Safety and Performance of the SUTUREFIX ULTRA and SUTUREFIX CURVED Suture Anchors in Shoulder and Hip Arthroscopic Repair

Study Overview
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Brief Summary
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The scientific justification is to fulfill post-market clinical requirements in order to support re-certification of the CE-Mark for this marketed product and to look into safety and efficacy.

Detailed Description
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Shoulder: The superior labrum (fibrous cartilage) and biceps anchor improve joint stability by acting like a secondary stabilizer to the shoulder. Labral injuries are usually associated with anterior shoulder dislocation. When conservative treatment fails, such as physical therapy, strengthening programs, anti-inflammatories and activity modification to improve symptoms, surgical intervention may be required. Surgical treatments can include simple debridement (the medical removal of dead damaged or infected tissue), stabilization of the biceps-labrum complex through repair, or biceps tenodesis where the end of a tendon is joined surgically to the bone. Outcomes of SLAP (superior labral tear from anterior to posterior) repairs have been reported good throughout the literature, with reported success rates ranging from 71-97%. Hip: The labrum of the hip is a fibrocartilaginous tissue that connects to the bone edge of the acetabulum (the socket of the hip bone), and deepens the acetabular socket while extending coverage of the femoral head; it also aids in hip stabilization. The goal of surgical intervention is to restore normal hip mechanics and treat existing damage. In an epidemiology study published in 2017, labral pathology was the most common diagnosis at 82% of the population. Of the 1,124 tears reported, 75.3% were repaired, 13.7% were reconstructed and 7.2% were debrided.

Official Title
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Prospective, Multicenter, Post-Market 1 Year Clinical Follow-up Study to Evaluate Safety and Performance of the SUTUREFIX ULTRA and SUTUREFIX CURVED Suture Anchors in Shoulder and Hip Arthroscopic Repair

Conditions
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Instability, Joint

Intervention / Treatment
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* Device: Suturefix Ultra and Suturefix Curved Suture Anchor


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject has consented to participate in the study by signing the EC-approved informed consent form Subject condition meets proposed indication to SUTUREFIX ULTRA and SUTUREFIX CURVED Suture Anchor Subject requiring shoulder or hip arthroscopic labral repair surgery from physical findings, subject symptoms and radiographic finding Hip subjects FAI (Femoroacetabular Impingement) Shoulder subjects Subject with a history of recurrent dislocation/subluxation of the shoulder Exclusion Criteria: Participation in the treatment period of another clinical trial within thirty (30) days of Visit 1 (pre-operative) Women who are pregnant, nursing, or of child-bearing potential who are not utilizing highly effective birth control measures Contraindications or hypersensitivity to the use of the SUTUREFIX ULTRA and/or SUTUREFIX CURVED Suture Anchor, or their components (e.g. silicone, polyester). Where material sensitivity is suspected, appropriate tests should be performed and sensitivity ruled out prior to implantation Pathological conditions of bone, such as cystic changes or severe osteopenia, which would compromise secure anchor fixation Pathological conditions in the soft tissues to be attached that would impair secure fixation by suture Comminuted bone surface, which would compromise secure anchor fixation Hip subjects Dysplasia latera/central less than 20° Shoulder subjects Glenoid and/or humeral bone loss considered excessive by the treating orthopaedic surgeon

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Arthroscopic hip repair<br> | Device: Suturefix Ultra and Suturefix Curved Suture Anchor<br>* Fixation device intended to provide secure fixation of soft tissue to bone to stabilize hip<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical success rate | Subjects without signs of failure and/or re-intervention | 6 month post-surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical success rate | Subjects without signs of failure and/or re-intervention | 12 months post-operative | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Suturefix, hip instability, shoulder instability