N/A
N=19
Retrospective Encore Reverse Shoulder Prosthesis Study
Rotator Cuff Deficiency · Glenohumeral Arthritis
Bottom Line
View on ClinicalTrials.gov: NCT00765037 ↗Enrolled (actual)
19
Serious AEs
0.0%
Results posted
Aug 2010
Primary outcome: Primary: Survivorship of the Encore Reverse Shoulder Prosthesis — 13 participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Encore Reverse Shoulder Prosthesis (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Encore Medical, L.P.
- Primary completion
- May 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Survivorship of the Encore Reverse Shoulder Prosthesis |
13 | — |
Summary
The purpose of this study is to evaluate the survivorship and efficacy of the Encore Reverse Shoulder Prosthesis in a group of no more than 50 subjects for whom data collection has already begun.
Eligibility Criteria
Inclusion Criteria
- The RSP is indicated for use in patients with a grossly rotator cuff deficient shoulder joint with severe arthropathy or a previously failed joint replacement with a grossly rotator cuff deficient shoulder joint.
- The patient's joint must be anatomically and structurally suited to receive the selected implant(s), and a functional deltoid muscle is necessary to use the device.
- The glenoid baseplate is intended for Cementless application with the addition of screws for fixation. The humeral stem is intended for cemented use only.
Exclusion Criteria
- Infection or sepsis
- Insufficient bone quality which may affect the stability of the implant, as determined by the physician
- Muscular, neurological, or vascular deficiencies, which compromise the affected extremity
- Alcoholism or other addictions
- Materials (metals, etc) sensitivity
- Loss of ligamentous structures
- High levels of physical activity
- Non-functional deltoid muscle
Data sourced from ClinicalTrials.gov (NCT00765037). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.