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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

83 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-11-07

Study Completion Date

2021-05-21

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.

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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, 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.

Conditions

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Instability, Joint

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Arthroscopic hip and shoulder repair

SUTUREFIX ULTRA Suture Anchor and SUTUREFIX CURVED Suture Anchor

Intervention Type DEVICE

Fixation device intended to provide secure fixation of soft tissue to bone

Interventions

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SUTUREFIX ULTRA Suture Anchor and SUTUREFIX CURVED Suture Anchor

Fixation device intended to provide secure fixation of soft tissue to bone

Intervention Type DEVICE

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 only:

* FAI (Femoroacetabular Impingement)
* Shoulder subjects only:

* 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 only:

* Dysplasia latera/central less than 20°
* Shoulder subjects only:

* Glenoid and/or humeral bone loss considered excessive by the treating orthopaedic surgeon

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No