Robotized Navigation Compared to Conventional Technique in Total Knee Replacement

NCT04525950 | Active Not Recruiting

• 1 other identifier: 2020/68448
• Study Type: interventional
• Target: 214
• Locations: 1 country
• Sites: 2

Brief Summary

Navio is a new generation of computer navigation systems allowing intraoperative navigation of the bone cuts relative to both ligaments and skeletal axes, prior to bone removal. An improved accuracy is incorporated by the use of robotics in a burr for bone removal. This study investigates whether this advanced technology leads to better clinical or radiostereometric results, by comparing one group operated with Navio to another group operated with conventional technique.

Conditions

Arthritis, Degenerative; Osteo Arthritis Knee

Outcome Measures

Primary Outcomes (7)

• Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) high responders

  Difference in rate (0.00-1.00) of high responders (calculated from KOOS)

  3 months

• WOMAC high responders

  Difference in rate (0.00-1.00) of high responders (calculated from KOOS)

  1 year

• WOMAC high responders

  Difference in rate (0.00-1.00) of high responders (calculated from KOOS)

  2 years

• WOMAC high responders

  Difference in rate (0.00-1.00) of high responders (calculated from KOOS)

  5 years

• Radiostereometric migration

  Maximum total point of motion MTPM (millimeters), (includes only first 60 patients)

  1 year

• Radiostereometric migration

  Maximum total point of motion MTPM (millimeters), (includes only first 60 patients)

  2 years

• Radiostereometric migration

  Maximum total point of motion MTPM (millimeters), (includes only first 60 patients)

  5 years

Secondary Outcomes (25)

• Knee injury and osteoarthritis outcome score (KOOS)

  3 months

• Knee injury and osteoarthritis outcome score (KOOS)

  1 year

• Knee injury and osteoarthritis outcome score (KOOS)

  2 years

• Knee injury and osteoarthritis outcome score (KOOS)

  5 years

• Knee society score (KSS)

  3 months

Other Outcomes (1)

• Position of the implant on radiographs, coronal and sagittal plane

  3 months

Study Arms (2)

Navio

EXPERIMENTAL

Using the new technology during surgery

Procedure: Navio

Conventional

ACTIVE COMPARATOR

Using the conventional surgical instruments

Procedure: Conventional

Interventions

Navio PROCEDURE

New generation computer navigation with haptics and robotics

Navio

Conventional PROCEDURE

Total knee arthroplasty using conventional instruments

Conventional

Eligibility Criteria

• Age: 45 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Degenerative knee in need of a total knee arthroplasty
• Recruited from the hospital's waiting list
• Informed consent

You may not qualify if:

• Severe systemic illness
• Infections
• Severe neurological dysfunction
• Severe cancer disease
• Severe incompensated heart failure
• Severe incompensated lung disease
• Dementia
• Previous fracture or deformity of the limb, making the use of an intramedullary rod impossible (same side hip or ankle implant is not to be excluded if the rod unaffectedly reaches more than the first half of the femoral canal)

Sponsors & Collaborators

• Haukeland University Hospital: lead
• University of Bergen: collaborator
• Haugesund Rheumatism Hospital: collaborator

Study Sites (2)

Haugesund sanitetsforenings revmatismesykehus

Haugesund, Haugesund, 5504, Norway

Location

Haukeland university hospital

Bergen, 5021, Norway

Location

Related Publications (18)

• Batailler C, White N, Ranaldi FM, Neyret P, Servien E, Lustig S. Improved implant position and lower revision rate with robotic-assisted unicompartmental knee arthroplasty. Knee Surg Sports Traumatol Arthrosc. 2019 Apr;27(4):1232-1240. doi: 10.1007/s00167-018-5081-5. Epub 2018 Jul 31.

  PMID: 30066017 BACKGROUND

• Petursson G, Fenstad AM, Gothesen O, Dyrhovden GS, Hallan G, Rohrl SM, Aamodt A, Furnes O. Computer-Assisted Compared with Conventional Total Knee Replacement: A Multicenter Parallel-Group Randomized Controlled Trial. J Bone Joint Surg Am. 2018 Aug 1;100(15):1265-1274. doi: 10.2106/JBJS.17.01338.

  PMID: 30063588 BACKGROUND

• Robinson PG, Clement ND, Hamilton D, Blyth MJG, Haddad FS, Patton JT. A systematic review of robotic-assisted unicompartmental knee arthroplasty: prosthesis design and type should be reported. Bone Joint J. 2019 Jul;101-B(7):838-847. doi: 10.1302/0301-620X.101B7.BJJ-2018-1317.R1.

  PMID: 31256672 BACKGROUND

• Bollars P, Boeckxstaens A, Mievis J, Kalaai S, Schotanus MGM, Janssen D. Preliminary experience with an image-free handheld robot for total knee arthroplasty: 77 cases compared with a matched control group. Eur J Orthop Surg Traumatol. 2020 May;30(4):723-729. doi: 10.1007/s00590-020-02624-3. Epub 2020 Jan 16.

  PMID: 31950265 BACKGROUND

• Roos EM, Roos HP, Lohmander LS, Ekdahl C, Beynnon BD. Knee Injury and Osteoarthritis Outcome Score (KOOS)--development of a self-administered outcome measure. J Orthop Sports Phys Ther. 1998 Aug;28(2):88-96. doi: 10.2519/jospt.1998.28.2.88.

  PMID: 9699158 BACKGROUND

• Roos EM, Roos HP, Ekdahl C, Lohmander LS. Knee injury and Osteoarthritis Outcome Score (KOOS)--validation of a Swedish version. Scand J Med Sci Sports. 1998 Dec;8(6):439-48. doi: 10.1111/j.1600-0838.1998.tb00465.x.

  PMID: 9863983 BACKGROUND

• Heijbel S, Naili JE, Hedin A, W-Dahl A, Nilsson KG, Hedstrom M. The Forgotten Joint Score-12 in Swedish patients undergoing knee arthroplasty: a validation study with the Knee Injury and Osteoarthritis Outcome Score (KOOS) as comparator. Acta Orthop. 2020 Feb;91(1):88-93. doi: 10.1080/17453674.2019.1689327. Epub 2019 Nov 12.

  PMID: 31711349 BACKGROUND

• Ko V, Naylor JM, Harris IA, Crosbie J, Yeo AE. The six-minute walk test is an excellent predictor of functional ambulation after total knee arthroplasty. BMC Musculoskelet Disord. 2013 Apr 24;14:145. doi: 10.1186/1471-2474-14-145.

  PMID: 23617377 BACKGROUND

• Unver B, Kalkan S, Yuksel E, Kahraman T, Karatosun V. Reliability of the 50-foot walk test and 30-sec chair stand test in total knee arthroplasty. Acta Ortop Bras. 2015 Jul-Aug;23(4):184-7. doi: 10.1590/1413-78522015230401018.

  PMID: 26327798 BACKGROUND

• Nyberg LA, Hellenius ML, Wandell P, Kowalski J, Sundberg CJ. Maximal step-up height as a simple and relevant health indicator: a study of leg muscle strength and the associations to age, anthropometric variables, aerobic fitness and physical function. Br J Sports Med. 2013 Oct;47(15):992-7. doi: 10.1136/bjsports-2013-092577. Epub 2013 Aug 21.

  PMID: 23966416 BACKGROUND

• Gothesen O, Espehaug B, Havelin LI, Petursson G, Hallan G, Strom E, Dyrhovden G, Furnes O. Functional outcome and alignment in computer-assisted and conventionally operated total knee replacements: a multicentre parallel-group randomised controlled trial. Bone Joint J. 2014 May;96-B(5):609-18. doi: 10.1302/0301-620X.96B5.32516.

  PMID: 24788494 BACKGROUND

• Inui H, Taketomi S, Yamagami R, Shirakawa N, Kawaguchi K, Tanaka S. The Relationship between Soft-Tissue Balance and Intraoperative Kinematics of Guided Motion Total Knee Arthroplasty. J Knee Surg. 2019 Jan;32(1):91-96. doi: 10.1055/s-0038-1636545. Epub 2018 Mar 7.

  PMID: 29514366 BACKGROUND

• Iriuchishima T, Ryu K. Bicruciate Substituting Total Knee Arthroplasty Improves Stair Climbing Ability When Compared with Cruciate-Retain or Posterior Stabilizing Total Knee Arthroplasty. Indian J Orthop. 2019 Sep-Oct;53(5):641-645. doi: 10.4103/ortho.IJOrtho_392_18.

  PMID: 31488934 BACKGROUND

• Harris AI, Christen B, Malcorps JJ, O'Grady CP, Kopjar B, Sensiba PR, Vandenneucker H, Huang BK, Cates HE, Hur J, Marra DA. Midterm Performance of a Guided-Motion Bicruciate-Stabilized Total Knee System: Results From the International Study of Over 2000 Consecutive Primary Total Knee Arthroplasties. J Arthroplasty. 2019 Jul;34(7S):S201-S208. doi: 10.1016/j.arth.2019.02.011. Epub 2019 Feb 14.

  PMID: 31031156 BACKGROUND

• Kono K, Inui H, Tomita T, Yamazaki T, Taketomi S, Sugamoto K, Tanaka S. Bicruciate-stabilised total knee arthroplasty provides good functional stability during high-flexion weight-bearing activities. Knee Surg Sports Traumatol Arthrosc. 2019 Jul;27(7):2096-2103. doi: 10.1007/s00167-019-05375-9. Epub 2019 Apr 10.

  PMID: 30972466 BACKGROUND

• Di Benedetto P, Buttironi MM, Magnanelli S, Cainero V, Causero A. Comparison between standard technique and image-free robotic technique in medial unicompartmental knee arthroplasty. Preliminary data. Acta Biomed. 2019 Dec 5;90(12-S):104-108. doi: 10.23750/abm.v90i12-S.8994.

  PMID: 31821293 BACKGROUND

• Unver B, Kahraman T, Kalkan S, Yuksel E, Karatosun V. Reliability of the six-minute walk test after total hip arthroplasty. Hip Int. 2013 Nov-Dec;23(6):541-5. doi: 10.5301/hipint.5000073. Epub 2013 Aug 6.

  PMID: 23934905 BACKGROUND

• Petursson G, Fenstad AM, Gothesen O, Haugan K, Dyrhovden GS, Hallan G, Rohrl SM, Aamodt A, Nilsson KG, Furnes O. Similar migration in computer-assisted and conventional total knee arthroplasty. Acta Orthop. 2017 Apr;88(2):166-172. doi: 10.1080/17453674.2016.1267835. Epub 2016 Dec 20.

  PMID: 27996349 BACKGROUND

MeSH Terms

Conditions

Osteoarthritis

Interventions

Congresses as Topic

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Organizations; Health Care Economics and Organizations

Study Officials

• Ove Furnes, MD/PhD

  University of Bergen

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Participants are blinded as the Navio system will be switched on at all operations, the outcomes assessors, statisticians and co-researchers will not get access to the randomization information.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized, blinded (patient and outcomes assessor), clinical and radiostereometric trial

Study Record Dates

• First Submitted: August 17, 2020
• First Posted: August 25, 2020
• Study Start: September 7, 2020
• Primary Completion: May 1, 2023
• Study Completion (Estimated): December 31, 2031
• Last Updated: March 14, 2025

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

NO (2)