Psoas Tenotomy Under Ultrasound
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Psoas tenotomy under ultrasound.
- Who it may be relevant to
- Registry conditions: Hip Injuries. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Procedure Psoas tenotomy under ultrasound
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°.
Primary outcome measures
- Evaluate the success rate of this new ultrasound-guided ilio-psoas tendon tenotomy technique [Time frame: 3 weeks post-operative]
Secondary outcome measures (12)
- 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]
Eligibility criteria
Inclusion criteria
- 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.
- Allergies to local anesthetics
- Patient on anticoagulant or antiplatelet agents
- Contraindication to surgery
- Refusal of patient involvement
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
France · 1 center
- Nice University Hospital — Nice
Identifiers
NCT: NCT06064136 · 22-AOIP-07