Psoas Tenotomy Under Ultrasound

Hip Injuries Clinical Trial

— TEPSe  

Official title:

Psoas Tenotomy Under Ultrasound

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06064136
• Other study ID #: 22-AOIP-07
• Status: Recruiting
• Phase: N/A
• Start date: March 2024
• Est. completion date: March 2026

Study information

• Verified date: February 2024
• Source: Centre Hospitalier Universitaire de Nice
• Contact: Grégoire MICICOI
• Phone: 0492036904
• Email: micicoi.g[@]chu-nice.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 15
• Est. completion date: March 2026
• Est. primary completion date: March 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hip Injuries

Intervention

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°.

Locations

Country	Name	City	State
France	Nice University Hospital	Nice	Alpes Maritimes

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nice

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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	Pre-operative, 3 hours, 1 day, 3 weeks, 6 weeks, 3 and 6 months post-operative
Secondary	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).	At baseline, 3 weeks, 6 weeks, 3 and 6 months post-operative
Secondary	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	At baseline, 3 weeks, 6 weeks, 3 and 6 months post-operative
Secondary	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	At baseline, 3 weeks, 6 weeks, 3 and 6 months post-operative
Secondary	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.	the day after surgery
Secondary	Evaluate the operative time	The operative time will be expressed in minutes between skin incision and skin closure	the day of surgery
Secondary	Evaluate the installation time	The installation time will be expressed in minutes between the end of intubation and the beginning of the brush	the day of surgery
Secondary	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	in the month before surgery and the day after surgery
Secondary	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	the day after surgery
Secondary	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.	6 weeks post-operative
Secondary	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.	At baseline, 6 weeks, 3 and 6 months post-operative
Secondary	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.	3 weeks, 6 weeks, 3 and 6 months post-operative
Secondary	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.	at baseline, 3 weeks, 6 weeks, 3 and 6 months post-operative
Secondary	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.	3 weeks, 6 weeks, 3 and 6 months post-operative
Secondary	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.	at baseline, 6 weeks, 3 and 6 months post-operative
Secondary	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	During 6 months after surgery
Secondary	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	During 6 months after surgery