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

Completed

Conditions studied: Instability, Joint

In brief

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.

Key facts

Study ID

NCT03691298

Run by

Smith & Nephew Orthopaedics AG

People needed

83

Starts

2018-11-07

Expected to finish

2021-05-21

Last updated by the study team

2025-01-06

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• 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
• Azienda Ospedaliera San Camillo Forlanini — Roma, Italy
• Asepeyo Hospital Sant Cugat — Sant Cugat del Vallès, Barcelona, Spain
• Hospital Universitario Fundación Jiménez Díaz — Madrid, Spain
• Queen Alexandra Hospital — Cosham, United Kingdom
• Fortius Clinic — London, United Kingdom

Full record on ClinicalTrials.gov

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