Trial Outcomes & Findings for ATTUNE Single-Use Instrumentation vs. ATTUNE Reusable Instrumentation in Primary Total Knee Arthroplasty (NCT NCT02574312)
NCT ID: NCT02574312
Last Updated: 2020-04-09
Results Overview
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
88 participants
Primary outcome timeframe
3 Months Post Surgery
Results posted on
2020-04-09
Participant Flow
The first patient was operated on 16 November 2015 and recruitment lasted for 37 months with the last patient operated on 19 December 2018.
Consent was taken for 102 knees, 14 subjects were deemed ineligible for the study. This left 88 subjects in the safety population that could be randomised for the study.
Participant milestones
| Measure |
RUI (Reuseable Instrumentation)
Patients were operated on using Reusable TKA Instrumentation
|
SUI (Single-Use Instrumentation)
Patients were operated on using Single-Use TKA Instrumentation
|
|---|---|---|
|
Pre-Operative
STARTED
|
44
|
44
|
|
Pre-Operative
COMPLETED
|
44
|
44
|
|
Pre-Operative
NOT COMPLETED
|
0
|
0
|
|
3 Months Follow-up
STARTED
|
44
|
44
|
|
3 Months Follow-up
COMPLETED
|
43
|
44
|
|
3 Months Follow-up
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
| Measure |
RUI (Reuseable Instrumentation)
Patients were operated on using Reusable TKA Instrumentation
|
SUI (Single-Use Instrumentation)
Patients were operated on using Single-Use TKA Instrumentation
|
|---|---|---|
|
3 Months Follow-up
Withdrawal by Subject
|
1
|
0
|
Baseline Characteristics
ATTUNE Single-Use Instrumentation vs. ATTUNE Reusable Instrumentation in Primary Total Knee Arthroplasty
Baseline characteristics by cohort
| Measure |
RUI (Reuseable Instrumentation)
n=44 Participants
Patients were operated on using Reusable TKA Instrumentation
|
SUI (Single-Use Instrumentation)
n=44 Participants
Patients were operated on using Single-Use TKA Instrumentation
|
Total
n=88 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
66.0 years
STANDARD_DEVIATION 6.89 • n=5 Participants
|
69.3 years
STANDARD_DEVIATION 7.98 • n=7 Participants
|
67.9 years
STANDARD_DEVIATION 8.0 • n=5 Participants
|
|
Sex: Female, Male
Female
|
20 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
46 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
24 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
42 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
22 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
44 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
22 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
44 Participants
n=5 Participants
|
|
Region of Enrollment
United Kingdom
|
22 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
44 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
22 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
44 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 3 Months Post SurgeryPopulation: All patients with readable radiographs who were enrolled without major protocol violations
Outcome measures
| Measure |
RUI (Reuseable Instrumentation)
n=34 Radiographs
Patients were operated on using Reusable TKA Instrumentation
|
SUI (Single-Use Instrumentation)
n=41 Radiographs
Patients were operated on using Single-Use TKA Instrumentation
|
|---|---|---|
|
Difference in Absolute Mechanical Axis Alignment Angle Between Subjects Operated on With RUI and SUI TKA Instrumentation
|
2.55 Degrees
Standard Deviation 2.44
|
2.97 Degrees
Standard Deviation 2.33
|
SECONDARY outcome
Timeframe: 3 Months Post SurgeryPopulation: All patients with readable radiographs who were enrolled without major protocol violations
Outcome measures
| Measure |
RUI (Reuseable Instrumentation)
n=34 Radiographs
Patients were operated on using Reusable TKA Instrumentation
|
SUI (Single-Use Instrumentation)
n=41 Radiographs
Patients were operated on using Single-Use TKA Instrumentation
|
|---|---|---|
|
Femoral Component Varus Valgus Angle Between Subjects Operated on With RUI and SUI TKA Instrumentation
|
94.9 Degrees
Standard Deviation 2.10
|
95.8 Degrees
Standard Deviation 2.40
|
SECONDARY outcome
Timeframe: 3 Months Post SurgeryPopulation: All patients with readable radiographs who were enrolled without major protocol violations
Outcome measures
| Measure |
RUI (Reuseable Instrumentation)
n=34 Radiographs
Patients were operated on using Reusable TKA Instrumentation
|
SUI (Single-Use Instrumentation)
n=41 Radiographs
Patients were operated on using Single-Use TKA Instrumentation
|
|---|---|---|
|
Tibial Component Varus Valgus Angle Between Subjects Operated on With RUI and SUI TKA Instrumentation
|
88.4 Degrees
Standard Deviation 2.18
|
88.7 Degrees
Standard Deviation 2.23
|
SECONDARY outcome
Timeframe: 3 Months Post SurgeryPopulation: All patients with readable radiographs who were enrolled without major protocol violations
Outcome measures
| Measure |
RUI (Reuseable Instrumentation)
n=34 Radiographs
Patients were operated on using Reusable TKA Instrumentation
|
SUI (Single-Use Instrumentation)
n=41 Radiographs
Patients were operated on using Single-Use TKA Instrumentation
|
|---|---|---|
|
Femoral Component Flexion Angle Between Subjects Operated on With RUI and SUI Instrumentation
|
6.21 Degrees
Standard Deviation 2.70
|
7.91 Degrees
Standard Deviation 3.20
|
SECONDARY outcome
Timeframe: 3 Months Post SurgeryPopulation: All patients with readable radiographs who were enrolled without major protocol violations
Outcome measures
| Measure |
RUI (Reuseable Instrumentation)
n=34 Radiographs
Patients were operated on using Reusable TKA Instrumentation
|
SUI (Single-Use Instrumentation)
n=41 Radiographs
Patients were operated on using Single-Use TKA Instrumentation
|
|---|---|---|
|
Posterior Tibial Slope Between Subjects Operated on With RUI and SUI Instrumentation
|
1.04 Degrees
Standard Deviation 2.49
|
0.78 Degrees
Standard Deviation 2.70
|
SECONDARY outcome
Timeframe: 3 Months Post SurgeryPopulation: All subjects who received the study device
Outcome measures
| Measure |
RUI (Reuseable Instrumentation)
n=44 Participants
Patients were operated on using Reusable TKA Instrumentation
|
SUI (Single-Use Instrumentation)
n=44 Participants
Patients were operated on using Single-Use TKA Instrumentation
|
|---|---|---|
|
Number of Participants With Treatment-related Adverse Events
|
0 Participants
|
0 Participants
|
Adverse Events
RUI (Reuseable Instrumentation)
Serious events: 1 serious events
Other events: 5 other events
Deaths: 0 deaths
SUI (Single-Use Instrumentation)
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
RUI (Reuseable Instrumentation)
n=44 participants at risk
Patients were operated on using Reusable TKA Instrumentation
|
SUI (Single-Use Instrumentation)
n=44 participants at risk
Patients were operated on using Single-Use TKA Instrumentation
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal
|
2.3%
1/44 • Number of events 1 • All participants had reached the 3 month follow-up visit at the time of uploading adverse events.
Final assessment of adverse events were classified by system organ class in lieu of specific adverse event terms.
|
0.00%
0/44 • All participants had reached the 3 month follow-up visit at the time of uploading adverse events.
Final assessment of adverse events were classified by system organ class in lieu of specific adverse event terms.
|
Other adverse events
| Measure |
RUI (Reuseable Instrumentation)
n=44 participants at risk
Patients were operated on using Reusable TKA Instrumentation
|
SUI (Single-Use Instrumentation)
n=44 participants at risk
Patients were operated on using Single-Use TKA Instrumentation
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal
|
4.5%
2/44 • Number of events 2 • All participants had reached the 3 month follow-up visit at the time of uploading adverse events.
Final assessment of adverse events were classified by system organ class in lieu of specific adverse event terms.
|
4.5%
2/44 • Number of events 2 • All participants had reached the 3 month follow-up visit at the time of uploading adverse events.
Final assessment of adverse events were classified by system organ class in lieu of specific adverse event terms.
|
|
Vascular disorders
Vascular
|
2.3%
1/44 • Number of events 1 • All participants had reached the 3 month follow-up visit at the time of uploading adverse events.
Final assessment of adverse events were classified by system organ class in lieu of specific adverse event terms.
|
0.00%
0/44 • All participants had reached the 3 month follow-up visit at the time of uploading adverse events.
Final assessment of adverse events were classified by system organ class in lieu of specific adverse event terms.
|
|
Infections and infestations
Infections and infestations
|
2.3%
1/44 • Number of events 1 • All participants had reached the 3 month follow-up visit at the time of uploading adverse events.
Final assessment of adverse events were classified by system organ class in lieu of specific adverse event terms.
|
2.3%
1/44 • Number of events 1 • All participants had reached the 3 month follow-up visit at the time of uploading adverse events.
Final assessment of adverse events were classified by system organ class in lieu of specific adverse event terms.
|
|
Immune system disorders
Immune System Disorder
|
2.3%
1/44 • Number of events 1 • All participants had reached the 3 month follow-up visit at the time of uploading adverse events.
Final assessment of adverse events were classified by system organ class in lieu of specific adverse event terms.
|
0.00%
0/44 • All participants had reached the 3 month follow-up visit at the time of uploading adverse events.
Final assessment of adverse events were classified by system organ class in lieu of specific adverse event terms.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee DePuy reserves the right to review the contents of publications in advance.The PI may freely disclose the trial results only after DePuy has been given the opportunity of reviewing the proposed results communications at least 30 days prior to the intended release.DePuy will advise the PI of any perceived errors,omissions or corrections but PI will retain final editorial control. In case of disagreement, DePuy and PI will make every effort to meet in order to discuss and resolve any issues.
- Publication restrictions are in place
Restriction type: OTHER