Avascular Necrosis, Humeral Fractures, Osteoarthritis, Rheumatoid Arthritis
Conditions
Keywords
Total Elbow Arthroplasty, Total Elbow Replacement, Osteoarthritis, Elbow arthritis
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.
Interventions
None listed
Sponsors
Biomet Orthopedics, LLC
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patient Derived American Shoulder and Elbow Society Score (ASES) Function | 5 Years | This is a measure of patient function as answered by the patient. The maximum score is 36 and the minimum is 0. The maximum score represents maximum function. |
| Surgeon Derived American Shoulder and Elbow Society Score (ASES) Stability | 5 Years | Surgeon assessment of patient elbow stability. Maximum instability score is 9 and the minimum is 0. The maximum score indicates the least stability. |
| American Shoulder and Elbow Society Score (ASES) Pain Assessment | 5 years | This is a patient reported outcome measure that indicates the patient's pain as measured on the ASES form. The maximum pain score is 50 and the minimum score is 0. A higher pain score indicates the subject is in more pain. A lower pain score indicates less pain. |
| Surgeon Derived American Shoulder and Elbow Society Score (ASES) Strength | 5 Years | Measure of elbow strength as defined by the investigator. Maximum score is 20 and the minimum is 0. The maximum score indicates maximum strength. |
| Patient Derived American Shoulder and Elbow Society Score (ASES) Satisfaction | 5 Years | This is a measure of patient satisfaction as answered by the patient. The maximum score is 10 and the minimum is 0. The maximum score indicates maximum satisfaction. |
| Surgeon Derived American Shoulder and Elbow Society Score (ASES) Signs | 5 Years | This is a measure of the elbow signs as reported by the investigator. Signs include various assessments of joint tenderness, impingement, and pain in range of motion. The maximum score is 39 and the minimum is 0. The maximum score indicates the most abnormal signs. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Surviving Elbows | Up to 5 Years | Proportion of elbows that did not require revision or removal |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Discovery™ Elbow Discovery™ Elbow minimally constrained | 118 |
| Total | 118 |
Baseline characteristics
| Characteristic | Discovery™ Elbow |
|---|---|
| Age, Customized 20-29 | 1 Elbows |
| Age, Customized 30-39 | 7 Elbows |
| Age, Customized 40-49 | 10 Elbows |
| Age, Customized 50-59 | 24 Elbows |
| Age, Customized 60-69 | 41 Elbows |
| Age, Customized 70-79 | 22 Elbows |
| Age, Customized 80-89 | 11 Elbows |
| Age, Customized 90-99 | 2 Elbows |
| Age, Customized Less than 20 | 0 Elbows |
| Hand Dominance Ambidextrous | 2 elbows |
| Hand Dominance Left | 5 elbows |
| Hand Dominance Right | 111 elbows |
| Primary Diagnosis Functional Deformity | 1 elbows |
| Primary Diagnosis Humeral Fracture | 20 elbows |
| Primary Diagnosis Osteoarthritis | 8 elbows |
| Primary Diagnosis Other | 13 elbows |
| Primary Diagnosis Other Inflammatory Arthroses | 1 elbows |
| Primary Diagnosis Recurrent Dislocation/Stability | 5 elbows |
| Primary Diagnosis Revision Surgery | 1 elbows |
| Primary Diagnosis Rheumatoid Arthritis | 52 elbows |
| Primary Diagnosis Traumatic Arthritis | 15 elbows |
| Primary Diagnosis Ulnar Fracture | 2 elbows |
| Region of Enrollment United States | 118 elbows |
| Sex/Gender, Customized Female | 90 elbows |
| Sex/Gender, Customized Male | 28 elbows |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 32 / 118 |
| serious Total, serious adverse events | 17 / 118 |
Outcome results
Primary
American Shoulder and Elbow Society Score (ASES) Pain Assessment
This is a patient reported outcome measure that indicates the patient's pain as measured on the ASES form. The maximum pain score is 50 and the minimum score is 0. A higher pain score indicates the subject is in more pain. A lower pain score indicates less pain.
Time frame: 5 years
Population: Discovery Elbow
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Discovery™ Elbow | American Shoulder and Elbow Society Score (ASES) Pain Assessment | 5.4 Scores on a scale | Standard Deviation 7.1 |
Primary
Patient Derived American Shoulder and Elbow Society Score (ASES) Function
This is a measure of patient function as answered by the patient. The maximum score is 36 and the minimum is 0. The maximum score represents maximum function.
Time frame: 5 Years
Population: Discovery elbows
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Discovery™ Elbow | Patient Derived American Shoulder and Elbow Society Score (ASES) Function | 29.7 Scores on a scale | Standard Deviation 7 |
Primary
Patient Derived American Shoulder and Elbow Society Score (ASES) Satisfaction
This is a measure of patient satisfaction as answered by the patient. The maximum score is 10 and the minimum is 0. The maximum score indicates maximum satisfaction.
Time frame: 5 Years
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Discovery™ Elbow | Patient Derived American Shoulder and Elbow Society Score (ASES) Satisfaction | 8.7 Scores on a scale | Standard Deviation 2.9 |
Primary
Surgeon Derived American Shoulder and Elbow Society Score (ASES) Signs
This is a measure of the elbow signs as reported by the investigator. Signs include various assessments of joint tenderness, impingement, and pain in range of motion. The maximum score is 39 and the minimum is 0. The maximum score indicates the most abnormal signs.
Time frame: 5 Years
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Discovery™ Elbow | Surgeon Derived American Shoulder and Elbow Society Score (ASES) Signs | 1.0 Scores on a scale | Standard Deviation 1.8 |
Primary
Surgeon Derived American Shoulder and Elbow Society Score (ASES) Stability
Surgeon assessment of patient elbow stability. Maximum instability score is 9 and the minimum is 0. The maximum score indicates the least stability.
Time frame: 5 Years
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Discovery™ Elbow | Surgeon Derived American Shoulder and Elbow Society Score (ASES) Stability | 0.00 Scores on a scale | Standard Deviation 0 |
Primary
Surgeon Derived American Shoulder and Elbow Society Score (ASES) Strength
Measure of elbow strength as defined by the investigator. Maximum score is 20 and the minimum is 0. The maximum score indicates maximum strength.
Time frame: 5 Years
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Discovery™ Elbow | Surgeon Derived American Shoulder and Elbow Society Score (ASES) Strength | 19.8 Scores on a scale | Standard Deviation 0.8 |
Secondary
Incidence of Surviving Elbows
Proportion of elbows that did not require revision or removal
Time frame: Up to 5 Years
Population: Subjects with complete 5 year data.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Discovery™ Elbow | Incidence of Surviving Elbows | 0.9778 Proportion of Elbows |