Trial Outcomes & Findings for Scorpio® Cruciate Retaining (CR) Outcomes Study (NCT NCT00965146)
NCT ID: NCT00965146
Last Updated: 2017-11-17
Results Overview
This study was terminated prior to the protocol defined 15 year endpoint. As such, final outcome measures cannot be posted.
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
215 participants
Primary outcome timeframe
15 years
Results posted on
2017-11-17
Participant Flow
215/229 subjects/cases enrolled and 5 subjects/cases censored=210/224 subjects/cases started
Participant milestones
| Measure |
Scorpio® CR Device
All subjects were implanted with the Scorpio® CR Total Knee System Study Device
|
|---|---|
|
Overall Study
STARTED
|
210
|
|
Overall Study
COMPLETED
|
0
|
|
Overall Study
NOT COMPLETED
|
210
|
Reasons for withdrawal
| Measure |
Scorpio® CR Device
All subjects were implanted with the Scorpio® CR Total Knee System Study Device
|
|---|---|
|
Overall Study
Death
|
7
|
|
Overall Study
Lost to Follow-up
|
22
|
|
Overall Study
Withdrawal by Subject
|
17
|
|
Overall Study
Unable to return
|
1
|
|
Overall Study
Unwilling to return
|
11
|
|
Overall Study
Intercurrent illness
|
1
|
|
Overall Study
Revision / Removal of Study Implant
|
6
|
|
Overall Study
Overall Study Termination
|
145
|
Baseline Characteristics
Scorpio® Cruciate Retaining (CR) Outcomes Study
Baseline characteristics by cohort
| Measure |
Scorpio® CR Total Knee System Study Device
n=210 Participants
All subjects were implanted with the Scorpio® CR Knee Arthroplasty Study Device
|
|---|---|
|
Age, Continuous
|
64.46 years
FULL_RANGE 8.98 • n=5 Participants
|
|
Sex: Female, Male
Female
|
137 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
73 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
210 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 15 yearsThis study was terminated prior to the protocol defined 15 year endpoint. As such, final outcome measures cannot be posted.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: 15 yearsThis study was terminated prior to the protocol defined 15 year endpoint. As such, final outcome measures cannot be posted.
Outcome measures
Outcome data not reported
Adverse Events
Scorpio® CR Total Knee System Study Device
Serious events: 6 serious events
Other events: 53 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Scorpio® CR Total Knee System Study Device
n=210 participants at risk
All subjects were implanted with the Scorpio® CR Knee Arthroplasty Study Device
|
|---|---|
|
Cardiac disorders
Cardiac Disorder
|
0.48%
1/210 • Number of events 1
There were a total of 8 serious adverse events reported in 6 subjects.
|
|
Infections and infestations
Infection and Infestations
|
0.95%
2/210 • Number of events 2
There were a total of 8 serious adverse events reported in 6 subjects.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and Connective Tissue Disorders (Non-operative site)
|
0.48%
1/210 • Number of events 1
There were a total of 8 serious adverse events reported in 6 subjects.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and Connective Tissue Disorder (Operative Site)
|
0.48%
1/210 • Number of events 1
There were a total of 8 serious adverse events reported in 6 subjects.
|
|
Nervous system disorders
Nervous System Disorders
|
0.48%
1/210 • Number of events 1
There were a total of 8 serious adverse events reported in 6 subjects.
|
|
Vascular disorders
Vascular Disorders
|
0.95%
2/210 • Number of events 2
There were a total of 8 serious adverse events reported in 6 subjects.
|
Other adverse events
| Measure |
Scorpio® CR Total Knee System Study Device
n=210 participants at risk
All subjects were implanted with the Scorpio® CR Knee Arthroplasty Study Device
|
|---|---|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and Connective Tissue Disorders - (Operative Site)
|
25.2%
53/210 • Number of events 68
There were a total of 8 serious adverse events reported in 6 subjects.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The disclosure restriction on the PI to publish results of this Clinical Study or the results of the activities hereunder, any abstract, manuscript, presentation or other communication shall be submitted to sponsor for review and approval at least 60 days prior to submission for publication. The sponsor retains the right to deny publication or, at its sole option, to revise the manuscript to delete proprietary or other confidential commercial information.
- Publication restrictions are in place
Restriction type: OTHER