Psoas Tenotomy Under Ultrasound
ConditionHip Injuries
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorCentre Hospitalier Universitaire de Nice
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
None
Trial design
Design model
Single group
Treatments tested in this trial
Psoas tenotomy under ultrasound
Procedure/SurgeryTenotomy 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°.
Treatment groups
15 Participants
are divided into 1 treatment groupGroup A: Patient with ilio-psoas conflict and having a tenotomy indicationExperimental treatment 1 intervention
Trial outcomes
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
Time frame
3 weeks post-operativeSecondary outcomes
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
Time frame
Pre-operative, 3 hours, 1 day, 3 weeks, 6 weeks, 3 and 6 months post-operative2
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).
Time frame
At baseline, 3 weeks, 6 weeks, 3 and 6 months post-operative3
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
Time frame
At baseline, 3 weeks, 6 weeks, 3 and 6 months post-operative4
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
Time frame
At baseline, 3 weeks, 6 weeks, 3 and 6 months post-operativeSponsors and contacts
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Source ClinicalTrials.gov