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| Sponsor: | Encore Medical, L.P. |
|---|---|
| Information provided by: | Encore Medical, L.P. |
| ClinicalTrials.gov Identifier: | NCT00764504 |
Purpose
The objective of this clinical study is to evaluate the safety and efficacy of the Encore Reverse Shoulder Prosthesis (RSP). The clinical results of the RSP will be compared to clinical results published in literature for rotator cuff arthropathy and salvage procedures.
| Condition | Intervention | Phase |
|---|---|---|
|
Rotator Cuff Arthropathy Failed Total Shoulder Failed Hemi-Arthroplasty |
Device: Reverse Shoulder Prosthesis |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Non-Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | Encore Reverse Shoulder Prosthesis |
| Enrollment: | 569 |
| Study Start Date: | October 2002 |
| Study Completion Date: | August 2008 |
| Primary Completion Date: | June 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Primary: Experimental
Primary shoulder
|
Device: Reverse Shoulder Prosthesis
For subjects with rotator cuff arthropathy and no previous shoulder device implanted.
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|
Revision: Experimental
Revision shoulder
|
Device: Reverse Shoulder Prosthesis
For subjects with rotator cuff arthropathy and a failed hemi or total shoulder implant.
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Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations
Show 25 Study Locations| Principal Investigator: | Mark Frankle, M.D. | Florida Orthopedic Institute |
More Information
| Responsible Party: | DJO Surgical ( Jane M. Jacob Ph.D. ) |
| Study ID Numbers: | Study 300 |
| Study First Received: | September 30, 2008 |
| Last Updated: | October 9, 2008 |
| ClinicalTrials.gov Identifier: | NCT00764504 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
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Musculoskeletal Diseases Joint Diseases |