TORNIER PERFORM™ Stemless Reverse IDE Study

Overview

About this study

The purpose of this study is to evaluate safety and efficacy and show non-inferiority of the investigational PERFORM Stemless Reverse device to the control PERFORM Stem Reverse device in subjects who are candidates for the treatment of noninflammatory degenerative joint disease (i.e., osteoarthritis), avascular necrosis, pseudoparalysis or anterior superior escape, rotator cuff tear arthropathy, correction of functional deformity, and post-traumatic arthritis.

 

 

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

  • Adult subject 18 years or older.
  • Scapula and proximal humerus must have reached skeletal maturity.
  • 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.
  • Willing and able to comply with the protocol.
  • Willing and able to sign the informed consent form.
  • Patients with an adjusted Constant Score ≤ 65.

Exclusion Criteria:

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

Eligibility last updated 1/21/22. Questions regarding updates should be directed to the study team contact.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Joaquin Sanchez-Sotelo, M.D., Ph.D.

Open for enrollment

Contact information:

Damian Paulson

(507) 293-7613

Paulson.Damian@mayo.edu

More information

Publications

Publications are currently not available