Clinical Improvement Obtained by Endoscopic Ilio-Psoas Tenotomy (Lesser Trochanter Versus Acetabular Notch)

NCT ID: NCT05950022

Last Updated: 2025-03-30

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 108 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-12-19
• Study Completion Date: 2028-12-31

Brief Summary

The purpose of the study is to assess Oxford Hip Score at baseline, at 2 months and at over 12 months.

Detailed Description

This is an interventional, comparative, randomized study, in 2 parallel groups, single-blind (the patient does not know which technique he will benefit from, the surgeon will carry out the surgery and will therefore be informed of the result of the randomization ) and monocentric.

Comparative prospective cohort study of an endoscopic tenotomy surgery of the iliopsoas tendon at the level of the lesser trochanter versus at the level of the acetabular notch, in the context of anterior pain for impingement between the iliopsoas tendon and the prosthetic cup in patients after Total Hip Prosthesis.

The study will be proposed to the patient during the preoperative consultation. Patients eligible for surgery will be offered the study. After a reflection period of at least 15 days, patients who agree to participate in the study will be included. Randomization will be done by drawing lots to decide whether the endoscopic tenotomy will be performed at the level of the lesser trochanter or at the level of the acetabular notch. The surgery will be performed under general anesthesia with standardized multimodal analgesia. Whatever the techniques, the approaches, the instruments to perform the procedure and the postoperative course will be identical, as in usual practice.

Conditions

Tendinopathy

Study Design

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

Study Groups

Endoscopic tenotomy at the level of the lesser trochanter

Patients will benefit from endoscopic tenotomy surgery of the iliopsoas tendon at the level of the lesser trochanter.

Group Type: EXPERIMENTAL

Endoscopic tenotomy surgery of the iliopsoas tendon

Intervention Type: PROCEDURE

The surgery will be performed under general anesthesia with standardized multimodal analgesia. Whatever the techniques, the approaches, the instruments to perform the procedure and the postoperative course will be identical, as in usual practice.

Endoscopic tenotomy at the level of the acetabular notch

Patients will benefit from endoscopic tenotomy surgery of the iliopsoas tendon at the level of the acetabular notch.

Group Type: EXPERIMENTAL

Endoscopic tenotomy surgery of the iliopsoas tendon

Intervention Type: PROCEDURE

The surgery will be performed under general anesthesia with standardized multimodal analgesia. Whatever the techniques, the approaches, the instruments to perform the procedure and the postoperative course will be identical, as in usual practice.

Interventions

Endoscopic tenotomy surgery of the iliopsoas tendon

The surgery will be performed under general anesthesia with standardized multimodal analgesia. Whatever the techniques, the approaches, the instruments to perform the procedure and the postoperative course will be identical, as in usual practice.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Age ≥ 18 years old;
• Definite diagnosis of iliopsoas tendinopathy due to conflict between the tendon and the prosthetic cup;
• Failure of first-line conservative treatment;
• Planned endoscopic tenotomy;
• Affiliation to the social security scheme;
• Signed informed consent.

Exclusion Criteria

• Revision total hip prosthesis, multiple operations prior to tenotomy;
• Other surgical or medical interventions planned during the study;
• Participation in another clinical trial, or during a period of exclusion from another clinical trial;
• Pregnant or likely to be pregnant (of childbearing age, without effective contraception) or breastfeeding;
• Patient deprived of liberty or under guardianship or curatorship or unable to give consent.

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

Sponsors

Euraxi Pharma

INDUSTRY

Sponsor Role: collaborator

GCS Ramsay Santé pour l'Enseignement et la Recherche

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Clinique de la Sauvegarde

Lyon, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Nicolas BONIN, MD

Role: CONTACT

n.bonin@gmail.com

6 71 89 10 99 ext. +33

Facility Contacts

Nicolas BONIN, MD

Role: primary

n.bonin@gmail.com

6 71 89 10 99 ext. +33

Other Identifiers

2023-A00802-43

Identifier Type: -

Identifier Source: org_study_id