A Clinical Investigation of the Discovery™ Elbow System
This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
Biomet, Inc. ( Biomet Orthopedics, LLC )
First received: June 13, 2008
Last updated: July 30, 2014
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.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
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
||July 30, 2014
||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 September 18, 2014
Connective Tissue Diseases
Immune System Diseases
Wounds and Injuries