Trial Outcomes & Findings for Prospective Clinical Study Evaluating Tibiofemoral Rotational Alignment Using Intraoperative Sensing During Total Knee Arthroplasty (TKA) (NCT NCT02286739)

Last Updated: 2024-08-19

Results Overview

Evaluate how intra-operative sensing with VERASENSE may assist the surgeon with balancing. A load differential of up to 15 pound (lbs) or less between the medial and lateral condyles is indicative of soft-tissue balance. A load differential more than 15 lbs is indicative for soft-tissue unbalance.

Recruitment status

TERMINATED

Study phase

Target enrollment

500 participants

Primary outcome timeframe

Intra-operative with trial implants in place and after completing all surgical corrections.

Results posted on

2024-08-19

Participant Flow

Participant milestones

Participant milestones
Measure	Group A TKA Without VERASENSE patients who undergo primary Posterior Cruciate Ligament (PCL-retaining or - sacrificing TKA without the use of VERASENSE to guide rotational alignment and balance. TKA without "Verasense": TKA will be performed manually without the use of Verasense	Group B TKA With VERASENSE patients who undergo primary PCL-retaining or - sacrificing TKA with the use of VERASENSE to guide rotational alignment and balance. TKA with "Verasense": VERASENSE replaces the standard tibial trial inserts and is embedded with microelectronics and sensors to provide surgeons with real-time knee kinetic data. The data is wirelessly transmitted to a graphic display (VERASENSE Knee Application), allowing surgeons to quantify and assess soft tissue intercompartmental loads throughout the range of motion. The VERASENSE sensor is not an investigational device. OrthoSensor, Inc., received FDA 510K clearance in 2009. The indication for use is a tool for adjustment of the femoral knee implant to reduce instability from flexion gap asymmetry. The VERASENSE sensor is sterile and single patient use.
Overall Study STARTED	170	162
Overall Study COMPLETED	46	9
Overall Study NOT COMPLETED	124	153

Reasons for withdrawal

Reasons for withdrawal
Measure	Group A TKA Without VERASENSE patients who undergo primary Posterior Cruciate Ligament (PCL-retaining or - sacrificing TKA without the use of VERASENSE to guide rotational alignment and balance. TKA without "Verasense": TKA will be performed manually without the use of Verasense	Group B TKA With VERASENSE patients who undergo primary PCL-retaining or - sacrificing TKA with the use of VERASENSE to guide rotational alignment and balance. TKA with "Verasense": VERASENSE replaces the standard tibial trial inserts and is embedded with microelectronics and sensors to provide surgeons with real-time knee kinetic data. The data is wirelessly transmitted to a graphic display (VERASENSE Knee Application), allowing surgeons to quantify and assess soft tissue intercompartmental loads throughout the range of motion. The VERASENSE sensor is not an investigational device. OrthoSensor, Inc., received FDA 510K clearance in 2009. The indication for use is a tool for adjustment of the femoral knee implant to reduce instability from flexion gap asymmetry. The VERASENSE sensor is sterile and single patient use.
Overall Study Verasense type posterior stabilizing (PS)	37	16
Overall Study No Verasense type documented	0	23
Overall Study Adverse Event	1	2
Overall Study Lost to follow-up (LTFU), Patient withdrawal or Physician decision but not specified	86	112

Baseline Characteristics

Incomplete baseline data collected for all participants in each sub-category (Group A: 4 missing / Group B: 11 missing).

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Group A TKA Without VERASENSE n=170 Participants patients who undergo primary PCL-retaining or - sacrificing TKA without the use of VERASENSE to guide rotational alignment and balance. TKA without "Verasense": TKA will be performed manually without the use of Verasense	Group B TKA With VERASENSE n=162 Participants patients who undergo primary PCL-retaining or - sacrificing TKA with the use of VERASENSE to guide rotational alignment and balance. TKA with "Verasense": VERASENSE replaces the standard tibial trial inserts and is embedded with microelectronics and sensors to provide surgeons with real-time knee kinetic data. The data is wirelessly transmitted to a graphic display (VERASENSE Knee Application), allowing surgeons to quantify and assess soft tissue intercompartmental loads throughout the range of motion. The VERASENSE sensor is not an investigational device. OrthoSensor, Inc., received FDA 510K clearance in 2009. The indication for use is a tool for adjustment of the femoral knee implant to reduce instability from flexion gap asymmetry. The VERASENSE sensor is sterile and single patient use.	Total n=332 Participants Total of all reporting groups
Age, Continuous	67.29 years STANDARD_DEVIATION 8.42 • n=166 Participants • Incomplete baseline data collected for all participants in each sub-category (Group A: 4 missing / Group B: 11 missing).	68.06 years STANDARD_DEVIATION 8.12 • n=151 Participants • Incomplete baseline data collected for all participants in each sub-category (Group A: 4 missing / Group B: 11 missing).	67.73 years STANDARD_DEVIATION 8.25 • n=317 Participants • Incomplete baseline data collected for all participants in each sub-category (Group A: 4 missing / Group B: 11 missing).
Sex: Female, Male Female	112 Participants n=170 Participants • Incomplete baseline data collected for all participants in each sub-category (Group A: 0 missing / Group B: 2 missing).	101 Participants n=160 Participants • Incomplete baseline data collected for all participants in each sub-category (Group A: 0 missing / Group B: 2 missing).	213 Participants n=330 Participants • Incomplete baseline data collected for all participants in each sub-category (Group A: 0 missing / Group B: 2 missing).
Sex: Female, Male Male	58 Participants n=170 Participants • Incomplete baseline data collected for all participants in each sub-category (Group A: 0 missing / Group B: 2 missing).	59 Participants n=160 Participants • Incomplete baseline data collected for all participants in each sub-category (Group A: 0 missing / Group B: 2 missing).	117 Participants n=330 Participants • Incomplete baseline data collected for all participants in each sub-category (Group A: 0 missing / Group B: 2 missing).
Race/Ethnicity, Customized African American or Black	19 Participants n=134 Participants • Incomplete baseline data collected for all participants in each sub-category (Group A: 36 missing / Group B: 20 missing).	22 Participants n=142 Participants • Incomplete baseline data collected for all participants in each sub-category (Group A: 36 missing / Group B: 20 missing).	41 Participants n=276 Participants • Incomplete baseline data collected for all participants in each sub-category (Group A: 36 missing / Group B: 20 missing).
Race/Ethnicity, Customized Asian	0 Participants n=134 Participants • Incomplete baseline data collected for all participants in each sub-category (Group A: 36 missing / Group B: 20 missing).	3 Participants n=142 Participants • Incomplete baseline data collected for all participants in each sub-category (Group A: 36 missing / Group B: 20 missing).	3 Participants n=276 Participants • Incomplete baseline data collected for all participants in each sub-category (Group A: 36 missing / Group B: 20 missing).
Race/Ethnicity, Customized Hispanic or Latino	6 Participants n=134 Participants • Incomplete baseline data collected for all participants in each sub-category (Group A: 36 missing / Group B: 20 missing).	6 Participants n=142 Participants • Incomplete baseline data collected for all participants in each sub-category (Group A: 36 missing / Group B: 20 missing).	12 Participants n=276 Participants • Incomplete baseline data collected for all participants in each sub-category (Group A: 36 missing / Group B: 20 missing).
Race/Ethnicity, Customized Other	4 Participants n=134 Participants • Incomplete baseline data collected for all participants in each sub-category (Group A: 36 missing / Group B: 20 missing).	2 Participants n=142 Participants • Incomplete baseline data collected for all participants in each sub-category (Group A: 36 missing / Group B: 20 missing).	6 Participants n=276 Participants • Incomplete baseline data collected for all participants in each sub-category (Group A: 36 missing / Group B: 20 missing).
Race/Ethnicity, Customized White	105 Participants n=134 Participants • Incomplete baseline data collected for all participants in each sub-category (Group A: 36 missing / Group B: 20 missing).	109 Participants n=142 Participants • Incomplete baseline data collected for all participants in each sub-category (Group A: 36 missing / Group B: 20 missing).	214 Participants n=276 Participants • Incomplete baseline data collected for all participants in each sub-category (Group A: 36 missing / Group B: 20 missing).
Body Mass Index (BMI)	31.29 kg / m^2 STANDARD_DEVIATION 6.65 • n=169 Participants • Incomplete baseline data collected for all participants in each sub-category (Group A: 1 missing / Group B: 2 missing).	31.11 kg / m^2 STANDARD_DEVIATION 6.27 • n=160 Participants • Incomplete baseline data collected for all participants in each sub-category (Group A: 1 missing / Group B: 2 missing).	31.20 kg / m^2 STANDARD_DEVIATION 6.46 • n=329 Participants • Incomplete baseline data collected for all participants in each sub-category (Group A: 1 missing / Group B: 2 missing).

PRIMARY outcome

Timeframe: Intra-operative with trial implants in place and after completing all surgical corrections.

Population: Data was not collected for all participants. Numbers analyzed represent evaluable cases.

Outcome measures

Outcome measures
Measure	Group A TKA Without VERASENSE n=133 Participants Patients who undergo primary PCL-retaining or - sacrificing TKA without the use of VERASENSE to guide rotational alignment and balance. TKA without "Verasense": TKA will be performed manually without the use of Verasense	Group B TKA With VERASENSE n=123 Participants Patients who undergo primary PCL-retaining or - sacrificing TKA with the use of VERASENSE to guide rotational alignment and balance. TKA with "Verasense": VERASENSE replaces the standard tibial trial inserts and is embedded with microelectronics and sensors to provide surgeons with real-time knee kinetic data. The data is wirelessly transmitted to a graphic display (VERASENSE Knee Application), allowing surgeons to quantify and assess soft tissue intercompartmental loads throughout the range of motion. The VERASENSE sensor is not an investigational device. OrthoSensor, Inc., received FDA 510K clearance in 2009. The indication for use is a tool for adjustment of the femoral knee implant to reduce instability from flexion gap asymmetry. The VERASENSE sensor is sterile and single patient use.
Number of Participants With Quantitatively Balanced and Unbalanced Knees in Primary Unilateral Total Knee Arthroplasty Participants with balanced knee	65 Participants	103 Participants
Number of Participants With Quantitatively Balanced and Unbalanced Knees in Primary Unilateral Total Knee Arthroplasty Participants with unbalanced knee	68 Participants	20 Participants

SECONDARY outcome

Timeframe: pre-operative, 6 weeks, 6 months, 1 year, 2 years

Population: Data was not collected for all participants. Numbers analyzed represent evaluable cases.

"Patient Satisfaction" is a three-question 40-point scale and has a score of 0 (not satisfied) to 40 (very satisfied) that is collected preoperatively and at each follow-up visit. "Patient Expectations" is a five-question fifteen-point scale and has a score of 0 (low expectation) to 15 (high expectation) that is collected pre-operatively and post-operatively. The pre-operative questions reflect the patient's opinion on the extent to which the patient expects that the operation will improve their knee pain, and their ability to perform their activities of daily living and recreational activities. The post-operative questions reflect the extent to which the outcome after the operation has met the patient's pre-operative expectations with respect to pain and function. The "functional score" is composed of four subgroups (Walking and standing, standard activities, advanced activities, discretionary activities) and has a score of 0 (poor) to 100 (excellent).

Outcome measures

Outcome measures
Measure	Group A TKA Without VERASENSE n=165 Participants Patients who undergo primary PCL-retaining or - sacrificing TKA without the use of VERASENSE to guide rotational alignment and balance. TKA without "Verasense": TKA will be performed manually without the use of Verasense	Group B TKA With VERASENSE n=140 Participants Patients who undergo primary PCL-retaining or - sacrificing TKA with the use of VERASENSE to guide rotational alignment and balance. TKA with "Verasense": VERASENSE replaces the standard tibial trial inserts and is embedded with microelectronics and sensors to provide surgeons with real-time knee kinetic data. The data is wirelessly transmitted to a graphic display (VERASENSE Knee Application), allowing surgeons to quantify and assess soft tissue intercompartmental loads throughout the range of motion. The VERASENSE sensor is not an investigational device. OrthoSensor, Inc., received FDA 510K clearance in 2009. The indication for use is a tool for adjustment of the femoral knee implant to reduce instability from flexion gap asymmetry. The VERASENSE sensor is sterile and single patient use.
Knee Society Knee Scoring System Satisfaction Score pre-operative	13.61 units on a scale Standard Deviation 6.94	13.35 units on a scale Standard Deviation 6.85
Knee Society Knee Scoring System Satisfaction Score 6 weeks	26.20 units on a scale Standard Deviation 7.93	26.45 units on a scale Standard Deviation 8.28
Knee Society Knee Scoring System Satisfaction Score 6 months	31.11 units on a scale Standard Deviation 8.71	31.30 units on a scale Standard Deviation 8.93
Knee Society Knee Scoring System Satisfaction Score 1 year	32.44 units on a scale Standard Deviation 8.48	32.98 units on a scale Standard Deviation 8.22
Knee Society Knee Scoring System Satisfaction Score 2 years	32.15 units on a scale Standard Deviation 7.90	33.21 units on a scale Standard Deviation 7.32
Knee Society Knee Scoring System Expectations Score pre-operative	14.30 units on a scale Standard Deviation 1.40	14.19 units on a scale Standard Deviation 1.48
Knee Society Knee Scoring System Expectations 6 weeks	9.62 units on a scale Standard Deviation 2.72	9.50 units on a scale Standard Deviation 2.74
Knee Society Knee Scoring System Expectations 6 months	10.01 units on a scale Standard Deviation 2.82	9.92 units on a scale Standard Deviation 2.89
Knee Society Knee Scoring System Expectations 1 year	10.28 units on a scale Standard Deviation 3.08	10.44 units on a scale Standard Deviation 3.04
Knee Society Knee Scoring System Expectations 2 years	10.69 units on a scale Standard Deviation 3.35	10.81 units on a scale Standard Deviation 3.25
Knee Society Knee Scoring System Functional Score pre-operative	36.75 units on a scale Standard Deviation 15.88	37.13 units on a scale Standard Deviation 16.11
Knee Society Knee Scoring System Functional Score 6 weeks 6 weeks	44.84 units on a scale Standard Deviation 19.02	46.73 units on a scale Standard Deviation 18.91
Knee Society Knee Scoring System Functional Score 6 months	69.25 units on a scale Standard Deviation 19.24	68.95 units on a scale Standard Deviation 19.03
Knee Society Knee Scoring System Functional Score 1 year	71.82 units on a scale Standard Deviation 17.34	72.44 units on a scale Standard Deviation 17.09
Knee Society Knee Scoring System Functional Score 2 years	68.69 units on a scale Standard Deviation 18.65	69.77 units on a scale Standard Deviation 18.29

SECONDARY outcome

Timeframe: Pre-operative, 6 weeks, 6 months, 1 year and 2 years

Population: Data was not collected for all participants. Numbers analyzed represent evaluable cases.

The EQ-5D Time Trade-off (TTO) descriptive system comprises the following five dimensions: mobility, self-care, usual activities, pain/comfort and anxiety/depression. Each dimension has three levels: no problems, some problems and extreme problems. The scores range from -0.59 (worst possible health state) to 1 (best possible health state).

Outcome measures

Outcome measures
Measure	Group A TKA Without VERASENSE n=165 Participants Patients who undergo primary PCL-retaining or - sacrificing TKA without the use of VERASENSE to guide rotational alignment and balance. TKA without "Verasense": TKA will be performed manually without the use of Verasense	Group B TKA With VERASENSE n=137 Participants Patients who undergo primary PCL-retaining or - sacrificing TKA with the use of VERASENSE to guide rotational alignment and balance. TKA with "Verasense": VERASENSE replaces the standard tibial trial inserts and is embedded with microelectronics and sensors to provide surgeons with real-time knee kinetic data. The data is wirelessly transmitted to a graphic display (VERASENSE Knee Application), allowing surgeons to quantify and assess soft tissue intercompartmental loads throughout the range of motion. The VERASENSE sensor is not an investigational device. OrthoSensor, Inc., received FDA 510K clearance in 2009. The indication for use is a tool for adjustment of the femoral knee implant to reduce instability from flexion gap asymmetry. The VERASENSE sensor is sterile and single patient use.
Investigation of Clinical Performance and Patient Outcome With the EuroQuol-5 Dimension Health Questionnaire (EQ-5D). EQ-5D TTO pre-operative	0.66 units on a scale Standard Deviation 0.18	0.63 units on a scale Standard Deviation 0.19
Investigation of Clinical Performance and Patient Outcome With the EuroQuol-5 Dimension Health Questionnaire (EQ-5D). EQ-5D TTO 6 weeks	0.75 units on a scale Standard Deviation 0.18	0.78 units on a scale Standard Deviation 0.15
Investigation of Clinical Performance and Patient Outcome With the EuroQuol-5 Dimension Health Questionnaire (EQ-5D). EQ-5D TTO 6 months	0.87 units on a scale Standard Deviation 0.14	0.85 units on a scale Standard Deviation 0.16
Investigation of Clinical Performance and Patient Outcome With the EuroQuol-5 Dimension Health Questionnaire (EQ-5D). EQ-5D TTO 1 year	0.86 units on a scale Standard Deviation 0.18	0.87 units on a scale Standard Deviation 0.13
Investigation of Clinical Performance and Patient Outcome With the EuroQuol-5 Dimension Health Questionnaire (EQ-5D). EQ-5D TTO 2 years	0.86 units on a scale Standard Deviation 0.14	0.73 units on a scale Standard Deviation 0.18

SECONDARY outcome

Timeframe: 6 weeks, 6 months, 1 year, 2 years

Population: Data was not collected for all participants. Numbers analyzed represent evaluable cases.

The FJS is based on the patients' ability to forget about a joint as a result of the treatment. The FJS assessment is scored on a 0-100 scale. The higher the score, the less the patient is aware of their affected joint when performing daily activities.

Outcome measures

Outcome measures
Measure	Group A TKA Without VERASENSE n=103 Participants Patients who undergo primary PCL-retaining or - sacrificing TKA without the use of VERASENSE to guide rotational alignment and balance. TKA without "Verasense": TKA will be performed manually without the use of Verasense	Group B TKA With VERASENSE n=98 Participants Patients who undergo primary PCL-retaining or - sacrificing TKA with the use of VERASENSE to guide rotational alignment and balance. TKA with "Verasense": VERASENSE replaces the standard tibial trial inserts and is embedded with microelectronics and sensors to provide surgeons with real-time knee kinetic data. The data is wirelessly transmitted to a graphic display (VERASENSE Knee Application), allowing surgeons to quantify and assess soft tissue intercompartmental loads throughout the range of motion. The VERASENSE sensor is not an investigational device. OrthoSensor, Inc., received FDA 510K clearance in 2009. The indication for use is a tool for adjustment of the femoral knee implant to reduce instability from flexion gap asymmetry. The VERASENSE sensor is sterile and single patient use.
Forgotten Joint Score (FJS) FJS 6 weeks	30.55 units on a scale Standard Deviation 25.52	33.31 units on a scale Standard Deviation 27.88
Forgotten Joint Score (FJS) FJS 6 months	55.11 units on a scale Standard Deviation 26.89	55.46 units on a scale Standard Deviation 26.77
Forgotten Joint Score (FJS) FJS 1 year	57.88 units on a scale Standard Deviation 28.23	60.34 units on a scale Standard Deviation 27.35
Forgotten Joint Score (FJS) FJS 2 years	59.78 units on a scale Standard Deviation 32.22	65.73 units on a scale Standard Deviation 31.11

Adverse Events

Group A TKA Without VERASENSE

Serious events: 8 serious events

Other events: 0 other events

Deaths: 0 deaths

Group B TKA With VERASENSE

Serious events: 6 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Group A TKA Without VERASENSE n=170 participants at risk patients who undergo primary PCL-retaining or - sacrificing TKA without the use of VERASENSE to guide rotational alignment and balance. TKA without "Verasense": TKA will be performed manually without the use of Verasense	Group B TKA With VERASENSE n=162 participants at risk patients who undergo primary PCL-retaining or - sacrificing TKA with the use of VERASENSE to guide rotational alignment and balance. TKA with "Verasense": VERASENSE replaces the standard tibial trial inserts and is embedded with microelectronics and sensors to provide surgeons with real-time knee kinetic data. The data is wirelessly transmitted to a graphic display (VERASENSE Knee Application), allowing surgeons to quantify and assess soft tissue intercompartmental loads throughout the range of motion. The VERASENSE sensor is not an investigational device. OrthoSensor, Inc., received FDA 510K clearance in 2009. The indication for use is a tool for adjustment of the femoral knee implant to reduce instability from flexion gap asymmetry. The VERASENSE sensor is sterile and single patient use.
Musculoskeletal and connective tissue disorders Stiffness	2.4% 4/170 • Number of events 4 • Date of inclusion to 2 years The definition of adverse event and/or serious adverse event does not differ from ClinicalTrilas.gov definition.	1.9% 3/162 • Number of events 3 • Date of inclusion to 2 years The definition of adverse event and/or serious adverse event does not differ from ClinicalTrilas.gov definition.
General disorders Chest pain unspecific	0.59% 1/170 • Number of events 1 • Date of inclusion to 2 years The definition of adverse event and/or serious adverse event does not differ from ClinicalTrilas.gov definition.	0.00% 0/162 • Date of inclusion to 2 years The definition of adverse event and/or serious adverse event does not differ from ClinicalTrilas.gov definition.
Infections and infestations Deep joint infection	0.00% 0/170 • Date of inclusion to 2 years The definition of adverse event and/or serious adverse event does not differ from ClinicalTrilas.gov definition.	1.2% 2/162 • Number of events 2 • Date of inclusion to 2 years The definition of adverse event and/or serious adverse event does not differ from ClinicalTrilas.gov definition.
Infections and infestations Shingles	0.59% 1/170 • Number of events 1 • Date of inclusion to 2 years The definition of adverse event and/or serious adverse event does not differ from ClinicalTrilas.gov definition.	0.00% 0/162 • Date of inclusion to 2 years The definition of adverse event and/or serious adverse event does not differ from ClinicalTrilas.gov definition.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Melanoma	0.59% 1/170 • Number of events 1 • Date of inclusion to 2 years The definition of adverse event and/or serious adverse event does not differ from ClinicalTrilas.gov definition.	0.00% 0/162 • Date of inclusion to 2 years The definition of adverse event and/or serious adverse event does not differ from ClinicalTrilas.gov definition.
Injury, poisoning and procedural complications Kidney injury	0.00% 0/170 • Date of inclusion to 2 years The definition of adverse event and/or serious adverse event does not differ from ClinicalTrilas.gov definition.	0.62% 1/162 • Number of events 1 • Date of inclusion to 2 years The definition of adverse event and/or serious adverse event does not differ from ClinicalTrilas.gov definition.
Musculoskeletal and connective tissue disorders Hematoma	0.59% 1/170 • Number of events 1 • Date of inclusion to 2 years The definition of adverse event and/or serious adverse event does not differ from ClinicalTrilas.gov definition.	0.00% 0/162 • Date of inclusion to 2 years The definition of adverse event and/or serious adverse event does not differ from ClinicalTrilas.gov definition.

Other adverse events

Adverse event data not reported

Additional Information

Kevin Barga

Stryker

Phone: 201 831 5073

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60