KARDS - Knee ARthroplasty versus joint Distraction Study
Research type
Research Study
Full title
Knee ARthroplasty versus joint Distraction Study for osteoarthritis (KARDS)
IRAS ID
270040
Contact name
Hemant Pandit
Contact email
Sponsor organisation
University of Leeds
ISRCTN Number
ISRCTN14879004
Duration of Study in the UK
2 years, 2 months, 31 days
Research summary
KARDS will investigate a new procedure to treat the symptoms of knee osteoarthritis - knee joint distraction (KJD) - in people under 65 who need a knee replacement/arthroplasty (KR). The aim is to see whether knee joint distraction can relieve pain and improve function as well as a knee replacement, delaying need for a joint replacement. Eligible patients who have been have been listed for a knee replacement will be informed about the trial in their initial outpatient appointment. If they want to participate they will come back to hospital up to 6 weeks before their planned surgery to give informed consent and will be randomly assigned to have either KR (standard) or KJD (intervention). \n\nThe standard group will have a knee replacement in line with their hospital’s usual standard of care. The intervention arm will have an external frame attached to their leg for 6 weeks which pulls the knee joint apart about 5mm, allowing the cartilage in the joint to repair. They will then return to hospital for the frame to be removed. Both groups will attend study visits at 3, 12 and 24 months after their surgery where they will fill in five short questionnaires and have their knee function assessed. The intervention group will also have an x-ray at these visits to assess the amount of cartilage healing in their knee joint. Participants will also be sent short questionnaires to fill in at home at 6 months after surgery.\nKARDS will also include an embedded process evaluation. Fidelity of intervention delivery will be monitored and recruitment feasibility will be assessed from site screening logs. Qualitative interviews will be conducted with a sample of surgeons, participants and non-recruited patients to evaluate feasibility of recruitment, address any barriers to recruitment and assess surgeon experience and patient acceptability.
REC name
Yorkshire & The Humber - Leeds East Research Ethics Committee
REC reference
19/YH/0368
Date of REC Opinion
9 Jan 2020
REC opinion
Further Information Favourable Opinion