PHYSICA KR Clinical Trial
Research type
Research Study
Full title
A multicentre, prospective clinical study evaluating the outcomes of a new knee system with a physiological rollback mechanism.
IRAS ID
137766
Contact name
Adrian Harvey
Contact email
Sponsor organisation
Limacorporate spa
Research summary
Research summary
The PHYSICA KR study is an international, multi-centre clinical study. It will include patients who require surgery for a disease of the knee, including osteoarthritis and rheumatoid arthritis.
The aim of the study is to assess the clinical, radiographic and patient-reported outcomes after total knee replacement.
The study will enrol 156 patients across 3 sites (2 in the UK and 1 in Italy). Patients that are recruited into the study will return for follow-up visits at 6 weeks,6 months, 1 year, 2 year, 3 year and 5 years post-surgery.Lay summary of study results:
Study Title: The study tested a new knee system called Physica KR.Who Carried Out the Research?
Doctors from 3 hospitals: Royal Bournemouth Hospital and Dorset County Hospital in the UK, and the Careggi hospital in Italy. The study was sponsored by Lima Corporate spa.
Public Involvement:
Patients who needed a knee replacement were involved in the study.
Where and When the Study Took Place:
The study happened in the UK and Italy. It started in November 2014 and finished in January 2023.Why was the Study on the New Knee System Needed?
The company who made the new knee system, (Physica KR), wanted to know if it was good for people with knee problems.
Main Questions Studied:
The doctors wanted to see if the new knee system helped people feel better and if it worked well for a long time.Who Took Part in the Study?
156 people took part in the study. They had knee problems, and the doctors chose them based on certain rules e.g.they couldn't be too overweight or have other health issues.
Treatments or other Interventions/help:
The participants got the new knee system, Physica KR, to see if it helped their knee problems.What Happened During the Study?
The doctors checked how well the new knee worked for the people who took part. They used different tests to check if their knees felt better.
Results of the Study:
Five years after the study first started, the doctors found out that the new knee system (Physica KR) really helped. The majority of knee felt better, and the new knee stayed working well for 99.4% of the people.How has this Study Helped Patients?
The study shows that the new knee system is good for people with knee problems.REC name
East of England - Cambridge East Research Ethics Committee
REC reference
13/EE/0438
Date of REC Opinion
13 Feb 2014
REC opinion
Further Information Favourable Opinion