Arthroplasty, Replacement, Knee Clinical Trial
— iNAVOfficial title:
Randmised Controlled Trial Comparing Electromagnetically Navigated Versus Conventional Mechanically Aligned Total Knee Arthroplasty
NCT number | NCT05325060 |
Other study ID # | RN07OR001 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | June 25, 2007 |
Est. completion date | July 2, 2021 |
Verified date | April 2022 |
Source | NHS Greater Glasgow and Clyde |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 200 |
Est. completion date | July 2, 2021 |
Est. primary completion date | December 7, 2010 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 120 Years |
Eligibility | Inclusion Criteria: - 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. Exclusion Criteria: - 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. - Subjects who are currently invovled in any injury litigation claims. |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
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NHS Greater Glasgow and Clyde |
Bäthis H, Perlick L, Tingart M, Lüring 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. — View Citation
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. — View Citation
Bolognesi M, Hofmann A. Computer navigation versus standard instrumentation for TKA: a single-surgeon experience. Clin Orthop Relat Res. 2005 Nov;440:162-9. — View Citation
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. — View Citation
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):3451-345 — View Citation
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. — View Citation
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. — View Citation
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, Avon). 2013 Jan;28(1):23-8. doi: 10.1016/j.cl — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Oxford knee score | Patient reported outcome measure validated for total knee arthroplasty | Up to 10 years post operatively | |
Secondary | American Knee Society Score | Patient reported outcome measure validated for total knee arthroplasty | Up to 10 years post operatively | |
Secondary | Short Form 36 Health Survey Questionnaire (SF-36) | Validated self reported outcome measure of health | Up to 10 years post operatively | |
Secondary | Range of motion | Measured by research assistant post operatively using established techniques | 10 years post operatively | |
Secondary | All cause revision surgery | Examines re-intervention rates for any cause post-operatively. We defined revision using the United Kingdom National Joint registery definition of any intervention that results in the addition, removal or exchange of any component of the primary implant | 10 years post operatively |
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