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Recruiting NCT04677907

NCT04677907 TRabecular Metal Economic and Clinical Knee Trial

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Clinical Trial Summary
NCT ID NCT04677907
Status Recruiting
Phase
Sponsor NHS Greater Glasgow and Clyde
Condition Total Knee Replacement
Study Type INTERVENTIONAL
Enrollment 144 participants
Start Date 2022-05-10
Primary Completion 2025-11-30

Trial Parameters

Condition Total Knee Replacement
Sponsor NHS Greater Glasgow and Clyde
Study Type INTERVENTIONAL
Phase N/A
Enrollment 144
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2022-05-10
Completion 2025-11-30
Interventions
Persona (Zimmer) posterior stabilised uncemented Trabecular Metal™ (Tibia and Femur) prosthesisPersona (Zimmer) posterior stabilised cemented Trabecular Metal™ (Tibia and Femur) prosthesis

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Brief Summary

To compare the differences, if any, in clinical outcome, patient satisfaction and survivorship between cemented and uncemented Total Knee Replacements (TKR)? To investigate if there are health economic implications of using uncemented TKRs in the NHS?

Eligibility Criteria

Inclusion Criteria: * Male or female subjects may be recruited to the evaluation. * Age - there are no restrictions relating to age of the patient. * 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 hospital for all the required post-operative follow-ups. * Subjects with uni-lateral osteoarthritis of the knee or subjects with bi-lateral osteoarthritis of the knee, who have a well functioning and pain free knee replacement in the contralateral knee. * Subjects who require a TKR for surgical management of osteoarthritis Exclusion Criteria: * Patients who, in the opinion of the Investigator, have an existing condition that would compromise their participation and follow-up in the study. * Patients with bi-lateral disease that

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