Trial Outcomes & Findings for Conventional Alignment System Versus Surgical Navigation System in Total Knee Arthroplasty (NCT NCT01797731)

Results Overview

The primary outcome will be the number of patients (percentage of patients) that met a predetermined criteria for Alignment as defined by within 2° of perpendicular to the tibial mechanical axis or 2° of a 3° posterior slope, postoperative tibial component alignment (mechanical varus/valgus, and posterior slope) as measured on postoperative standing anteroposterior hip-to-ankle radiographs, and standing, lateral knee-to-ankle radiographs, respectively.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

100 participants

Primary outcome timeframe

6 weeks after surgery

Results posted on

2017-07-11

Participant Flow

Participant milestones

Participant milestones
Measure	Conventional System Conventional tibial extramedullary alignment system used by surgeon during surgery. Conventional tibial extramedullary alignment system: This is the standard of care for total knee arthroplasty.	KneeAlign System Digital hand-held surgical navigation system for tibial component placement used by surgeon during surgery. Digital hand-held surgical navigation system: Digital hand-held surgical navigation system used for tibial component placement in total knee arthroplasty
Overall Study STARTED	50	50
Overall Study COMPLETED	47	47
Overall Study NOT COMPLETED	3	3

Reasons for withdrawal

Reasons for withdrawal
Measure	Conventional System Conventional tibial extramedullary alignment system used by surgeon during surgery. Conventional tibial extramedullary alignment system: This is the standard of care for total knee arthroplasty.	KneeAlign System Digital hand-held surgical navigation system for tibial component placement used by surgeon during surgery. Digital hand-held surgical navigation system: Digital hand-held surgical navigation system used for tibial component placement in total knee arthroplasty
Overall Study Didn't have proper radiographs required	3	3

Baseline Characteristics

Conventional Alignment System Versus Surgical Navigation System in Total Knee Arthroplasty

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Conventional System n=47 Participants Conventional tibial extramedullary alignment system used by surgeon during surgery. Conventional tibial extramedullary alignment system: This is the standard of care for total knee arthroplasty.	KneeAlign System n=47 Participants Digital hand-held surgical navigation system for tibial component placement used by surgeon during surgery. Digital hand-held surgical navigation system: Digital hand-held surgical navigation system used for tibial component placement in total knee arthroplasty	Total n=94 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	27 Participants n=5 Participants	17 Participants n=7 Participants	44 Participants n=5 Participants
Age, Categorical >=65 years	20 Participants n=5 Participants	30 Participants n=7 Participants	50 Participants n=5 Participants
Age, Continuous	66.1 Years STANDARD_DEVIATION 10.1 • n=5 Participants	67.1 Years STANDARD_DEVIATION 7.5 • n=7 Participants	66.12 Years STANDARD_DEVIATION 10.66 • n=5 Participants
Sex: Female, Male Female	20 Participants n=5 Participants	29 Participants n=7 Participants	49 Participants n=5 Participants
Sex: Female, Male Male	27 Participants n=5 Participants	18 Participants n=7 Participants	45 Participants n=5 Participants

PRIMARY outcome

Timeframe: 6 weeks after surgery

The primary outcome will be the number of patients (percentage of patients) that met a predetermined criteria for Alignment as defined by within 2° of perpendicular to the tibial mechanical axis or 2° of a 3° posterior slope, postoperative tibial component alignment (mechanical varus/valgus, and posterior slope) as measured on postoperative standing anteroposterior hip-to-ankle radiographs, and standing, lateral knee-to-ankle radiographs, respectively.

Outcome measures

Outcome measures
Measure	Conventional System n=47 Participants Conventional tibial extramedullary alignment system used by surgeon during surgery. Conventional tibial extramedullary alignment system: This is the standard of care for total knee arthroplasty.	KneeAlign System n=47 Participants Digital hand-held surgical navigation system for tibial component placement used by surgeon during surgery. Digital hand-held surgical navigation system: Digital hand-held surgical navigation system used for tibial component placement in total knee arthroplasty
Postoperative Tibial Component Alignment	68.1 percentage of participants	95.7 percentage of participants

SECONDARY outcome

Timeframe: Minutes during surgery ( Estimated time per surgery 1 hour)

The amount of time required to utilize conventional, tibial extramedullary alignment guides versus the KneeAlignTM system, which will be recorded intraoperatively.

Outcome measures

Outcome measures
Measure	Conventional System n=50 Participants Conventional tibial extramedullary alignment system used by surgeon during surgery. Conventional tibial extramedullary alignment system: This is the standard of care for total knee arthroplasty.	KneeAlign System n=50 Participants Digital hand-held surgical navigation system for tibial component placement used by surgeon during surgery. Digital hand-held surgical navigation system: Digital hand-held surgical navigation system used for tibial component placement in total knee arthroplasty
Time Required to Utilize System	289.92 seconds Standard Deviation 125.34	70.58 seconds Standard Deviation 28.14

Adverse Events

Conventional System

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

KneeAlign System

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

David Mayman

Hospital for Special Surgery

Phone: 2127742024

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place