Evaluating the Need for Transosseous Anchoring in Anterolateral Hip Prosthetic Surgery

NCT ID: NCT06675968

Last Updated: 2024-11-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 108 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-05-02
• Study Completion Date: 2023-12-12

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Direct suture

Group Type: EXPERIMENTAL

Direct Suture

Intervention Type: 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.

Transsosseus suture

Group Type: EXPERIMENTAL

Transosseus Suture

Intervention Type: 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.

Interventions

Direct Suture

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.

Intervention Type: PROCEDURE

Transosseus Suture

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.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mireia Vinas Noguera

OTHER

Sponsor Role: lead

Responsible Party

Mireia Vinas Noguera

Doctor

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Hospital Parc Taulí

Sabadell, Barcelona, Spain

Countries

Spain

Other Identifiers

Gluteus Medius

Identifier Type: -

Identifier Source: org_study_id