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Amplitude Clinical Outcomes

Case Study: The National Ligament Registry


Anterior Cruciate Ligament (ACL) Reconstruction is a popular procedure in the UK, prompting many questions about the best techniques of managing and treating the injury. Currently, there is a lack of information regarding number of procedures, functional outcome and complication rates following ACL reconstructions in the UK, especially data that is complete, accurate and in context of the many factors that have an impact on recovery. In order to improve best practice there needs to be constant analysis of the outcome of knee ligament reconstruction, placing even more value on attempting to close the gap in outcome data for ACLs.

In parallel, there is also an ongoing and increasing pressure on consultant surgeons to provide outcomes based evidence as part of revalidation, in order to demonstrate their quality of practice and case mix. These drivers led a group of consultant knee surgeons to explore the values in establishing a registry that would support both data collection for individual surgeons and country-wide for effective research and trends analysis.

The registry concept is not new by any means – it currently exists in various permutations, differing in size, aims and methods for data collection. Notoriously, registry contribution is a paper based approach, with a significant amount of administrative support from surgeons, medical professionals and support teams.

The vision for the National Ligament Registry was something a little different. The aim was for a platform controlled by surgeons but automated in its approach, ensuring large volumes of clinically valid data for relatively little resource.

Sean O’Leary, Consultant Orthopaedic Surgeon and Chairman of the National Ligament Registry said: “We wanted a secure, web-based database that was flexible to meet the needs of users – surgeons and patients. The system needed to be clinically driven but also user friendly, fitting into the normal working practice of surgeons as unobtrusively as possible. Although the data we wanted to collect was clinically quite complex, the process itself needed to be unquestionably simple.”

The solution

The registry Steering Group approached Amplitude in June 2012 with their vision, having heard of Amplitude’s work with other emerging orthopaedic registries in the UK.

A product specification was put together by the Steering Group and the Amplitude team to understand the short term and long term goals of the registry and it was agreed that the Amplitude pro registry™ software met the requirements for the vision.

The Amplitude web based pro registry™ software was provided as a standard web based, accessible platform which formed the base of the registry. The software enables safe and secure access from any location and is securely hosted by Amplitude. pro registry™ is easily accessible from PCs, tablets and smartphones, appealing to various patient demographics and simplifying data entry options for clinicians.

Clinically driven

The registry team worked with Amplitude to design and build their customised datasets, including complexity factors, minimum and maximum operative data and other clinically reported information.

Each element of the dataset has been designed to the Steering Group requirements, with the Amplitude team bringing their relevant experience and support to ensure the clinical pathway is detailed but also user friendly, and translates appropriately to an electronic data capture method. This work has resulted in a clinically relevant and engaging pathway which ensures increased buy in from surgeons.

Minimum and maximum dataset collection options are offered to give choice to surgeon users and to integrate with their current process and working environments. The ability to collect information on complications, procedure and complexity factors that link to the patient outcomes ensures the data is completely representative of the context of each patient, resulting in more accurate data.

Tim Spalding, Consultant Orthopaedic Surgeon and National Ligament Registry Secretary said: “A software platform like the one Amplitude provide is what we were waiting for; something reliable and robust to collect and automatically graph outcomes and put that data into clinical context that we as surgeons trust. It is important to understand the effectiveness and impact of our ACL treatments and the National Ligament Registry is proud to accomplish that in a very user friendly, forward thinking and innovative way.”

The NLR was initiated with the agreement of BASK, BOSTA and the BOA.

The story so far

The third in a long line of registries created using the Amplitude pro registry™ software, the National Ligament Registry is embarking on its third year of data collection.

There are now over 3,600 patients in the programme, a number set to double in the next 12 months as more surgeons are on boarded and begin their own data collection. 304 surgeons are registered and defined as “enthusiasts”, a huge endorsement at this stage of the project, and 23,961 data forms have been completed successfully.

The NLR successfully produced the first Annual Report in March 2015, which already shows the richness of the data and the assumptions and trends already being identified. The next Annual Report, due in March 2016, will take these a step further as more data and outcome scores are completed.

An annual meeting is held every year at the BASK Congress, which is always very well attended by clinical users. New strategies and developments are unveiled and high volume users offer support and advice to others on how to practically integrate the NLR into workflow practices.

As far as development is concerned, a new patient portal has been rolled out with Amplitude which is already having a directly positive impact on patient compliance.

Working collaboratively

The National Ligament Registry’s Steering Group, consisting of orthopaedic surgeon representatives from various Trusts and areas of the country, drives the core strategy of the registry. The relationship with Amplitude has been a collaborative one from the early stages; a theme that has continued through the first two years of recruitment and establishing the registry in the UK space.

Sean O’Leary said: “It’s great working with a company like Amplitude where we can take a collaborative approach to working. They also bring a lot of experience outside of the technology they provide us – supporting us in launching, marketing and driving the success of the registry in it’s crucial first two years. They understand our vision and are keen to help us achieve it.”

The Steering Group work closely with their Amplitude account manager on annual and quarterly goals to ensure the Amplitude software is meeting the needs of the registry users and the registry as a whole maintains a clinically relevant vision. The clinical and development teams are on hand and receptive to new requests, as well as naturally enhancing the software in line with one of the business’ core values of continuous improvement.

Each of the NLR users is supported by Amplitude’s highly experienced Customer Support and Training team who are used to working with clinical and administrative staff who are often under significant pressure themselves. The experience and insight to the demands of the environment in which the NLR users work ensures effective and appropriate training and support is delivered in a timely manner.

Susan Williams, Managing Director of Amplitude said: “The strength in our Amplitude systems is that they are clinically driven, ensuring they translate seamlessly into clinical working environments and, most importantly, work at a practical level for our clinician customers. Designed to capture only clinically validated and representative data, the end result is highly accurate and trusted by surgeons and results in huge buy in and support from them.”

Robust information governance

All Amplitude registry software is hosted in the UK with an ISO27001 accredited data centre. The company has an IG Toolkit compliance of level three (100%) which is the highest rated compliance level in the UK. The National Ligament Registry Steering Group is the Data Controller and as such is registered with the ICO.

Robust information governance packs are provided to all users to engage with their NHS Caldecott Guardian ensuring appropriate measures are in place regarding data security and protection, patient consent, information governance protocols and server and software security. The registry is approved for use at over 15 Trusts in the UK, with more coming on board every day.

The next chapter

The registry is expecting rapid growth in patient numbers over the next twelve months, with many patients at post-operative review stages. Excitingly, two year post-operative data is due in late 2015 which is set to spark the first academic research paper and clinical evaluation of techniques and emerging trends.

Particular research focus for the next two years will cover the nature of injury, emerging trends in clinical practice, tracking and monitoring new developments and detecting techniques that may have sub-optimal outcomes. There are also plans for the Steering Group to look at further analysis of patient profile, including ethnicity and social area of deprivation, in order to help better understand the epidemiology of ACL injuries.

In terms of clinical and software development, Amplitude and the NLR are looking ahead to the development of a patient smartphone app to support the ongoing patient compliance project. The reporting tool is also currently undergoing some exciting development which will enable the production of easy revalidation reports for surgeons – a real tangible and useful tool that is set to give a big value add to all NLR users.

All of these future focuses and developments look towards one common long term goal – to continue to expand on the success of the registry in order to create one central source of clinically validated outcome data for all knee ligament procedures in the UK. 

To find out more about the NLR, contact or visit the website

To find out more about Amplitude Clinical Outcomes, contact or visit

Image belongs to National Ligament Registry

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