Trial Outcomes & Findings for Orthosensor vs Conventional Total Knee Arthroplasty (NCT NCT03628378)

NCT ID: NCT03628378

Last Updated: 2024-09-24

Results Overview

SF-12 is a patient-reported outcome measure assessing the impact of health on an individual's everyday life. The SF-12 is composed of a mental component score and a physical component score. The score range for each component is 0 to 100. Scores above 50 indicate a better-than-average health-related quality of life, while scores below 50 suggest below-average health.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 130 participants
• Primary outcome timeframe: 3 months, 1 year, 2 years
• Results posted on: 2024-09-24

Participant Flow

Participant milestones

Measure	Non-Sensor Group Patients will undergo standard total knee replacement surgery without Verasense assisted balancing technology.	Sensor Group Patients will undergo total knee replacement surgery with Verasense assisted balancing technology. Verasense: Ligamentous balancing device
Overall Study STARTED	67	63
Overall Study COMPLETED	67	63
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Non-Sensor Group n=67 Participants Patients will undergo standard total knee replacement surgery without Verasense assisted balancing technology.	Sensor Group n=63 Participants Patients will undergo total knee replacement surgery with Verasense assisted balancing technology. Verasense: Ligamentous balancing device	Total n=130 Participants Total of all reporting groups
Age, Continuous	70 years STANDARD_DEVIATION 9 • n=67 Participants	72 years STANDARD_DEVIATION 8 • n=63 Participants	71 years STANDARD_DEVIATION 8 • n=130 Participants
Sex: Female, Male Female	47 Participants n=67 Participants	50 Participants n=63 Participants	97 Participants n=130 Participants
Sex: Female, Male Male	20 Participants n=67 Participants	13 Participants n=63 Participants	33 Participants n=130 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United States	67 participants n=67 Participants	63 participants n=63 Participants	130 participants n=130 Participants
BMI	29 kg/m2 STANDARD_DEVIATION 6 • n=67 Participants	30 kg/m2 STANDARD_DEVIATION 6 • n=63 Participants	29.5 kg/m2 STANDARD_DEVIATION 6 • n=130 Participants

PRIMARY outcome

Timeframe: 3 months, 1 year, 2 years

SF-12 is a patient-reported outcome measure assessing the impact of health on an individual's everyday life. The SF-12 is composed of a mental component score and a physical component score.

The score range for each component is 0 to 100. Scores above 50 indicate a better-than-average health-related quality of life, while scores below 50 suggest below-average health.

Outcome measures

Measure	Non-Sensor Group n=67 Participants Patients will undergo standard total knee replacement surgery without Verasense assisted balancing technology.	Sensor Group n=63 Participants Patients will undergo total knee replacement surgery with Verasense assisted balancing technology. Verasense: Ligamentous balancing device
Average Score on the 12-Item Short Form Survey (SF-12) - Physical Component 3 months	46 score on a scale Standard Deviation 8	43 score on a scale Standard Deviation 8
Average Score on the 12-Item Short Form Survey (SF-12) - Physical Component 1 year	45 score on a scale Standard Deviation 8	46 score on a scale Standard Deviation 6
Average Score on the 12-Item Short Form Survey (SF-12) - Physical Component 2 years	49 score on a scale Standard Deviation 6	47 score on a scale Standard Deviation 6

PRIMARY outcome

Timeframe: 3 months, 1 year, 2 years

SF-12 is a patient-reported outcome measure assessing the impact of health on an individual's everyday life. The SF-12 is composed of a mental component score and a physical component score.

The score range for each component is 0 to 100. Scores above 50 indicate a better-than-average health-related quality of life, while scores below 50 suggest below-average health.

Outcome measures

Measure	Non-Sensor Group n=67 Participants Patients will undergo standard total knee replacement surgery without Verasense assisted balancing technology.	Sensor Group n=63 Participants Patients will undergo total knee replacement surgery with Verasense assisted balancing technology. Verasense: Ligamentous balancing device
Average Score on the 12-Item Short Form Survey (SF-12) - Mental Component 3 months	48 score on a scale Standard Deviation 5	48 score on a scale Standard Deviation 7
Average Score on the 12-Item Short Form Survey (SF-12) - Mental Component 1 year	46 score on a scale Standard Deviation 7	45 score on a scale Standard Deviation 7
Average Score on the 12-Item Short Form Survey (SF-12) - Mental Component 2 years	43 score on a scale Standard Deviation 7	43 score on a scale Standard Deviation 6

PRIMARY outcome

Timeframe: 3 months, 1 year, 2 years

The Western Ontario and McMaster Universities Arthritis Index (WOMAC) is a 24-item patient-report questionnaire used to assess pain (score range 0-20), stiffness (score range 0-8), and functional limitation (score range 0-68). Higher scores indicate worse pain, stiffness, and functional limitations. The WOMAC-F score is derived as the sum of the 17 item scores in the pain domain. It will be normalized and expressed on a 0-100 scale. This is done by dividing raw score by the highest possible value of the Functional score and multiplying by 100.

Outcome measures

Measure	Non-Sensor Group n=67 Participants Patients will undergo standard total knee replacement surgery without Verasense assisted balancing technology.	Sensor Group n=63 Participants Patients will undergo total knee replacement surgery with Verasense assisted balancing technology. Verasense: Ligamentous balancing device
Average Score on the WOMAC Functional (F) Limitation Subscale 3 months	22 score on a scale Standard Deviation 17	28 score on a scale Standard Deviation 19
Average Score on the WOMAC Functional (F) Limitation Subscale 1 year	21 score on a scale Standard Deviation 20	22 score on a scale Standard Deviation 21
Average Score on the WOMAC Functional (F) Limitation Subscale 2 years	13 score on a scale Standard Deviation 19	16 score on a scale Standard Deviation 21

PRIMARY outcome

Timeframe: 3 months, 1 year, 2 years

The Western Ontario and McMaster Universities Arthritis Index (WOMAC) is a 24-item patient-report questionnaire used to assess pain (score range 0-20), stiffness (score range 0-8), and functional limitation (score range 0-68). Higher scores indicate worse pain, stiffness, and functional limitations. The WOMAC-S score is derived as the sum of the 2 item scores in the pain domain. It will be normalized and expressed on a 0-100 scale. This is done by dividing raw score by the highest possible value of the Functional score and multiplying by 100.

Outcome measures

Measure	Non-Sensor Group n=67 Participants Patients will undergo standard total knee replacement surgery without Verasense assisted balancing technology.	Sensor Group n=63 Participants Patients will undergo total knee replacement surgery with Verasense assisted balancing technology. Verasense: Ligamentous balancing device
Average Score on the WOMAC Stiffness (S) Subscale 3 months	35 score on a scale Standard Deviation 22	37 score on a scale Standard Deviation 19
Average Score on the WOMAC Stiffness (S) Subscale 1 year	31 score on a scale Standard Deviation 21	30 score on a scale Standard Deviation 26
Average Score on the WOMAC Stiffness (S) Subscale 2 years	18 score on a scale Standard Deviation 22	20 score on a scale Standard Deviation 27

PRIMARY outcome

Timeframe: 3 months, 1 year, 2 years

The Western Ontario and McMaster Universities Arthritis Index (WOMAC) is a 24-item patient-report questionnaire used to assess pain (score range 0-20), stiffness (score range 0-8), and functional limitation (score range 0-68). Higher scores indicate worse pain, stiffness, and functional limitations. The WOMAC-P score is derived as the sum of the 5 item scores in the pain domain. It will be normalized and expressed on a 0-100 scale. This is done by dividing raw score by the highest possible value of the Pain score and multiplying by 100.

Outcome measures

Measure	Non-Sensor Group n=67 Participants Patients will undergo standard total knee replacement surgery without Verasense assisted balancing technology.	Sensor Group n=63 Participants Patients will undergo total knee replacement surgery with Verasense assisted balancing technology. Verasense: Ligamentous balancing device
Average Score on the WOMAC Pain (P) Subscale 3 months	18 score on a scale Standard Deviation 15	25 score on a scale Standard Deviation 21
Average Score on the WOMAC Pain (P) Subscale 1 year	16 score on a scale Standard Deviation 21	16 score on a scale Standard Deviation 18
Average Score on the WOMAC Pain (P) Subscale 2 years	12 score on a scale Standard Deviation 17	12 score on a scale Standard Deviation 19

PRIMARY outcome

Timeframe: 3 months, 1 year, 2 years

The investigators will ask participants to answer survey questions about knee functionality on a scale of 0-100, 0 being the least functionality and 100 being the most functionality.

Outcome measures

Measure	Non-Sensor Group n=67 Participants Patients will undergo standard total knee replacement surgery without Verasense assisted balancing technology.	Sensor Group n=63 Participants Patients will undergo total knee replacement surgery with Verasense assisted balancing technology. Verasense: Ligamentous balancing device
Knee Society Functional Score (KSFS) 3 months	68 score on a scale Standard Deviation 18	55 score on a scale Standard Deviation 21
Knee Society Functional Score (KSFS) 1 year	65 score on a scale Standard Deviation 22	68 score on a scale Standard Deviation 20
Knee Society Functional Score (KSFS) 2 years	77 score on a scale Standard Deviation 23	71 score on a scale Standard Deviation 26

PRIMARY outcome

Timeframe: 3 months, 1 year, 2 years

A normal range of motion is 0º extension (completely straight leg) to 130º (a fully flexed leg).

Outcome measures

Measure	Non-Sensor Group n=67 Participants Patients will undergo standard total knee replacement surgery without Verasense assisted balancing technology.	Sensor Group n=63 Participants Patients will undergo total knee replacement surgery with Verasense assisted balancing technology. Verasense: Ligamentous balancing device
Average Arc of Range of Motion (Extension to Flexion) 1 year	117 degrees Standard Deviation 13	119 degrees Standard Deviation 13
Average Arc of Range of Motion (Extension to Flexion) 2 years	117 degrees Standard Deviation 12	116 degrees Standard Deviation 12
Average Arc of Range of Motion (Extension to Flexion) 3 months	116 degrees Standard Deviation 13	113 degrees Standard Deviation 11

SECONDARY outcome

Timeframe: 1 week

Pain levels on a scale from 1-10 (1 being the least amount of pain possible and 10 being the most amount of pain possible).

Outcome measures

Measure	Non-Sensor Group n=67 Participants Patients will undergo standard total knee replacement surgery without Verasense assisted balancing technology.	Sensor Group n=63 Participants Patients will undergo total knee replacement surgery with Verasense assisted balancing technology. Verasense: Ligamentous balancing device
Visual Analogue Scale Pain Level	3.2 score on a scale Standard Deviation 1.9	3.2 score on a scale Standard Deviation 1.7

SECONDARY outcome

Timeframe: 1 week

ambulation distance during inpatient physical therapy (PT) postoperatively - presented in daily PT performance in feet.

Outcome measures

Measure	Non-Sensor Group n=67 Participants Patients will undergo standard total knee replacement surgery without Verasense assisted balancing technology.	Sensor Group n=63 Participants Patients will undergo total knee replacement surgery with Verasense assisted balancing technology. Verasense: Ligamentous balancing device
Ambulation (Distance)	351 feet Standard Deviation 290	361 feet Standard Deviation 263

Adverse Events

Non-Sensor Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Sensor 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

Jeffrey A. Geller, MD

Columbia University Irving Medical Center

Phone: 212-305-1120

Email: jg2520@cumc.columbia.edu

Results disclosure agreements

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