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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Persona (Zimmer) posterior stabilised uncemented Trabecular Metal™ (Tibia and Femur) prosthesis
DevicePersona (Zimmer) posterior stabilised uncemented Trabecular Metal™ (Tibia and Femur) prosthesis vs a Persona (Zimmer) posterior stabilised cemented prosthesis
Persona (Zimmer) posterior stabilised cemented Trabecular Metal™ (Tibia and Femur) prosthesis
DevicePersona (Zimmer) posterior stabilised uncemented Trabecular Metal™ (Tibia and Femur) prosthesis vs a Persona (Zimmer) posterior stabilised cemented prosthesis
Treatment groups
144 Participants
are divided into 2 treatment groupsGroup A: Cemented knee replacementActive comparator 1 intervention
Group B: Uncemented knee replacementExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Change in Oxford Knee Score (Patient reported outcome measure of pain and function)
Oxford Knee Score is a joint specific 12 question questionnaire related to the pain and function participants believe they are experiencing in their affected knee. A score of 0 indicating high pain and poor function, while a score of 48 is a healthy highly functioning knee joint. Oxford Knee Score will be recorded pre-operatively, at 3 months and 1 year post-operatively. The difference measured at 1 year will be the primary outcome. The questionnaire will be completed either, face-to-face, via postal questionnaires or via virtual appointments.
Time frame
Baseline, 3 months, 1, 2, 5 and 10 years post-operativelySecondary outcomes
1
Change in costs per quality adjusted life year (QALY) per participant.
Measured using a breadth of health economic data collected during the course of the study, including, cost of surgery, surgical time, implant costs, other related surgical costs (consumables etc), recovery time, rehabilitation costs, readmissions, revisions surgeries and GP visits in conjunction with quality of life data. This will provide a cost per quality of adjusted life year per participant.
Time frame
1, 2 and 10 years post-operatively2
Change in operation time (minutes)
Measured using video recordings for surgical procedures. Data will be collected from recordings to conduct motion and time analysis to provide an accurate operation time.
Time frame
After last intervention is administered3
Change in clinical movement: walking
Participants will be given an inertial measurement unit which is an electronic device that records movement during an activity.
Time frame
Baseline, 3 months, 1, 2 years post-operatively4
Change in clinical movement: standing from sitting
Participants will be given an inertial measurement unit which is an electronic device that records movement during an activity.
Time frame
Baseline, 3 months, 1, 2 years post-operativelySponsors and contacts
Click on the lead sponsor to view all of their trials.
NHS Greater Glasgow and Clyde
Lead sponsor
Zimmer Biomet
Collaborator
University of Strathclyde
Collaborator
Source ClinicalTrials.gov