repaired Bursa group; 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.	Procedure: Trochanteric bursa repaired; As a routine procedure in our centre, the trochanteric bursa is left unrepaired after a hip arthroplasty.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Ankara City Hospital Bilkent
• Investigators: Principal Investigator: Enejd Veizi, MD, Ankara Bilkent City Hospital

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2022
• Primary Completion (Actual): December 31, 2022
• Study Completion (Actual): January 1, 2023

Study Registration Dates

• First Submitted: August 12, 2024
• First Submitted That Met QC Criteria: August 13, 2024
• First Posted (Actual): August 14, 2024

Study Record Updates

• Last Update Posted (Actual): August 16, 2024
• Last Update Submitted That Met QC Criteria: August 14, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Keywords: hip arthroplasty; deep gluteal syndrome; piriformis syndrome; bursa; greater trochanter
• Additional Relevant MeSH Terms: Pathologic Processes; Disease; Joint Diseases; Musculoskeletal Diseases; Syndrome; Bursitis
• Other Study ID Numbers: E2-21-1124

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No