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Psoas Tenotomy Under Ultrasound (TEPSe)

Primary Purpose

Hip Injuries

Status
Not yet recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Psoas tenotomy under ultrasound
Sponsored by
Centre Hospitalier Universitaire de Nice
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hip Injuries

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Nice University Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Patient with ilio-psoas conflict and having a tenotomy indication

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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
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).
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
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
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.
Evaluate the operative time
The operative time will be expressed in minutes between skin incision and skin closure
Evaluate the installation time
The installation time will be expressed in minutes between the end of intubation and the beginning of the brush
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
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
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.
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.
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.
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.
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.
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.
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
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

Full Information

First Posted
September 26, 2023
Last Updated
October 5, 2023
Sponsor
Centre Hospitalier Universitaire de Nice
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1. Study Identification

Unique Protocol Identification Number
NCT06064136
Brief Title
Psoas Tenotomy Under Ultrasound
Acronym
TEPSe
Official Title
Psoas Tenotomy Under Ultrasound
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
November 2023 (Anticipated)
Primary Completion Date
November 2025 (Anticipated)
Study Completion Date
November 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Nice

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hip Injuries

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Patient with ilio-psoas conflict and having a tenotomy indication
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
Psoas tenotomy under ultrasound
Intervention Description
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 Measure Information:
Title
Evaluate the success rate of this new ultrasound-guided ilio-psoas tendon tenotomy technique
Description
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-operative
Secondary Outcome Measure Information:
Title
Evaluate the new ultrasound-guided ilio-psoas tendon tenotomy technique compared to standard practice on pain experienced by the patient
Description
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-operative
Title
Evaluate the Oxford Hip Score
Description
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-operative
Title
Evaluate the Harris Hip Score
Description
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-operative
Title
Evaluation the Postel and Merle Aubigne score
Description
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-operative
Title
Evaluate the technical difficulty of surgical procedure
Description
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.
Time Frame
the day after surgery
Title
Evaluate the operative time
Description
The operative time will be expressed in minutes between skin incision and skin closure
Time Frame
the day of surgery
Title
Evaluate the installation time
Description
The installation time will be expressed in minutes between the end of intubation and the beginning of the brush
Time Frame
the day of surgery
Title
Evaluate the total blood loss
Description
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
Time Frame
in the month before surgery and the day after surgery
Title
Evaluate the length of hospital stay
Description
The length of hospital stay will be expressed in hours, between the entry and the discharge of the patient
Time Frame
the day after surgery
Title
Evaluate the scarring after surgery
Description
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.
Time Frame
6 weeks post-operative
Title
Evaluate the impact of the patient's quality of life
Description
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.
Time Frame
At baseline, 6 weeks, 3 and 6 months post-operative
Title
Evaluate the patient satisfaction with the results of the operation
Description
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.
Time Frame
3 weeks, 6 weeks, 3 and 6 months post-operative
Title
Evaluate the subjective value of the hip
Description
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.
Time Frame
at baseline, 3 weeks, 6 weeks, 3 and 6 months post-operative
Title
Evaluate the forgotten hip sensation
Description
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.
Time Frame
3 weeks, 6 weeks, 3 and 6 months post-operative
Title
Evaluate the Forgotten Hip score.
Description
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.
Time Frame
at baseline, 6 weeks, 3 and 6 months post-operative
Title
Evaluate the early (< 90 days) and late (> 90 days) surgical complications related to surgery
Description
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
Time Frame
During 6 months after surgery
Title
Evaluate the rate of patient requiring a stay in a rehabilitation center
Description
The number of patients requiring rehabilitation will be collected for the duration of the study
Time Frame
During 6 months after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Grégoire MICICOI
Phone
0492036904
Ext
+33
Email
micicoi.g@chu-nice.fr
Facility Information:
Facility Name
Nice University Hospital
City
Nice
State/Province
Alpes Maritimes
ZIP/Postal Code
06000
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Grégoire MICICOI
Phone
0492036904
Ext
+33
Email
micicoi.g@chu-nice.fr
First Name & Middle Initial & Last Name & Degree
Grégoire MICICOI

12. IPD Sharing Statement

Plan to Share IPD
No

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Psoas Tenotomy Under Ultrasound

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