Clinical Improvement Obtained by Endoscopic Ilio-Psoas Tenotomy (Lesser Trochanter Versus Acetabular Notch)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Endoscopic tenotomy surgery of the iliopsoas tendon.
- Who it may be relevant to
- Registry conditions: Tendinopathy. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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
Overview
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.
Interventions
- 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.
Primary outcome measures
- Oxford Hip Score [Time frame: 1 year]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
France · 1 center
- Clinique de la Sauvegarde — Lyon
Identifiers
NCT: NCT05950022 · 2023-A00802-43