A Clinical Investigation of the Discovery™ Elbow System

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

118 participants

Study Classification

OBSERVATIONAL

Study Start Date

2002-06-30

Study Completion Date

2016-07-31

Brief Summary

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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.

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Detailed Description

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

Conditions

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Osteoarthritis Rheumatoid Arthritis Avascular Necrosis Humeral Fractures

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Discovery™ Elbow

Discovery™ Elbow minimally constrained

No interventions assigned to this group

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No