Orthosensor vs Conventional Total Knee Arthroplasty

NCT03628378 | Completed Results DMC FDA Device

• 1 other identifier: AAAR6137
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Osteoarthritis, Knee

Outcome Measures

Primary Outcomes (7)

• Average Score on the 12-Item Short Form Survey (SF-12) - Physical Component

  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, 1 year, 2 years

• Average Score on the 12-Item Short Form Survey (SF-12) - Mental Component

  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, 1 year, 2 years

• Average Score on the WOMAC Functional (F) Limitation Subscale

  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, 1 year, 2 years

• Average Score on the WOMAC Stiffness (S) Subscale

  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, 1 year, 2 years

• Average Score on the WOMAC Pain (P) Subscale

  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, 1 year, 2 years

• Knee Society Functional Score (KSFS)

  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, 1 year, 2 years

• Average Arc of Range of Motion (Extension to Flexion)

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

  3 months, 1 year, 2 years

Secondary Outcomes (2)

• Visual Analogue Scale Pain Level

  1 week

• Ambulation (Distance)

  1 week

Study Arms (2)

Non-Sensor Group

NO INTERVENTION

Patients will undergo standard total knee replacement surgery without Verasense assisted balancing technology.

Sensor Group

EXPERIMENTAL

Patients will undergo total knee replacement surgery with Verasense assisted balancing technology.

Device: Verasense

Interventions

Verasense DEVICE

Ligamentous balancing device

Also known as: Orthosensor

Sensor Group

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Primary total knee replacement

You may not qualify if:

• Revision knee surgery
• Prior knee surgery

Sponsors & Collaborators

• Columbia University: lead

Study Sites (2)

NewYork-Presbyterian Lawrence Hospital

Bronxville, New York, 10708, United States

Location

Columbia University Irving Medical Center

New York, New York, 10032, United States

Location

Related Publications (15)

• Kurtz S, Ong K, Lau E, Mowat F, Halpern M. Projections of primary and revision hip and knee arthroplasty in the United States from 2005 to 2030. J Bone Joint Surg Am. 2007 Apr;89(4):780-5. doi: 10.2106/JBJS.F.00222.

  PMID: 17403800 BACKGROUND

• Chow JC, Breslauer L. The Use of Intraoperative Sensors Significantly Increases the Patient-Reported Rate of Improvement in Primary Total Knee Arthroplasty. Orthopedics. 2017 Jul 1;40(4):e648-e651. doi: 10.3928/01477447-20170503-01. Epub 2017 May 8.

  PMID: 28481384 BACKGROUND

• Jacobs CA, Christensen CP, Karthikeyan T. Patient and intraoperative factors influencing satisfaction two to five years after primary total knee arthroplasty. J Arthroplasty. 2014 Aug;29(8):1576-9. doi: 10.1016/j.arth.2014.03.022. Epub 2014 Mar 28.

  PMID: 24768544 BACKGROUND

• Judge A, Arden NK, Cooper C, Kassim Javaid M, Carr AJ, Field RE, Dieppe PA. Predictors of outcomes of total knee replacement surgery. Rheumatology (Oxford). 2012 Oct;51(10):1804-13. doi: 10.1093/rheumatology/kes075. Epub 2012 Apr 24.

  PMID: 22532699 BACKGROUND

• Kim KW, Han JW, Cho HJ, Chang CB, Park JH, Lee JJ, Lee SB, Seong SC, Kim TK. Association between comorbid depression and osteoarthritis symptom severity in patients with knee osteoarthritis. J Bone Joint Surg Am. 2011 Mar 16;93(6):556-63. doi: 10.2106/JBJS.I.01344.

  PMID: 21411706 BACKGROUND

• Camarata DA. Soft tissue balance in total knee arthroplasty with a force sensor. Orthop Clin North Am. 2014 Apr;45(2):175-84. doi: 10.1016/j.ocl.2013.12.001. Epub 2014 Feb 1.

  PMID: 24684911 BACKGROUND

• Churchill JL, Khlopas A, Sultan AA, Harwin SF, Mont MA. Gap-Balancing versus Measured Resection Technique in Total Knee Arthroplasty: A Comparison Study. J Knee Surg. 2018 Jan;31(1):13-16. doi: 10.1055/s-0037-1608820. Epub 2017 Nov 27.

  PMID: 29179222 BACKGROUND

• Krackow KA. Instability in total knee arthroplasty: loose as a goose. J Arthroplasty. 2003 Apr;18(3 Suppl 1):45-7. doi: 10.1054/arth.2003.50069.

  PMID: 12730928 BACKGROUND

• Gustke KA, Golladay GJ, Roche MW, Elson LC, Anderson CR. A new method for defining balance: promising short-term clinical outcomes of sensor-guided TKA. J Arthroplasty. 2014 May;29(5):955-60. doi: 10.1016/j.arth.2013.10.020. Epub 2013 Oct 24.

  PMID: 24269069 BACKGROUND

• Fehring TK, Odum S, Griffin WL, Mason JB, Nadaud M. Early failures in total knee arthroplasty. Clin Orthop Relat Res. 2001 Nov;(392):315-8. doi: 10.1097/00003086-200111000-00041.

  PMID: 11716402 BACKGROUND

• Meneghini RM, Ziemba-Davis MM, Lovro LR, Ireland PH, Damer BM. Can Intraoperative Sensors Determine the "Target" Ligament Balance? Early Outcomes in Total Knee Arthroplasty. J Arthroplasty. 2016 Oct;31(10):2181-7. doi: 10.1016/j.arth.2016.03.046. Epub 2016 Apr 4.

  PMID: 27155997 BACKGROUND

• Incavo SJ, Wild JJ, Coughlin KM, Beynnon BD. Early revision for component malrotation in total knee arthroplasty. Clin Orthop Relat Res. 2007 May;458:131-6. doi: 10.1097/BLO.0b013e3180332d97.

  PMID: 17224835 BACKGROUND

• Walker PS, Meere PA, Bell CP. Effects of surgical variables in balancing of total knee replacements using an instrumented tibial trial. Knee. 2014 Jan;21(1):156-61. doi: 10.1016/j.knee.2013.09.002. Epub 2013 Sep 19.

  PMID: 24103411 BACKGROUND

• Geller JA, Lakra A, Murtaugh T. The Use of Electronic Sensor Device to Augment Ligament Balancing Leads to a Lower Rate of Arthrofibrosis After Total Knee Arthroplasty. J Arthroplasty. 2017 May;32(5):1502-1504. doi: 10.1016/j.arth.2016.12.019. Epub 2016 Dec 24.

  PMID: 28109758 BACKGROUND

• Sarpong NO, Held MB, Grosso MJ, Herndon CL, Santos W, Lakra A, Shah RP, Cooper HJ, Geller JA. No Benefit to Sensor-guided Balancing Compared With Freehand Balancing in TKA: A Randomized Controlled Trial. Clin Orthop Relat Res. 2022 Aug 1;480(8):1535-1544. doi: 10.1097/CORR.0000000000002168. Epub 2022 Apr 7.

  PMID: 35394462 DERIVED

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Results Point of Contact

• Title: Jeffrey A. Geller, MD
• Organization: Columbia University Irving Medical Center

jg2520@cumc.columbia.edu

212-305-1120

Study Officials

• Jeffrey Geller, MD

  Columbia University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Orthopaedic Surgery

Study Record Dates

• First Submitted: July 26, 2018
• First Posted: August 14, 2018
• Study Start: December 20, 2017
• Primary Completion: June 22, 2022
• Study Completion: June 22, 2022
• Last Updated: September 24, 2024
• Results First Posted: September 24, 2024

Record last verified: 2024-09

Locations

US (2)