Trial Outcomes & Findings for Discovery Elbow Long-Term Survivorship (NCT NCT01308463)
NCT ID: NCT01308463
Last Updated: 2017-05-01
Results Overview
This is the patient's perception of pain related to the operative elbow. Maximum pain score = 50 (worst) Minimum pain score = 0 (best)
TERMINATED
29 participants
10 Years Post-op
2017-05-01
Participant Flow
Recruitment has been discontinued.
Participant milestones
| Measure |
Discovery Elbow
This arm includes all subjects who underwent total elbow arthroplasty with the Discovery Total Elbow and entered the long-term survival study.
|
|---|---|
|
Overall Study
STARTED
|
29
|
|
Overall Study
6 Months
|
23
|
|
Overall Study
1 Year
|
21
|
|
Overall Study
2 Years
|
18
|
|
Overall Study
3 Years
|
17
|
|
Overall Study
4 Years
|
20
|
|
Overall Study
5 Years
|
20
|
|
Overall Study
6 Years
|
11
|
|
Overall Study
7 Years
|
12
|
|
Overall Study
8 Years
|
14
|
|
Overall Study
9 Years
|
11
|
|
Overall Study
10 Years
|
8
|
|
Overall Study
11 Years
|
8
|
|
Overall Study
12 Years
|
2
|
|
Overall Study
COMPLETED
|
0
|
|
Overall Study
NOT COMPLETED
|
29
|
Reasons for withdrawal
| Measure |
Discovery Elbow
This arm includes all subjects who underwent total elbow arthroplasty with the Discovery Total Elbow and entered the long-term survival study.
|
|---|---|
|
Overall Study
Study Discontinued
|
23
|
|
Overall Study
Death
|
4
|
|
Overall Study
Revision
|
2
|
Baseline Characteristics
Discovery Elbow Long-Term Survivorship
Baseline characteristics by cohort
| Measure |
Discovery Elbow
n=29 Participants
This arm includes all subjects who underwent total elbow arthroplasty with the Discovery Total Elbow and entered the long-term survival study.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
16 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
13 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
22 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
29 Participants
n=5 Participants
|
|
Hand Dominance
Ambidextrous
|
1 Participants
n=5 Participants
|
|
Hand Dominance
Left
|
2 Participants
n=5 Participants
|
|
Hand Dominance
Right
|
25 Participants
n=5 Participants
|
|
Hand Dominance
Unknown
|
1 Participants
n=5 Participants
|
|
Primary Diagnosis
Functional Deformity
|
1 Participants
n=5 Participants
|
|
Primary Diagnosis
Humeral Fracture
|
3 Participants
n=5 Participants
|
|
Primary Diagnosis
Osteoarthritis
|
2 Participants
n=5 Participants
|
|
Primary Diagnosis
Other
|
4 Participants
n=5 Participants
|
|
Primary Diagnosis
Rheumatoid Arthritis
|
11 Participants
n=5 Participants
|
|
Primary Diagnosis
Traumatic Arthritis
|
7 Participants
n=5 Participants
|
|
Primary Diagnosis
Unknown
|
1 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 10 Years Post-opPopulation: 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.
This is the patient's perception of pain related to the operative elbow. Maximum pain score = 50 (worst) Minimum pain score = 0 (best)
Outcome measures
| Measure |
Discovery Elbow
n=9 Elbows
This arm includes all subjects who underwent total elbow arthroplasty with the Discovery Total Elbow and entered the long-term survival study.
|
|---|---|
|
Patient Derived American Shoulder and Elbow Society (ASES) Pain Score
|
5.3 units on a scale
Standard Deviation 6.8
|
PRIMARY outcome
Timeframe: 10 Years Post-opPopulation: 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.
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.
Outcome measures
| Measure |
Discovery Elbow
n=9 Elbows
This arm includes all subjects who underwent total elbow arthroplasty with the Discovery Total Elbow and entered the long-term survival study.
|
|---|---|
|
Patient Derived American Shoulder and Elbow Society (ASES) Function
|
25.1 units on a scale
Standard Deviation 8.8
|
PRIMARY outcome
Timeframe: 10 Years Post-opPopulation: 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.
This is the patient's perception of satisfaction with the elbow replacement surgery. Maximum Score = 10 Minimum Score = 0 Maximum Score represents maximum satisfaction.
Outcome measures
| Measure |
Discovery Elbow
n=9 Elbows
This arm includes all subjects who underwent total elbow arthroplasty with the Discovery Total Elbow and entered the long-term survival study.
|
|---|---|
|
Patient Derived American Shoulder and Elbow Society (ASES) Satisfaction
|
9.2 units on a scale
Standard Deviation 1.4
|
SECONDARY outcome
Timeframe: 10 years Post-opPopulation: 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.
The consented Patient will answer specific questions about their elbow replacement such as; if the elbow replacement has been removed
Outcome measures
Outcome data not reported
Adverse Events
Discovery Elbow
Serious adverse events
| Measure |
Discovery Elbow
n=29 participants at risk
This arm includes all subjects who underwent total elbow arthroplasty with the Discovery Total Elbow and entered the long-term survival study.
|
|---|---|
|
Infections and infestations
Infection in Operative Joint
|
3.4%
1/29 • Number of events 7
|
|
Skin and subcutaneous tissue disorders
Complex Laceration of Arm
|
3.4%
1/29 • Number of events 1
|
|
Surgical and medical procedures
Ulnar Bearing Loosening
|
3.4%
1/29 • Number of events 1
|
|
Surgical and medical procedures
Screw Loose from Bearing
|
3.4%
1/29 • Number of events 1
|
|
Surgical and medical procedures
Bushing Failure
|
3.4%
1/29 • Number of events 1
|
|
General disorders
Unspecified Events Leading to Death
|
13.8%
4/29 • Number of events 4
|
|
Surgical and medical procedures
TEA Revision
|
3.4%
1/29 • Number of events 1
|
|
Surgical and medical procedures
Revision - Loose Humeral Component
|
3.4%
1/29 • Number of events 1
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER