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

Smith & Nephew

Status: Completed

Conditions: Instability, Joint

Treatments: Device: SUTUREFIX ULTRA Suture Anchor and SUTUREFIX CURVED Suture Anchor

Study type: Observational

Funder types: Industry

Identifiers

NCT03691298

17-5010-06

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 83 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

83 participants in 1 patient group

Arthroscopic hip and shoulder repair

Treatment:

Device: SUTUREFIX ULTRA Suture Anchor and SUTUREFIX CURVED Suture Anchor