Arthropathy of Shoulder Region, Grossly Deficient Rotator Cuff, Osteoarthritis of the Shoulder, Post-Traumatic Arthitis, Rheumatoid Arthritis Without Humeral Metaphyseal Defects
Conditions
Keywords
Reverse Shoulder Arthroplasty, Medical Device, Performance, Safety, Shoulder Prosthesis, Glenoid Erosion
Brief summary
This study is a multicenter, prospective, non-randomized, non-controlled clinical outcome study. The primary objective of this study is to evaluate improvement of pain score at one year for the Biomet Comprehensive Reverse Shoulder. The secondary objective is collection of long term clinical outcomes.
Detailed description
The Biomet Comprehensive Reverse Shoulder was developed to provide an additional surgical option for patients anatomically and structurally suited to receive a reverse shoulder arthroplasty. The aim of the Biomet Comprehensive Reverse Shoulder is to increase shoulder function while reducing pain. This is a multi-center study. Having several clinical sites will allow for multiple investigators to contribute to the results of the study. 175 implants will be included into the study. All potential study subjects will be required to participate in the Informed Consent Process.
Interventions
DEVICEBiomet Comprehensive Reverse Shoulder
Designed to eliminate the potential for scapular notching, this reverse shoulder system combines a a true locking mechanism that minimized wear and oxidative breakdown with a modular central screw for secure fixation.
Sponsors
Zimmer Biomet
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Biomet® Comprehensive™ Reverse Shoulder products are indicated for use in patients whose shoulder joint has a grossly deficient rotator cuff with severe arthropathy and/or previously failed shoulder joint replacement with a grossly deficient rotator cuff. * The patient must be anatomically and structurally suited to receive the implants and a functional deltoid muscle is necessary. * The Comprehensive® Reverse Shoulder is indicated for primary, fracture, or revision total shoulder replacement for the relief of pain and significant disability due to gross rotator cuff deficiency.
Exclusion criteria
* Absolute contraindications include infection, sepsis, and osteomyelitis. * Uncooperative patient or patient with neurologic disorders who is incapable or unwilling to follow directions. * Osteoporosis. * Metabolic disorders which may impair bone formation. * Osteomalacia. * Distant foci of infections which may spread to the implant site. * Rapid joint destruction, marked bone loss or bone resorption apparent on roentgenogram.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain Score | 1 year | Pain Score is assessed for each subject by asking them to indicate their current level of pain based on a 5 level scale, with None as the best outcome and Severe as the worst. Improvement of pain score at one year from pre-operative levels will be assessed. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Constant Shoulder Score | Pre-operative, 3 months, 6 months, 1 year, 3 years, 5 years, 7 years, 10 years | The Constant-Murley Shoulder Score is a scoring method used by clinicians to assess function of the shoulder. The score is on a scale of 0 to 100, with 0 being no shoulder function and 100 being excellent function. |
| Presence of Scapular Notching | 3 months, 6 months, 1 year, 3 years, 5 years, 7 years, 10 years | All radiographic images collected during the study are assessed by the Principal Investigator for the presence of scapular notching. The severity of notching will be assessed using the Nerot system, where Grade 0 indicates no notch and Grade 4 indicates the largest-sized defect in the scapula. |
Countries
United States
Outcome results
None listed