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

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

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.

Study Overview

• Status: Completed
• Conditions: Instability, Joint
• Intervention / Treatment: Device: Suturefix Ultra and Suturefix Curved Suture Anchor

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 (the medical removal of dead damaged or infected tissue), 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. In an epidemiology study published in 2017, labral pathology was the most common diagnosis at 82% of the population. Of the 1,124 tears reported, 75.3% were repaired, 13.7% were reconstructed and 7.2% were debrided.

• Study Type: Observational
• Enrollment (Actual): 83

Contacts and Locations

Study Locations

• Denmark
  • Farum, Denmark, 3520
    • CPH Privathospital
• Finland
  • Turku, Finland, 20100
    • Pihlajalinna Turku Hospital
• Italy
  • Roma, Italy, 00152
    • Azienda Ospedaliera San Camillo Forlanini
• Spain
  • Madrid, Spain, 28040
    • Hospital Universitario Fundacion Jimenez Diaz
  • Barcelona
    • Sant Cugat del Vallès, Barcelona, Spain, 08174
      • Asepeyo Hospital Sant Cugat
• United Kingdom
  • Cosham, United Kingdom, PO6 3LY
    • Queen Alexandra Hospital
  • London, United Kingdom, W1H 6EQ
    • Fortius Clinic
• United States
  • New York
    • New York, New York, United States, 10016
      • New York University Langone Orthopaedic Center
  • Tennessee
    • Knoxville, Tennessee, United States, 37922
      • OrthoTennessee

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Subject with hip or shoulder instability

Description

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
• FAI (Femoroacetabular Impingement) Shoulder subjects
• 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 Dysplasia latera/central less than 20° Shoulder subjects
• Glenoid and/or humeral bone loss considered excessive by the treating orthopaedic surgeon

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Arthroscopic hip repair	Device: Suturefix Ultra and Suturefix Curved Suture Anchor; Fixation device intended to provide secure fixation of soft tissue to bone to stabilize hip

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical success rate	Subjects without signs of failure and/or re-intervention	6 month post-surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical success rate	Subjects without signs of failure and/or re-intervention	12 months post-operative

Collaborators and Investigators

• Sponsor: Smith & Nephew Orthopaedics AG
• Investigators: Study Chair: Emma Whatley, PhD, Smith & Nephew Ltd

Study record dates

Study Major Dates

• Study Start (Actual): October 17, 2018
• Primary Completion (Actual): May 21, 2021
• Study Completion (Actual): May 21, 2021

Study Registration Dates

• First Submitted: September 28, 2018
• First Submitted That Met QC Criteria: September 28, 2018
• First Posted (Actual): October 1, 2018

Study Record Updates

• Last Update Posted (Actual): June 15, 2022
• Last Update Submitted That Met QC Criteria: June 14, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Keywords: shoulder instability; Suturefix; hip instability
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Joint Instability
• Other Study ID Numbers: 17-5010-06

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No