AzTrials
AzTrials

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.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
Search all trials

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.
Show all 10Show fewer
  • 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.

France1 site
  • Nice University Hospital

    Nice, Alpes Maritimes, 06000

Other trials in France

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 groups in NCT06064136
Study groupRoleWhat they receive
Patient with ilio-psoas conflict and having a tenotomy indicationExperimentalNot described
Receives: Procedure: Psoas tenotomy under ultrasound

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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)
  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. Evaluate the operative time

    The operative time will be expressed in minutes between skin incision and skin closure

    Measured: the day of surgery

  7. 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

  8. 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

  9. 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

  10. 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

  11. 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

  12. 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

  13. 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

  14. 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

  15. 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

  16. 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

  17. 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.

  1. First posted3 Oct 2023
  2. Study start20 Nov 2025
  3. Primary completion2 Feb 2026
  4. Study completion2 Feb 2026

Why it stopped: Failure of the surgical procedure under investigation to achieve satisfactory results.

Resources

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)
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

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.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in