20/76 Reverse vs conventional shoulder replacement for adults with osteoarthritis
The aim of the HTA Programme is to ensure that high quality research information on the effectiveness, costs and broader impact of health technology is produced in the most efficient way for those who use, manage, provide care in or develop policy for the NHS. Topics for research are identified and prioritised to meet the needs of the NHS. Health technology assessment forms a substantial portfolio of work within the National Institute for Health Research and each year about fifty new studies are commissioned to help answer questions of direct importance to the NHS. The studies include both primary research and evidence synthesis.
What is the clinical and cost-effectiveness of conventional compared with reverse total shoulder arthroplasty for adults having primary elective shoulder replacement for osteoarthritis with no rotator cuff tear?
- Intervention: Reverse total shoulder arthroplasty.
- Patient group: Adults with an intact rotator cuff being referred for primary elective shoulder replacement surgery to treat osteoarthritis (to be defined and justified by applicants including an appropriate age range).
Applications are encouraged which include recruitment from geographic populations with high disease burden which have been historically underserved by research activity in this field.
- Setting: Secondary care.
- Comparator: Conventional total shoulder arthroplasty.
- Study design: A randomised controlled trial with an internal pilot phase to test the ability to recruit and randomise. Clear stop/go criteria should be provided to inform progression from pilot to full trial.
Data should be submitted to the National Joint Registry or other appropriate long-term data repository.
- Important outcomes: Health related quality of life, Patient Reported Outcome Measures (PROMs) e.g. pain, function.
Other outcomes: Adverse effects; need for further intervention; cost-effectiveness; time to event data for clinical (PROM) and cost outcomes; revision surgery; patient acceptability.
Where established Core Outcomes exist they should be included amongst the list of outcomes unless there is good reason to do otherwise.
- Minimum duration of follow-up: 2 years.
Longer-term follow up: Researchers are encouraged to obtain consent from participants to allow potential future follow up through efficient means (such as routine data) as part of a separately funded study e.g. to investigate the longer-term cost-effectiveness and need for revision surgery after 5 and 10 years.
Osteoarthritis can cause chronic pain and stiffness, swelling and reduced mobility owing to the breakdown of cartilage, bony growths and inflammation in the joint. Most of the joint replacements performed are done to reduce pain and improve function in osteoarthritis sufferers. How this is done can vary widely. There are varying procedures, different implants available, several ways to fix implants in place, and differing materials that these implants are made of. These can all have an impact on patient outcomes, and prosthesis longevity, and a recent NICE guideline aimed to provide understanding on the various joint replacement options available.
Shoulder replacement surgery is increasing every year, and although the information around the use of partial replacement techniques in patients with an intact rotator cuff is clear (conventional total shoulder replacement offers more benefit than partial replacement), there is a lack of evidence and equipoise over the effectiveness of conventional vs reverse total shoulder replacement. Conventional total shoulder arthroplasty maintains the "natural anatomy" of the shoulder and involves replacing the ball and socket shoulder joint with prosthetic components. In contrast, reverse total shoulder arthroplasty involves replacing and reversing the ball and the socket.
Reverse total shoulder replacement is indicated for patients with rotator cuff tears, but is also being used more and more in patients with an intact rotator cuff (especially in the older age group), to reduce the need for revision surgery should the rotator cuff fail. This increasing practice is based on little evidence and as such NICE has produced a research recommendation to address the gap. The HTA programme is therefore interested in commissioning the study outlined above to provide evidence so that patients receive the most appropriate prothesis for them, and to inform future guidance.
Additional commissioning brief background information
A background document is available that provides further information to support applicants for this call. It is intended to summarise what prompted the call and the existing evidence base, including relevant work from the HTA and wider NIHR research portfolio. It was researched and written on the basis of information from a search of relevant sources and databases, and in consultation with a number of experts in the field. If you would like a copy please email email@example.com.
Making an application
If you wish to submit a Stage 1 application for this call, the online application form can be found on the Funding opportunities page. To select this call, use the filters on the right of the screen or search using the call name and/or number.
Your application must be submitted on-line no later than 1pm on the 2nd December 2020. Applications will be considered by the HTA Funding Committee at its meeting in January 2021.
IMPORTANT: Shortlisted Stage 1 applicants will be given eight weeks to submit a Stage 2 application. The Stage 2 application will be considered at the Funding Committee in May 2021.
Applications received electronically after 1300 hours on the due date will not be considered.
For commissioned topics, the Programme strongly discourages the practice of the same co-applicant joining more than one competing team. There may be unusual circumstances where the same person could be included on more than on application eg a lead from a named charity or a unique national expert in a condition.
For such exceptions (i) each application needs to state the case as to why the same person is included (ii) the shared co-applicant should not divulge application details between teams and (iii) both teams should acknowledge in their application that they are aware that one of their co-applicants is part of a competing application and that study details have not been shared.
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