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Overview

Perform IDE: TORNIER PERFORM Stemless Reverse IDE Study
Description

Tornier, Inc. (the Sponsor), is sponsoring the TORNIER PERFORM™ Stemless Reverse IDE Study, a prospective, randomized, controlled, multicenter study. The purpose of this clinical study is to evaluate the safety and efficacy of the investigational TORNIER PERFORM™ Humeral System – Stemless Reverse (PERFORM Stemless Reverse) and demonstrate non-inferiority to the control device TORNIER PERFORM™ Humeral System – Stem Reverse (PERFORM Stem Reverse) in subjects who are candidates for reverse total shoulder replacement. The data generated by this study are intended to provide adequate safety and effectiveness information necessary to support a Food and Drug Administration (FDA) pre-market submission. Data from this clinical study may be used to support future regulatory submissions, including those outside of the United States (US). 

Learn more at clinicaltrials.gov
Eligibility Criteria

Inclusion

A subject must meet all of the following inclusion criteria to enter the study:
  1. Adult subject 18 years or older.
  2. Scapula and proximal humerus must have reached skeletal maturity. 
  3. Clinical indication for reversed TSA due to: non-inflammatory degenerative joint disease (i.e., osteoarthritis), avascular necrosis, pseudoparalysis or anterior superior escape, functional deformity, post-traumatic arthritis, and/or rotator cuff tear arthropathy. 
  4. Willing and able to comply with the protocol.
  5. Willing and able to sign the informed consent form.
  6. Patients with an adjusted Constant Score ≤ 65.

Exclusion

A subject will not be eligible to participate in the study if any of the following conditions are present:
  1. Active local or systemic infection, sepsis, or osteomyelitis.
  2. In the opinion of the clinician, there is inadequate bone stock in the proximal humerus or glenoid fossa for supporting the components.
  3. In the opinion of the clinician, there is poor bone quality where there could be a considerable migration of the prosthesis and/or a chance of fracture of the humerus or glenoid.
  4. In surgeon’s opinion, rotator cuff tear requires a latissimus dorsi transfer.
  5. In the clinician’s opinion, the subject is unwilling or unable to be compliant with the recommendations of the healthcare professional. 
  6. Metabolism disorder that could compromise bone formation, or Osteomalacia. 
  7. Rapid destruction of the joint, marked bone loss, or bone resorption apparent on imaging.
  8. Known allergy or suspected allergy to the materials.
  9. Female subjects who are pregnant or planning to become pregnant within the study period.
  10. Medical condition(s) or balance impairments that could lead to falls (e.g. epilepsy not well controlled with medication, Multiple Sclerosis, etc).
  11. Previous failed arthroplasty.
  12. Nonfunctional deltoid muscle
  13. Neuromuscular compromise condition of the shoulder (e.g., neuropathic joints or brachial plexus injury with a flail shoulder joint).
  14. Known active metastatic or neoplastic disease, Paget’s disease or Charcot’s disease.
  15. Currently, or within the last six months, or planning to be on chemotherapy or radiation.
  16. Recent or ongoing alcohol or drug abuse as determined by the investigator.
  17. Taking > 5mg/day corticosteroids (e.g., prednisone), excluding inhalers and one-time injections, within three months before surgery.
  18. Currently enrolled in any clinical research study that might interfere with the current study. 
  19. Known history of severe depression. 
  20. Primary insurance is Workers’ Compensation [11].
  21. The study has completed 109 implant attempts for the randomized treatment arm. 
  22. Sequela of proximal humerus trauma requiring greater tuberosity osteotomy during RSA.
  23. Chronic shoulder dislocation with or without fracture, > 6 weeks
  24. Parkinson’s disease