Suturefix Ultra and Curved, Version 1.0 09May2018

• Research type

  Research Study

• Full title

  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

• IRAS ID

  249085

• Contact name

  Andrew Wallace

• Contact email

  andrew.wallace@fortiusclinic.com

• Sponsor organisation

  Smith & Nephew Orthopaedics AG

• Clinicaltrials.gov Identifier

  NCT03691298

• Duration of Study in the UK

  2 years, 0 months, 1 days

• Research summary

  Research Summary
  80 subjects (40 for the shoulder group and 40 for the hip group) across approximately 8 sites, requiring shoulder or hip arthroscopic surgery (a type of keyhole surgery) repair on a ring of cartilage called the labrum, will be recruited to this study. Patients will be chosen based on physical findings, symptoms and imaging (radiographic) findings such as X-rays. Patients who have provided written informed consent will receive either the Suturefix Ultra and/or Suturefix Curved Suture Anchor at in-patient and out-patient clinics and followed up to determine the safety and effectiveness of the implant. Patients will be assessed at 6 months and 1 year and asked to complete questionnaires as well as provide information about any adverse events experienced.

  Summary of Results
  Not yet available.

• REC name

  London - Dulwich Research Ethics Committee

• REC reference

  19/LO/0058

• Date of REC Opinion

  12 Mar 2019

• REC opinion

  Further Information Favourable Opinion