HipHOP
Research type
Research Study
Full title
Feasibility study for a comparative trial of hybrid or cemented implants for total hip replacement. Hip arthroplasty with Hybrid Or cemented implants: Patient reported outcomes
IRAS ID
271885
Contact name
Tony Coffey
Contact email
Sponsor organisation
Wrightington, Wigan & Leigh Teaching Hospitals NHS Foundation Trust
ISRCTN Number
ISRCTN11097021
Clinicaltrials.gov Identifier
IRAS, 271885
Duration of Study in the UK
2 years, 0 months, 0 days
Research summary
Research Summary
Hip replacement is a common procedure but patients vary in how well their hip works after surgery. The type of hip socket implant used may affect how successful the surgery is, but there is no clear evidence on which is the best type of implant. We wish to undertake a feasibility trial of two types of socket implant to see if the full trial is possible.Forty patients from a two hospitals will receive either a ‘cemented’ or a ‘hybrid’ hip replacement. Patients’ hip function will be assessed at 6 weeks and 6 months later using standard, validated questionnaires. A bespoke questionnaire will also be used to collect information on what health resources patients have used in the six months following their surgery.
Our main outcome is the rate of recruitment. We want to know how many patients will agree to take part, how long recruitment will take, and whether patients will complete the follow-up assessments after surgery. We will also learn how many patients will be needed for the full trial. In interviews, we will ask patients about their experiences of the trial and their reasons for taking part; we will also ask people who declined about their thoughts on why they chose not to participate.
We will ask surgeons about their willingness to take part in a trial and about any barriers there might be to changing their surgery practice following the full trial results.
We will also ask research nurses about their experiences of recruiting patients and collecting data, and their thoughts regarding patient perceptions of the study.
Summary of Results
Hip replacement is a common operation, but patients vary in how well their hip works after surgery. The type of hip implant used may affect how successful the surgery is, but there is no clear evidence on which type of implant leads to the best outcomes for patients. We have undertaken a feasibility study to see if it would be possible to run a full randomised trial to answer this important question.
Our patient and public involvement (PPI) group helped design the study and also helped write the patient facing documents.
Just over 60% of patients who were eligible agreed to take part. Forty patients were randomised to receive either a 'cemented' or 'hybrid' type of hip replacement. We tracked their progress using questionnaires to record how well the hip was working and the effect on their quality of life. We also spoke to patients, research staff and surgeons to understand their feelings about the trial to help make the full trial run smoothly.
All patients who had surgery completed the questionnaires, which demonstrated how their hips had improved. We were also able to calculate the costs associated with each type of treatment.
It seems that the 'hybrid' type of hip replacement might produce better function but also cost slightly more.
Some patients were uncertain about treatment being decided by chance, but many were reassured by both implant types having good track records. Surgeons were keen that patients have treatments that they thought would work well for them.
The results we now have will enable us to design a robust full randomised trial. We haven't yet presented or published our results but will again be working with our PPI group to assist with this. We plan to ask the NHS (HTA) to fund the next stage of this research.REC name
HSC REC B
REC reference
20/NI/0096
Date of REC Opinion
26 Aug 2020
REC opinion
Further Information Favourable Opinion