Trial Outcomes & Findings for Randomized Fixed Bearing vs Mobile Bearing Cruciate Retaining TKA (NCT NCT00289094)
NCT ID: NCT00289094
Last Updated: 2022-09-13
Results Overview
The Knee Society Score (KSS) is comprised to two sections (each worth 100 points) for a maximum 200 points. One section is the Knee Society Clinical Score (KSCS) - points are given for pain, motion, and stability and points are deducted for flexion contracture, extension lag, and misalignment. The other section is the Knee Society Functional Score (KSFS) - points are assigned for walking distances and climbing stairs and points are deducted for use of walking aids. For each section, a score of 80-100 = excellent, 70-79 = good; 60-69 = fair; and \< 60 = poor.
COMPLETED
NA
99 participants
Pre-operative, 6 and 12 months and annually thereafter for at least 5 years.
2022-09-13
Participant Flow
Two US clinical centers performed 99 primary knee replacements in 86 subjects. Recruitment was based on the inclusion and exclusion criteria as specified in the clinical investigation plan.
Immediately before surgery, the implant type was determined according to the randomization schedule. Before treatment assignment, consented subjects could be excluded from the trial based on results of pre-operative clinical evaluations and/or radiographs, as per the exclusion criteria in the CIP.
Participant milestones
| Measure |
Rotating Platform
P.F.C.® Sigma™ Rotating Platform (RP) Cruciate Retaining Knee System has a modular polyethylene insert that is free to rotate around a central pivot point during knee motion.
|
Fixed Bearing
P.F.C.® Sigma™ Fixed Cruciate Retaining Knee System implant has a modular polyethylene insert that is intraoperatively locked into position on the metal tibial base.
|
|---|---|---|
|
Overall Study
STARTED
|
50
|
49
|
|
Overall Study
COMPLETED
|
3
|
2
|
|
Overall Study
NOT COMPLETED
|
47
|
47
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Randomized Fixed Bearing vs Mobile Bearing Cruciate Retaining TKA
Baseline characteristics by cohort
| Measure |
Rotating Platform
n=50 Participants
P.F.C.® Sigma™ Rotating Platform (RP) Cruciate Retaining Knee System has a modular polyethylene insert that is free to rotate around a central pivot point during knee motion.
|
Fixed Bearing
n=49 Participants
P.F.C.® Sigma™ Fixed Cruciate Retaining Knee System implant has a modular polyethylene insert that is intraoperatively locked into position on the metal tibial base.
|
Total
n=99 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
63.7 years
STANDARD_DEVIATION 6.2 • n=5 Participants
|
66.9 years
STANDARD_DEVIATION 5.1 • n=7 Participants
|
65.3 years
STANDARD_DEVIATION 5.9 • n=5 Participants
|
|
Sex: Female, Male
Female
|
31 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
57 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
19 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
42 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
50 participants
n=5 Participants
|
49 participants
n=7 Participants
|
99 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Pre-operative, 6 and 12 months and annually thereafter for at least 5 years.The Knee Society Score (KSS) is comprised to two sections (each worth 100 points) for a maximum 200 points. One section is the Knee Society Clinical Score (KSCS) - points are given for pain, motion, and stability and points are deducted for flexion contracture, extension lag, and misalignment. The other section is the Knee Society Functional Score (KSFS) - points are assigned for walking distances and climbing stairs and points are deducted for use of walking aids. For each section, a score of 80-100 = excellent, 70-79 = good; 60-69 = fair; and \< 60 = poor.
Outcome measures
| Measure |
Rotating Platform
n=50 Participants
P.F.C.® Sigma™ Rotating Platform (RP) Cruciate Retaining Knee System has a modular polyethylene insert that is free to rotate around a central pivot point during knee motion.
|
Fixed Bearing
n=49 Participants
P.F.C.® Sigma™ Fixed Cruciate Retaining Knee System implant has a modular polyethylene insert that is intraoperatively locked into position on the metal tibial base.
|
|---|---|---|
|
Knee Society Scores
Pre-operative
|
40.8 Scores on a scale
Standard Deviation 19.8
|
43.4 Scores on a scale
Standard Deviation 23.0
|
|
Knee Society Scores
6 months
|
84.3 Scores on a scale
Standard Deviation 14.7
|
77.8 Scores on a scale
Standard Deviation 14.9
|
|
Knee Society Scores
12 months
|
86.4 Scores on a scale
Standard Deviation 13.0
|
86.4 Scores on a scale
Standard Deviation 10.0
|
|
Knee Society Scores
24 months
|
89.7 Scores on a scale
Standard Deviation 9.2
|
88.1 Scores on a scale
Standard Deviation 8.8
|
|
Knee Society Scores
36 months
|
92.3 Scores on a scale
Standard Deviation 8.2
|
87.1 Scores on a scale
Standard Deviation 10.4
|
|
Knee Society Scores
48 months
|
94.3 Scores on a scale
Standard Deviation 5.6
|
86.0 Scores on a scale
Standard Deviation 14.7
|
|
Knee Society Scores
60 months
|
95.0 Scores on a scale
Standard Deviation 4.6
|
95.5 Scores on a scale
Standard Deviation 3.5
|
SECONDARY outcome
Timeframe: On-going to end of study.Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Pre-operative, 6 and 12 months and annually thereafter for at least 5 years.Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Pre-operative, 6 and 12 months and annually thereafter for at least 5 years.Outcome measures
Outcome data not reported
Adverse Events
Rotating Platform
Fixed Bearing
Serious adverse events
| Measure |
Rotating Platform
n=50 participants at risk
P.F.C.® Sigma™ Rotating Platform (RP) Cruciate Retaining Knee System has a modular polyethylene insert that is free to rotate around a central pivot point during knee motion.
|
Fixed Bearing
n=49 participants at risk
P.F.C.® Sigma™ Fixed Cruciate Retaining Knee System implant has a modular polyethylene insert that is intraoperatively locked into position on the metal tibial base.
|
|---|---|---|
|
General disorders
Death
|
2.0%
1/50 • Number of events 1
|
0.00%
0/49
|
|
Musculoskeletal and connective tissue disorders
Femoral Fracture
|
0.00%
0/50
|
2.0%
1/49 • Number of events 1
|
|
Cardiac disorders
Cardiacvascular arrhythmia
|
4.0%
2/50 • Number of events 2
|
0.00%
0/49
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60