NCT03691298

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

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 83 (actual)
• Sponsor: Smith & Nephew Orthopaedics AG · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

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

• Instability, Joint

Interventions

Type	Name	Description
DEVICE	SUTUREFIX ULTRA Suture Anchor and SUTUREFIX CURVED Suture Anchor	Fixation device intended to provide secure fixation of soft tissue to bone

Timeline

• Start date: 2018-11-07
• Primary completion: 2021-05-21
• Completion: 2021-05-21
• First posted: 2018-10-01
• Last updated: 2025-01-06
• Results posted: 2025-01-06

Locations

9 sites across 6 countries: United States, Denmark, Finland, Italy, Spain, United Kingdom