Psoas Tenotomy Under Ultrasound

NCT06064136 | Recruiting DMC

• 1 other identifier: 22-AOIP-07
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Hip Injuries

Outcome Measures

Primary Outcomes (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

  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

  Pre-operative, 3 hours, 1 day, 3 weeks, 6 weeks, 3 and 6 months post-operative

• Evaluate the Oxford Hip Score

  At baseline, 3 weeks, 6 weeks, 3 and 6 months post-operative

• Evaluate the Harris Hip Score

  At baseline, 3 weeks, 6 weeks, 3 and 6 months post-operative

• Evaluation the Postel and Merle Aubigne score

  At baseline, 3 weeks, 6 weeks, 3 and 6 months post-operative

• Evaluate the technical difficulty of surgical procedure

  the day after surgery

Study Arms (1)

Patient with ilio-psoas conflict and having a tenotomy indication

EXPERIMENTAL

Procedure: Psoas tenotomy under ultrasound

Interventions

Psoas tenotomy under ultrasound PROCEDURE

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°.

Patient with ilio-psoas conflict and having a tenotomy indication

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Allergies to local anesthetics
• Patient on anticoagulant or antiplatelet agents
• Contraindication to surgery
• Refusal of patient involvement

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nice: lead

Study Sites (1)

Nice University Hospital

Nice, Alpes Maritimes, 06000, France

RECRUITING

MeSH Terms

Conditions

Hip Injuries

Condition Hierarchy (Ancestors)

Wounds and Injuries

Central Study Contacts

Grégoire MICICOI

CONTACT

0492036904; micicoi.g@chu-nice.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 26, 2023
• First Posted: October 3, 2023
• Study Start: December 1, 2025
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: December 4, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)