A Clinical Investigation of the Discovery™ Elbow System
This study is enrolling participants by invitation only.
Information provided by (Responsible Party):
Biomet, Inc. ( Biomet Orthopedics, LLC )
First received: June 13, 2008
Last updated: December 17, 2013
Last verified: December 2013
The purpose of this study is to perform a five-year, multi-center prospective evaluation of the Discovery™ Elbow System for outcome and durability. Relief of pain and restoration of function will determine long-term clinical outcome while durability will be measured by the absence of revisions.
||Observational Model: Cohort
Time Perspective: Prospective
||A Prospective, Non-controlled, Clinical Investigation of the Discovery™ Elbow System
Primary Outcome Measures:
Secondary Outcome Measures:
- Incidence of revision or removals [ Time Frame: Any time ] [ Designated as safety issue: Yes ]
| Estimated Enrollment:
| Study Start Date:
| Estimated Study Completion Date:
| Estimated Primary Completion Date:
||June 2015 (Final data collection date for primary outcome measure)
Discovery™ Elbow minimally constrained
Patient follow-up outcomes measured by the ASES score, radiographs and adverse events/revisions.
|Ages Eligible for Study:
||18 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
Patients in need of relief from painful or disabling Joint Disease in need of total elbow replacment.
- Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis.
- Inflammatory arthritis
- Revision where other devices or treatments have failed
- Correction of functional deformity
- Treatment of acute fractures or non-union about the elbow
Patient Selection factors to be considered include:
- Need to obtain pain relief and improve function.
- Ability and willingness to follow instructions including control of weight and activity levels.
- Patients who are able and willing to return for follow-up evaluations.
- Patients with a good nutritional state.
- Patients with full skeletal maturity.
- Patients of all races and gender.
- Patients who are able to follow care instructions.
- Patients less than 18 years.
- Patients with marked bone loss which would preclude proper fixation of the prosthesis.
- Metabolic disorders, which may impair bone formation.
- Patients who are pregnant.
- Patients with an active or suspected infection in or around the elbow or distant foci of infections, which may spread to the implant site.
- Patients with a highly communicable disease or diseases that may limit follow-up (e.g. immuno-compromised conditions, hepatitis, active tuberculosis, neoplastic disease, etc.).
- Patients unwilling or unable to comply with a rehabilitation program for elbow replacement or who indicate difficulty or inability to return for follow-up visits prescribed by the study protocol.
- Patients who qualify for inclusion in the study, but refuse consent to participate in the study.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00698867
|Florida Orthopedic Institute
|Tampa, Florida, United States, 33637 |
|Indiana Hand to Shoulder Center
|Indianapolis, Indiana, United States, 46260 |
|Massachusetts General Hospital
|Boston, Massachusetts, United States, 02114 |
|Vanderbilt Hand Center
|Nashville, Tennessee, United States, 37232 |
Biomet Orthopedics, LLC
||Russell Schenck, PhD
||Director, Clinical Research, Biomet Orthopedics, LLC
No publications provided
||Biomet, Inc. ( Biomet Orthopedics, LLC )
History of Changes
|Other Study ID Numbers:
|Study First Received:
||June 13, 2008
||December 17, 2013
||United States: Institutional Review Board
Keywords provided by Biomet, Inc.:
Total Elbow Arthroplasty
Total Elbow Replacement
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on April 22, 2014
Connective Tissue Diseases
Immune System Diseases
Wounds and Injuries