TRabecular Metal Economic and Clinical Knee Trial
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorNHS Greater Glasgow and Clyde
About this trial
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
Qualifiers
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.
Disqualifiers
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 significantly impacts on their current function and pain.
Patients who require revision knee arthroplasty surgery.
Disorders of the feet, ankles, hips or spine causing significant abnormal gait or significant pain.
Trial design
Treatments tested in this trial
- Persona (Zimmer) posterior stabilised uncemented Trabecular Metal™ (Tibia and Femur) prosthesis
- Persona (Zimmer) posterior stabilised cemented Trabecular Metal™ (Tibia and Femur) prosthesis
Treatment groups
144 Participants
are divided into 2 treatment groupsSponsors and collaborators
NHS Greater Glasgow and Clyde
Lead sponsor
Zimmer Biomet
Collaborator
University of Strathclyde
Collaborator
Source ClinicalTrials.gov