A Clinical Investigation of the Discovery™ Elbow System



Status:Active, not recruiting
Conditions:Arthritis, Arthritis, Osteoarthritis (OA), Rheumatoid Arthritis, Orthopedic
Therapuetic Areas:Rheumatology, Orthopedics / Podiatry
Healthy:No
Age Range:18 - Any
Updated:4/21/2016
Start Date:June 2002
End Date:June 2016

Use our guide to learn which trials are right for you!

A Prospective, Non-controlled, Clinical Investigation of the Discovery™ Elbow System

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.

Patient follow-up outcomes measured by the ASES score, radiographs and adverse
events/revisions.

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.
We found this trial at
4
sites
Indianapolis, Indiana 46260
?
mi
from
Indianapolis, IN
Click here to add this to my saved trials
185 Cambridge Street
Boston, Massachusetts 02114
617-724-5200
?
mi
from
Boston, MA
Click here to add this to my saved trials
Tampa, Florida 33606
?
mi
from
Tampa, FL
Click here to add this to my saved trials
Nashville, Tennessee 37232
?
mi
from
Nashville, TN
Click here to add this to my saved trials