MedTrace Logo

Trial Outcomes & Findings for Range of Motion of Standard and High-Flexion Posterior Cruciate Retaining Total Knee Prostheses (NCT NCT00837447)

NCT ID: NCT00837447

Last Updated: 2013-04-10

Results Overview

change in knee score will be compared with baseline and follow up of 3 years. The knee society knee score range from 0 to 100 points, 100 being the best possible outcome. Baseline-NexGen (CR) knee socre:29 points Baseline-NexGen (CR-Flex) knee socre:29 points Follow up of 3 years-NexGen (CR) knee socre: 93.7 points Follow up of 3 years-NexGen (CR-Flex) knee socre: 93.9 points

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

54 participants

Primary outcome timeframe

baseline and 3 years

Results posted on

2013-04-10

Participant Flow

Participant milestones

Participant milestones
Measure
NexGen CR and CR-flex Knee Prosthesis
The NexGen posterior cruciate-retaining total knee arthroplasty prosthesis (NexGen CR Prosthesis; Zimmer)) on one side and The NexGen posterior cruciate-retaining flex total knee arthroplasty prosthesis (NexGen CR-Flex; Zimmer) on the other side
Overall Study
STARTED
54
Overall Study
COMPLETED
54
Overall Study
NOT COMPLETED
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Range of Motion of Standard and High-Flexion Posterior Cruciate Retaining Total Knee Prostheses

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
NexGen CR and CR-flex Knee Prosthesis
n=54 Participants
The NexGen posterior cruciate-retaining total knee arthroplasty prosthesis (NexGen CR Prosthesis; Zimmer)) on one side and The NexGen posterior cruciate-retaining flex total knee arthroplasty prosthesis (NexGen CR-Flex; Zimmer) on the other side
Age, Categorical
<=18 years
0 Participants
n=99 Participants
Age, Categorical
Between 18 and 65 years
11 Participants
n=99 Participants
Age, Categorical
>=65 years
43 Participants
n=99 Participants
Age Continuous
69.7 years
STANDARD_DEVIATION 6.43 • n=99 Participants
Sex: Female, Male
Female
49 Participants
n=99 Participants
Sex: Female, Male
Male
5 Participants
n=99 Participants
Region of Enrollment
Korea, Republic of
54 participants
n=99 Participants

PRIMARY outcome

Timeframe: baseline and 3 years

change in knee score will be compared with baseline and follow up of 3 years. The knee society knee score range from 0 to 100 points, 100 being the best possible outcome. Baseline-NexGen (CR) knee socre:29 points Baseline-NexGen (CR-Flex) knee socre:29 points Follow up of 3 years-NexGen (CR) knee socre: 93.7 points Follow up of 3 years-NexGen (CR-Flex) knee socre: 93.9 points

Outcome measures

Outcome measures
Measure
High-Flexion Posterior Cruciate Retaining TKA
n=54 Participants
High-Flexion Posterior Cruciate Scrificing TKA
n=54 Participants
Change in Knee Society Knee Score
93.9 scores on a scale
Standard Deviation 4.66
93.7 scores on a scale
Standard Deviation 4.53

Adverse Events

NexGen CR and CR-flex Knee Prosthesis

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

Young-Hoo Kim, MD

Ewha Womans University School of Medicine

Phone: 822-26505900

Results disclosure agreements

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