Hip InjuriesTEPSeNCT06064136
Psoas Tenotomy Under Ultrasound
A study testing Psoas tenotomy under ultrasound in people with Hip Injuries, run by Centre Hospitalier Universitaire de Nice at 1 site in France.
Trial summary
The ilio-psoas conflict is a commonly accepted complication after total hip replacement, often linked to a mispositioning of the acetabular prosthetic component that conflicts with the ilio-psoas tendon. To correct these pains, a psoas tenotomy can be proposed. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hip Injuries
- What is being tested?
- Psoas tenotomy under ultrasound
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteFrance
- Study dates
- 20 Nov 2025to 2 Feb 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Patients 18 years of age or older
- Indication of psoas tenotomy for ilio-psoas conflict after total hip replacement
- Signature of the written informed consent form by the patient
- Affiliation to a French health insurance scheme or equivalent
- Non Inclusion criteria:
- Vulnerable people: pregnant or breast-feeding women (patients will undergo a pregnancy test: urinary test), adult under guardianship or deprived of freedom.
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- Allergies to local anesthetics
- Patient on anticoagulant or antiplatelet agents
- Contraindication to surgery
- Refusal of patient involvement
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
The ilio-psoas conflict is a commonly accepted complication after total hip replacement, often linked to a mispositioning of the acetabular prosthetic component that conflicts with the ilio-psoas tendon. To correct these pains, a psoas tenotomy can be proposed. The results proven by the literature are very satisfactory. Psoas tenotomy is performed endoscopically, arthroscopically, or more rarely open.
The contribution of echo surgery allows to limit the scar ransom but also to free itself from a complex infrastructure to the operating room including an arthroscopy column and an intraoperative fluoroscopy for a conventional tenotomy, This also saves procedural and installation time.
Read more
No studies to date have described ultrasound-assisted psoas tenotomy Yhe investigators conducted a cadaveric study of the feasibility of psoas tenotomy under ultrasound that confirms the feasibility of this technique and the safety of the gesture for the surrounding anatomical structures.
The objectives of this study are to assess the feasibility, pain and functional outcomes of ultrasound-assisted psoas tenotomy in patients with ilio-psoas conflict after total hip replacement.
- Conditions
- Hip Injuries
- Being tested
- Psoas tenotomy under ultrasound
- Medical subject headings
- Hip Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Psoas tenotomy under ultrasoundProcedure or surgery
Tenotomy of the ilio-psoas tendon under ultrasound is performed using an ultrasound machine, a 3 mm Acufex hook blade and a specific kit usually used for guided vertebroplasty and which allows the introduction of the Acufex hook blade atraumatically (foam end). The patient, under general anesthesia, is placed in supine position with the hip extending from 15 to 20°.
| Study group | Role | What they receive |
|---|---|---|
| Patient with ilio-psoas conflict and having a tenotomy indication | Experimental | Not described Receives: Procedure: Psoas tenotomy under ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the success rate of this new ultrasound-guided ilio-psoas tendon tenotomy technique
The success of this new ultrasound-guided ilio-psoas tendon tenotomy technique will be assessed by the disappearance of the ilio-psoas conflict after surgery. This criterion will be measured at the first control consultation
Measured: 3 weeks post-operative
Secondary outcomes (17)
Evaluate the new ultrasound-guided ilio-psoas tendon tenotomy technique compared to standard practice on pain experienced by the patient
The pain felt by the patient will be collected using a numerical scale from 0 to 10 before surgery, 3 hours after surgery, the day after surgery, then 3 weeks, 6 weeks, 3 months and 6 months after surgery. Zero '0', means that the patient has no pain ; '10', means that the patient has extreme pain. The non-inferiority limit is set at 1.5 on the pain EVA scale
Measured: Pre-operative, 3 hours, 1 day, 3 weeks, 6 weeks, 3 and 6 months post-operative
Evaluate the Oxford Hip Score
The Oxford Hip Score is a questionnaire that assesses pain and hip function of patients who have undergone total hip replacement surgery. Patient should reflect on their pain and functional abilities on the previous 4 weeks. The questionnaire is divided into 2 domains (pain and function), each domain being composed of 6 questions. For each question, 5 answers are possible, each with a score of 0 to 4 (None = 4, Minimal = 3, Slight = 2, Moderate = 1, Severe = 0). The total score ranges from 0 (most severe symptoms) to 48 (no symptoms).
Measured: At baseline, 3 weeks, 6 weeks, 3 and 6 months post-operative
Evaluate the Harris Hip Score
The Harris Hip Score assess the results of hip surgery. It is composed of 10 questions divided into 4 domains (pain, function without deformation and amplitude of movements). A score is assigned to each response. The total score varies from 0 to 100. The higher the score, the better the results and the less dysfunctional the patient
Measured: At baseline, 3 weeks, 6 weeks, 3 and 6 months post-operative
Evaluation the Postel and Merle Aubigne score
the Postel and Merle Aubigne score measures pain, joint mobility and walking. For each question, 6 answers are possible, each one having a score of 0 to 6. The total score varies from 0 to 18, 18 indicating a perfect hip
Measured: At baseline, 3 weeks, 6 weeks, 3 and 6 months post-operative
Evaluate the technical difficulty of surgical procedure
The technical difficulty of surgical procedure will be assessed using a 4-point Likert scale: on the day of the operation, the surgeon will have to answer the question "What was the difficulty experienced by you in the operation?". He may answer by: Very difficult, difficult, moderately difficult or easy.
Measured: the day after surgery
Evaluate the operative time
The operative time will be expressed in minutes between skin incision and skin closure
Measured: the day of surgery
Evaluate the installation time
The installation time will be expressed in minutes between the end of intubation and the beginning of the brush
Measured: the day of surgery
Evaluate the total blood loss
Total blood loss will be calculated according to the ostheo formula, including pre-operative (in the month preceding the surgery) and post-operative (the day after surgery) hematocrit values. This measure makes it possible to accurately assess the hidden blood losses related to the hematic extravasation
Measured: in the month before surgery and the day after surgery
Evaluate the length of hospital stay
The length of hospital stay will be expressed in hours, between the entry and the discharge of the patient
Measured: the day after surgery
Evaluate the scarring after surgery
The scarring after surgery will be evaluated at 6 weeks after surgery using a subjective scar satisfaction score (4-point Likert scale), transmitted by the patient himself. The patient will have to answer the question "Are you satisfied with your scar?". He can answer: Very satisfied, satisfied, dissatisfied or very dissatisfied.
Measured: 6 weeks post-operative
Evaluate the impact of the patient's quality of life
Quality of life will be evaluated using the EuroQol five-dimension questionnaire (EQ-5D-5L), at inclusion, 6 weeks, 3 and 6 months after surgery.The EQ-5D-5L comprises a descriptive system and a visual analogue scale (VAS). The descriptive system is composed of five health dimensions (mobility, self-care, usual activities, pain/discomfort and anxiety/depression) with 5 levels of health (no problems, slight problems, moderate problems, severe problems and extreme problems). For each of the 5 dimensions, the participant's answer is converted to a number between 1 and 5, expressing the health state reported. The responses are combined to produce a five-digit number describing the participant's health status which is converted to a utility value from the country specific value set. The French EQ-5D-5L value set has utility between -0.530 (health condition worse than death) and 1 (best possible health). The VAS records the self-rated health status on a graduated scale from 0 to 100.
Measured: At baseline, 6 weeks, 3 and 6 months post-operative
Evaluate the patient satisfaction with the results of the operation
Patient satisfaction will be assessed at 3 weeks, 6 weeks, 3 months and 6 months post-surgery using a 4-point Likert scale. To do this, the patient will have to answer the question: "Are you satisfied with the results of your surgery?". They can answer with: very satisfied, satisfied, dissatisfied, or very dissatisfied.
Measured: 3 weeks, 6 weeks, 3 and 6 months post-operative
Evaluate the subjective value of the hip
The subjective value of the hip will be assessed at inclusion, 3 weeks, 6 weeks, 3 months and 6 months after surgery by the patient himself. By answering the question "What then is the overall percentage value of your hip if a completely normal hip equals 100%?" , the patient should assess his hip on a scale of 0 to 100, 100 corresponding to a perfect hip.
Measured: at baseline, 3 weeks, 6 weeks, 3 and 6 months post-operative
Evaluate the forgotten hip sensation
The forgotten hip sensation will be assessed by the patient himself at 3 weeks, 6 weeks, 3 months and 6 months after surgery by answering the question "Have you forgotten your hip?". The patient can answer yes or no.
Measured: 3 weeks, 6 weeks, 3 and 6 months post-operative
Evaluate the Forgotten Hip score.
The forgotten hip score will be assessed at inclusion, 6 weeks, 3 and 6 months after surgery. The score is composed of 12 questions assessing the degree of forgetfulness. For each question, the patient may respond with never, almost never, rarely, sometimes, often.
Measured: at baseline, 6 weeks, 3 and 6 months post-operative
Evaluate the early (< 90 days) and late (> 90 days) surgical complications related to surgery
Early complications (< 90 days after surgery) and late complications (> 90 days after surgery) will be sought the day after surgery and throughout the follow-up period. They will be classified as major (infections at the surgical site or medical complications increasing the length of hospitalization) or minor according to the series of the literature
Measured: During 6 months after surgery
Evaluate the rate of patient requiring a stay in a rehabilitation center
The number of patients requiring rehabilitation will be collected for the duration of the study
Measured: During 6 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2023
- Study start20 Nov 2025
- Primary completion2 Feb 2026
- Study completion2 Feb 2026
Why it stopped: Failure of the surgical procedure under investigation to achieve satisfactory results.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hip InjuriesStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NiceThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nice
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06064136
- Sponsor's protocol ID
- 22-AOIP-07
- Acronym
- TEPSe
- Status last verified
- Oct 2026
- First submitted
- 26 Sep 2023
- Last updated
- 21 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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 21 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Psoas Tenotomy Under Ultrasound
- ClinicalTrials.gov ID
- NCT06064136
- Acronym / sponsor ID
- TEPSe / 22-AOIP-07
- Conditions
- Hip Injuries
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Failure of the surgical procedure under investigation to achieve satisfactory results.
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NiceUniversity, hospital or other
- Study start
- 20 Nov 2025 (actual)
- Primary completion
- 2 Feb 2026 (actual)
- Study completion
- 2 Feb 2026 (actual)
- First posted
- 3 Oct 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 ilio-psoas conflict is a commonly accepted complication after total hip replacement, often linked to a mispositioning of the acetabular prosthetic component that conflicts with the ilio-psoas tendon. To correct these pains, a psoas tenotomy can be proposed. The results proven by the literature are very satisfactory. Psoas tenotomy is performed endoscopically, arthroscopically, or more rarely open.
The contribution of echo surgery allows to limit the scar ransom but also to free itself from a complex infrastructure to the operating room including an arthroscopy column and an intraoperative fluoroscopy for a conventional tenotomy, This also saves procedural and installation time.
No studies to date have described ultrasound-assisted psoas tenotomy Yhe investigators conducted a cadaveric study of the feasibility of psoas tenotomy under ultrasound that confirms the feasibility of this technique and the safety of the gesture for the surrounding anatomical structures.
The objectives of this study are to assess the feasibility, pain and functional outcomes of ultrasound-assisted psoas tenotomy in patients with ilio-psoas conflict after total hip replacement.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patient with ilio-psoas conflict and having a tenotomy indication | Experimental | Procedure: Psoas tenotomy under ultrasound |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Patients 18 years of age or older
- Indication of psoas tenotomy for ilio-psoas conflict after total hip replacement
- Signature of the written informed consent form by the patient
- Affiliation to a French health insurance scheme or equivalent
- Vulnerable people: pregnant or breast-feeding women (patients will undergo a pregnancy test: urinary test), adult under guardianship or deprived of freedom.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Psoas tenotomy under ultrasoundTenotomy of the ilio-psoas tendon under ultrasound is performed using an ultrasound machine, a 3 mm Acufex hook blade and a specific kit usually used for guided vertebroplasty and which allows the introduction of the Acufex hook blade atraumatically (foam end). The patient, under general anesthesia, is placed in supine position with the hip extending from 15 to 20°. | Procedure or surgery | Patient with ilio-psoas conflict and having a tenotomy indication |
Primary outcome
Evaluate the success rate of this new ultrasound-guided ilio-psoas tendon tenotomy technique
Time frame: 3 weeks post-operative
The success of this new ultrasound-guided ilio-psoas tendon tenotomy technique will be assessed by the disappearance of the ilio-psoas conflict after surgery. This criterion will be measured at the first control consultation
17 secondary outcomes
Evaluate the new ultrasound-guided ilio-psoas tendon tenotomy technique compared to standard practice on pain experienced by the patient
Time frame: Pre-operative, 3 hours, 1 day, 3 weeks, 6 weeks, 3 and 6 months post-operative
Evaluate the Oxford Hip Score
Time frame: At baseline, 3 weeks, 6 weeks, 3 and 6 months post-operative
Evaluate the Harris Hip Score
Time frame: At baseline, 3 weeks, 6 weeks, 3 and 6 months post-operative
Evaluation the Postel and Merle Aubigne score
Time frame: At baseline, 3 weeks, 6 weeks, 3 and 6 months post-operative
Evaluate the technical difficulty of surgical procedure
Time frame: the day after surgery
Evaluate the operative time
Time frame: the day of surgery
Evaluate the installation time
Time frame: the day of surgery
Evaluate the total blood loss
Time frame: in the month before surgery and the day after surgery
Evaluate the length of hospital stay
Time frame: the day after surgery
Evaluate the scarring after surgery
Time frame: 6 weeks post-operative
Evaluate the impact of the patient's quality of life
Time frame: At baseline, 6 weeks, 3 and 6 months post-operative
Evaluate the patient satisfaction with the results of the operation
Time frame: 3 weeks, 6 weeks, 3 and 6 months post-operative
Evaluate the subjective value of the hip
Time frame: at baseline, 3 weeks, 6 weeks, 3 and 6 months post-operative
Evaluate the forgotten hip sensation
Time frame: 3 weeks, 6 weeks, 3 and 6 months post-operative
Evaluate the Forgotten Hip score.
Time frame: at baseline, 6 weeks, 3 and 6 months post-operative
Evaluate the early (< 90 days) and late (> 90 days) surgical complications related to surgery
Time frame: During 6 months after surgery
Evaluate the rate of patient requiring a stay in a rehabilitation center
Time frame: During 6 months after surgery
Results and safety
The study was stopped early (reason given: Failure of the surgical procedure under investigation to achieve satisfactory results.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Psoas tenotomy under ultrasound in people with Hip Injuries, run by Centre Hospitalier Universitaire de Nice 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 10 inclusion and 0 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: stopped early, as of the sponsor's last update on 21 Oct 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?
The study was stopped early (reason given: Failure of the surgical procedure under investigation to achieve satisfactory results.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate the success rate of this new ultrasound-guided ilio-psoas tendon tenotomy technique (time frame: 3 weeks post-operative). 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 21 Oct 2026.