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 Suture Anchor 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, 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.

• 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

• 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 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

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 and shoulder repair	Device: SUTUREFIX ULTRA Suture Anchor and SUTUREFIX CURVED Suture Anchor; Fixation device intended to provide secure fixation of soft tissue to bone

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical Success at 6 Months	Number of participants without signs of failure and/or re-intervention as assessed by the surgeon.	6 month post-surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical Success at 12 Months	Number of participants without signs of failure and/or re-intervention at 12 months, as assessed by the surgeon.	12 months post-operative
Intra-operative Anchor Deployment Success	Number of suture anchors that were successfully deployed to bone, soft tissues, or both.	Intraoperatively
Intraoperative Suture Anchor Failure	Suture anchor failures categorized by number of participants with: Intra-operative failures (Yes/No); Anchors pulled out (Yes/No); Additional anchors used as a result of failure (Yes/No)	Intraoperatively
Device-related Re-Intervention	Number of participants with a device-related adverse event (AE) that required a re-intervention due to the device-related AE.	12 months
Visual Analog Scale (VAS) Pain Score - All Participants	Assessed participant pain using Visual Analog Scale (VAS) assessments taken 6 and 12 months postoperative intervals. The VAS Pain Score was based on a scale of 0 to 10, with 0 representing no pain and 10 the worst possible pain. Note: This Patient Reported Outcome (PRO) was optional and used according to the surgeon's preference.	6 and 12 months postoperative
Visual Analog Scale (VAS) Satisfaction Score - All Participants	Assessed participant satisfaction using a Visual Analog Scale (VAS) assessments taken at 6 and 12 month postoperative intervals. The VAS Subject Satisfaction Questionnaire was based on a scale of 0 to 10, with 0 representing very satisfied and 10 very unsatisfied. This Patient Reported Outcome (PRO) was optional and used according to the surgeon's preference.	6 and 12 months postoperative
Analysis of EQ-5D-5L Index - All Participants	The EQ-5D-5L Index Score was based on a scale of 0 to 1, with higher index values indicating better health and lower index values indicating worse health. This Patient Reported Outcome (PRO) was optional and used according to the surgeon's preference.	6 months and 12 months postoperative
Analysis of Hip Outcome Score Activities of Daily Living (HOOS-ADL) - Hip Participants	The Hip Outcome Score Activities of Daily Living (HOOS-ADL) Score included 5 domains (Symptoms, Pain, Daily Living, Sport & Recreation and Quality of Life) each assessed at 6 and 12 months postoperative. Each HOOS domain range was based on a scale of 0 to 100, where 0 represents extreme symptoms and 100 represents no symptoms.	6 and 12 months postoperative
Modified Harris Hip Score (mHHS) - Hip Participants	The Modified Harris Hip Score (mHHS) is a measurement of dysfunction; the higher the score, the better the outcome. The mHHS score range was as follows: <70 (poor result); 70-79 (fair result); 80-89 (good result); >90 (excellent result) This Patient Reported Outcome (PRO) was optional and used according to the surgeon's preference.	Preoperative, 6 and 12 months Postoperative
Rowe Score - Shoulder Participants	The Rowe Scores address categories of shoulder stability, motion, and function. Scores range from 0 to 100 with a score of 90 to 100 points indicating an excellent evaluation, 75 to 89 points indicating a good evaluation, 51 to 74 points indicating a fair evaluation, and 0 to 50 points indicating a poor evaluation. This Patient Reported Outcome (PRO) was optional and used according to the surgeon's preference.	6 and 12 months postoperative
American Shoulder and Elbow Surgeons Score - Shoulder Participants	The American Shoulder and Elbow Surgeons Score (ASES) was based on a scale of 0 to 100 points, where 0 indicated a worse shoulder condition and 100 indicated a better shoulder condition	6 and 12 months postoperative
Constant-Murley Shoulder Scores (CMS) - Shoulder Participants	The Constant-Murley Shoulder Score (CMS) was based on a scale of 0 to 100 points divided into 4 subscales; pain (15 points), Activities of Daily Living (20 points), strength (25 points), and Range of Motion, including: forward elevation, external rotation, abduction, and internal rotation (40 points). The higher the score, the higher the quality of the function (less disability).	6 months and 12 months Postoperative

Collaborators and Investigators

• Sponsor: Smith & Nephew Orthopaedics AG
• Investigators: Study Chair: Laura Everson, Smith & Nephew Ltd

Study record dates

Study Major Dates

• Study Start (Actual): November 7, 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): March 25, 2025
• Last Update Submitted That Met QC Criteria: November 12, 2024
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Keywords: shoulder instability; Suturefix; hip instability
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Joint 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