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

NCT05950022 | Recruiting

• 1 other identifier: 2023-A00802-43
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Tendinopathy

Outcome Measures

Primary Outcomes (1)

• Oxford Hip Score

  Compare the clinical improvement experienced by patients having an endoscopic tenotomy of the iliopsoas tendon at the level of the lesser trochanter versus at the level of the notch at more than 1 year minimum. The Oxford Hip Score is a self-administered patient-administered 12-item "Patient Reported Outcome Measures" questionnaire that allows the surgeon to assess clinical outcomes after total hip replacement.

  1 year

Study Arms (2)

Endoscopic tenotomy at the level of the lesser trochanter

EXPERIMENTAL

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

Procedure: Endoscopic tenotomy surgery of the iliopsoas tendon

Endoscopic tenotomy at the level of the acetabular notch

EXPERIMENTAL

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

Procedure: Endoscopic tenotomy surgery of the iliopsoas tendon

Interventions

Endoscopic tenotomy surgery of the iliopsoas tendon 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; Endoscopic tenotomy at the level of the lesser trochanter

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• Revision total hip prosthesis, multiple operations prior to tenotomy;
• Other surgical or medical interventions planned during the study;
• 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.

Sponsors & Collaborators

• GCS Ramsay Santé pour l'Enseignement et la Recherche: lead
• Euraxi Pharma: collaborator

Study Sites (1)

Clinique de la Sauvegarde

Lyon, 69009, France

RECRUITING

MeSH Terms

Conditions

Tendinopathy

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Tendon Injuries; Wounds and Injuries

Central Study Contacts

Nicolas BONIN, MD

CONTACT

6 71 89 10 99; n.bonin@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: The patient does not know which technique he will benefit from, the surgeon will proceed with the surgery and will therefore be informed of the result of the randomization
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Interventional, comparative, randomized study, in 2 parallel groups, single-blind

Study Record Dates

• First Submitted: July 4, 2023
• First Posted: July 18, 2023
• Study Start: December 19, 2023
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: April 1, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)