Retrospective Encore Reverse Shoulder Prosthesis Study
This study has been completed.
Sponsor:
Encore Medical, L.P.
Information provided by:
Encore Medical, L.P.
ClinicalTrials.gov Identifier:
NCT00765037
First received: September 30, 2008
Last updated: August 3, 2010
Last verified: August 2010
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Rotator Cuff Deficiency Glenohumeral Arthritis |
Device: Encore Reverse Shoulder Prosthesis |
Phase 4 |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Retrospective |
| Official Title: | Post Market Study on the Efficacy of the Encore Reverse Shoulder Prosthesis in a Small Group of Subjects |
Further study details as provided by Encore Medical, L.P.:
Primary Outcome Measures:
- Survivorship of the Encore Reverse Shoulder Prosthesis [ Time Frame: 1 year ] [ Designated as safety issue: No ]Number of subjects who completed all study visits through the 1 year visit.
| Enrollment: | 19 |
| Study Start Date: | August 2008 |
| Study Completion Date: | May 2009 |
| Primary Completion Date: | May 2009 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
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.
|
Device: Encore Reverse Shoulder Prosthesis
rotator cuff deficiency and glenohumeral arthritis
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study Population
Individuals who meet the indications for use of the RSP device AND who meet the inclusion/exclusion criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00765037
Locations
| United States, Tennessee | |
| Nashville Orthopedic Specialists | |
| Nashville, Tennessee, United States, 37203 | |
Sponsors and Collaborators
Encore Medical, L.P.
Investigators
| Principal Investigator: | J. Michael Kioschos, M.D. | Nashville Orthopedic Specialists |
More Information
Additional Information:
No publications provided
| Responsible Party: | Jane M. Jacob Ph.D., DJO Surgical |
| ClinicalTrials.gov Identifier: | NCT00765037 History of Changes |
| Other Study ID Numbers: | PS - 902 |
| Study First Received: | September 30, 2008 |
| Results First Received: | June 8, 2009 |
| Last Updated: | August 3, 2010 |
| Health Authority: | United States: Institutional Review Board |
Additional relevant MeSH terms:
|
Arthritis Joint Diseases Musculoskeletal Diseases |
ClinicalTrials.gov processed this record on May 21, 2013