A Prospective, Multicentre Study Evaluating the Clinical Performance of the T.E.S.S Anatomic and Reverse Shoulder Prostheses
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Arthritis
- Sponsor
- Zimmer Biomet
- Enrollment
- 600
- Locations
- 13
- Primary Endpoint
- Change in Constant Murley Score
- Status
- Terminated
- Last Updated
- 6 years ago
Overview
Brief Summary
This observational study intends to collect efficacy and safety data on TESS shoulder system
Detailed Description
The T.E.S.S.® shoulder system has been developed to provide a complete solution for all the indications for Shoulder Arthroplasty, Arthritis, Rotator Cuff Arthropathy, Proximal Humeral Fracture, minimising bone resection and restoring the natural anatomy of the patient.
Investigators
Eligibility Criteria
Inclusion Criteria
- •A pre-operative level of pain and function the same as for conventional joint replacement
- •A likelihood of obtaining relief of pain and improved function
- •Full skeletal maturity
- •Ability to follow instructions
- •Good general health for age
- •Willing to return for follow-up evaluations
Exclusion Criteria
- •Glenohumeral joint infection, osteomyelitis
- •Neuro-muscular complications
- •Inability to co-operate with and complete the study
Outcomes
Primary Outcomes
Change in Constant Murley Score
Time Frame: 6 months, 1 year, 2 year, 3 year, 4 year, 5 year, 7 year and 10 year
Improvement in this score will be collected at every follow-up visit.This is a 100-point score, containing 8 questions. Higher score indicate a better outcome.
Change in Oxford Score
Time Frame: 6 months, 1 year, 2 year, 3 year, 4 year, 5 year, 7 year and 10 year
Improvement in this score will be collected at every follow-up visit.This is a 60-point score, containing 12 questions. Higher score indicate a better outcome.
Secondary Outcomes
- Patient Satisfaction(6 months, 1 year, 2 year, 3 year, 4 year, 5 year, 7 year and 10 year)
- Complications(Any time)