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Trial Outcomes & Findings for Comparison of Mobile-Bearing and Fixed-Bearing All-Polyethylene Tibia Total Knee Designs (NCT NCT00894361)

NCT ID: NCT00894361

Last Updated: 2020-09-07

Results Overview

range of motion of the knee postoperatively at 2 years

Recruitment status

TERMINATED

Study phase

PHASE4

Target enrollment

400 participants

Primary outcome timeframe

2 years

Results posted on

2020-09-07

Participant Flow

October 1, 2001 to January 1, 2007 recruitment period from the Minneapolis VAMC Orthopaedic Clinic

Patients that were recruited but not enrolled either failed the inclusion criteria or elected not to participate

Participant milestones

Participant milestones
Measure
Rotating-platform Design Total Knee Arthroplasty (TKA)
patients who were randomized to receive the rotating platform mobile-bearing TKA design
All-polyethylene Tibia Design Total Knee Arthroplasty (TKA)
patients who were randomized to receive the all-polyethylene tibial component design
Overall Study
STARTED
200
200
Overall Study
COMPLETED
176
136
Overall Study
NOT COMPLETED
24
64

Reasons for withdrawal

Reasons for withdrawal
Measure
Rotating-platform Design Total Knee Arthroplasty (TKA)
patients who were randomized to receive the rotating platform mobile-bearing TKA design
All-polyethylene Tibia Design Total Knee Arthroplasty (TKA)
patients who were randomized to receive the all-polyethylene tibial component design
Overall Study
deaths and less than 2 years followup
24
64

Baseline Characteristics

Comparison of Mobile-Bearing and Fixed-Bearing All-Polyethylene Tibia Total Knee Designs

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Rotating-platform Design Total Knee Arthroplasty (TKA)
n=200 Participants
patients who were randomized to receive the rotating platform mobile-bearing total knee arthroplasty (TKA) design
All-polyethylene Tibia Design Total Knee Arthroplasty (TKA)
n=200 Participants
patients who were randomized to receive the all-polyethylene tibial component design
Total
n=400 Participants
Total of all reporting groups
Age, Categorical
<=18 years
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Age, Categorical
Between 18 and 65 years
79 Participants
n=5 Participants
74 Participants
n=7 Participants
153 Participants
n=5 Participants
Age, Categorical
>=65 years
121 Participants
n=5 Participants
126 Participants
n=7 Participants
247 Participants
n=5 Participants
Sex: Female, Male
Female
5 Participants
n=5 Participants
7 Participants
n=7 Participants
12 Participants
n=5 Participants
Sex: Female, Male
Male
195 Participants
n=5 Participants
193 Participants
n=7 Participants
388 Participants
n=5 Participants
Region of Enrollment
United States
200 participants
n=5 Participants
200 participants
n=7 Participants
400 participants
n=5 Participants
range of motion of knee
113.7 degrees
STANDARD_DEVIATION 1.0 • n=5 Participants
111.9 degrees
STANDARD_DEVIATION 1.1 • n=7 Participants
112.8 degrees
STANDARD_DEVIATION 1.2 • n=5 Participants

PRIMARY outcome

Timeframe: 2 years

range of motion of the knee postoperatively at 2 years

Outcome measures

Outcome measures
Measure
Rotating-platform Design Total Knee Arthroplasty (TKA)
n=176 Participants
patients who were randomized to receive the rotating platform mobile-bearing TKA design
All-polyethylene Tibia Design Total Knee Arthroplasty (TKA)
n=136 Participants
patients who were randomized to receive the all-polyethylene tibial component design
Knee Postoperative Range of Motion (ROM) at 2 Years
110.4 degrees
Standard Deviation 0.8
111.9 degrees
Standard Deviation 0.9

SECONDARY outcome

Timeframe: 10 or more years

Population: PI/study coordinator retired due to personal family health matters and study sponsor withdrew funding. Study was terminated and no data was collected or analyzed from any participant for this outcome measure.

Outcome measures

Outcome data not reported

Adverse Events

Rotating-platform Design Total Knee Arthroplasty (TKA)

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

All-polyethylene Tibia Design Total Knee Arthroplasty (TKA)

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

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Terence J. Gioe, M.D.

PI/study coordinator retired due to personal family health matters and study sponsor then withdrew funding. Study terminated and no data was collected or analyzed from any participant.

Results disclosure agreements

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