The personalKNEE Trial

NCT06507046 | Recruiting

• 1 other identifier: 738578
• Study Type: interventional
• Target: 152
• Locations: 1 country
• Sites: 1

Brief Summary

Robotic knee surgery makes it possible to adopt different alignment philosophies in total knee arthroplasty. The classical operation where the knee is placed in a neutral manner, the so called mechanical alignment, has been used for decades. The kinematical alignment has recently won popularity. With this technique the focus is to render the natural knee anatomy even if this means to end up with a varus or valgus position. In this study, the investigators will compare the mechanical alignment and kinematical alignment and test the patients clinically and with a special CT scan to see if this technique gives equal or better longevity of the implants.

Conditions

Knee Osteoarthritis

Outcome Measures

Primary Outcomes (1)

• MTPM

  Maximum Total Point Motion measured by CT -based RSA in millimeters.

  2 years

Secondary Outcomes (13)

• XYZ translation

  2 years

• XYZ rotation

  2 years

• Steps per day

  1 year and 2 years

• Walking speed

  1 and 2 years

• Stair climbing

  1 and 2 years

Study Arms (2)

Mechanical alignment

ACTIVE COMPARATOR

Patients are operated with ROSA robot and mechanical alignment

Procedure: Total knee replacement

Personalized alignment

EXPERIMENTAL

Patients are operated with ROSA robot and kinematic alignment

Procedure: Total knee replacement

Interventions

Total knee replacement PROCEDURE

Mechanical or Personalized alignment

Mechanical alignment; Personalized alignment

Eligibility Criteria

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

You may qualify if:

• femoro-tibial or patello-femoral osteoarthritis (Kellgren-Lawrence, K-L) grade 2-4 with persistent pain, referred to Kristiansund Hospital for primary TKA

You may not qualify if:

• serious psychiatric disorders
• dementia
• drug abuse
• patients not able to speak and read Norwegian language making them noncompliant or unable to perform an informed consent
• Patients with ongoing cancer therapy
• Patients with ASA (The American Society of Anesthesiologists physical status class risk stratification system) classification \>3
• Patients in the need of walking aid devices
• Patients in need of primary revision arthroplasty or more than 15 degrees of varus or 5 degrees of valgus on preoperative HKA images.

Sponsors & Collaborators

• Helse Møre og Romsdal HF: lead
• Oslo University Hospital: collaborator
• National Taiwan Normal University: collaborator
• University of Oslo: collaborator
• Sectra AB: collaborator

Study Sites (1)

Kristiansund Hospital, Møre and Romsdal Hospital Trust

Kristiansund, Møre and Romsdal, 6508, Norway

RECRUITING

Related Publications (39)

• Bellemans J, Colyn W, Vandenneucker H, Victor J. The Chitranjan Ranawat award: is neutral mechanical alignment normal for all patients? The concept of constitutional varus. Clin Orthop Relat Res. 2012 Jan;470(1):45-53. doi: 10.1007/s11999-011-1936-5.

  PMID: 21656315 BACKGROUND

• Lee YS, Howell SM, Won YY, Lee OS, Lee SH, Vahedi H, Teo SH. Kinematic alignment is a possible alternative to mechanical alignment in total knee arthroplasty. Knee Surg Sports Traumatol Arthrosc. 2017 Nov;25(11):3467-3479. doi: 10.1007/s00167-017-4558-y. Epub 2017 Apr 24.

  PMID: 28439636 BACKGROUND

• Begum FA, Kayani B, Magan AA, Chang JS, Haddad FS. Current concepts in total knee arthroplasty : mechanical, kinematic, anatomical, and functional alignment. Bone Jt Open. 2021 Jun;2(6):397-404. doi: 10.1302/2633-1462.26.BJO-2020-0162.R1.

  PMID: 34139884 BACKGROUND

• Lustig S, Sappey-Marinier E, Fary C, Servien E, Parratte S, Batailler C. Personalized alignment in total knee arthroplasty: current concepts. SICOT J. 2021;7:19. doi: 10.1051/sicotj/2021021. Epub 2021 Mar 26.

  PMID: 33812467 BACKGROUND

• Liu B, Feng C, Tu C. Kinematic alignment versus mechanical alignment in primary total knee arthroplasty: an updated meta-analysis of randomized controlled trials. J Orthop Surg Res. 2022 Apr 4;17(1):201. doi: 10.1186/s13018-022-03097-2.

  PMID: 35379289 BACKGROUND

• Hasan S, Kaptein BL, Nelissen RGHH, van Hamersveld KT, Toksvig-Larsen S, Marang-van de Mheen PJ. The Influence of Postoperative Coronal Alignment on Tibial Migration After Total Knee Arthroplasty in Preoperative Varus and Valgus Knees: A Secondary Analysis of 10 Randomized Controlled Trials Using Radiostereometric Analysis. J Bone Joint Surg Am. 2021 Dec 15;103(24):2281-2290. doi: 10.2106/JBJS.20.01659.

  PMID: 34648477 BACKGROUND

• van Hamersveld KT, Marang-van de Mheen PJ, Nelissen RGHH. The Effect of Coronal Alignment on Tibial Component Migration Following Total Knee Arthroplasty: A Cohort Study with Long-Term Radiostereometric Analysis Results. J Bone Joint Surg Am. 2019 Jul 3;101(13):1203-1212. doi: 10.2106/JBJS.18.00691.

  PMID: 31274722 BACKGROUND

• Laende EK, Richardson CG, Dunbar MJ. A randomized controlled trial of tibial component migration with kinematic alignment using patient-specific instrumentation versus mechanical alignment using computer-assisted surgery in total knee arthroplasty. Bone Joint J. 2019 Aug;101-B(8):929-940. doi: 10.1302/0301-620X.101B8.BJJ-2018-0755.R3.

  PMID: 31362561 BACKGROUND

• Choi BS, Kim SE, Yang M, Ro DH, Han HS. Functional alignment with robotic-arm assisted total knee arthroplasty demonstrated better patient-reported outcomes than mechanical alignment with manual total knee arthroplasty. Knee Surg Sports Traumatol Arthrosc. 2023 Mar;31(3):1072-1080. doi: 10.1007/s00167-022-07227-5. Epub 2022 Nov 15.

  PMID: 36378291 BACKGROUND

• Vermue H, Batailler C, Monk P, Haddad F, Luyckx T, Lustig S. The evolution of robotic systems for total knee arthroplasty, each system must be assessed for its own value: a systematic review of clinical evidence and meta-analysis. Arch Orthop Trauma Surg. 2023 Jun;143(6):3369-3381. doi: 10.1007/s00402-022-04632-w. Epub 2022 Sep 25.

  PMID: 36153769 BACKGROUND

• Petersen ET, Rytter S, Koppens D, Dalsgaard J, Hansen TB, Andersen MS, Stilling M. Medial congruent polyethylene design show different tibiofemoral kinematics and enhanced congruency compared to a standard symmetrical cruciate retaining design for total knee arthroplasty-an in vivo randomized controlled study of gait using dynamic radiostereometry. Knee Surg Sports Traumatol Arthrosc. 2023 Mar;31(3):933-945. doi: 10.1007/s00167-022-07036-w. Epub 2022 Jul 9.

  PMID: 35809105 BACKGROUND

• Scott G, Imam MA, Eifert A, Freeman MA, Pinskerova V, Field RE, Skinner J, Banks SA. Can a total knee arthroplasty be both rotationally unconstrained and anteroposteriorly stabilised? A pulsed fluoroscopic investigation. Bone Joint Res. 2016 Mar;5(3):80-6. doi: 10.1302/2046-3758.53.2000621.

  PMID: 26965166 BACKGROUND

• Mathijssen NMC, Verburg H, London NJ, Landsiedl M, Dominkus M. Patient reported outcomes and implant survivorship after Total knee arthroplasty with the persona knee implant system: two year follow up. BMC Musculoskelet Disord. 2019 Mar 4;20(1):97. doi: 10.1186/s12891-019-2470-y.

  PMID: 30832636 BACKGROUND

• Christensson A, Tveit M, Kesteris U, Flivik G. Similar migration for medial congruent and cruciate-retaining tibial components in an anatomic TKA system: a randomized controlled trial of 60 patients followed with RSA for 2 years. Acta Orthop. 2022 Jan 3;93:68-74. doi: 10.1080/17453674.2021.1983709.

  PMID: 34633885 BACKGROUND

• Koster LA, Meinardi JE, Kaptein BL, Van der Linden-Van der Zwaag E, Nelissen RGHH. Two-year RSA migration results of symmetrical and asymmetrical tibial components in total knee arthroplasty: a randomized controlled trial. Bone Joint J. 2021 May;103-B(5):855-863. doi: 10.1302/0301-620X.103B5.BJJ-2020-1575.R2.

  PMID: 33934647 BACKGROUND

• Tuecking LR, Savov P, Zander M, Jeremic D, Windhagen H, Ettinger M. Comparable accuracy of femoral joint line reconstruction in different kinematic and functional alignment techniques. Knee Surg Sports Traumatol Arthrosc. 2023 Sep;31(9):3871-3879. doi: 10.1007/s00167-023-07360-9. Epub 2023 Mar 14.

  PMID: 36917247 BACKGROUND

• Behrend H, Giesinger K, Giesinger JM, Kuster MS. The "forgotten joint" as the ultimate goal in joint arthroplasty: validation of a new patient-reported outcome measure. J Arthroplasty. 2012 Mar;27(3):430-436.e1. doi: 10.1016/j.arth.2011.06.035. Epub 2011 Oct 13.

  PMID: 22000572 BACKGROUND

• Roos EM, Lohmander LS. The Knee injury and Osteoarthritis Outcome Score (KOOS): from joint injury to osteoarthritis. Health Qual Life Outcomes. 2003 Nov 3;1:64. doi: 10.1186/1477-7525-1-64.

  PMID: 14613558 BACKGROUND

• Kersten P, Kucukdeveci AA, Tennant A. The use of the Visual Analogue Scale (VAS) in rehabilitation outcomes. J Rehabil Med. 2012 Jun;44(7):609-10. doi: 10.2340/16501977-0999. No abstract available.

  PMID: 22674245 BACKGROUND

• Shim J, Hamilton DF. Comparative responsiveness of the PROMIS-10 Global Health and EQ-5D questionnaires in patients undergoing total knee arthroplasty. Bone Joint J. 2019 Jul;101-B(7):832-837. doi: 10.1302/0301-620X.101B7.BJJ-2018-1543.R1.

  PMID: 31256677 BACKGROUND

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  PMID: 7753121 BACKGROUND

• Unhjem R, van den Hoven LT, Nygard M, Hoff J, Wang E. Functional Performance With Age: The Role of Long-Term Strength Training. J Geriatr Phys Ther. 2019 Jul/Sep;42(3):115-122. doi: 10.1519/JPT.0000000000000141.

  PMID: 28786909 BACKGROUND

• Petersson N, Langgard Jorgensen S, Kjeldsen T, Mechlenburg I, Aagaard P. Blood Flow Restricted Walking in Elderly Individuals with Knee Osteoarthritis: A Feasibility Study. J Rehabil Med. 2022 Jun 20;54:jrm00282. doi: 10.2340/jrm.v54.2163.

  PMID: 35266006 BACKGROUND

• Engseth LHW, Schulz A, Pripp AH, Rohrl SMH, Ohrn FD. CT-based migration analysis is more precise than radiostereometric analysis for tibial implants: a phantom study on a porcine cadaver. Acta Orthop. 2023 Apr 27;94:207-214. doi: 10.2340/17453674.2023.12306.

  PMID: 37114404 BACKGROUND

• Ohrn FD, Lian OB, Tsukanaka M, Rohrl SM. Early migration of a medially stabilized total knee arthroplasty : a radiostereometric analysis study up to two years. Bone Jt Open. 2021 Sep;2(9):737-744. doi: 10.1302/2633-1462.29.BJO-2021-0115.R1.

  PMID: 34493056 BACKGROUND

• Garling EH, Kaptein BL, Geleijns K, Nelissen RG, Valstar ER. Marker Configuration Model-Based Roentgen Fluoroscopic Analysis. J Biomech. 2005 Apr;38(4):893-901. doi: 10.1016/j.jbiomech.2004.04.026.

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  PMID: 34862921 BACKGROUND

• Van Leeuwen JAMJ, Snorrason F, Rohrl SM. No radiological and clinical advantages with patient-specific positioning guides in total knee replacement. Acta Orthop. 2018 Feb;89(1):89-94. doi: 10.1080/17453674.2017.1393732. Epub 2017 Nov 22.

  PMID: 29161930 BACKGROUND

• Husby VS, Rian T, Klaksvik J, Wik TS, Winther SB. Physical activity in the first postoperative week in 132 knee arthroplasty patients randomized to 3 different analgesic regimens. Medicine (Baltimore). 2023 Apr 21;102(16):e33471. doi: 10.1097/MD.0000000000033471.

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• Bin Sheeha B, Granat M, Williams A, Johnson DS, Jones R. Does free-living physical activity improve one-year following total knee arthroplasty in patients with osteoarthritis: A prospective study. Osteoarthr Cartil Open. 2020 Apr 13;2(3):100065. doi: 10.1016/j.ocarto.2020.100065. eCollection 2020 Sep.

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• Masse V, Cholewa J, Shahin M. Personalized alignment for total knee arthroplasty using the ROSA(R) Knee and Persona(R) knee systems: Surgical technique. Front Surg. 2023 Jan 10;9:1098504. doi: 10.3389/fsurg.2022.1098504. eCollection 2022.

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• Ohrn FD, Engseth LHW, Pripp AH, Rohrl SMH, Schulz A. Dose reduction does not impact the precision of CT-based RSA in tibial implants: a diagnostic accuracy study on precision in a porcine cadaver. Acta Orthop. 2023 Oct 31;94:550-544. doi: 10.2340/17453674.2023.24022.

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Related Links

• Consort Statement
• ASA classification system

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

Arthroplasty, Replacement, Knee

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Arthroplasty, Replacement; Arthroplasty; Orthopedic Procedures; Surgical Procedures, Operative; Plastic Surgery Procedures; Prosthesis Implantation

Study Officials

• Frank-David Øhrn, MD, PhD

  Møre og Romsdal Hospital Trust

  STUDY DIRECTOR

• Kirsti Sevaldsen, MD, PhD

  Møre og Romsdal Hospital Trust

  STUDY CHAIR

Central Study Contacts

Myrhle Hoel, Nurse

CONTACT

71120000; Myrthle.Slettvag.Hoel@helse-mr.no

Frank-David Øhrn, MD, PhD

CONTACT

91824169; frank-david.ohrn@helse-mr.no

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: Patient, nurses and physiotherapists are blinded. Surgeon is of course not blinded.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: Randomized controlled trial

Study Record Dates

• First Submitted: July 8, 2024
• First Posted: July 18, 2024
• Study Start: August 25, 2024
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): May 1, 2035
• Last Updated: June 11, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: After publication and for 2 years

Locations

NO (1)