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19/124 Effectiveness of meniscal allograft transplantation

 

Contents

Introduction

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.

Research Question:

What is the clinical and cost-effectiveness of meniscal allograft transplantation, compared to usual care, for people with symptomatic meniscal deficiency?

  1. Intervention:  Meniscal allograft transplant (MAT).
  2. Patient group:  Adults with a symptomatic meniscal-deficient compartment of the knee suitable for MAT – to be defined and justified by applicants.
    Applications are encouraged which include recruitment from geographic populations with high disease burden which have been historically underserved by research activity in this field.
  3. Setting:  Secondary care.
  4. Comparator:  Usual care – to be defined and justified by applicants.
  5. 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.
  6. Important outcomes:  Pain; function.
    Other outcomes: Patient reported outcome measures; health related quality of life; occupational outcomes; need for further intervention; adverse effects; cost-effectiveness.
  7. Minimum duration of follow-up:  2 years.
    Longer-term follow up: If appropriate, researchers should consider obtaining consent from participants to allow potential future follow up through efficient means (such as routine data) as part of a separately funded study.

Rationale:

Every knee joint contains an inner and outer meniscus (thick pads of cartilage) which act as shock absorbers between the thigh and shin bones and play a role in joint stability, lubrication and load distribution. The menisci can become damaged through general wear and tear or from traumatic injury causing symptoms such as pain, stiffness and locking of the knee which can be debilitating.

Meniscal damage is among the most commonly encountered injuries in the knee, most of which will not heal and require treatment. If the damage is a small tear, it may be possible to repair the meniscus with suturing. More commonly though, the damage requires partial or total removal of the meniscus (meniscectomy). Although these treatments are often effective at relieving the symptoms of meniscal damage, they leave the patient with a meniscal deficiency that will often progress towards further symptoms and further damage to the knee, such as osteoarthritis.

Degenerative meniscal damage is more common in the older population whereas acute traumatic tears are predominant in the younger population due to sporting injuries. For young patients in particular, treatment options for symptomatic meniscal deficiency are limited to conservative interventions aimed at preserving function, reducing further damage and delaying the need for a knee replacement.

However, there is increasing evidence demonstrating the effectiveness of meniscal allograft transplants (MAT) – inserting a donor meniscus - to improve pain and function in patients with meniscal deficiency. Systematic reviews of numerous non-randomised studies have suggested benefits of MAT, and the technique is currently being performed on the NHS in some centres and is beginning to be used more. However, to date, no fully powered RCT exists to examine its clinical and cost-effectiveness, including consideration of blinded outcomes.

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 htaresearchers@nihr.ac.uk.

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 1st April 2020. Applications will be considered by the HTA Funding Committee at its meeting in May 2020.

Guidance notes and supporting information for HTA Programme applications are available by clicking the links.

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 September 2020.

Applications received electronically after 1300 hours on the due date will not be considered.

Should you have any queries please contact us:

Email:   
htacommissioning@nihr.ac.uk 

Telephone:  
Commissioning Funding Committee 02380 595510