Glenohumeral Arthritis, Rotator Cuff Deficiency
Conditions
Brief 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.
Interventions
DEVICEEncore Reverse Shoulder Prosthesis
rotator cuff deficiency and glenohumeral arthritis
Sponsors
Encore Medical, L.P.
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Survivorship of the Encore Reverse Shoulder Prosthesis | 1 year | Number of subjects who completed all study visits through the 1 year visit. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Encore RSP Subjects who need treatment for rotator cuff deficiency or glenohumeral arthritis, received the Encore Reverse Shoulder Prosthesis and are willing to participate in the study. | 19 |
| Total | 19 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 1 |
| Overall Study | Lost to Follow-up | 5 |
Baseline characteristics
| Characteristic | Encore RSP |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 19 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants |
| Age Continuous | 75 years STANDARD_DEVIATION 4 |
| Region of Enrollment United States | 19 participants |
| Sex: Female, Male Female | 14 Participants |
| Sex: Female, Male Male | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 11 / 19 |
| serious Total, serious adverse events | 0 / 19 |
Outcome results
Primary
Survivorship of the Encore Reverse Shoulder Prosthesis
Number of subjects who completed all study visits through the 1 year visit.
Time frame: 1 year
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Encore RSP | Survivorship of the Encore Reverse Shoulder Prosthesis | 13 participants |