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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.
Patient follow-up outcomes measured by the ASES score, radiographs and adverse events/revisions.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Discovery™ Elbow | Discovery™ Elbow minimally constrained |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | 5 years |
| 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. | 5 Years |
| 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. | 5 Years |
| 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. | 5 Years |
| 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. | 5 Years |
| Surgeon Derived American Shoulder and Elbow Society Score (ASES) Strength |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Surviving Elbows | Proportion of elbows that did not require revision or removal | Up to 5 Years |
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Inclusion Criteria:
Patient Selection factors to be considered include:
Exclusion Criteria:
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Patients in need of relief from painful or disabling Joint Disease in need of total elbow replacment.
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| Name | Affiliation | Role |
|---|---|---|
| Russell Schenck, PhD | Director, Clinical Research, Biomet Orthopedics, LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Florida Orthopedic Institute | Tampa | Florida | 33637 | United States | ||
| Indiana Hand to Shoulder Center |
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| ID | Title | Description |
|---|---|---|
| FG000 | Discovery™ Elbow | Discovery™ Elbow minimally constrained |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Elbows with preoperative data
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| ID | Title | Description |
|---|---|---|
| BG000 | Discovery™ Elbow | Discovery™ Elbow minimally constrained |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Discovery Elbow | Posted | Mean | Standard Deviation | Scores on a scale | 5 years | Elbows | Elbows |
|
|
Adverse events were collected from the time of enrollment to the time of study completion (5 year visit). The numbers at risk refer to the number of elbows implanted.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Discovery™ Elbow | Discovery™ Elbow minimally constrained |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Left shoulder arthroplasty due to rheumatoid arthritis | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fracture Near Operative Site | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kelly Francher, Clinical Affairs Manager | Zimmer Biomet | 574-371-9783 | kelly.francher@zimmerbiomet.com |
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| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001172 | Arthritis, Rheumatoid |
| D010020 | Osteonecrosis |
| D006810 | Humeral Fractures |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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Measure of elbow strength as defined by the investigator. Maximum score is 20 and the minimum is 0. The maximum score indicates maximum strength.
| 5 Years |
| Indianapolis |
| Indiana |
| 46260 |
| United States |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
| Vanderbilt Hand Center | Nashville | Tennessee | 37232 | United States |
| Elbows |
|
| Sex/Gender, Customized | Number | elbows |
|
| Region of Enrollment | Number | elbows |
|
| Hand Dominance | Number | elbows |
|
| Primary Diagnosis | Number | elbows |
|
|
| Elbows |
|
|
| 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. | Discovery elbows | Posted | Mean | Standard Deviation | Scores on a scale | 5 Years | Elbows | Elbows |
|
|
|
| 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. | Posted | Mean | Standard Deviation | Scores on a scale | 5 Years | Elbows | Elbows |
|
|
|
| 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. | Posted | Mean | Standard Deviation | Scores on a scale | 5 Years | Elbows | Elbows |
|
|
|
| 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. | Posted | Mean | Standard Deviation | Scores on a scale | 5 Years | Elbows | Elbows |
|
|
|
| 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. | Posted | Mean | Standard Deviation | Scores on a scale | 5 Years | Elbows | Elbows |
|
|
|
| Secondary | Incidence of Surviving Elbows | Proportion of elbows that did not require revision or removal | Subjects with complete 5 year data. | Posted | Number | 95% Confidence Interval | Proportion of Elbows | Up to 5 Years | Elbows | Elbows |
|
|
|
| 17 |
| 118 |
| 32 |
| 118 |
| Infection requiring intervention | Infections and infestations | Non-systematic Assessment |
|
| Humeral Fracture | Musculoskeletal and connective tissue disorders | Non-systematic Assessment | Postoperative humeral fracture |
|
| Sucutaneous Abscess | Infections and infestations | Non-systematic Assessment | Patient developed 2 subcutaneous abscesses both requiring operative intervention. One abscess was located on the right dorsal wrist and the second was located on the plantar aspect of the right foot. |
|
| Post-op Hematoma | Blood and lymphatic system disorders | Non-systematic Assessment |
|
| GI Bleed | Gastrointestinal disorders | Non-systematic Assessment |
|
| Loosening of total elbow | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Non-elbow Fracture | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Elbow Contracture | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Failed Ulnar Bushing | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Resection of Distal Ulna | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Patient Fell | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Stitch Abscess | Infections and infestations | Non-systematic Assessment |
|
| Olecranon and Triceps Deficiency | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Motor Vehicle Accident | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Lung Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment |
|
| Elbow Bursitis | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Perforation Anterior Medical Proximal Ulna | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Ulnar Neuropathy | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Foreign Body Reaction/Excision Olecranon Mass | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Elbow Squeaking | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| MCP Replacement | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Coagulase Negative Staph Infection | Infections and infestations | Non-systematic Assessment |
|
| Posterior Screw Backing Out | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Humeral radiolucency | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Humeral Component Loosening | Metabolism and nutrition disorders | Non-systematic Assessment |
|
| Posterior Nerve Palsy | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Painful Lateral Elbow | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Leukemia | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment |
|
| Wound Drainage | Infections and infestations | Non-systematic Assessment |
|
| Olecranon Impingement | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Insidious Onset Edema Elbow | Infections and infestations | Non-systematic Assessment |
|
| Ectopic Bone Formation | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Elbow Contracture | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
A publication which uses data in addition to the authors will be reviewed by all who have contributed data, and all of the contributors will be recognized. All publications will be reviewed by BIOMET at least 30 days prior to publication.
| D003240 |
| Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D001847 | Bone Diseases |
| D009336 | Necrosis |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001134 | Arm Injuries |
| D014947 | Wounds and Injuries |
| D050723 | Fractures, Bone |