Physica KR vs CR V1.0
Research type
Research Study
Full title
A post-market, monocentric, randomised, open-label, parallel group, prospective clinical study evaluating the functional outcome of the kinematic Physica KR total knee replacement system vs the standard Physica CR total knee replacement system.
IRAS ID
290023
Contact name
Adrian Harvey
Contact email
Clinicaltrials.gov Identifier
Duration of Study in the UK
3 years, 3 months, 30 days
Research summary
Total Knee Replacement (TKR) has proved to be a successful and cost-effective treatment for reducing pain and improving function in patients with advanced osteoarthritis.
The aim of this study is to assess and compare the clinical, radiographic and patient-reported outcome measures (PROMs) after total knee replacement with Physica KR (Kinematic Retaining) kinematic implant versus the standard Physica CR (Cruciate Retaining) implant. The hypothesis formulated is that the Physica KR implant has non-inferior function to the Physica CR implant and both configurations may contribute to ensure a fast-functional recovery with a pain relief. The main goal of a joint implant is to reproduce the anatomy of the natural knee, to reduce pain and restore the mobility of the patient. Changes in the Oxford Knee score from pre-operative (baseline) to 1 year after the implant of the Physica KR will be compared to the Physica CR designs.
The study will enrol 114 adult subjects randomised to either be implanted with the Physica KR or CR design. The investigation will be carried out at one NHS site in England, the University Hospitals Dorset NHS Foundation Trust. It is anticipated that recruitment will be completed within 2 years; all participants will be followed up until 1 year post TKR. Participants will attend for 6 visits to consist of a pre-operative visit before the device implant), intra-operative visit (same day as device implant), discharge visit (after the device implant according to clinical practice), and follow-up visits at 6 weeks, 6 months and 1 year after the implant.Summary of results
The early termination due to low enrolment did not allow neither to reach sufficient power nor to complete the study schedule, thus it is not possible to demonstrate any of the study objectives.Only 3 subjects were indeed enrolled out of the 114 planned and they performed only the pre-operative, intra-operative, and at discharge visits. No revisions nor adverse device effects occurred up to 4 months after surgery.
REC name
North West - Greater Manchester South Research Ethics Committee
REC reference
21/NW/0014
Date of REC Opinion
21 Jan 2021
REC opinion
Favourable Opinion