Trial Outcomes & Findings for Comparison of Outcomes in Mobile and Fixed-bearing Total Knee Arthroplasty (NCT NCT01027819)

Results Overview

Recruitment status

UNKNOWN

Study phase

PHASE4

Target enrollment

80 participants

Primary outcome timeframe

2 weeks

Results posted on

2012-12-20

Participant Flow

Recruitment was started from Sep 2005 to Aug 2006 in medical clinic and randomly allocated into two groups.

Participant milestones

Participant milestones
Measure	Mobile Bearing Mobile bearing vs Fixed bearing	Fixed Bearing Mobile bearing vs Fixed bearing
Overall Study STARTED	40	40
Overall Study COMPLETED	40	40
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Comparison of Outcomes in Mobile and Fixed-bearing Total Knee Arthroplasty

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Mobile Bearing n=40 Participants Mobile bearing vs Fixed bearing	Fixed Bearing n=40 Participants Mobile bearing vs Fixed bearing	Total n=80 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Age, Categorical Between 18 and 65 years	9 Participants n=93 Participants	17 Participants n=4 Participants	26 Participants n=27 Participants
Age, Categorical >=65 years	31 Participants n=93 Participants	23 Participants n=4 Participants	54 Participants n=27 Participants
Age Continuous	68.36 years STANDARD_DEVIATION 5.61 • n=93 Participants	66.08 years STANDARD_DEVIATION 5.55 • n=4 Participants	67.24 years STANDARD_DEVIATION 5.81 • n=27 Participants
Sex: Female, Male Female	2 Participants n=93 Participants	1 Participants n=4 Participants	3 Participants n=27 Participants
Sex: Female, Male Male	38 Participants n=93 Participants	39 Participants n=4 Participants	77 Participants n=27 Participants
Region of Enrollment Korea, Republic of	40 participants n=93 Participants	40 participants n=4 Participants	80 participants n=27 Participants

PRIMARY outcome

Timeframe: 2 weeks

Population: The rotational angle between the femur and tibia was collected by postoperative CT and asssessed between the transepicondylar angle in the femur and the vertical line of the AP axis of the tibia(the line between the insertion of the PCL and the medial 1/3 point of the tibial tuberosity).

Outcome measures

Outcome measures
Measure	Mobile Bearing n=40 Participants Mobile bearing vs Fixed bearing	Fixed Bearing n=40 Participants Mobile bearing vs Fixed bearing
Rotational Angle Between Femur and Tibia	-0.48 degree Standard Deviation 2.18	-0.66 degree Standard Deviation 1.52

SECONDARY outcome

Timeframe: 6 months

Outcome measures

Outcome data not reported

Adverse Events

Mobile Bearing

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Fixed Bearing

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

Dr. Dongwook Kim

Seoul National University Hospital

Phone: 821067395311

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place