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Clinical Improvement Obtained by Endoscopic Ilio-Psoas Tenotomy (Lesser Trochanter Versus Acetabular Notch) (ETIPIC)

Primary Purpose

Tendinopathy

Status
Not yet recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Endoscopic tenotomy surgery of the iliopsoas tendon
Sponsored by
GCS Ramsay Santé pour l'Enseignement et la Recherche
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tendinopathy

Eligibility Criteria

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

Inclusion Criteria: Age ≥ 18 years old; Definite diagnosis of iliopsoas tendinopathy due to conflict between the tendon and the prosthetic cup; Failure of first-line conservative treatment; Planned endoscopic tenotomy; Affiliation to the social security scheme; Signed informed consent. Exclusion Criteria: Revision total hip prosthesis, multiple operations prior to tenotomy; Other surgical or medical interventions planned during the study; Participation in another clinical trial, or during a period of exclusion from another clinical trial; Pregnant or likely to be pregnant (of childbearing age, without effective contraception) or breastfeeding; Patient deprived of liberty or under guardianship or curatorship or unable to give consent.

Sites / Locations

  • Clinique de la Sauvegarde

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Endoscopic tenotomy at the level of the lesser trochanter

Endoscopic tenotomy at the level of the acetabular notch

Arm Description

Patients will benefit from endoscopic tenotomy surgery of the iliopsoas tendon at the level of the lesser trochanter.

Patients will benefit from endoscopic tenotomy surgery of the iliopsoas tendon at the level of the acetabular notch.

Outcomes

Primary Outcome Measures

Oxford Hip Score
Compare the clinical improvement experienced by patients having an endoscopic tenotomy of the iliopsoas tendon at the level of the lesser trochanter versus at the level of the notch at more than 1 year minimum. The Oxford Hip Score is a self-administered patient-administered 12-item "Patient Reported Outcome Measures" questionnaire that allows the surgeon to assess clinical outcomes after total hip replacement.

Secondary Outcome Measures

Full Information

First Posted
July 4, 2023
Last Updated
July 17, 2023
Sponsor
GCS Ramsay Santé pour l'Enseignement et la Recherche
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1. Study Identification

Unique Protocol Identification Number
NCT05950022
Brief Title
Clinical Improvement Obtained by Endoscopic Ilio-Psoas Tenotomy (Lesser Trochanter Versus Acetabular Notch)
Acronym
ETIPIC
Official Title
Study Evaluating the Clinical Improvement Obtained by Endoscopic Tenotomy of the Ilio-Psoas, at the Level of the Lesser Trochanter Versus at the Level of the Acetabular Notch, on Psoas Cup Impingements After Total Hip Prosthesis
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
July 2023 (Anticipated)
Primary Completion Date
June 2028 (Anticipated)
Study Completion Date
June 2028 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GCS Ramsay Santé pour l'Enseignement et la Recherche

4. Oversight

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

5. Study Description

Brief Summary
The purpose of the study is to assess Oxford Hip Score at baseline, at 2 months and at over 12 months.
Detailed Description
This is an interventional, comparative, randomized study, in 2 parallel groups, single-blind (the patient does not know which technique he will benefit from, the surgeon will carry out the surgery and will therefore be informed of the result of the randomization ) and monocentric. Comparative prospective cohort study of an endoscopic tenotomy surgery of the iliopsoas tendon at the level of the lesser trochanter versus at the level of the acetabular notch, in the context of anterior pain for impingement between the iliopsoas tendon and the prosthetic cup in patients after Total Hip Prosthesis. The study will be proposed to the patient during the preoperative consultation. Patients eligible for surgery will be offered the study. After a reflection period of at least 15 days, patients who agree to participate in the study will be included. Randomization will be done by drawing lots to decide whether the endoscopic tenotomy will be performed at the level of the lesser trochanter or at the level of the acetabular notch. The surgery will be performed under general anesthesia with standardized multimodal analgesia. Whatever the techniques, the approaches, the instruments to perform the procedure and the postoperative course will be identical, as in usual practice.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Interventional, comparative, randomized study, in 2 parallel groups, single-blind
Masking
Participant
Masking Description
The patient does not know which technique he will benefit from, the surgeon will proceed with the surgery and will therefore be informed of the result of the randomization
Allocation
Randomized
Enrollment
108 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Endoscopic tenotomy at the level of the lesser trochanter
Arm Type
Experimental
Arm Description
Patients will benefit from endoscopic tenotomy surgery of the iliopsoas tendon at the level of the lesser trochanter.
Arm Title
Endoscopic tenotomy at the level of the acetabular notch
Arm Type
Experimental
Arm Description
Patients will benefit from endoscopic tenotomy surgery of the iliopsoas tendon at the level of the acetabular notch.
Intervention Type
Procedure
Intervention Name(s)
Endoscopic tenotomy surgery of the iliopsoas tendon
Intervention Description
The surgery will be performed under general anesthesia with standardized multimodal analgesia. Whatever the techniques, the approaches, the instruments to perform the procedure and the postoperative course will be identical, as in usual practice.
Primary Outcome Measure Information:
Title
Oxford Hip Score
Description
Compare the clinical improvement experienced by patients having an endoscopic tenotomy of the iliopsoas tendon at the level of the lesser trochanter versus at the level of the notch at more than 1 year minimum. The Oxford Hip Score is a self-administered patient-administered 12-item "Patient Reported Outcome Measures" questionnaire that allows the surgeon to assess clinical outcomes after total hip replacement.
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age ≥ 18 years old; Definite diagnosis of iliopsoas tendinopathy due to conflict between the tendon and the prosthetic cup; Failure of first-line conservative treatment; Planned endoscopic tenotomy; Affiliation to the social security scheme; Signed informed consent. Exclusion Criteria: Revision total hip prosthesis, multiple operations prior to tenotomy; Other surgical or medical interventions planned during the study; Participation in another clinical trial, or during a period of exclusion from another clinical trial; Pregnant or likely to be pregnant (of childbearing age, without effective contraception) or breastfeeding; Patient deprived of liberty or under guardianship or curatorship or unable to give consent.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nicolas BONIN, MD
Phone
6 71 89 10 99
Ext
+33
Email
n.bonin@gmail.com
Facility Information:
Facility Name
Clinique de la Sauvegarde
City
Lyon
ZIP/Postal Code
69009
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nicolas BONIN, MD
Phone
6 71 89 10 99
Ext
+33
Email
n.bonin@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Clinical Improvement Obtained by Endoscopic Ilio-Psoas Tenotomy (Lesser Trochanter Versus Acetabular Notch)

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