Using ROSA for Challenging The TKA Standard of Care

NCT06267482 | Recruiting Phase 4

• 1 other identifier: 122311
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

This is a prospective, randomized controlled trial using the cruciate retaining, MC Persona to comparing the conventional TKA to ROSA assisted TKA. Patients will be randomized to one of three study trial arms.

1. 1.Standard of care medial parapetallar approach (Control)
2. 2.ROSA PSA medial parapetallar approach
3. 3.ROSA PSA medial subvastus approach Participants will be followed for 1 year post surgery with a combination of perioperative parameters, imaging, patient reported outcomes, functional outcomes, blood and tissue sampling for inflammatory information and activity levels.

Conditions

Knee Osteoarthritis

Outcome Measures

Primary Outcomes (8)

• Functional Outcome - Weight-bearing CT scan

  Patients will undergo a weight-bearing CT scan to examine implant migration and bone position in the knee.

  Pre-operation, 1-3 days post-op, 6-weeks post-op, and 1-year post-op

• Functional Outcome - 3D Ultrasound

  Patients will undergo a 3D Ultrasound to measure the inflammatory characteristics including Synovial fluid and synovial thickness for fibrosis in the supra-patellar region of the knee

  Pre-operation, 6-weeks post-op, 3-months post-op and 1-year post-op

• Functional Outcome - Timed Up and Go test

  Patients will undergo a Timed Up and Go (TUG) test. Patients will have to get up from a seated position, walk 10 feet, turn around and walk another 10 feet. This test is used to examine the function of the lower extremities. A time improvement of 2.27 Seconds will be considered clinically meaningful

  Pre-operation, 6-weeks post-op, 3-months post-op and 1-year post-op

• Patient health status - Knee Society Score

  This will be done by comparing the Knee Society Score (KSS) Patient-reported outcome measurement questionnaire given to patients. The KSS questionnaire looks at several factors such as patient satisfaction (scale from 1-5, 5 being the best), Patient expectation (scale from 1-5, 5 being the best) and patient's pain during activities (scale from No pain to severe pain)

  Pre-operation, 6-weeks post-op, 3-months post-op and 1-year post-op

• Patient health status - EuroQuol Survey

  This will be done by comparing the EuroQuol (EQ-5D) Patient-reported outcome measurement questionnaire given to patients. EQ-5D looks at the overall quality of life of a patient. The survey has 2 sections, the first asking the patient to best describe their health (Scale from Unable to perform the activity to no problem performing the activity) and an overall health assessment (scale 0-100, 100 being the best health you can imagine)

  Pre-operation, 6-weeks post-op, 3-months post-op and 1-year post-op

• Patient health status - Knee Injury and Osteoarthritis Outcome Score

  This will be done by comparing the Knee Injury and Osteoarthritis Outcome score (KOOS) Patient-reported outcome measurement questionnaire given to patients. The KOOS survey looks at the pain and function of the operated knee. Patients will be asked questions about the pain they feel during activities (Scale from none-extreme) and the function of their joint (scale from none-extreme)

  Pre-operation, 6-weeks post-op, 3-months post-op and 1-year post-op

• Patient health status - Western Ontario and McMaster Universities Arthritis Index

  This will be done by comparing the Western Ontario and McMaster Universities Arthritis Index (WOMAC) Patient-reported outcome measurement questionnaire given to patients. This survey will ask patients about the pain, stiffness and difficulty of using their knee. This survey is scaled from 0-4, 0 being none and 4 being extreme.

  Pre-operation, 6-weeks post-op, 3-months post-op and 1-year post-op

• Patient health status - Global Assessment

  This will be done by comparing the UCLA Activity Score (UCLA) Patient-reported outcome measurement questionnaire given to patients. This survey assesses the activity level of patients on a scale from 0 - 10 with 10 being the patient regularly participates in impact sports.

  Pre-operation, 6-weeks post-op, 3-months post-op and 1-year post-op

Secondary Outcomes (1)

• Health Ecominics

  Pre-operation, 1-3 days post-op, 6-weeks post-op, 3-months post-op

Study Arms (3)

Control

NO INTERVENTION

Standard of care medial parapetallar approach

ROSA PSA Parapatellar Approach

ACTIVE COMPARATOR

Arm using the ROSA with PSA and medial parapetallar approach

Procedure: ROSA PSA Parapatellar Approach

ROSA PSA Subvastus Approach

ACTIVE COMPARATOR

Arm using the ROSA with PSA and medial subvastus approach

Procedure: ROSA PSA Subvastus Approach

Interventions

ROSA PSA Parapatellar Approach PROCEDURE

This intervention will consist of using the ROSA alongside patient-specific alignment. The knee incision will be the same as the standard of care (medial parapatellar approach).

ROSA PSA Parapatellar Approach

ROSA PSA Subvastus Approach PROCEDURE

This intervention will consist of using the ROSA alongside patient-specific alignment. The knee incision will be an alternative, quad-sparring, subvastus approach.

ROSA PSA Subvastus Approach

Eligibility Criteria

• Age: 21 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Symptomatic osteoarthritis of the knee indicating primary total knee arthroplasty
• Varus knee deformity of 0 to 10 degrees
• Sufficient ligamentous function to warrant retention of the posterior cruciate ligament
• Between the ages of 21 and 80 inclusive
• Patients willing and able to comply with follow-up requirements and self-evaluations
• Ability to give informed consent

You may not qualify if:

• Active or prior infection
• Medical condition precluding major surgery
• Predominantly inflammatory arthropathy
• Patellectomy
• PCL deficiency
• Major coronal plane deformity
• Prior trauma to the tibia or femur resulting in malalignment, canal occlusion, or open reduction and internal fixation
• Valgus alignment
• Neurologic condition limiting mobility
• Bone defects requiring augments, cones and/or stemmed implants

Sponsors & Collaborators

• London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's: lead
• Zimmer Biomet: collaborator

Study Sites (1)

University Hospital

London, Ontario, Canada

RECRUITING

Related Publications (28)

• 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

• Abdel MP, Oussedik S, Parratte S, Lustig S, Haddad FS. Coronal alignment in total knee replacement: historical review, contemporary analysis, and future direction. Bone Joint J. 2014 Jul;96-B(7):857-62. doi: 10.1302/0301-620X.96B7.33946.

  PMID: 24986936 BACKGROUND

• Lanting BA, Lieberman JR, Callaghan JJ, Berend ME, MacDonald SJ. Ensuring a Winner: The ABCs of Primary Total Knee Arthroplasty. Instr Course Lect. 2015;64:369-79.

  PMID: 25745921 BACKGROUND

• Bourne RB, Chesworth BM, Davis AM, Mahomed NN, Charron KD. Patient satisfaction after total knee arthroplasty: who is satisfied and who is not? Clin Orthop Relat Res. 2010 Jan;468(1):57-63. doi: 10.1007/s11999-009-1119-9.

  PMID: 19844772 BACKGROUND

• Dunbar MJ, Richardson G, Robertsson O. I can't get no satisfaction after my total knee replacement: rhymes and reasons. Bone Joint J. 2013 Nov;95-B(11 Suppl A):148-52. doi: 10.1302/0301-620X.95B11.32767.

  PMID: 24187375 BACKGROUND

• Gunaratne R, Pratt DN, Banda J, Fick DP, Khan RJK, Robertson BW. Patient Dissatisfaction Following Total Knee Arthroplasty: A Systematic Review of the Literature. J Arthroplasty. 2017 Dec;32(12):3854-3860. doi: 10.1016/j.arth.2017.07.021. Epub 2017 Jul 21.

  PMID: 28844632 BACKGROUND

• Noble PC, Conditt MA, Cook KF, Mathis KB. The John Insall Award: Patient expectations affect satisfaction with total knee arthroplasty. Clin Orthop Relat Res. 2006 Nov;452:35-43. doi: 10.1097/01.blo.0000238825.63648.1e.

  PMID: 16967035 BACKGROUND

• Vandekerckhove PTK, Matlovich N, Teeter MG, MacDonald SJ, Howard JL, Lanting BA. The relationship between constitutional alignment and varus osteoarthritis of the knee. Knee Surg Sports Traumatol Arthrosc. 2017 Sep;25(9):2873-2879. doi: 10.1007/s00167-016-3994-4. Epub 2016 Feb 1.

  PMID: 26831863 BACKGROUND

• Lanting BA, Williams HA, Matlovich NF, Vandekerckhove PJ, Teeter MG, Vasarhelyi EM, Howard JL, Somerville LE. The impact of residual varus alignment following total knee arthroplasty on patient outcome scores in a constitutional varus population. Knee. 2018 Dec;25(6):1278-1282. doi: 10.1016/j.knee.2018.08.019. Epub 2018 Oct 9.

  PMID: 30314879 BACKGROUND

• Howell SM, Hodapp EE, Vernace JV, Hull ML, Meade TD. Are undesirable contact kinematics minimized after kinematically aligned total knee arthroplasty? An intersurgeon analysis of consecutive patients. Knee Surg Sports Traumatol Arthrosc. 2013 Oct;21(10):2281-7. doi: 10.1007/s00167-012-2220-2. Epub 2012 Oct 2.

  PMID: 23052114 BACKGROUND

• Howell SM, Howell SJ, Kuznik KT, Cohen J, Hull ML. Does a kinematically aligned total knee arthroplasty restore function without failure regardless of alignment category? Clin Orthop Relat Res. 2013 Mar;471(3):1000-7. doi: 10.1007/s11999-012-2613-z. Epub 2012 Sep 21.

  PMID: 22996362 BACKGROUND

• Howell SM, Papadopoulos S, Kuznik KT, Hull ML. Accurate alignment and high function after kinematically aligned TKA performed with generic instruments. Knee Surg Sports Traumatol Arthrosc. 2013 Oct;21(10):2271-80. doi: 10.1007/s00167-013-2621-x. Epub 2013 Aug 15.

  PMID: 23948721 BACKGROUND

• Dossett HG, Estrada NA, Swartz GJ, LeFevre GW, Kwasman BG. A randomised controlled trial of kinematically and mechanically aligned total knee replacements: two-year clinical results. Bone Joint J. 2014 Jul;96-B(7):907-13. doi: 10.1302/0301-620X.96B7.32812.

  PMID: 24986944 BACKGROUND

• Dossett HG, Swartz GJ, Estrada NA, LeFevre GW, Kwasman BG. Kinematically versus mechanically aligned total knee arthroplasty. Orthopedics. 2012 Feb 17;35(2):e160-9. doi: 10.3928/01477447-20120123-04.

  PMID: 22310400 BACKGROUND

• Fang D, Ritter MA. Malalignment: forewarned is forearmed. Orthopedics. 2009 Sep;32(9):orthosupersite.com/view.asp?rID=42850. doi: 10.3928/01477447-20090728-29.

  PMID: 19751003 BACKGROUND

• Moreland JR, Bassett LW, Hanker GJ. Radiographic analysis of the axial alignment of the lower extremity. J Bone Joint Surg Am. 1987 Jun;69(5):745-9.

  PMID: 3597474 BACKGROUND

• Berend ME, Ritter MA, Meding JB, Faris PM, Keating EM, Redelman R, Faris GW, Davis KE. Tibial component failure mechanisms in total knee arthroplasty. Clin Orthop Relat Res. 2004 Nov;(428):26-34. doi: 10.1097/01.blo.0000148578.22729.0e.

  PMID: 15534515 BACKGROUND

• Ritter MA, Davis KE, Meding JB, Pierson JL, Berend ME, Malinzak RA. The effect of alignment and BMI on failure of total knee replacement. J Bone Joint Surg Am. 2011 Sep 7;93(17):1588-96. doi: 10.2106/JBJS.J.00772.

  PMID: 21915573 BACKGROUND

• Fang DM, Ritter MA, Davis KE. Coronal alignment in total knee arthroplasty: just how important is it? J Arthroplasty. 2009 Sep;24(6 Suppl):39-43. doi: 10.1016/j.arth.2009.04.034. Epub 2009 Jun 24.

  PMID: 19553073 BACKGROUND

• Alcelik I, Sukeik M, Pollock R, Misra A, Naguib A, Haddad FS. Comparing the mid-vastus and medial parapatellar approaches in total knee arthroplasty: a meta-analysis of short term outcomes. Knee. 2012 Aug;19(4):229-36. doi: 10.1016/j.knee.2011.07.010. Epub 2011 Aug 20.

  PMID: 21862334 BACKGROUND

• Liu HW, Gu WD, Xu NW, Sun JY. Surgical approaches in total knee arthroplasty: a meta-analysis comparing the midvastus and subvastus to the medial peripatellar approach. J Arthroplasty. 2014 Dec;29(12):2298-304. doi: 10.1016/j.arth.2013.10.023. Epub 2013 Oct 28.

  PMID: 24295800 BACKGROUND

• Xu SZ, Lin XJ, Tong X, Wang XW. Minimally invasive midvastus versus standard parapatellar approach in total knee arthroplasty: a meta-analysis of randomized controlled trials. PLoS One. 2014 May 20;9(5):e95311. doi: 10.1371/journal.pone.0095311. eCollection 2014.

  PMID: 24845859 BACKGROUND

• Thienpont E. Faster quadriceps recovery with the far medial subvastus approach in minimally invasive total knee arthroplasty. Knee Surg Sports Traumatol Arthrosc. 2013 Oct;21(10):2370-4. doi: 10.1007/s00167-012-2215-z. Epub 2012 Sep 25.

  PMID: 23007414 BACKGROUND

• Schroer WC, Diesfeld PJ, Reedy ME, Lemarr AR. Surgical accuracy with the mini-subvastus total knee arthroplasty a computer tomography scan analysis of postoperative implant alignment. J Arthroplasty. 2008 Jun;23(4):543-9. doi: 10.1016/j.arth.2007.05.034. Epub 2007 Nov 7.

  PMID: 18514872 BACKGROUND

• Kayani B, Tahmassebi J, Ayuob A, Konan S, Oussedik S, Haddad FS. A prospective randomized controlled trial comparing the systemic inflammatory response in conventional jig-based total knee arthroplasty versus robotic-arm assisted total knee arthroplasty. Bone Joint J. 2021 Jan;103-B(1):113-122. doi: 10.1302/0301-620X.103B1.BJJ-2020-0602.R2.

  PMID: 33380182 BACKGROUND

• Vasarhelyi EM, Williams HA, Howard JL, Petis S, Barfett J, Lanting BA. The Effect of Total Hip Arthroplasty Surgical Technique on Postoperative Muscle Atrophy. Orthopedics. 2020 Nov 1;43(6):361-366. doi: 10.3928/01477447-20200910-01. Epub 2020 Sep 22.

  PMID: 32956472 BACKGROUND

• Giesinger K, Hamilton DF, Jost B, Holzner B, Giesinger JM. Comparative responsiveness of outcome measures for total knee arthroplasty. Osteoarthritis Cartilage. 2014 Feb;22(2):184-9. doi: 10.1016/j.joca.2013.11.001. Epub 2013 Nov 18.

  PMID: 24262431 BACKGROUND

• Bloomfield RA, Williams HA, Broberg JS, Lanting BA, McIsaac KA, Teeter MG. Machine Learning Groups Patients by Early Functional Improvement Likelihood Based on Wearable Sensor Instrumented Preoperative Timed-Up-and-Go Tests. J Arthroplasty. 2019 Oct;34(10):2267-2271. doi: 10.1016/j.arth.2019.05.061. Epub 2019 Jun 5.

  PMID: 31255408 BACKGROUND

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

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

Study Officials

• Brent Lanting, PhD

  London Health Sciences Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lyndsay Somerville, PhD

CONTACT

(519) 685-8500; lyndsay.somerville@lhsc.on.ca

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 2, 2024
• First Posted: February 20, 2024
• Study Start: April 16, 2024
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: May 14, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)