Trial Outcomes & Findings for Alignment Comparison Between TruMatch™ Personalized Solutions and Conventional Total Knee Replacement Instrumentation (NCT NCT01108237)

Results Overview

Limb alignment in TKR is important for accurate implant positioning. It is measured by looking at the mechanical axis of the limb. This axis is an imaginary line that starts at center of the femoral head and ends in the center of the talus. In a knee with normal alignment, this line (axis) passes near the joint center. Before surgery, the planned joint angle is recorded. This study measured the difference between the mechanical axis angle reached after surgery and the planned angle. Subjects with a mechanical alignment within 3 degrees of the planned angle were considered a success.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

78 participants

Primary outcome timeframe

12 weeks postoperatively (when subject has reached full knee extension)

Results posted on

2023-10-24

Participant Flow

The TruMatch (patient-specific instruments) arm of this study was a prospective, multi-center, non-randomized, clinical investigation conducted at 4 sites. The other arm of this study (conventional instruments) included 86 historical control subjects.

Participant milestones

Participant milestones
Measure	TruMatch™ Personalized Solutions Cruciate Retaining and Posterior Stabilized Fixed-Bearing or Rotating Platform Total Knee Arthroplasty (PFC Sigma System) implanted using TruMatch™ Personalized Solutions	Total Knee Arthroplasty With Conventional Instrumentation Total Knee Arthroplasty (PFC Sigma System) implanted using conventional instruments, not TruMatch™ instrumentation.
Overall Study STARTED	73	101
Overall Study COMPLETED	64	86
Overall Study NOT COMPLETED	9	15

Reasons for withdrawal

Reasons for withdrawal
Measure	TruMatch™ Personalized Solutions Cruciate Retaining and Posterior Stabilized Fixed-Bearing or Rotating Platform Total Knee Arthroplasty (PFC Sigma System) implanted using TruMatch™ Personalized Solutions	Total Knee Arthroplasty With Conventional Instrumentation Total Knee Arthroplasty (PFC Sigma System) implanted using conventional instruments, not TruMatch™ instrumentation.
Overall Study No alignment data	2	15
Overall Study Did not meet criteria for analysis	7	0

Baseline Characteristics

Alignment Comparison Between TruMatch™ Personalized Solutions and Conventional Total Knee Replacement Instrumentation

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	TruMatch™ Personalized Solutions n=66 Participants Cruciate Retaining and Posterior Stabilized Fixed-Bearing or Rotating Platform Total Knee Arthroplasty (PFC Sigma System) implanted using TruMatch™ Personalized Solutions	Total Knee Arthroplasty With Conventional Instrumentation n=86 Participants Total Knee Arthroplasty (PFC Sigma System) implanted using conventional instruments, not TruMatch™ instrumentation.	Total n=152 Participants Total of all reporting groups
Age, Continuous	66.4 years STANDARD_DEVIATION 8.4 • n=5 Participants	64.6 years STANDARD_DEVIATION 7.6 • n=7 Participants	65.3 years STANDARD_DEVIATION 8.0 • n=5 Participants
Sex: Female, Male Female	41 Participants n=5 Participants	57 Participants n=7 Participants	98 Participants n=5 Participants
Sex: Female, Male Male	25 Participants n=5 Participants	29 Participants n=7 Participants	54 Participants n=5 Participants
Region of Enrollment United States · United States	66 Participants n=5 Participants	86 Participants n=7 Participants	152 Participants n=5 Participants

PRIMARY outcome

Timeframe: 12 weeks postoperatively (when subject has reached full knee extension)

Limb alignment in TKR is important for accurate implant positioning. It is measured by looking at the mechanical axis of the limb. This axis is an imaginary line that starts at center of the femoral head and ends in the center of the talus. In a knee with normal alignment, this line (axis) passes near the joint center. Before surgery, the planned joint angle is recorded. This study measured the difference between the mechanical axis angle reached after surgery and the planned angle. Subjects with a mechanical alignment within 3 degrees of the planned angle were considered a success.

Outcome measures

Outcome measures
Measure	TruMatch™ Personalized Solutions n=64 Participants Cruciate Retaining and Posterior Stabilized Fixed-Bearing or Rotating Platform Total Knee Arthroplasty (PFC Sigma System) implanted using TruMatch™ Personalized Solutions	Total Knee Arthroplasty With Conventional Instrumentation n=84 Participants Total Knee Arthroplasty (PFC Sigma System) implanted using conventional instruments, not TruMatch™ instrumentation.	Tibial Component to Mechanical Axis TruMatch Tibial component to mechanical axis (degrees) for TruMatch at 3-months	Tibial Component to Mechanical Axis Conventional Tibial component to mechanical axis (degrees) for Conventional at 3-months
Mechanical Axis Alignment(Absolute Value Measured in Degrees)Using 51 Inch Long Leg Films	2.15 Absolute value in degrees Standard Deviation 1.85	2.14 Absolute value in degrees Standard Deviation 1.84	—	—

SECONDARY outcome

Timeframe: During the Procedure

Population: Per protocol, to compare intraoperative time data, average skin to skin surgical time for knees, when using TruMatch and Conventional instrumentation

Intraoperative (skin to skin) time was measured to the nearest minute. TruMatch personalized Solutions and Conventional instrumentation outcomes are provided

Outcome measures

Outcome measures
Measure	TruMatch™ Personalized Solutions n=66 Knees Cruciate Retaining and Posterior Stabilized Fixed-Bearing or Rotating Platform Total Knee Arthroplasty (PFC Sigma System) implanted using TruMatch™ Personalized Solutions	Total Knee Arthroplasty With Conventional Instrumentation n=86 Knees Total Knee Arthroplasty (PFC Sigma System) implanted using conventional instruments, not TruMatch™ instrumentation.	Tibial Component to Mechanical Axis TruMatch Tibial component to mechanical axis (degrees) for TruMatch at 3-months	Tibial Component to Mechanical Axis Conventional Tibial component to mechanical axis (degrees) for Conventional at 3-months
Compare Intraoperative Time Data During Procedure for Skin-to-skin Time in Minutes	74.6 Minutes Standard Deviation 15.3	79.8 Minutes Standard Deviation 20.0	—	—

SECONDARY outcome

Timeframe: During the Procedure

Population: Per protocol, to compare intraoperative Tourniquet time data during knee replacement when using TruMatch and Conventional instrumentation

Intraoperative Tourniquet time was measured to the nearest minute. TruMatch and Conventional instrumentation outcomes are provided

Outcome measures

Outcome measures
Measure	TruMatch™ Personalized Solutions n=66 Knees Cruciate Retaining and Posterior Stabilized Fixed-Bearing or Rotating Platform Total Knee Arthroplasty (PFC Sigma System) implanted using TruMatch™ Personalized Solutions	Total Knee Arthroplasty With Conventional Instrumentation n=86 Knees Total Knee Arthroplasty (PFC Sigma System) implanted using conventional instruments, not TruMatch™ instrumentation.	Tibial Component to Mechanical Axis TruMatch Tibial component to mechanical axis (degrees) for TruMatch at 3-months	Tibial Component to Mechanical Axis Conventional Tibial component to mechanical axis (degrees) for Conventional at 3-months
Tourniquet Time Measured in Minutes During the Procedure for TruMatch and Conventional Instruments	61.7 Minutes Standard Deviation 16.3	60.5 Minutes Standard Deviation 16.9	—	—

SECONDARY outcome

Timeframe: During the Procedure

Population: Per protocol, to compare intraoperative Tourniquet time data during knee replacement when using TruMatch, Conventional instrumentation and Computer Assisted Surgery (CAS)

Intraoperative Tourniquet to 1st Bone Cut time was measured to the nearest minute. TruMatch and Conventional instrumentation outcomes provided

Outcome measures

Outcome measures
Measure	TruMatch™ Personalized Solutions n=64 Knees Cruciate Retaining and Posterior Stabilized Fixed-Bearing or Rotating Platform Total Knee Arthroplasty (PFC Sigma System) implanted using TruMatch™ Personalized Solutions	Total Knee Arthroplasty With Conventional Instrumentation n=85 Knees Total Knee Arthroplasty (PFC Sigma System) implanted using conventional instruments, not TruMatch™ instrumentation.	Tibial Component to Mechanical Axis TruMatch Tibial component to mechanical axis (degrees) for TruMatch at 3-months	Tibial Component to Mechanical Axis Conventional Tibial component to mechanical axis (degrees) for Conventional at 3-months
Tourniquet to 1st Bone Cut Measured in Minutes During the Procedure for TruMatch and Conventional Instruments	9.0 Minutes Standard Deviation 2.5	10.3 Minutes Standard Deviation 4.0	—	—

SECONDARY outcome

Timeframe: 3-months

Femoral Component to mechanical axis (degrees) and Tibial component to mechanical axis (degrees)

Outcome measures

Outcome measures
Measure	TruMatch™ Personalized Solutions n=66 Participants Cruciate Retaining and Posterior Stabilized Fixed-Bearing or Rotating Platform Total Knee Arthroplasty (PFC Sigma System) implanted using TruMatch™ Personalized Solutions	Total Knee Arthroplasty With Conventional Instrumentation n=86 Participants Total Knee Arthroplasty (PFC Sigma System) implanted using conventional instruments, not TruMatch™ instrumentation.	Tibial Component to Mechanical Axis TruMatch n=66 Participants Tibial component to mechanical axis (degrees) for TruMatch at 3-months	Tibial Component to Mechanical Axis Conventional n=86 Participants Tibial component to mechanical axis (degrees) for Conventional at 3-months
Coronal Alignment Femoral and Tibial	89.8 Degrees Standard Deviation 1.3	90.0 Degrees Standard Deviation 1.7	90.0 Degrees Standard Deviation 1.1	90.5 Degrees Standard Deviation 1.9

SECONDARY outcome

Timeframe: Collected at Pre-Op, 3 months

Sagittal Component Alignment analyzed and reported at 3- months

Outcome measures

Outcome measures
Measure	TruMatch™ Personalized Solutions n=64 Participants Cruciate Retaining and Posterior Stabilized Fixed-Bearing or Rotating Platform Total Knee Arthroplasty (PFC Sigma System) implanted using TruMatch™ Personalized Solutions	Total Knee Arthroplasty With Conventional Instrumentation n=86 Participants Total Knee Arthroplasty (PFC Sigma System) implanted using conventional instruments, not TruMatch™ instrumentation.	Tibial Component to Mechanical Axis TruMatch n=64 Participants Tibial component to mechanical axis (degrees) for TruMatch at 3-months	Tibial Component to Mechanical Axis Conventional n=86 Participants Tibial component to mechanical axis (degrees) for Conventional at 3-months
Sagittal Component Alignment	90.1 Degrees Standard Deviation 2.5	89.8 Degrees Standard Deviation 2.2	88.5 Degrees Standard Deviation 2.8	86.7 Degrees Standard Deviation 2.7

Adverse Events

TruMatch™ Personalized Solutions

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Total Knee Arthroplasty With Conventional Instrumentation

Serious events: 0 serious events

Other events: 17 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	TruMatch™ Personalized Solutions n=64 participants at risk Cruciate Retaining and Posterior Stabilized Fixed-Bearing or Rotating Platform Total Knee Arthroplasty (PFC Sigma System) implanted using TruMatch™ Personalized Solutions	Total Knee Arthroplasty With Conventional Instrumentation n=84 participants at risk Total Knee Arthroplasty (PFC Sigma System) implanted using conventional instruments, not TruMatch™ instrumentation.
Musculoskeletal and connective tissue disorders Musculoskeletal	0.00% 0/64	20.2% 17/84 • Number of events 30

Additional Information

Sam Himden

DePuy Orthopaedics, Inc.

Phone: 574-372-7231

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60