Trial Outcomes & Findings for Comparison of a Metal Backed Fixed-Bearing Tibial Baseplate and an All-Polyethylene Tibia in Total Knee Arthroplasty (NCT NCT00979147)

Results Overview

Patient recorded outcome measures as noted

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

400 participants

Primary outcome timeframe

2 year follow-up intervals up to 20 years

Results posted on

2020-09-07

Participant Flow

PI/study coordinator retired due to personal family health matters; study sponsor withdrew funding. Study terminated and no data collected or analyzed

Participant milestones

Participant milestones
Measure	Modular Metal Tibial Baseplate Patients who were randomized to receive the modular polished tibial baseplate/XLK TKA TKA surgery with modular polished tibial baseplate/XLK design: TKA surgery with modular polished tibial baseplate/XLK design P.F.C.® Sigma Knee System: P.F.C.® Sigma Knee System with modular XLK poly	All Polyethylene Tibial Baseplate Patients who were randomized to receive the nonmodular APT/GVF TKA design. TKA surgery with the nonmodular APT/GVF design: TKA surgery with the nonmodular APT/GVF design P.F.C.® Sigma Knee System: P.F.C. ® Sigma Knee System with an all-poly GVF tibia
Overall Study STARTED	0	0
Overall Study COMPLETED	0	0
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Comparison of a Metal Backed Fixed-Bearing Tibial Baseplate and an All-Polyethylene Tibia in Total Knee Arthroplasty

Baseline characteristics by cohort

Baseline data not reported

PRIMARY outcome

Timeframe: 2 year follow-up intervals up to 20 years

Population: PI/study coordinator retired due to personal family health matters; study sponsor withdrew funding. Study terminated and no data collected or analyzed

Patient recorded outcome measures as noted

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 2 year followup intervals to 20 years

Population: PI/study coordinator retired due to personal family health matters; study sponsor withdrew funding. Study terminated and no data collected or analyzed

Wear characteristics as above

Outcome measures

Outcome data not reported

Adverse Events

Modular Metal Tibial Baseplate

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

All Polyethylene Tibial Baseplate

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 Gioe M.D.

Minneapolis VAMC

Phone: 612-467-1780

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place