Impact case study database

Warwick-led research in Trauma and Orthopaedic surgery has directly changed clinical practice and underpinned NICE guidelines and clinical guidance for trauma surgery, regenerative medicine, and joint replacement surgery. These have led significant NHS cost savings, more effective clinical practice and improved long-term patient outcomes.

Improving treatment of wrist fractures and open fractures of the lower limb

1,800,000 fractures occur in England each year. Wrist fractures (distal radius fractures) are very common, representing up to 20% of all fractures treated in emergency departments. Warwick research [3.1] underpinned the change in NICE guidance Fractures (non-complex): assessment and management (NG38) in February 2016 [5.1] recommending “Kirschner wire should be used in favour of internal fixation to treat distal radial fractures that require fixation.” Before the DRAFFT trial 75% of patients were treated with plate fixation versus 12% with Kirschner wires, whereas in the three years after publication, the number of patients treated with locking plates dropped to 48%, while Kirschner wires rose to 42% (Hospital Episode Statistics), demonstrating a strong change to clinical practice [5.2]. The cost saving to the NHS of this change has been calculated to be GBP2,000,000 every year [5.2]. The British Orthopaedic Association and the British Society for Surgery of the Hand’s Best practice for management of Distal Radial Fractures (2018) also recommends that “When surgery is needed for dorsally displaced distal radius fractures that can be reduced closed, offer Kirschner wire fixation and cast” [5.3].

Lower limb fractures are common injuries. Open fractures are exposed to contamination and infection rates can be up to 27%, even in specialist trauma centres. Previous international clinical guidelines recommended the use of expensive negative pressure wound therapy for open fracture wounds. Warwick research [3.2] prompted an exceptional review of NICE’s Fractures (complex): assessment and management guideline (NG37) in 2018 [5.4] and plan to update the NICE guideline based on the trial results. This change in practice is estimated to save the NHS at least GBP80 per patient, for an estimated 5000 patients every year across the UK who sustain these serious injuries.

Enabling NICE’s first regenerative medicine product approval to repair articular cartilage in the knee in the NHS

Damage to the articular cartilage in the knee is a common injury, particularly for young people during sport or in manual occupations, who are often too young to have knee replacements and available treatments were often unsatisfactory. Autologous chondrocyte implantation (ACI) uses healthy cartilage producing cells from the knee which are cultured and then inserted in the damaged part of the joint to produce new cartilage. While ACI has been available since 1987, in different, evolving forms, NICE recommended against routine ACI use in the NHS in 2000 and 2005 because of the shortcomings of the evidence base and doubts about cost-effectiveness (cost of GBP20,717) [5.5]. Between 2015 and 2017, the NICE Appraisal Committee considered Warwick’s HTA [3.4] and further Warwick analyses, with Waugh, Mistry and Metcalfe attending the Committee meetings, providing the underpinning evidence that enabled NICE to change their recommendation. Since October 2017, ACI has been available in the NHS (subject to certain restrictions) via the NICE Autologous chondrocyte implantation for treating symptomatic articular cartilage defects of the knee Technology appraisal guidance [TA477] (October 2017) [5.6], and Autologous chondrocyte implantation using chondrosphere for treating symptomatic articular cartilage defects of the knee Technology appraisal guidance [TA508] (March 2018) [5.7]. It is estimated that 500 people are eligible for ACI each year. ACI is the first NICE approved regenerative medicine product and surgeons and patients now have access to ACI. Patients are able to return to normal activities and their risk of later osteoarthritis is reduced. This NICE recommendation has also benefited ACI cell manufacturers in Germany; and Warwick research has attracted considerable interest overseas [5.8].

Improving long term outcomes for hip replacements

The WAT trial and a subsequent HTA [3.4, 3.5] directly underpinned NICE guidance on Total hip replacement and resurfacing arthroplasty for end-stage arthritis of the hip (TA304) published in February 2014 [5.9]. The guidance recommends that “Prostheses for total hip replacement and resurfacing arthroplasty are recommended as treatment options for people with end-stage arthritis of the hip only if the prostheses have rates (or projected rates) of revision of 5% or less at 10 years.” The Committee concluded “Revision rate was the most important key driver of costs and quality-adjusted life years in the model” [5.9]. This guidance has resulted in a 9% decrease in the use of the more expensive resurfacing arthroplasty in the NHS from 10% of all hip replacements to 1%. Commissioners or providers have a responsibility to provide the funding required to enable the guidance to be applied when individual health professionals and their patients wish to use it, in accordance with the NHS Constitution. Hip resurfacing has an additional risk that the patient may react to the metal bearing, resulting in early failure and complications which have consequently been avoided as a result of this change in practice. Therefore, the change in guidance recommendations has contributed to improved long-term outcomes for patients undergoing hip replacement operations.