NCT03628378

Orthosensor vs Conventional Total Knee Arthroplasty

Completed NA Results posted Last updated 24 September 2024

What this trial tests

NA trial testing Verasense in Osteoarthritis, Knee in 130 participants. Completed in 22 June 2022.

Timeline

20 December 2017

Primary endpoint
22 June 2022

22 June 2022

Quick facts

Lead sponsor	Columbia University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	130
Start date	20 December 2017
Primary completion	22 June 2022
Estimated completion	22 June 2022
Sites	2 locations across United States

Drugs / interventions tested

• Verasense

Conditions studied

• Osteoarthritis, Knee — all drugs for Osteoarthritis, Knee →

Sponsor

Columbia University

Who can join

Adults 18 to 85, any sex, with Osteoarthritis, Knee. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Average Score on the 12-Item Short Form Survey (SF-12) - Physical Component Primary · 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.

3 months

Group	Value	95% CI
Non-Sensor Group	46	± 8
Sensor Group	43	± 8

1 year

Group	Value	95% CI
Non-Sensor Group	45	± 8
Sensor Group	46	± 6

2 years

Group	Value	95% CI
Non-Sensor Group	49	± 6
Sensor Group	47	± 6

Average Score on the 12-Item Short Form Survey (SF-12) - Mental Component Primary · 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.

3 months

Group	Value	95% CI
Non-Sensor Group	48	± 5
Sensor Group	48	± 7

1 year

Group	Value	95% CI
Non-Sensor Group	46	± 7
Sensor Group	45	± 7

2 years

Group	Value	95% CI
Non-Sensor Group	43	± 7
Sensor Group	43	± 6

Average Score on the WOMAC Functional (F) Limitation Subscale Primary · 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.

3 months

Group	Value	95% CI
Non-Sensor Group	22	± 17
Sensor Group	28	± 19

1 year

Group	Value	95% CI
Non-Sensor Group	21	± 20
Sensor Group	22	± 21

2 years

Group	Value	95% CI
Non-Sensor Group	13	± 19
Sensor Group	16	± 21

Average Score on the WOMAC Stiffness (S) Subscale Primary · 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.

3 months

Group	Value	95% CI
Non-Sensor Group	35	± 22
Sensor Group	37	± 19

1 year

Group	Value	95% CI
Non-Sensor Group	31	± 21
Sensor Group	30	± 26

2 years

Group	Value	95% CI
Non-Sensor Group	18	± 22
Sensor Group	20	± 27

Average Score on the WOMAC Pain (P) Subscale Primary · 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.

3 months

Group	Value	95% CI
Non-Sensor Group	18	± 15
Sensor Group	25	± 21

1 year

Group	Value	95% CI
Non-Sensor Group	16	± 21
Sensor Group	16	± 18

2 years

Group	Value	95% CI
Non-Sensor Group	12	± 17
Sensor Group	12	± 19

Knee Society Functional Score (KSFS) Primary · 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.

3 months

Group	Value	95% CI
Non-Sensor Group	68	± 18
Sensor Group	55	± 21

1 year

Group	Value	95% CI
Non-Sensor Group	65	± 22
Sensor Group	68	± 20

2 years

Group	Value	95% CI
Non-Sensor Group	77	± 23
Sensor Group	71	± 26

Average Arc of Range of Motion (Extension to Flexion) Primary · 3 months, 1 year, 2 years

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

3 months

Group	Value	95% CI
Non-Sensor Group	116	± 13
Sensor Group	113	± 11

1 year

Group	Value	95% CI
Non-Sensor Group	117	± 13
Sensor Group	119	± 13

2 years

Group	Value	95% CI
Non-Sensor Group	117	± 12
Sensor Group	116	± 12

Visual Analogue Scale Pain Level Secondary · 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).

Group	Value	95% CI
Non-Sensor Group	3.2	± 1.9
Sensor Group	3.2	± 1.7

Ambulation (Distance) Secondary · 1 week

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

Group	Value	95% CI
Non-Sensor Group	351	± 290
Sensor Group	361	± 263

Sponsor's own description

In a randomized-controlled fashion, this investigation will evaluate the use of the Verasense technology to achieve optimal TKA balance. Patients will be randomized to either: 1) undergo manual soft tissue balancing or 2) soft tissue balancing with the Verasense. The primary outcomes of interest will include patient-reported outcomes as well knee range of motion at 3 months, 6 months, 1 year, and 2 years. Secondary outcomes of interest will include pain level as assessed by the visual analogue scale (VAS) in the acute post-operative and follow up periods, ambulation distance during inpatient physical therapy postoperatively, surgical time, tourniquet time, amount of opioid consumption, length of hospital stay, incidence of arthrofibrosis and subsequent manipulation under anesthesia. The investigators hypothesize that the use of the Verasense technology will lead to improved soft tissue balancing in TKA and ultimately result in favorable patient-reported outcomes and postoperative knee range of motion.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. No Benefit to Sensor-guided Balancing Compared With Freehand Balancing in TKA: A Randomized Controlled Trial.
   Sarpong NO, Held MB, Grosso MJ, Herndon CL, et al · · 2022 · cited 14× · PMID 35394462 · DOI 10.1097/corr.0000000000002168