Clinical trial NCT06064136: Psoas Tenotomy Under Ultrasound
Official title: Psoas Tenotomy Under Ultrasound
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hip Injuries
Lead sponsor: Centre Hospitalier Universitaire de Nice
Sponsor class: OTHER
First posted: 2023-10-03
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Evaluate the success rate of this new ultrasound-guided ilio-psoas tendon tenotomy technique
timeFrame: 3 weeks post-operative
Secondary outcomes:
measure: Evaluate the new ultrasound-guided ilio-psoas tendon tenotomy technique compared to standard practice on pain experienced by the patient
timeFrame: Pre-operative, 3 hours, 1 day, 3 weeks, 6 weeks, 3 and 6 months post-operative
measure: Evaluate the Oxford Hip Score
timeFrame: At baseline, 3 weeks, 6 weeks, 3 and 6 months post-operative
measure: Evaluate the Harris Hip Score
timeFrame: At baseline, 3 weeks, 6 weeks, 3 and 6 months post-operative
measure: Evaluation the Postel and Merle Aubigne score
timeFrame: At baseline, 3 weeks, 6 weeks, 3 and 6 months post-operative
measure: Evaluate the technical difficulty of surgical procedure
timeFrame: the day after surgery
measure: Evaluate the operative time
timeFrame: the day of surgery
measure: Evaluate the installation time
timeFrame: the day of surgery
measure: Evaluate the total blood loss
timeFrame: in the month before surgery and the day after surgery
measure: Evaluate the length of hospital stay
timeFrame: the day after surgery
measure: Evaluate the scarring after surgery
timeFrame: 6 weeks post-operative
measure: Evaluate the impact of the patient's quality of life
timeFrame: At baseline, 6 weeks, 3 and 6 months post-operative
measure: Evaluate the patient satisfaction with the results of the operation
timeFrame: 3 weeks, 6 weeks, 3 and 6 months post-operative
measure: Evaluate the subjective value of the hip
timeFrame: at baseline, 3 weeks, 6 weeks, 3 and 6 months post-operative
measure: Evaluate the forgotten hip sensation
timeFrame: 3 weeks, 6 weeks, 3 and 6 months post-operative
measure: Evaluate the Forgotten Hip score.
timeFrame: at baseline, 6 weeks, 3 and 6 months post-operative
measure: Evaluate the early (< 90 days) and late (> 90 days) surgical complications related to surgery
timeFrame: During 6 months after surgery
measure: Evaluate the rate of patient requiring a stay in a rehabilitation center
timeFrame: During 6 months after surgery
Other outcomes:
Locations:
city: Nice
country: France
facility: Nice University Hospital
state: Alpes Maritimes
Study officials:
References: