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OpenTrials
Completed

NCT Number: NCT06675968

Evaluating the Need for Transosseous Anchoring in Anterolateral Hip Prosthetic Surgery

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.

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Key information

Conditions

Suture, Complication

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Parc Taulí

Sabadell, Barcelona, 08208, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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
  • Patients with a diagnosis other than the inclusion criteria (e.g. acute femoral fracture requiring total hip arthroplasty

Treatment and study plan

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.

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.

Primary outcomes

  1. Trendelenburg Test

    Time frame: preoperative and 3 months

    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.

Secondary outcomes

  1. Pain Level

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

    Pain levels, assessed with a visual analogue scale (VAS) from 0 to 10, with 0 being no pain and 10 being the maximum bearable pain.

  2. Quality of life

    Time frame: Preoperative, 3, 6 and 12 months.

    Functionality and quality of life are assessed with the Harris Hip Score questionnaire (questionnaire on functionality, quality of life, limp, mobility, deformity). This functional test is approved by the International Society of Hip Surgery (Harris Hip Score)

  3. Surgeons sensation

    Time frame: 3 and 12 months

    Score 1-3, 1 suture stability, 2 partial stability, 3 sensation of instability.

  4. Patient Satisfaction

    Time frame: 3 and 12 months

    Questionnaire with 5 possible and gradual responses, from zero to complete satisfaction.

  5. Complications

    Time frame: Up to 1 year

    Determine the presence and, where appropriate, the type.

  6. Complementary tests

    Time frame: Up to 1 year

    In the case of a positive Trendelenburg test, the integrity of the abductor apparatus and motor innervation can be studied. Ultrasound is a non-invasive test usually performed in the case of clinical suspicion of abductor apparatus insufficiency. Electromyography is a non-invasive test, performed using surface electrodes, which assesses the functionality of the superior gluteal nerve, responsible for innervation of the gluteus medius muscle, usually requested in the case of suspicion of the abductor apparatus.

Sponsors and collaborators

Lead sponsor

Mireia Vinas Noguera

Other

Registry information

Official study title

A Randomized, Prospective, Single-blind Controlled Clinical Trial to Systematically Assess the Need for Transosseous Anchoring in the Anterolateral Approach to Primary Hip Prosthetic Surgery

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Nov 6, 2024
Registry last updated
Nov 6, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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