Status:
COMPLETED
Navigated Versus Convention Total Knee Arthroplasty
Lead Sponsor:
NHS Greater Glasgow and Clyde
Conditions:
Arthroplasty, Replacement, Knee
Surgery, Computer-Assisted
Eligibility:
All Genders
18-120 years
Phase:
NA
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 navigati...
Detailed Description
Participants Patients were identified by members of the research team from TKA surgical waiting lists. Patients were invited to participate if they had osteoarthritis of the knee suitable for TKA, wer...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 25 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 2 2021
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT05325060
Start Date
June 25 2007
End Date
July 2 2021
Last Update
April 20 2022
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