Clinical trial NCT00698867: A Clinical Investigation of the Discovery™ Elbow System
Official title: A Prospective, Non-controlled, Clinical Investigation of the Discovery™ Elbow System
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Osteoarthritis
Rheumatoid Arthritis
Avascular Necrosis
Humeral Fractures
Keywords: Total Elbow Arthroplasty
Total Elbow Replacement
Osteoarthritis
Elbow arthritis
Lead sponsor: Zimmer Biomet
Sponsor class: INDUSTRY
First posted: 2008-06-17
Enrollment: 118
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients in need of relief from painful or disabling Joint Disease in need of total elbow replacment.

Brief 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.

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

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.

Primary outcomes:
measure: American Shoulder and Elbow Society Score (ASES) Pain Assessment
timeFrame: 5 years
measure: Patient Derived American Shoulder and Elbow Society Score (ASES) Function
timeFrame: 5 Years
measure: Patient Derived American Shoulder and Elbow Society Score (ASES) Satisfaction
timeFrame: 5 Years
measure: Surgeon Derived American Shoulder and Elbow Society Score (ASES) Signs
timeFrame: 5 Years
measure: Surgeon Derived American Shoulder and Elbow Society Score (ASES) Stability
timeFrame: 5 Years
measure: Surgeon Derived American Shoulder and Elbow Society Score (ASES) Strength
timeFrame: 5 Years
Secondary outcomes:
measure: Incidence of Surviving Elbows
timeFrame: Up to 5 Years
Other outcomes:
Locations:
city: Tampa
country: United States
facility: Florida Orthopedic Institute
state: Florida
city: Indianapolis
country: United States
facility: Indiana Hand to Shoulder Center
state: Indiana
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Nashville
country: United States
facility: Vanderbilt Hand Center
state: Tennessee
Study officials:
affiliation: Director, Clinical Research, Biomet Orthopedics, LLC
name: Russell Schenck, PhD
role: STUDY_DIRECTOR
References: