Pain, Survivorship
Conditions
Keywords
elbow long-term Survivorship, Study participant Discovery Elbow Multi-center Study who, consent for the Discovery Elbow Long-term SurvivorshipStudy
Brief summary
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.
Detailed description
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.
Interventions
DEVICEDiscovery elbow minimally constrained
patient participating in the Discovery Elbow Multi-center study
Sponsors
Zimmer Biomet
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
1. Participant in the Discovery Elbow Multi-center Study 2. Consent to participate in the Discovery Elbow Long-Term Survivorship Study
Exclusion criteria
1. Patient is not a Discovery Elbow Multi-center Participant 2. Patient does not provide consent for the Discovery Elbow Long-term Survivorship Study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patient Derived American Shoulder and Elbow Society (ASES) Pain Score | 10 Years Post-op | This is the patient's perception of pain related to the operative elbow. Maximum pain score = 50 (worst) Minimum pain score = 0 (best) |
| Patient Derived American Shoulder and Elbow Society (ASES) Function | 10 Years Post-op | 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. |
| Patient Derived American Shoulder and Elbow Society (ASES) Satisfaction | 10 Years Post-op | This is the patient's perception of satisfaction with the elbow replacement surgery. Maximum Score = 10 Minimum Score = 0 Maximum Score represents maximum satisfaction. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Survivorship Will be Measured by the Incidence of Revision or Removals | 10 years Post-op | The consented Patient will answer specific questions about their elbow replacement such as; if the elbow replacement has been removed |
Countries
United States
Participant flow
Recruitment details
Recruitment has been discontinued.
Participants by arm
| Arm | Count |
|---|---|
| Discovery Elbow This arm includes all subjects who underwent total elbow arthroplasty with the Discovery Total Elbow and entered the long-term survival study. | 29 |
| Total | 29 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Death | 4 |
| Overall Study | Revision | 2 |
| Overall Study | Study Discontinued | 23 |
Baseline characteristics
| Characteristic | Discovery Elbow |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 13 Participants |
| Age, Categorical Between 18 and 65 years | 16 Participants |
| Hand Dominance Ambidextrous | 1 Participants |
| Hand Dominance Left | 2 Participants |
| Hand Dominance Right | 25 Participants |
| Hand Dominance Unknown | 1 Participants |
| Primary Diagnosis Functional Deformity | 1 Participants |
| Primary Diagnosis Humeral Fracture | 3 Participants |
| Primary Diagnosis Osteoarthritis | 2 Participants |
| Primary Diagnosis Other | 4 Participants |
| Primary Diagnosis Rheumatoid Arthritis | 11 Participants |
| Primary Diagnosis Traumatic Arthritis | 7 Participants |
| Primary Diagnosis Unknown | 1 Participants |
| Region of Enrollment United States | 29 Participants |
| Sex: Female, Male Female | 22 Participants |
| Sex: Female, Male Male | 7 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 29 |
| serious Total, serious adverse events | 10 / 29 |
Outcome results
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.
Time frame: 10 Years Post-op
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Discovery Elbow | Patient Derived American Shoulder and Elbow Society (ASES) Function | 25.1 units on a scale | Standard Deviation 8.8 |
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)
Time frame: 10 Years Post-op
Population: 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.
| Arm | Measure | Value (MEDIAN) | Dispersion |
|---|---|---|---|
| Discovery Elbow | Patient Derived American Shoulder and Elbow Society (ASES) Pain Score | 5.3 units on a scale | Standard Deviation 6.8 |
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.
Time frame: 10 Years Post-op
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Discovery Elbow | Patient Derived American Shoulder and Elbow Society (ASES) Satisfaction | 9.2 units on a scale | Standard Deviation 1.4 |
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
Time frame: 10 years Post-op
Population: 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.