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

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions:
    Recurrent Shoulder Dislocation/subluxation Of The Shoulder Or Fai (femoroacetabular Impingement)
  • Age: Between 18 - 100 Years
  • Gender: Male or Female
  • Other Inclusion Criteria:
    1. Subject has consented to participate in the study by signing the EC-approved informed consent form
    2. Subject is > 18 years of age at time of surgery
    3. Subject condition meets proposed indication to SUTUREFIX ULTRA and SUTUREFIX CURVED Suture Anchor
    4. Subject requiring shoulder or hip arthroscopic labral repair surgery from physical findings, subject symptoms and radiographic finding
    5. Bone quality and quantity must be adequate to allow proper placement of the suture anchor
    6. Able to follow instructions.
    7. Willing and able to make all required study visits.
    8. For Hip subjects:
      • Subjects with FAI (Femoroacetabular Impingement)
    9. For Shoulder subjects:
      • Subject with a history of recurrent dislocation/subluxation of the shoulder Hip

You may not be eligible for this study if the following are true:

    1. Participation in the treatment period of another clinical trial within thirty (30) days of Visit 1 (pre-operative)
    2. Subjects who are pregnant, nursing, or of child-bearing potential who are not utilizing highly effective birth control measures
    3. Subjects with a history of poor compliance with medical treatment
    4. Subjects with contraindications or hypersensitivity to the use of the SUTUREFIX ULTRA and/or SUTUREFIX CURVED Suture Anchor, or their components
    5. Subjects with prior ipsilateral surgeries performed on the joint space
    6. Pathological conditions of bone, such as cystic changes or severe osteopenia, which would compromise secure anchor fixation
    7. Pathological conditions in the soft tissues to be attached that would impair secure fixation by suture
    8. Comminuted bone surface, which would compromise secure anchor fixation
    9. Physical conditions which would eliminate, or tend to eliminate, adequate anchor support or impair healing
    10. Epileptic history
    11. For Hip subjects:
      • Dysplasia latera/central less than 20°
    12. For Shoulder subjects
      • Glenoid and/or humeral bone loss considered excessive by the treating orthopaedic surgeon
      • For Shoulder subjects: MDI(Multi-directional instability)
      • For Shoulder subjects: Psychosomatic voluntary shoulder subluxation

If you are registered as a volunteer, please log in to contact the study team/express interest in this study.