Clinical trial NCT05950022: Clinical Improvement Obtained by Endoscopic Ilio-Psoas Tenotomy (Lesser Trochanter Versus Acetabular Notch)
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Tendinopathy
Lead sponsor: GCS Ramsay Santé pour l'Enseignement et la Recherche
Sponsor class: OTHER
Collaborators: name: Euraxi Pharma
First posted: 2023-07-18
Enrollment: 108
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Interventional, comparative, randomized study, in 2 parallel groups, single-blind
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Oxford Hip Score
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Lyon
country: France
facility: Clinique de la Sauvegarde
Study officials:
References: