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

Study Evaluating the Clinical Improvement Obtained by Endoscopic Tenotomy of the Ilio-Psoas, at the Level of the Lesser Trochanter Versus at the Level of the Acetabular Notch, on Psoas Cup Impingements After Total Hip Prosthesis

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

Study Overview

• Status: Recruiting
• Conditions: Tendinopathy
• Intervention / Treatment: Procedure: Endoscopic tenotomy surgery of the iliopsoas tendon

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.

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

Contacts and Locations

• Study Contact: Name: Nicolas BONIN, MD; Phone Number: +33 6 71 89 10 99; Email: n.bonin@gmail.com

Study Locations

• France
  • Lyon, France, 69009
    • Recruiting
    • Clinique de la Sauvegarde
    • Contact: Nicolas BONIN, MD; Phone Number: +33 6 71 89 10 99; Email: n.bonin@gmail.com

Participation Criteria

Eligibility Criteria

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

Description

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.

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: 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.	Procedure: 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.
Experimental: 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.	Procedure: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: GCS Ramsay Santé pour l'Enseignement et la Recherche

Study record dates

Study Major Dates

• Study Start (Actual): December 19, 2023
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2028

Study Registration Dates

• First Submitted: July 4, 2023
• First Submitted That Met QC Criteria: July 17, 2023
• First Posted (Actual): July 18, 2023

Study Record Updates

• Last Update Posted (Actual): December 22, 2023
• Last Update Submitted That Met QC Criteria: December 21, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Musculoskeletal Diseases; Muscular Diseases; Tendon Injuries; Tendinopathy
• Other Study ID Numbers: 2023-A00802-43

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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