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

Smith & Nephew Orthopaedics AG83 enrolled

Overview

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.

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Instability, Joint

Interventions

SUTUREFIX ULTRA Suture Anchor and SUTUREFIX CURVED Suture AnchorDEVICE

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (9)

New York University Langone Orthopaedic Center

New York, New York, United States

Orthotennessee

Knoxville, Tennessee, United States

CPH Privathospital

Farum, Denmark

Pihlajalinna Turku Hospital

Turku, Finland

Outcomes

Primary Outcomes

Clinical Success at 6 Months

Number of participants without signs of failure and/or re-intervention as assessed by the surgeon.

Time frame: 6 month post-surgery

Secondary Outcomes

Clinical Success at 12 Months

Number of participants without signs of failure and/or re-intervention at 12 months, as assessed by the surgeon.

Time frame: 12 months post-operative

Intra-operative Anchor Deployment Success

Number of suture anchors that were successfully deployed to bone, soft tissues, or both.

Time frame: Intraoperatively

Intraoperative Suture Anchor Failure

Suture anchor failures categorized by number of participants with: * Intra-operative failures (Yes/No) * Anchors pulled out (Yes/No) * Additional anchors used as a result of failure (Yes/No)

Time frame: Intraoperatively

Device-related Re-Intervention

Number of participants with a device-related adverse event (AE) that required a re-intervention due to the device-related AE.

Time frame: 12 months

Visual Analog Scale (VAS) Pain Score - All Participants

Assessed participant pain using Visual Analog Scale (VAS) assessments taken 6 and 12 months postoperative intervals. The VAS Pain Score was based on a scale of 0 to 10, with 0 representing no pain and 10 the worst possible pain. Note: This Patient Reported Outcome (PRO) was optional and used according to the surgeon's preference.

Time frame: 6 and 12 months postoperative

Visual Analog Scale (VAS) Satisfaction Score - All Participants

Data from ClinicalTrials.gov

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