Evaluating the Need for Transosseous Anchoring in Anterolateral Hip Prosthetic Surgery

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

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.

Study Overview

• Status: Completed
• Conditions: Suture, Complication
• Intervention / Treatment: Procedure: Direct Suture; Procedure: Transosseus Suture

• Study Type: Interventional
• Enrollment (Actual): 108
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Barcelona
    • Sabadell, Barcelona, Spain, 08208
      • Hospital Parc Tauli

Participation Criteria

Eligibility Criteria

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

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Direct suture	Procedure: 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.
Experimental: Transsosseus suture	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain Level	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.	Preoperative at 24 and 48 hours and postoperative at 3, 6 and 12 months
Quality of life	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)	Preoperative, 3, 6 and 12 months.
Surgeons sensation	Score 1-3, 1 suture stability, 2 partial stability, 3 sensation of instability.	3 and 12 months
Patient Satisfaction	Questionnaire with 5 possible and gradual responses, from zero to complete satisfaction.	3 and 12 months
Complications	Determine the presence and, where appropriate, the type.	Up to 1 year
Complementary tests	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.	Up to 1 year

Collaborators and Investigators

• Sponsor: Mireia Vinas Noguera

Study record dates

Study Major Dates

• Study Start (Actual): May 2, 2022
• Primary Completion (Actual): December 12, 2023
• Study Completion (Actual): December 12, 2023

Study Registration Dates

• First Submitted: October 30, 2024
• First Submitted That Met QC Criteria: November 4, 2024
• First Posted (Actual): November 6, 2024

Study Record Updates

• Last Update Posted (Actual): November 6, 2024
• Last Update Submitted That Met QC Criteria: November 4, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: Gluteus Medius

Drug and device information, study documents

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