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

NCT06553508 | Completed

• 1 other identifier: E2-21-1124
• Study Type: interventional
• Target: 104
• Locations: 1 country
• Sites: 1

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.

Conditions

Bursa; Tuberculous; Hip Bursitis; Deep Gluteal Syndrome; Hip Disease

Keywords

bursa; greater trochanter; hip arthroplasty; deep gluteal syndrome; piriformis syndrome

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (3)

• Range of motion (ROM)

  First postoperative 90 days

• Visual Analog Scale (VAS)

  First postoperative 90 days

• Harris Hip Score (HHS)

  First postoperative 90 days

Study Arms (2)

Unrepaired bursa group

ACTIVE COMPARATOR

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

Repaired Bursa group

EXPERIMENTAL

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

Interventions

Trochanteric bursa repaired PROCEDURE

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

Repaired Bursa group

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.

Unrepaired bursa group

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ankara City Hospital Bilkent: lead

Study Sites (1)

Ankara Bilkent City Hospital

Ankara, 06800, Turkey (Türkiye)

Location

Related Publications (3)

• 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.

  PMID: 26229811 BACKGROUND

• 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.

  PMID: 29195847 BACKGROUND

• 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.

  PMID: 33132093 BACKGROUND

MeSH Terms

Conditions

Latent Tuberculosis; Hip socket neuropathy; Piriformis Muscle Syndrome

Condition Hierarchy (Ancestors)

Tuberculosis; Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Latent Infection; Sciatic Neuropathy; Mononeuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Nerve Compression Syndromes; Neuralgia; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pelvic Pain

Study Officials

• Enejd Veizi, MD

  Ankara City Hospital Bilkent

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Randomized controlled trial

Study Record Dates

• First Submitted: August 12, 2024
• First Posted: August 14, 2024
• Study Start: January 1, 2022
• Primary Completion: December 31, 2022
• Study Completion: January 1, 2023
• Last Updated: August 16, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)