Trial Outcomes & Findings for Preoperative Alignment of Total Knee Replacement (NCT NCT01242085)

NCT ID: NCT01242085

Last Updated: 2013-05-14

Results Overview

the mean knee mechanical axis was determined from 3D CT data - negative value designates varus alignment

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 64 participants
• Primary outcome timeframe: postoperatively - CT done within 1 week of surgery
• Results posted on: 2013-05-14

Participant Flow

Participants were recruited from 6-2010 thru 6-2011 at the VA Palo Alto HCS

1 participant was excluded because withdrew prior to assignment

Participant milestones

Measure	Trumatch Group trumatch group will have customized knee instruments : CT based customized knee instruments	Control Group control group will have standard instrumentation of their knee replacement	Both Interventions one participant had both interventions - one for each knee
Overall Study STARTED	30	33	1
Overall Study COMPLETED	22	26	1
Overall Study NOT COMPLETED	8	7	0

Reasons for withdrawal

Measure	Trumatch Group trumatch group will have customized knee instruments : CT based customized knee instruments	Control Group control group will have standard instrumentation of their knee replacement	Both Interventions one participant had both interventions - one for each knee
Overall Study Withdrawal by Subject	4	2	0
Overall Study medically unable to have surgery	4	5	0

Baseline Characteristics

Preoperative Alignment of Total Knee Replacement

Baseline characteristics by cohort

Measure	Control n=33 Participants control group will have standard instrumentation of their knee replacement: standard instrumentation for knee replacement study group will have customized knee instruments : CT based customized knee instruments	Trumatch Group n=30 Participants patients randomized to study instrumentation	Both Interventions n=1 Participants one participant had bilateral knee replacement with one control knee and one trumatch knee	Total n=64 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	0 Participants n=4 Participants
Age, Categorical Between 18 and 65 years	20 Participants n=5 Participants	19 Participants n=7 Participants	0 Participants n=5 Participants	39 Participants n=4 Participants
Age, Categorical >=65 years	13 Participants n=5 Participants	11 Participants n=7 Participants	1 Participants n=5 Participants	25 Participants n=4 Participants
Age Continuous	65.1 years STANDARD_DEVIATION 8.3 • n=5 Participants	67.3 years STANDARD_DEVIATION 7.7 • n=7 Participants	81 years STANDARD_DEVIATION 0 • n=5 Participants	66.1 years STANDARD_DEVIATION 7.9 • n=4 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Sex: Female, Male Male	33 Participants n=5 Participants	30 Participants n=7 Participants	1 Participants n=5 Participants	64 Participants n=4 Participants
Region of Enrollment United States	33 participants n=5 Participants	30 participants n=7 Participants	1 participants n=5 Participants	64 participants n=4 Participants
knee replacement participant	33 participants n=5 Participants	30 participants n=7 Participants	1 participants n=5 Participants	64 participants n=4 Participants

PRIMARY outcome

Timeframe: postoperatively - CT done within 1 week of surgery

Population: all participants who completed the study

the mean knee mechanical axis was determined from 3D CT data - negative value designates varus alignment

Outcome measures

Measure	Control n=26 Participants control group will have standard instrumentation of their knee replacement: standard instrumentation for knee replacement study group will have customized knee instruments : CT based customized knee instruments	Trumatch Group n=22 Participants patients randomized to study instrumentation
Alignment of Knee - Measured Mechanical Axis From CT Data	-1.7 degrees Interval -3.0 to -0.4	-1.3 degrees Interval -2.5 to -0.2

SECONDARY outcome

Timeframe: intraoperative surgical time

Population: particpants who completed study

the difference between the average surgical time will be determined and compared with 95% CI

Outcome measures

Measure	Control n=26 Participants control group will have standard instrumentation of their knee replacement: standard instrumentation for knee replacement study group will have customized knee instruments : CT based customized knee instruments	Trumatch Group n=22 Participants patients randomized to study instrumentation
Surgical Time	4.0 delta between means in minutes Interval -2.1 to 10.2	0 delta between means in minutes Interval -2.1 to 10.2

Adverse Events

Control

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Trumatch Group

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

Steven T Woolson, MD

VA Palo Alto HCS

Phone: 650-493-5000

Email: steven.woolson@va.gov

Results disclosure agreements

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