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Trial Outcomes & Findings for Randomized Fixed Bearing vs Mobile Bearing Cruciate Substituting TKA (NCT NCT00289107)

NCT ID: NCT00289107

Last Updated: 2023-05-03

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

149 participants

Primary outcome timeframe

Pre-operative, 6 and 12 months and annually thereafter for at least 5 years.

Results posted on

2023-05-03

Participant Flow

Between April 2001 and October 2002, 106 subjects were recruited and enrolled at 3 US clinics by orthopaedic surgeons. Each study site could enroll up to 50 subjects (cohorts were re-assigned as necessary to complete enrollment in a timely manner). Recruitment was based on the inclusion and exclusion criteria 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 clinical investigation plan.

Participant milestones

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
77
72
Overall Study
COMPLETED
24
28
Overall Study
NOT COMPLETED
53
44

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Randomized Fixed Bearing vs Mobile Bearing Cruciate Substituting TKA

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Rotating Platform
n=77 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=72 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=149 Participants
Total of all reporting groups
Age, Continuous
64.5 years
STANDARD_DEVIATION 6.3 • n=93 Participants
65.5 years
STANDARD_DEVIATION 7.2 • n=4 Participants
65.0 years
STANDARD_DEVIATION 6.8 • n=27 Participants
Sex: Female, Male
Female
48 Participants
n=93 Participants
55 Participants
n=4 Participants
103 Participants
n=27 Participants
Sex: Female, Male
Male
29 Participants
n=93 Participants
17 Participants
n=4 Participants
46 Participants
n=27 Participants
Region of Enrollment
United States · United States
77 Participants
n=93 Participants
72 Participants
n=4 Participants
149 Participants
n=27 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

Outcome measures
Measure
Rotating Platform
n=77 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=72 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 Score
Pre-operative
39.3 Scores on a scale
Standard Deviation 15.8
37.2 Scores on a scale
Standard Deviation 16.5
Knee Society Score
6 Months
90.8 Scores on a scale
Standard Deviation 13.8
89.2 Scores on a scale
Standard Deviation 13.9
Knee Society Score
12 Months
96.1 Scores on a scale
Standard Deviation 6.6
93.0 Scores on a scale
Standard Deviation 9.9
Knee Society Score
24 Months
96.8 Scores on a scale
Standard Deviation 7.6
96.0 Scores on a scale
Standard Deviation 7.9
Knee Society Score
36 Months
97.2 Scores on a scale
Standard Deviation 5.2
94.3 Scores on a scale
Standard Deviation 9.9
Knee Society Score
48 Months
95.8 Scores on a scale
Standard Deviation 5.9
93.7 Scores on a scale
Standard Deviation 9.2
Knee Society Score
60 Months
93.6 Scores on a scale
Standard Deviation 9.0
93.5 Scores on a scale
Standard Deviation 8.9

SECONDARY outcome

Timeframe: On-going to end of study

Outcome measures

Outcome data not reported

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

Serious events: 15 serious events
Other events: 6 other events
Deaths: 0 deaths

Fixed Bearing

Serious events: 6 serious events
Other events: 8 other events
Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure
Rotating Platform
n=77 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=72 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.
Vascular disorders
Pulmonary Embolism
1.3%
1/77 • Number of events 1
1.4%
1/72 • Number of events 1
Gastrointestinal disorders
GI Bleeding
1.3%
1/77 • Number of events 1
0.00%
0/72
General disorders
Death
3.9%
3/77 • Number of events 3
0.00%
0/72
Musculoskeletal and connective tissue disorders
Manipulation under anesthesia
1.3%
1/77 • Number of events 1
0.00%
0/72
Musculoskeletal and connective tissue disorders
Intraoperative medial collateral ligament injury
1.3%
1/77 • Number of events 1
0.00%
0/72
Skin and subcutaneous tissue disorders
Infection - superficial
0.00%
0/77
1.4%
1/72 • Number of events 1
Musculoskeletal and connective tissue disorders
Adhesions
0.00%
0/77
1.4%
1/72 • Number of events 1
Cardiac disorders
Deep Vein Thrombosis, Pulmonary Embolism
1.3%
1/77 • Number of events 1
0.00%
0/72
Injury, poisoning and procedural complications
Delayed wound healing
1.3%
1/77 • Number of events 1
0.00%
0/72
Gastrointestinal disorders
Constipation/fecal impaction
1.3%
1/77 • Number of events 1
0.00%
0/72
Vascular disorders
Deep vein thrombosis
1.3%
1/77 • Number of events 1
1.4%
1/72 • Number of events 1
Cardiac disorders
Peripheral neuropathy or vascular disorder
0.00%
0/77
1.4%
1/72 • Number of events 1
General disorders
Pain
0.00%
0/77
1.4%
1/72 • Number of events 1
General disorders
General
1.3%
1/77 • Number of events 1
0.00%
0/72
Infections and infestations
Deep infection
1.3%
1/77 • Number of events 1
0.00%
0/72
Cardiac disorders
Cardiac Arrhythmia
3.9%
3/77 • Number of events 3
0.00%
0/72
Injury, poisoning and procedural complications
Necrosis/wound slough
0.00%
0/77
1.4%
1/72 • Number of events 1

Other adverse events

Other adverse events
Measure
Rotating Platform
n=77 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=72 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.
Musculoskeletal and connective tissue disorders
Adhesions
7.8%
6/77 • Number of events 6
11.1%
8/72 • Number of events 8

Additional Information

Tammy O'Dell, EMT, CCRA

DePuy Orthopaedics

Phone: 574-372-7104

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place

Restriction type: LTE60