Trial Outcomes & Findings for Comparison of Surgical Time and Efficiency of Total Knee Arthroplasty (NCT NCT01301950)

Results Overview

Skin-to skin time for conventional versus TruMatch® primary total knee replacements (recorded by Investigator on Operative case report forms).

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

30 participants

Primary outcome timeframe

Intraoperative (Time from first incision to first stitch)

Results posted on

2019-04-10

Participant Flow

Participant milestones

Participant milestones
Measure	Conventional Total Knee Replacement Cruciate Retaining and Posterior Stabilized Fixed-Bearing or Rotating Platform Total Knee Arthroplasty (PFC Sigma System) implanted using conventional instruments	TruMatch® Personalized Solutions Cruciate Retaining and Posterior Stabilized Fixed-Bearing or Rotating Platform Total Knee Arthroplasty (P.F.C. Sigma System) implanted using TruMatch® Personalized Solutions. Instrument: TruMatch® Personalized Solutions is the brand name of DePuy Orthopaedics, Inc. custom patient instrumentation. TruMatch® is a pair of custom-made cutting blocks that allow distal femoral and proximal tibial cuts to be made according to a predefined surgical plan. The inner surface of the femoral block is manufactured to match the geometry of the patients' distal femur. The inner surface of the tibial block is manufactured to match the patient's proximal tibia. The geometric data is obtained from a CT scan and a preoperative plan approved by the surgeon.
Overall Study STARTED	15	15
Overall Study COMPLETED	15	14
Overall Study NOT COMPLETED	0	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Conventional Total Knee Replacement Cruciate Retaining and Posterior Stabilized Fixed-Bearing or Rotating Platform Total Knee Arthroplasty (PFC Sigma System) implanted using conventional instruments	TruMatch® Personalized Solutions Cruciate Retaining and Posterior Stabilized Fixed-Bearing or Rotating Platform Total Knee Arthroplasty (P.F.C. Sigma System) implanted using TruMatch® Personalized Solutions. Instrument: TruMatch® Personalized Solutions is the brand name of DePuy Orthopaedics, Inc. custom patient instrumentation. TruMatch® is a pair of custom-made cutting blocks that allow distal femoral and proximal tibial cuts to be made according to a predefined surgical plan. The inner surface of the femoral block is manufactured to match the geometry of the patients' distal femur. The inner surface of the tibial block is manufactured to match the patient's proximal tibia. The geometric data is obtained from a CT scan and a preoperative plan approved by the surgeon.
Overall Study Surgery was cancelled by patient	0	1

Baseline Characteristics

Comparison of Surgical Time and Efficiency of Total Knee Arthroplasty

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	TruMatch® Personalized Solutions n=15 Participants Cruciate Retaining and Posterior Stabilized Fixed-Bearing or Rotating Platform Total Knee Arthroplasty (PFC Sigma System) implanted using TruMatch® Personalized Solutions Instrument: TruMatch® Personalized Solutions is the brand name of DePuy Orthopaedics, Inc. custom patient instrumentation. TruMatch® is a pair of custom-made cutting blocks that allow distal femoral and proximal tibial cuts to be made according to a predefined surgical plan. The inner surface of the femoral block is manufactured to match the geometry of the patient's distal femur. The inner surface of the tibial block is manufactured to match the patient's proximal tibia. The geometric data is obtained from a CT scan and a preoperative plan approved by the surgeon	Conventional Total Knee Replacement n=15 Participants Cruciate Retaining and Posterior Stabilized Fixed-Bearing or Rotating Platform Total Knee Arthroplasty (PFC Sigma System) implanted using conventional instruments	Total n=30 Participants Total of all reporting groups
Age, Continuous	62.9 years STANDARD_DEVIATION 12.9 • n=93 Participants	62.7 years STANDARD_DEVIATION 9.1 • n=4 Participants	62.8 years STANDARD_DEVIATION 10.9 • n=27 Participants
Sex: Female, Male Female	6 Participants n=93 Participants	11 Participants n=4 Participants	17 Participants n=27 Participants
Sex: Female, Male Male	9 Participants n=93 Participants	4 Participants n=4 Participants	13 Participants n=27 Participants
Region of Enrollment United States	15 participants n=93 Participants	15 participants n=4 Participants	30 participants n=27 Participants

PRIMARY outcome

Timeframe: Intraoperative (Time from first incision to first stitch)

Skin-to skin time for conventional versus TruMatch® primary total knee replacements (recorded by Investigator on Operative case report forms).

Outcome measures

Outcome measures
Measure	Conventional Total Knee Replacement n=15 Participants Cruciate Retaining and Posterior Stabilized Fixed-Bearing or Rotating Platform Total Knee Arthroplasty (PFC Sigma System) implanted using conventional instruments	TruMatch® Personalized Solutions n=14 Participants Cruciate Retaining and Posterior Stabilized Fixed-Bearing or Rotating Platform Total Knee Arthroplasty (P.F.C. Sigma System) implanted using TruMatch® Personalized Solutions. Instrument: TruMatch® Personalized Solutions is the brand name of DePuy Orthopaedics, Inc. custom patient instrumentation. TruMatch® is a pair of custom-made cutting blocks that allow distal femoral and proximal tibial cuts to be made according to a predefined surgical plan. The inner surface of the femoral block is manufactured to match the geometry of the patients' distal femur. The inner surface of the tibial block is manufactured to match the patient's proximal tibia. The geometric data is obtained from a CT scan and a preoperative plan approved by the surgeon.
Surgical Procedure Time to Compare Skin-to-Skin Time for Conventional Versus TruMatch® Primary Total Knee Replacements	65.8 minutes Standard Deviation 12.3	67.3 minutes Standard Deviation 20.6

SECONDARY outcome

Timeframe: Intraoperative (Operating Room cleaned up from previous case to surgical draping complete)

Operating Room setup time for conventional versus TruMatch® primary total knee replacements as recorded by video time analysis \[minutes\]

Outcome measures

Outcome measures
Measure	Conventional Total Knee Replacement n=15 Participants Cruciate Retaining and Posterior Stabilized Fixed-Bearing or Rotating Platform Total Knee Arthroplasty (PFC Sigma System) implanted using conventional instruments	TruMatch® Personalized Solutions n=14 Participants Cruciate Retaining and Posterior Stabilized Fixed-Bearing or Rotating Platform Total Knee Arthroplasty (P.F.C. Sigma System) implanted using TruMatch® Personalized Solutions. Instrument: TruMatch® Personalized Solutions is the brand name of DePuy Orthopaedics, Inc. custom patient instrumentation. TruMatch® is a pair of custom-made cutting blocks that allow distal femoral and proximal tibial cuts to be made according to a predefined surgical plan. The inner surface of the femoral block is manufactured to match the geometry of the patients' distal femur. The inner surface of the tibial block is manufactured to match the patient's proximal tibia. The geometric data is obtained from a CT scan and a preoperative plan approved by the surgeon.
Operating Room Setup - Operating Room Cleaned up From Previous Case to Surgical Draping Complete	28.9 minutes Standard Deviation 15.0	28.8 minutes Standard Deviation 14.4

SECONDARY outcome

Timeframe: Intraoperative (Time to clean Operating Room after surgery is completed)

Population: 1 site (9 subjects) was excluded from Turnover Time analysis as this substep could not be accurately assessed due to unexpected difficulties during video collection.

Turnover Time for conventional versus TruMatch® primary total knee replacements as recorded by video time analysis \[minutes\].

Outcome measures

Outcome measures
Measure	Conventional Total Knee Replacement n=10 Participants Cruciate Retaining and Posterior Stabilized Fixed-Bearing or Rotating Platform Total Knee Arthroplasty (PFC Sigma System) implanted using conventional instruments	TruMatch® Personalized Solutions n=10 Participants Cruciate Retaining and Posterior Stabilized Fixed-Bearing or Rotating Platform Total Knee Arthroplasty (P.F.C. Sigma System) implanted using TruMatch® Personalized Solutions. Instrument: TruMatch® Personalized Solutions is the brand name of DePuy Orthopaedics, Inc. custom patient instrumentation. TruMatch® is a pair of custom-made cutting blocks that allow distal femoral and proximal tibial cuts to be made according to a predefined surgical plan. The inner surface of the femoral block is manufactured to match the geometry of the patients' distal femur. The inner surface of the tibial block is manufactured to match the patient's proximal tibia. The geometric data is obtained from a CT scan and a preoperative plan approved by the surgeon.
Turnover Time (Time to Clean Operating Room After Surgery is Completed)	10.1 minutes Standard Deviation 4.8	11.4 minutes Standard Deviation 2.8

SECONDARY outcome

Timeframe: Intraoperative (Total duration of procedure)

Population: No cost data were collected, resulting in a sample size of 0.

Compare costs associated with surgery using conventional surgical technique versus TruMatch® primary total knee replacements .

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Intraoperative

Population: No operating room efficiency data was analyzed as a function of geography and institution, resulting in a sample size of 0.

Outcome measures

Outcome data not reported

Adverse Events

TruMatch™ Personalized Solutions

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Conventional Total Knee Replacement

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

Sam Himden, Clinical Portfolio Leader

DePuy Synthes

Phone: 574-372-7231

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60