N/A
Completed N=118
A Clinical Investigation of the Discovery™ Elbow System
Source: ClinicalTrials.gov NCT00698867 ↗Enrolled (actual)
118
Serious AEs
14.4%
Results posted
Aug 2017
Primary outcomePrimary: American Shoulder and Elbow Society Score (ASES) Pain Assessment — 5.4 Scores on a scale
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY American Shoulder and Elbow Society Score (ASES) Pain Assessment |
5.4 | — |
| PRIMARY Patient Derived American Shoulder and Elbow Society Score (ASES) Function |
29.7 | — |
| PRIMARY Patient Derived American Shoulder and Elbow Society Score (ASES) Satisfaction |
8.7 | — |
| PRIMARY Surgeon Derived American Shoulder and Elbow Society Score (ASES) Signs |
1.0 | — |
| PRIMARY Surgeon Derived American Shoulder and Elbow Society Score (ASES) Stability |
0.00 | — |
| PRIMARY Surgeon Derived American Shoulder and Elbow Society Score (ASES) Strength |
19.8 | — |
| SECONDARY Incidence of Surviving Elbows |
0.9778 | — |
Eligibility Criteria
Inclusion Criteria
- 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.
Exclusion Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT00698867). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.