Evaluating the Need for Transosseous Anchoring in Anterolateral Hip Prosthetic Surgery

NCT06675968 | Completed

• 1 other identifier: Gluteus Medius
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 1

Brief Summary

The study aims to discuss the challenges associated with breakage or failure of the abductor mechanism after total hip arthroplasty, which can lead to gait issues, instability, and the need for revision surgery. Sutures play a crucial role in preventing these failures, with two main types: transosseous and tendon sutures. Transosseous suturing involves using non-absorbable threads anchored in the bone, while tendon suturing uses absorbable threads for layered closure. Both techniques are commonly used, but there is a lack of evidence to determine which is more beneficial for patients. Current studies are limited and often focus on cases requiring revision surgery due to complications, with transosseous sutures generally being the preferred method. A meta-analysis indicated that transosseous repair may result in lower dislocation rates and less postoperative pain, but further randomized clinical trials with long-term follow-up are necessary for definitive conclusions. The text proposes a prospective study to compare transosseous suturing with the common absorbable tendon suturing in primary hip surgeries.

Conditions

Suture, Complication

Outcome Measures

Primary Outcomes (1)

• Trendelenburg Test

  It evaluates the paradoxical elevation of the pelvis in monopodal support on the observed limb. It suggests insufficiency or rupture of the abductor apparatus. It can be positive (+), that is, suggesting abductor pathology, or negative (-), that is, suggesting the absence of a clinical problem in that segment. This is a clinical test that is usually performed during preoperative and follow-up visits to the patient and does not present any risks for the patient. It is performed with the patient standing with body weight evenly distributed. The examiner stands behind the patient and identifies the iliac crests and posterior superior iliac spine. The patient raises the leg that is contralateral to the side being evaluated.

  preoperative and 3 months

Secondary Outcomes (6)

• Pain Level

  Preoperative at 24 and 48 hours and postoperative at 3, 6 and 12 months

• Quality of life

  Preoperative, 3, 6 and 12 months.

• Surgeons sensation

  3 and 12 months

• Patient Satisfaction

  3 and 12 months

• Complications

  Up to 1 year

Study Arms (2)

Direct suture

EXPERIMENTAL

Procedure: Direct Suture

Transsosseus suture

EXPERIMENTAL

Procedure: Transosseus Suture

Interventions

Direct Suture PROCEDURE

A capsular closure will be performed, closure of the gluteus medius with a direct tendon and absorbable suture. Addittionally, the iliotibial band, subcutaneous and skin suture closure will be performed.

Direct suture

Transosseus Suture PROCEDURE

A capsular closure will be performed, transosseous suture with a non-absorbable suture. Addittionally, the iliotibial band, subcutaneous and skin suture closure will be performed.

Transsosseus suture

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult population
• Patients diagnosed with coxarthrosis (stages 2 and 3), confirmed by X-ray, according to D. Tonnis's classification of 1972
• Willingness to follow up for up to 12 months
• Patients capable of understanding the study and giving their informed consent

You may not qualify if:

• Difficulty understanding and following the study procedure
• Patients with previous surgery on the same hip

Sponsors & Collaborators

• Mireia Vinas Noguera: lead

Study Sites (1)

Hospital Parc Taulí

Sabadell, Barcelona, 08208, Spain

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: October 30, 2024
• First Posted: November 6, 2024
• Study Start: May 2, 2022
• Primary Completion: December 12, 2023
• Study Completion: December 12, 2023
• Last Updated: November 6, 2024

Record last verified: 2024-11

Locations

ES (1)