TendinopathyETIPICNCT05950022
Clinical Improvement Obtained by Endoscopic Ilio-Psoas Tenotomy (Lesser Trochanter Versus Acetabular Notch)
A study testing Endoscopic tenotomy surgery of the iliopsoas tendon in people with Tendinopathy, run by GCS Ramsay Santé pour l'Enseignement et la Recherche at 1 site in France.
Trial summary
The purpose of the study is to assess Oxford Hip Score at baseline, at 2 months and at over 12 months. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tendinopathy
- What is being tested?
- Endoscopic tenotomy surgery of the iliopsoas tendon
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- 1 siteFrance
- Study dates
- 19 Dec 2023to Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Clinique de la Sauvegarde
Lyon, 69009
Nicolas BONIN, MD, 6 71 89 10 99 ext. +33, n.bonin@gmail.com
About this study
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
The purpose of the study is to assess Oxford Hip Score at baseline, at 2 months and at over 12 months.
Read the 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.
- Conditions
- Tendinopathy
- Being tested
- Endoscopic tenotomy surgery of the iliopsoas tendon
- Medical subject headings
- Tendinopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endoscopic tenotomy surgery of the iliopsoas tendonProcedure or surgery
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 group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: Endoscopic tenotomy surgery of the iliopsoas tendon |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2023
- Study start19 Dec 2023
- Primary completionDec 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TendinopathyStudies of the same condition, open and under way.
- More trials run by GCS Ramsay Santé pour l'Enseignement et la RechercheThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Interventional, comparative, randomized study, in 2 parallel groups, single-blind
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 108 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Euraxi Pharma
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05950022
- Sponsor's protocol ID
- 2023-A00802-43
- Acronym
- ETIPIC
- Status last verified
- Mar 2026
- First submitted
- 4 Jul 2023
- Last updated
- 1 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05950022
- Acronym / sponsor ID
- ETIPIC / 2023-A00802-43
- Conditions
- Tendinopathy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 108 participants (estimated)
- Lead sponsor
- GCS Ramsay Santé pour l'Enseignement et la RechercheUniversity, hospital or other
- Collaborators
- Euraxi Pharma
- Study start
- 19 Dec 2023 (actual)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 18 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Interventional, comparative, randomized study, in 2 parallel groups, single-blind
| Arm | Type | Receives |
|---|---|---|
| Endoscopic tenotomy at the level of the lesser trochanter | Experimental | Procedure: Endoscopic tenotomy surgery of the iliopsoas tendonPatients will benefit from endoscopic tenotomy surgery of the iliopsoas tendon at the level of the lesser trochanter. |
| Endoscopic tenotomy at the level of the acetabular notch | Experimental | Procedure: Endoscopic tenotomy surgery of the iliopsoas tendonPatients will benefit from endoscopic tenotomy surgery of the iliopsoas tendon at the level of the acetabular notch. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Endoscopic tenotomy surgery of the iliopsoas tendonThe 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. | Procedure or surgery | Endoscopic tenotomy at the level of the acetabular notch, Endoscopic tenotomy at the level of the lesser trochanter |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Endoscopic tenotomy surgery of the iliopsoas tendon in people with Tendinopathy, run by GCS Ramsay Santé pour l'Enseignement et la Recherche at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nicolas BONIN, MD (6 71 89 10 99 ext. +33, n.bonin@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Oxford Hip Score (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2026.