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NCT Number: NCT05950022

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

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Clinique de la Sauvegarde

Lyon, 69009, France

Location status: Recruiting

Location contact

Nicolas BONIN, MD

CONTACT

[email protected]

6 71 89 10 99 ext. +33

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Oxford Hip Score

    Time frame: 1 year

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Nicolas BONIN, MD

CONTACT

[email protected]

6 71 89 10 99 ext. +33

Sponsors and collaborators

Lead sponsor

GCS Ramsay Santé pour l'Enseignement et la Recherche

Other

Collaborators

  • Euraxi Pharma

Registry information

Official study 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

Acronym: ETIPIC

Important dates

Study start
2023
Primary completion
2028
Study completion
2028
First posted
Jul 18, 2023
Registry last updated
Apr 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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