Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Study terminated due to change in sponsorship
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The Discovery™ Elbow Multi-Center Prospective Study (5-year Study) patients will be consented at the two year or next scheduled follow-up period for the early-enrolled patients.
Eligibility: Patient(s) must be enrolled in the Discovery Multi-Center Prospective Study. The patient must consent to participation in the Discovery Long-term Survivorship Study.
In order to continue to follow the multi-center subjects long-term Biomet would like to extend the follow-up to include annual follow-ups from 10 to 15 years to document long-term survivorship. The annual follow-up will be obtained by sending annual questionnaire directly to the patients by mail. The Patient ASES questionnaire and survivorship data questions will be collected.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Discovery elbow minimally constrained | Device | patient participating in the Discovery Elbow Multi-center study |
| Measure | Description | Time Frame |
|---|---|---|
| Patient Derived American Shoulder and Elbow Society (ASES) Pain Score | This is the patient's perception of pain related to the operative elbow. Maximum pain score = 50 (worst) Minimum pain score = 0 (best) | 10 Years Post-op |
| Patient Derived American Shoulder and Elbow Society (ASES) Function | This is the patient's perception of function. The maximum score is 36 and the minimum score is 0. The maximum score represents maximum function. | 10 Years Post-op |
| Patient Derived American Shoulder and Elbow Society (ASES) Satisfaction | This is the patient's perception of satisfaction with the elbow replacement surgery. Maximum Score = 10 Minimum Score = 0 Maximum Score represents maximum satisfaction. | 10 Years Post-op |
| Measure | Description | Time Frame |
|---|---|---|
| Survivorship Will be Measured by the Incidence of Revision or Removals | The consented Patient will answer specific questions about their elbow replacement such as; if the elbow replacement has been removed | 10 years Post-op |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
The Study population shall be participanting in the Discovery Elbow Multi-center Study who provide consent for the Discovey Elbow Long-term Survivoship Study
Not provided
| 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 | ||
| The Indiana Hand to Shoulder Center |
Not provided
Recruitment has been discontinued.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Discovery Elbow | This arm includes all subjects who underwent total elbow arthroplasty with the Discovery Total Elbow and entered the long-term survival study. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Discovery Elbow | This arm includes all subjects who underwent total elbow arthroplasty with the Discovery Total Elbow and entered the long-term survival study. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Patient Derived American Shoulder and Elbow Society (ASES) Pain Score | This is the patient's perception of pain related to the operative elbow. Maximum pain score = 50 (worst) Minimum pain score = 0 (best) | The number of participants analyzed in this section is reflective of the number of participants/elbows with the complete data required to calculate this score. This is different than the number reflected in participant flow which is indicative of the number of participants/elbows with any data during the given interval. | Posted | Median | Standard Deviation | units on a scale | 10 Years Post-op | Elbows | Elbows |
|
Not provided
Not provided
Not provided
| 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 | This arm includes all subjects who underwent total elbow arthroplasty with the Discovery Total Elbow and entered the long-term survival study. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Infection in Operative Joint | Infections and infestations | Chronic infection and treatment of elbow |
Not provided
The early termination of this study lead to only a small number of consenting subjects available for analysis.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kelly Francher | Zimmer Biomet | 574-371-9783 | kelly.francher@zimmerbiomet.com |
Not provided
| ID | Term |
|---|---|
| D010146 | Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
Not provided
Not provided
Not provided
| Indianapolis |
| Indiana |
| 46260 |
| United States |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
| Vanderbilt Hand Center | Nashville | Tennessee | 37232 | United States |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Hand Dominance | Count of Participants | Participants |
|
| Primary Diagnosis | Count of Participants | Participants |
|
| Units | Counts |
|---|---|
| Participants |
|
| Elbows |
|
|
| Primary | Patient Derived American Shoulder and Elbow Society (ASES) Function | This is the patient's perception of function. The maximum score is 36 and the minimum score is 0. The maximum score represents maximum function. | The number of participants analyzed in this section is reflective of the number of participants/elbows with the complete data required to calculate this score. This is different than the number reflected in participant flow which is indicative of the number of participants/elbows with any data during the given interval. | Posted | Mean | Standard Deviation | units on a scale | 10 Years Post-op | Elbows | Elbows |
|
|
|
| Primary | Patient Derived American Shoulder and Elbow Society (ASES) Satisfaction | This is the patient's perception of satisfaction with the elbow replacement surgery. Maximum Score = 10 Minimum Score = 0 Maximum Score represents maximum satisfaction. | The number of participants analyzed in this section is reflective of the number of participants/elbows with the complete data required to calculate this score. This is different than the number reflected in participant flow which is indicative of the number of participants/elbows with any data during the given interval. | Posted | Mean | Standard Deviation | units on a scale | 10 Years Post-op | Elbows | Elbows |
|
|
|
| Secondary | Survivorship Will be Measured by the Incidence of Revision or Removals | The consented Patient will answer specific questions about their elbow replacement such as; if the elbow replacement has been removed | This analysis cannot be conducted due to the low number of cases available with 10 year data. There is not sufficient data to calculate survivorship. This study is being terminated since the product has been sold to another company. | Posted | 10 years Post-op | Elbows | Elbows |
|
|
| 10 |
| 29 |
| 0 |
| 29 |
| Complex Laceration of Arm | Skin and subcutaneous tissue disorders |
|
| Ulnar Bearing Loosening | Surgical and medical procedures | bearing exchange |
|
| Screw Loose from Bearing | Surgical and medical procedures | Bearing revision |
|
| Bushing Failure | Surgical and medical procedures | Squeaking in elbow. X-rays show bushing failure. |
|
| Unspecified Events Leading to Death | General disorders | Death |
|
| TEA Revision | Surgical and medical procedures |
|
| Revision - Loose Humeral Component | Surgical and medical procedures |
|
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.