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Completed

NCT Number: NCT03691298

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.

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Key information

Conditions

Instability, Joint Joint Diseases Joint Instability Musculoskeletal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CPH Privathospital, Farum, Denmark

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

SUTUREFIX ULTRA Suture Anchor and SUTUREFIX CURVED Suture Anchor

Device

Fixation device intended to provide secure fixation of soft tissue to bone

Primary outcomes

  1. Clinical Success at 6 Months

    Time frame: 6 month post-surgery

    Number of participants without signs of failure and/or re-intervention as assessed by the surgeon.

Secondary outcomes

  1. Clinical Success at 12 Months

    Time frame: 12 months post-operative

    Number of participants without signs of failure and/or re-intervention at 12 months, as assessed by the surgeon.

  2. Intra-operative Anchor Deployment Success

    Time frame: Intraoperatively

    Number of suture anchors that were successfully deployed to bone, soft tissues, or both.

  3. Intraoperative Suture Anchor Failure

    Time frame: Intraoperatively

    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)

  4. Device-related Re-Intervention

    Time frame: 12 months

    Number of participants with a device-related adverse event (AE) that required a re-intervention due to the device-related AE.

  5. Visual Analog Scale (VAS) Pain Score - All Participants

    Time frame: 6 and 12 months postoperative

    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. Visual Analog Scale (VAS) Satisfaction Score - All Participants

    Time frame: 6 and 12 months postoperative

    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.

  7. Analysis of EQ-5D-5L Index - All Participants

    Time frame: 6 months and 12 months postoperative

    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.

  8. Analysis of Hip Outcome Score Activities of Daily Living (HOOS-ADL) - Hip Participants

    Time frame: 6 and 12 months postoperative

    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.

  9. Modified Harris Hip Score (mHHS) - Hip Participants

    Time frame: Preoperative, 6 and 12 months Postoperative

    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.

  10. Rowe Score - Shoulder Participants

    Time frame: 6 and 12 months postoperative

    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.

  11. American Shoulder and Elbow Surgeons Score - Shoulder Participants

    Time frame: 6 and 12 months postoperative

    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

  12. Constant-Murley Shoulder Scores (CMS) - Shoulder Participants

    Time frame: 6 months and 12 months Postoperative

    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).

Sponsors and collaborators

Lead sponsor

Smith & Nephew Orthopaedics AG

Industry

Registry information

Official study 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

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
Oct 1, 2018
Registry last updated
Jan 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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