Navigated Versus Convention Total Knee Arthroplasty

NCT05325060 | Completed FDA Device

• 1 other identifier: RN07OR001
• Study Type: interventional
• Target: 200
• Locations: 0 countries
• Sites: N/A

Brief Summary

The aim of this single blinded randomised control trial study was to assess the accuracy of implantation of components and the clinical outcome and complications with the iNAV electromagnetic navigation system compared with conventional techniques. Secondary outcome measures include Patient reported outcome measures (PROMS) and rates of revision surgery up to 10 years post operatively.

Conditions

Arthroplasty, Replacement, Knee; Surgery, Computer-Assisted

Outcome Measures

Primary Outcomes (1)

• Knee coronal plane allignment

  The primary outcome measure for this study was alignment within 3 degrees of neutral mechanical alignment at three months after surgery

  3 months post operatively

Secondary Outcomes (5)

• Oxford knee score

  Up to 10 years post operatively

• American Knee Society Score

  Up to 10 years post operatively

• Short Form 36 Health Survey Questionnaire (SF-36)

  Up to 10 years post operatively

• Range of motion

  10 years post operatively

• All cause revision surgery

  10 years post operatively

Study Arms (2)

Electromagentically navigated Total knee arthroplasty

EXPERIMENTAL

Patients underwent total knee arthroplasty using the iNav portable EM navigation system (Zimmer GmbH, Winterthur, Switzerland and Medtronic, Minneapolis, MN, USA). The system employs small reference frames attached to the femur and tibia which are incorporated within the primary surgical incision. A standard process of joint registration maps the surface anatomy of the joint. Alignment targets were similar in both groups with a neutral Hip-Knee-Ankle-Axis and the aim to implant both femur and tibial components perpendicular to this in the coronal plane. All patients received a cemented posterior stabilized NexGen LPS Flex TKA (Zimmer, Warsaw, Indiana, USA).

Device: Electromagnetically navigated total knee arthroplasty

Conventional mechanically alligned Total knee arthroplasty

ACTIVE COMPARATOR

Participants randomized to the conventional group received a TKA implanted using standard instrumentation. All patients received a cemented posterior stabilized NexGen LPS Flex TKA (Zimmer, Warsaw, Indiana, USA). Alignment targets were similar in both groups with a neutral Hip-Knee-Ankle-Axis and the aim to implant both femur and tibial components perpendicular to this in the coronal plane.

Device: Conventional total knee arthroplasty

Interventions

Electromagnetically navigated total knee arthroplasty DEVICE

The navigated group had surgery using the iNav portable EM navigation system (Zimmer GmbH, Winterthur, Switzerland and Medtronic, Minneapolis, MN, USA) and the definitive implant used was NexGen LPS implant (Zimmer Inc, Warsaw, IN, USA), a fixed-bearing bicruciate-sacrificing total condylar implant using traditional instrumentation with no patellar resurfacing

Electromagentically navigated Total knee arthroplasty

Conventional total knee arthroplasty DEVICE

The conventional group received surgery using conventional instrumentation and jigs from the implant manufacturer (Zimmer Inc, Warsaw, IN, USA) and the definitive implant used was NexGen LPS implant (Zimmer Inc, Warsaw, IN, USA), a fixed-bearing bicruciate-sacrificing total condylar implant using traditional instrumentation with no patellar resurfacing

Conventional mechanically alligned Total knee arthroplasty

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female subjects
• Subjects must be at least 18 years of age and there will be no maximum age limit. The subjects age must be considered suitable by the Investigator for a knee arthroplasty using either of the two systems available in the evaluation.
• Subjects, who are able to give voluntary, written informed consent to participate in this investigation and from whom consent has been obtained.
• Subjects, who, in the opinion of the investigator, are able to understand this investigation, co-operate with the investigation procedures and are willing to return to the hopsital for all the required post-operative follow-ups.
• Subjects who require a knee arthroplasty for primary surgical management of the idiopathic osteoarthritis.
• Subjects, who in the opinion of the Investigator, are considered to be suitable for treatment with a NexGen LPS Flex Total Knee Replacement.

You may not qualify if:

• Subjects who, in the opinion of the investigator, have an existing condition that would compromise their participation and follow-up in the study
• Subjects who require revision total knee arthroplasty surgery
• Subjects with any tibial deformity requiring tibial component augmentation.
• Subjects whom, in the opinion of the Investigator, require a constratined prosthesis.
• Subjects with inflammatory polyarthritis.
• Subjects with disorders of the feet, ankles, hips, or spine caising significant abnormal gait or significant pain.
• Subjects with osteoarthritis of the contralateral knee causing significant abnormal gait or significant pain.
• Subjects with poorly functioning contralateral total knee replacement causing significant abnormal gait or significant pain. Subjects with a well functioning contralateral total knee replacement will not be excluded.
• Subjects with neurological conditions affecting movement.
• Subjects with a pathology which, in the opinion of the Investigator, will adversely affect healing.
• Subjects with other disorders which, in the opinion of the Investigator, will/could impair rehabilitation.
• Contra-indications for the use of the device, as detailed in the package insert.
• Women who are pregnant
• Subjects who are known drug or alcohol abusers or with psychological disorders that could effect follow-up care or treatment outcomes.
• Subjects who are currently invovled in another clinical study with an investigational product.

Sponsors & Collaborators

• NHS Greater Glasgow and Clyde: lead

Related Publications (8)

• Decking R, Markmann Y, Fuchs J, Puhl W, Scharf HP. Leg axis after computer-navigated total knee arthroplasty: a prospective randomized trial comparing computer-navigated and manual implantation. J Arthroplasty. 2005 Apr;20(3):282-8. doi: 10.1016/j.arth.2004.09.047.

  PMID: 15809943 BACKGROUND

• Chin PL, Yang KY, Yeo SJ, Lo NN. Randomized control trial comparing radiographic total knee arthroplasty implant placement using computer navigation versus conventional technique. J Arthroplasty. 2005 Aug;20(5):618-26. doi: 10.1016/j.arth.2005.04.004.

  PMID: 16309998 BACKGROUND

• Haaker RG, Stockheim M, Kamp M, Proff G, Breitenfelder J, Ottersbach A. Computer-assisted navigation increases precision of component placement in total knee arthroplasty. Clin Orthop Relat Res. 2005 Apr;(433):152-9. doi: 10.1097/01.blo.0000150564.31880.c4.

  PMID: 15805951 BACKGROUND

• Bolognesi M, Hofmann A. Computer navigation versus standard instrumentation for TKA: a single-surgeon experience. Clin Orthop Relat Res. 2005 Nov;440:162-9. doi: 10.1097/01.blo.0000186561.70566.95.

  PMID: 16239801 BACKGROUND

• Bathis H, Perlick L, Tingart M, Luring C, Zurakowski D, Grifka J. Alignment in total knee arthroplasty. A comparison of computer-assisted surgery with the conventional technique. J Bone Joint Surg Br. 2004 Jul;86(5):682-7. doi: 10.1302/0301-620x.86b5.14927.

  PMID: 15274263 BACKGROUND

• Clark AN, Hounat A, O'Donnell S, May P, Doonan J, Rowe P, Jones BG, Blyth MJG. Electromagnetic Navigated Versus Conventional Total Knee Arthroplasty-A Five-Year Follow-Up of a Single-Blind Randomized Control Trial. J Arthroplasty. 2021 Oct;36(10):3451-3455. doi: 10.1016/j.arth.2021.06.007. Epub 2021 Jun 12.

  PMID: 34226082 RESULT

• Blyth MJ, Smith JR, Anthony IC, Strict NE, Rowe PJ, Jones BG. Electromagnetic navigation in total knee arthroplasty-a single center, randomized, single-blind study comparing the results with conventional techniques. J Arthroplasty. 2015 Feb;30(2):199-205. doi: 10.1016/j.arth.2014.09.008. Epub 2014 Sep 16.

  PMID: 25263246 RESULT

• Smith JR, Rowe PJ, Blyth M, Jones B. The effect of electromagnetic navigation in total knee arthroplasty on knee kinematics during functional activities using flexible electrogoniometry. Clin Biomech (Bristol). 2013 Jan;28(1):23-8. doi: 10.1016/j.clinbiomech.2012.09.006. Epub 2012 Oct 18.

  PMID: 23083704 RESULT

Study Officials

• Mark JG Blyth, Mr

  NHS Greater Glasgow and Clyde

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 5, 2022
• First Posted: April 13, 2022
• Study Start: June 25, 2007
• Primary Completion: December 7, 2010
• Study Completion: July 2, 2021
• Last Updated: April 20, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share