T. Spalding (Coventry, GB)

University Hospitals Coventry & Warwickshire Orthopaedics

Presenter Of 4 Presentations

Extended Abstract (for invited Faculty only) Clinical Outcome

8.1.5 - Clinician Perspective

Presentation Number
8.1.5
Presentation Topic
Clinical Outcome
Lecture Time
10:25 - 10:35
Session Type
Special Session
Corresponding Author

Abstract

Introduction

My Best & Worst Experiences in Joint Preservation

Content

Joint preservation requires a combined approach from all members of the team integrating many disciplines. Someone said that regarding knee replacement that someone in the room needs to be over 50 before doing a knee replacement - and that is a reflection that experience counts.

We learn from experience and experience makes learning, no doubt about that. Cases presented reflect on the experience of listening, reading and trying, plus reflection and trying again.

TruFit plugs work in the end but not on an acceptable timescale. Meniscus Transplant works in most but when it goes bad it goes bad. Some patients don’t listen and break the rules creating new rules, if we don’t listen to them we don’t learn.

This presentation reflects on these messages, but not in print

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Extended Abstract (for invited Faculty only) Allografts

9.7.3 - Cost - Effectiveness of OCA – How to get it aAproved

Presentation Number
9.7.3
Presentation Topic
Allografts
Lecture Time
13:00 - 13:15
Session Type
Industry Satellite Symposium
Corresponding Author
Extended Abstract (for invited Faculty only) Clinical Outcome

15.3.2 - What Can We Learn from Registries?

Presentation Number
15.3.2
Presentation Topic
Clinical Outcome
Lecture Time
10:05 - 10:25
Session Name
Session Type
Special Session
Corresponding Author

Abstract

Introduction

What can we learn from registries

Tim Spalding.

Co-authors: Christopher Kaeding, Magnus Forssblad, Martin Lind, Greg Maletis

Registries collect data on large numbers of patients with the aim of providing information to effect change on practice. Registries take effort both for data entry and for data analysis. Over the years much has been learnt from Ligament reconstruction and joint replacement registries - summarized in this abstract.

Content

Cohort Studies and Registries: whats the difference?

Prospective cohort studies and national registries are observational studies to assess outcomes after a specific medical intervention, evaluating clinical outcomes and the predictors of those outcomes. Registries determine effectiveness of the intervention in the real world of general use – the poorly controlled multi-factorial world of general clinical practice. Cohort studies with controlled assessments are more able to determine how an intervention performs in the environment of carefully selected patients and this is evaluation of efficacy. Determining factors that predict outcome requires controlled clinical efficacy studies.

The Moon Studies

The MOON or Multicenter Orthopedic Outcomes Network was a prospective cohort study designed to look at the prognosis and predictors of clinically relevant outcomes after an ACL reconstruction. The design required a data base with large numbers, standardized independent variable assessment and data collection technique, validated outcome measures, a high capture rate and high quality data points that could be verified.

The cohort study evaluated 5 factors as below and each surgeon participated in inter and intra reliability studies.

activity level

patient oriented outcomes

signs and symptoms of osteoarthritis

recurrent ligament disruption

need for additional arthroscopic surgery

Surgeons entered >97% of patients and obtained >80% follow up – achieving this by calling patients on a Sunday evening. The result was 82% collection at both 2 and 5 years. Such high levels of data from enthusiasts carries the risk of the output not being generalizable, and potentially not large enough in number for more detailed analysis

Registries and Cohort studies

Large national registries are likely to have more generalizable conclusions, with more variables to analyze. But on the converse registries face a challenge of poor follow up with less commitment by surgeons and supporters, along with variability in selection and rehabilitation factors. Overall, both are complementary. Cohort studies are smaller, more focused, and better controlled with excellent follow-up. Registry studies are larger, more generalizable, and has potential for deeper analysis. Both are expensive and labor-intensive, but can be powerful clinic research tools. Both need to be carefully purposed, designed, executed and their weaknesses understood

Scandinavian Registries

The Scandinavian Ligament Registries were established in Norway in 2004 and in Sweden and Denmark in 2005. They now include data from 110,000 patients and the work from the three registries has led to more than 70 publications. The drive was to understand outcome as determined by patient related factors, treatment related factors and injury factors.

The main headline findings that emerged from the registries were that younger patients have an increased risk of additional ACL reconstruction and females have an increased risk of contralateral injury. Analysis of current graft choice shows that 90% of reconstructions in Sweden involve hamstrings but in Norway it is only 50%. Analysis of failure rates show an increased risk of revision with hamstring v patella tendon and the risk of ACL revision with hamstrings is reduced by 14% for every 0.5mm increase in hamstring graft diameter. It is clear that only large datasets can determine this level of detail.

The strength of the Swedish registry is that there is a greater than 90% uptake rate for surgeons with only 20 questions for the busy surgeon to complete. What has been learnt is that the response rate, as with all registries, is frustratingly low at around 70%, and that the KOOS outcome measure utilised may not be reliable as ACL specific. Recent trends analysis has shown an increase the use of quadriceps tendon, the vancomycin RAMP to reduce infection, and recognition of the value of contribution by group surgeon discussions.

Kaiser Permanente Registry

The Kaiser Permanente Registry had made a large impact on understanding of outcomes following ACL reconstruction in the USA. The basis is input from specific insurance company based hospitals who have collected data and importantly have subsequently shown that analysis and feedback can alter practice. 346 surgeons participate in the registry and currently over 44,000 ACL reconstructions are listed. Data has shown a difference in survival curves between allografts, hamstring autografts and patella tendon grafts. Allograft failure rates were particularly high in younger patients with data published in 2013. Specific analysis identified the Biocleanse processing method as having a higher failure rate as well as irradiation. BTB allografts also had higher failure and a particular at risk group were patients under aged 21.

The group noted that in 2010 44% of ACLs were performed using allografts and with the data identifying this group to be at risk information was disseminated amongst the surgeons such that over subsequent years use of allograft has halved, use of irradiated graft has reduced by 80% and, in particular, use in the high-risk patients under aged 22 has reduced by 80%. The drivers of this change is acknowledgement of the ability to spread the information. Registries can therefore alter practice.

Designing a new registry

When considering designing a new registry the team must understand the challenges and purpose of the registry involving surgeons, defining the exact content of the registry and methods for data entry. Management structure and governance is important, handling data protection (GDPR) and producing adequate feedback for surgeons to maintain enthusiasm. Clinician involvement and buy-in is key trusting the outcome produced and not fearing government control.

A balance must be struck between excessive data collection against inadequate detail. With the metric of patient compliance in outcome form completion this can be painfully assessed. Data entry can be online or through manual paper collection which involves an office to collate the information, however it is likely that a combination of the two systems is most efficient. The usefulness of the output depends on the data collected and the input from design team interpreting the information.

Summary

In summary a registry must define its purpose and acknowledge limitations. It needs to ensure clinician participation and co-ordinate the data content with the developers and collaborators. Outcome measures need to be responsive and validated and the registry needs defined management leadership and data ownership. Registries look at real world practice detecting procedures and devices that result in premature failure. From the large data sets factors can be identified and finally improved improvement in treatment outcomes can be achieved through feedback to surgeons.

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Podium Presentation Allografts

16.4.8 - Cost-effectiveness of allografts: highly effective for osteochondral, more research needed for meniscal allografts.

Presentation Number
16.4.8
Presentation Topic
Allografts
Lecture Time
12:18 - 12:27
Session Name
Session Type
Free Papers
Corresponding Author

Abstract

Purpose

The use of allograft tissue for reconstruction of articular cartilage and menisci is a viable and clinically effective solution. The purpose of this study was to evaluate the cost effectiveness of osteochondral allografts and meniscal allograft transplantation in knee reconstruction, as part of a European collaberative initiative.

Methods and Materials

A full health technology assessment was performed evaluating clinical and cost-effectiveness. Articles published from 2000 to February 15th 2018 were analysed using standard systematic review methods. Data, costs and natural history assumptions were formulated in a Markov model, developing base-case analysis, transition probabilities and utilities to quantify cost-effectiveness.

Results

Osteochondral allografts (OCA) are clinically effectiveness with a high graft survival rate over 20 years. OCA appears highly cost-effective, but the cost per quality adjusted life year varies according to the widely-varying costs of allografts. Using UK health service costs of £15,560 for surgery, and a survival rate of 68% at 20 years, the ICER for OCA was £4,692, far below the NICE threshold for treatment costs.

Meniscal transplantation (MAT) is clinically effective in relieving symptoms, as measured by KOOS, IKDC and Tegner scores. Cost-effectiveness analysis is problematic due to lack of evidence on chondroprotection. Control groups matching symptomatic patients undergoing MAT is lacking with only one small pilot RCT. Data on determining at risk groups was found to be lacking and is required to measure effect size. MAT is considered likely to be cost-effective in at risk group but defining such groups was unclear.

Conclusion

OCA is both clinically effective and cost effective. MAT is clinically effective, but cost-effectiveness is unclear. This analysis provides essential information to aid decision making for surgeons and funding authorities. Specific data and research is required to provide robust information on cost-effectiveness of meniscal allografts

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Moderator Of 1 Session

Regency Special Session
Session Type
Special Session
Date
07.10.2019
Time
16:00 - 17:00
Location
Regency