Finding the right hip implant for patient and surgeon: the Dutch strategy – empowering patients

© 2015 Wichtig Publishing

HIPISSN 1120-7000

Hip Int 2015; 25 (2): 131-137

ORIGINAL ARTICLE

Until recently, surgeons in most countries independently made the decision on which implant to use in surgery. How-ever, other stakeholders including patients’ associations, insur-ance companies, hospital management and the government have challenged this leading position. For an optimal decision process, it is essential that all groups involved have reliable and identical information about the results of orthopaedic im-plants (4). For these reasons the NOV asked a task force to pro-duce ranking lists of hip implants derived from evidence-based criteria, as recommended by the IDEAL group (5). The aim was to offer unequivocal information enabling a balanced choice of total hip prosthesis. The ultimate goal of the NOV is that all implanted total hip prostheses implanted in the Netherlands are based on reliable clinical evidence.

Dutch Hip Task Force

The board of the NOV established a Dutch Hip Task Force (DHTF) with the explicit assignment of formulating criteria to classify the quality of total hip implants on the Dutch market based on survivorship. This DHTF report will be updated an-nually and presented to the general assembly of the NOV at the beginning of each year and published on the website of the NOV (www.orthopeden.org).

Committees and stakeholders within the NOV concerned with the quality of hip prostheses were represented in the

DOI: 10.5301/hipint.5000209

Finding the right hip implant for patient and surgeon: the Dutch strategy – empowering patientsRudolf W. Poolman, Jan A.N. Verhaar, B. Willem Schreurs, L. Paul A. Bom, Rob G.H.H. Nelissen, Henk W.J. Koot, Jon H.M. Goosen, Cees C.P.M. Verheyen

Members Hip Task Force of the Nederlandse Orthopaedische Vereniging, Bruistensingel, ’s-Hertogenbosch - The Netherlands

Background

The recent problems with large head metal-on-metal hip prostheses resulted in substantial damage to the surgeons’ credibility and reputation in the media (1). This led to a true sense of urgency among orthopaedic surgeons to increase their activities to secure patient safety (2). In times of un-certainty safety prevails. For this reason, the board of the Dutch Orthopaedic Association (NOV) in the Netherlands, in-tervened by advising as the first orthopaedic association in the world, against the use of all large head metal-on-metal implants (3). All orthopaedic surgeons in the Netherlands fol-lowed this advice and this type of hip implant has not been used since (see www.lroi.nl).

ABSTRACTWe describe the implementation process of hip prostheses selection in the Netherlands. The recent problems with large head metal-on-metal hip prostheses resulted in substantial damage to the surgeons’ credibility and reputation in the media. This led to a true sense of urgency among orthopaedic surgeons to increase their activi-ties to secure patient safety. The board of the Dutch Orthopaedic Association (NOV) in the Netherlands estab-lished a Dutch Hip Task Force (DHTF) with the explicit assignment of formulating criteria to classify the quality of total hip implants on the Dutch market based on survivorship. The aim was to offer unequivocal information enabling a balanced choice of total hip prosthesis. The ultimate goal of the NOV is that all implanted total hip prostheses implanted in the Netherlands are based on reliable clinical evidence. The DHTF decided to adapt the principles of the National Institute for Health and Care Excellence (NICE, UK) (www.nice.org.uk). The taskforce uses data from the registries as well as the Orthopaedic Data Evaluation Panel (ODEP). If the ODEP guidelines had been chosen as standard alone, one quarter of our listed hip components would not have been included. In our view this underlines the strength in the Dutch approach where high quality registry data and ODEP ratings are complementary and result in a list of reliable hip prostheses. Most importantly we offer patients insights into the known quality of the implants by sharing the results of our implant review. This will facilitate shared decision making by empowering patients in their knowledge on available hip arthroplasties.Keywords: Hip, Arthroplasty, Introduction New Device

Accepted: October 29, 2014Published online: February 28, 2015

Corresponding author:Rudolf PoolmanOnze Lieve Vrouwe GasthuisJoint Research, Department of Orthopedic SurgeryPostbus 955001090 HMAmsterdam, The [email protected]

Finding the right hip implant for patient and surgeon132


DHTF: NOV board, NOV scientific committee, Dutch Implant Registry (LROI), NOV quality committee and the Dutch Hip Society.

The Taskforce defined NOV criteria for primary total hip implants (Tab. I).

The DHTF decided to adapt the principles of the National Institute for Health and Clinical Excellence (NICE, UK) (www.nice.org.uk year 2000). Two sources of data were used to classify the total hip implants according to the NICE year 2000 criteria at 5- and 10-year follow-ups: 1) national implant reg-istry data; and 2) Orthopaedic Data Evaluation Panel (ODEP) ratings (http://www.supplychain.nhs.uk/odep/). NICE tech-nology appraisal guidance 2014 now states: “Prostheses for total hip replacement and resurfacing arthroplasty are rec-ommended as treatment options for people with end-stage arthritis of the hip only if the prostheses have rates (or pro-jected rates) of revision of 5% or less at 10 years.” (https://www.nice.org.uk/guidance/ta304/chapter/1-guidance).

A prerequisite for the national implant registry data was that it contained at least 90% of all implants used in that coun-try. Thus only data from full members of the International Society of Arthroplasty Registries (ISAR; www.isarhome.org) with minimum 5 years follow-up and open access internet were collected. Additional requirements were a minimum of 500 patients with a certain implant and comparable methodol-ogy for data validation and data presentation. Hence for 2013 the Swedish Hip Arthroplasty Register, the Danish Hip Registry, the Australian National Joint Replacement Registry and the National Joint Registry for England, Wales and Northern Ireland were used for review. Although NICE included peer reviewed registries studies in its latest guidance no registry reports were used to our knowledge. Moreover, ODEP data have to com-ply to sound methodological criteria and has the advantage of evaluating potential well performing implants before the NICE 10-year bench, data are submitted by the industry. The latter might induce selection bias by the industry.

The Orthopaedic Data Evaluation Panel (ODEP) is an agen-cy that is part of the NHS and seeks to assess follow-up data for different primary hip replacement prostheses. Manufac-turers are requested, but not required, to submit data on their products and have it graded by ODEP. The highest rating available is 10A where 10 is maximum follow-up in years and A the strongest evidence.

All data sources, with the 5- and 10-year results mark (ISAR data) as well as the 5A, 7A and 10A mark, were reviewed and checked by the members of the DHTF.

Combining the NOV criteria and the information for the review of the data, from registries and ODEP lead to cat-egory NOV 1A (full benchmark) and NOV 1B (entry bench-mark). Each list was divided into 4 categories: 2 for hip stems (cemented and uncemented) and 2 for acetabular compo-nents (cemented and uncemented).

After these lists were approved by the board of the NOV, the national representatives of the orthopaedic industry sell-ing hip implants on the Dutch market were contacted. They were asked whether the lists were complete and correctly classified given the criteria used. If data were incomplete or false according to these criteria, the orthopaedic industry could send their feedback, which was evaluated by the Task-force. Also, the industry could remove their own products

from the list when the production had stopped or when the products were no longer available for the Dutch market. This Dutch list can be found on the NOV website (http://www. orthopeden.org/uploads/jF/Ro/jFRotsvdGZWpYbkQd1LXmQ/General-procedure-and-list-Classification-of-Orthopaedic- Implants-2014.pdf). The complete list, including prosthesis deleted by the orthopaedic industry but excluding hip im-plants contrary to applicable NOV regulations can be found on the Hip International site.

Relevance

The strengths of our lists of implants with low revision rates are underscored by the sources of information based on pre-defined criteria. We based our classification on both selected national registries and ODEP. Not all full ISAR mem-bers met our criteria for inclusion. The Norwegian, Finnish and Lithuanian arthroplasty registries were excluded due to the absence of open Internet access, furthermore, the first register lacks the results per individual prosthesis. The New Zealand joint registry and Slovakian arthroplasty registry were excluded because of a different methodology (observed component years and mean survival with failure rate, re-spectively, instead of 5- and 10- year survival per prosthesis). Since the Dutch Arthroplasty Registry has started to registry in 2007, the inclusion criteria of more than 500 prostheses with a minimum follow-up of 5 years were not met.

The taskforce decided to use data from the registries as well as ODEP. If the ODEP guidelines had been chosen as standard alone, one quarter of our listed hip components would not have been included. These implants did not qual-ify as 5A, 7A or 10A in ODEP, but showed sufficient results in the selected registries in order to qualify according to our criteria and were therefore classified as NOV 1A or 1B. In our view this underlines the strength in the Dutch approach where high quality registry data and ODEP ratings are com-plementary and result in a list of reliable hip prostheses. In the latest NICE guidance a systematic review of registry studies is included.

Our approach has certain limitations. The outcomes in registries and in the ODEP database are based on a particu-lar name of an implant. However, implants may have design alterations, but maintain the same name. These changes in design may have a negative effect on survival and may there-fore take some time to be discovered in registry data. In fact, a new and experimental implant could be presented as a reli-able implant with good long-term follow-up when the name does not change from one model to the next. In our view it should be obligatory to give new names to altered or re-designed implants. Another limitation is, that cohorts were selected based on larger patient numbers (i.e. more than 500 patients). Small case series with negative results were not included. This could have resulted in an underestimation of negative results of specific implants. Furthermore, a brand-level comparison between registries is currently lacking. In order to successfully implement a new classification system initiated and issued from a national orthopaedic associa-tion the initial restrictions have to be realistic. Therefore in the currently imposed classification it suffices to meet with the set requirements of just 1 of the selected registries even

Poolman et al 133


TABLE I - NOV criteria for primary total hip implants

5-year and 10-year survival uncemented acetabular components (2013)

Registries ODEP

Sweden Australia Denmark NJR (E/W/N-I)

5 yrs 10 yrs 5 yrs 10 yrs 5 yrs 10 yrs 5 yrs 10 yrs 5 yrs 10 yrs

Amplitude – Saturne Dual Mobility cup

92.9%

B Braun Plasmacup SC 93.8% 7A

Biomet - CMK cup 5A

Biomet - Exceed ABT cup 97.7% 5A

Biomet - Exceed cup 7A

Biomet - Mallory-Head cup 92.0-97.1% 93.4% 10A

Biomet - Universal cup 93.4% 10A

DePuy - Duraloc and Option cup 95.2% 97.7% 10A

DePuy Pinnacle 96.5% 90.0% 96.9%

FH Orthopaedics Atlas - ESOP cup 10AGruppo Bioimpianti - Finn II cup 96.7%JRI - Furlong CSF cup 98.0% 10A

JRI Furlong Threated cup 10A

Lima - SPH Blind 92.6%

Mathys - RM CUP TICP coated cup 10A

Mathys RM Pressfit cup 5A

Medacta - Versafit Dual Mobility cup 96.8%Serf Santé - Novae Dual Mobility cup 5A

Smith & Nephew - BICON Plus 10A

Smith & Nephew - EPF Plus 96.5% 95.7% 5A

Smith & Nephew - Polar Dual Mobility cup cementless

5A

Smith & Nephew - R3 cup (liner recall in 2012)

96.9%

Smith & Nephew - Reflection cup 97.4% 95.2% 99.1% 7A

Stryker ABG II ceramic system

Stryker ABG II cup 92% 93.0% 7A

Stryker ABG II -Duration cup 96.3% 7A

Stryker Secur-Fit cup 93.4%

Stryker Trident 98% 91.2-96.0% 97.5% 7A

Stryker Vitalock cup 94.1%Wright Medical Lineage Ceramic cup system

7A

Zimmer - Allofit cup 97.2% 95.2%

Zimmer - Allofit S cup 97% 10A

Zimmer - CLS Spotorno Shell 96.7% 10A

Zimmer - CSF ALLOCLASSIC 10A

Zimmer - Fitmore cup 94.6%

Zimmer Trabecular Metal Shell 96.6%

Zimmer Trilogy 95.5% 93.1%

Zimmer Trilogy HA cup 98% 96.4-98.9%

98.1%

To be continued



5-year and 10-year survival cemented acetabular components (2013)

Registries ODEP



Amplitude Saturne Dual Mobility cup 96.1%

Biomet - Müller cup 92.3%

Biomet - Stanmore cup 98.39% 10A

Biomet Apollo cup 5A

Biomet SHP cup 87.6-92.3% 5A

Corin Cenator cup 7A

DePuy - Charnley standard cup 94.4% 97.51% 10A

DePuy - Charnley Ogee cup 90.8% 88.9-96.8% 96.8-98.4% 10A

DePuy - Elite Plus cup 97.5% 93.4% 93.4% 10A

JRI Müller type cup 7A

Link FAL cup 96.9% 95.5%

Link IP cup 97.5% 95.5% 95.5% 10A

Mathys - CCB cup 92.3%

Mathys - CCB Low Profile cup 97.5% 92.3% 10A

Smith & Nephew - All Poly (Reflection)

93.6% 90.6% 90.6% 10A

Smith & Nephew - Opera flanged 7A

Stryker - Contemporary cup 94.3% 94% 94.0% 5A

Stryker - Exeter cup/Exeter Duration 97% 95.6% 92.1-95.0% 92.1-95.0% 10A

Zimmer - Muller Low Profile cup 94.5% 94.6-96.3% 10A

Zimmer - ZCA low profile 94.6-96.3%

5-year and 10-year survival uncemented stems (2013)

Registries ODEP



B Braun BiContact 93.8% 10A

B Braun Excia 7A

Biomet - Aura II uncemented 7A

Biomet - Bimetric 91.5-93.4% 10A

Biomet - Mallory-Head 94.1% 10A

Biomet - Taperloc 95.4% 97.7% 10A

De Puy - AML 10A

DePuy - Corail and Corail AMT 97% 95.2% 89.3-90.0% 96.9-97.7% 10A

DePuy - S-Rom 95.0% 10A

DePuy - Summit 97.9% 7A

JRI - Furlong HAC 98.0% 10A

JRI - Furlong HAC Active 7A

TABLE I - Continued

To be continued

Poolman et al 135


5-year and 10-year survival uncemented stems (2013)

Registries ODEP



Lima - F2L 92.6%

Mathys - Twinsys 5A

Medacta - Quadra H 96.7% 5A

Omnilife - Apex ARC 96.7%

Smith & Nephew - Anthology 96.9-98.2%

Smith & Nephew - Polar 5A

Smith & Nephew - SL Plus 96.5% 95.7% 10A

Smith & Nephew - Synergy 95.2% 99.1% 7A

Stryker - ABG II HA coated 91.2-93.0% 10A

Stryker - Accolade 98% 94.0% 96.8% 7A

Stryker - Citation 94.1-96.0%

Stryker - Omnifit HA 89.2-94.5% 10A

Stryker - Secur-Fit 96.2%

Stryker - Secur-Fit Plus 96.3%

Stryker - Symax 97.5%

Wright Medical Anca Fit 92.9% 7A

Wright Medical Profemur E and E plus

7A

Wright Medical Profemur L 5A

Zimmer - CLS Spotorno 98.7% 93.9-94.6% 95.2% 10A

Zimmer - Natural Hip 95.6%

Zimmer - SL Alloclassic 93.2-95.2% 95.7% 10A

Zimmer - Epoch 95.5%

Zimmer - M/L Taper Zimmer - Versys

95.1%

93.2%

5A

5-year and 10-year survival cemented stems (2013)

Registries ODEP



Biomet - Bi-metric cemented (titanium)

92.3% 10A

Biomet - Bi-metric CoCr cemented 5A

Biomet - MS Müller stem 5A

Biomet - Olympia Hip stem 5A

Biomet - Stanmore 10A

Biomet - Stanmore modular 5A

Corin - TaperFit 10A

TABLE I - Continued

To be continued



5-year and 10-year survival cemented stems (2013)

Registries ODEP



DePuy - Charnley Elite Plus 98.9% 92.8%

DePuy - Charnley flanged 94.7%

DePuy - Charnley modular 90.8-94.4% 7A

DePuy - Charnley Monobloc 95.3% 98.2% 10A

DePuy - C-stem 96.8% 98.8% 10A

DePuy - C Stem AMK 5A

JRI - Cemented Furlong modular 7A

Link - Lubinus SP2 98% 95.5% 10A

Mathys - CCA Muller Straight stem 10A

Smith & Nephew - CPCS 93.6% 7A

Smith & Nephew - CPS 5A

Smith & Nephew - Spectron EF 97% 91.1% 10A

Smith & Nephew - Synergy

Stryker - Exeter V40 97% 94.3-95.6% 94.0-95.1% 98.6% 10A

Stryker - Omnifit cemented 10A

Zimmer - CPT Stem 94.5% 96.3% 98.1% 10A

Zimmer -ME Müller straight stem 10A

Zimmer - MS 30 stem 97.5%

Grey: no longer manufactured.Bold: not in Dutch market.

TABLE I - Continued

without an ODEP 5 or 10A ranking. Some will state that this classification system is too soft but the most encountered feedback of our members and of the manufactures is that the bar is set too high. Whether in future the classification system will have an update with more stringent criteria is at this mo-ment hypothetical.

For now, the list of suggested implants is only based on phase 3 data since large scale RCTs are lacking. On the other hand, registry data represents survival in daily practice with-out selection through inclusion bias, which may be present in RCTs. Given the above-mentioned limitations we decided to update our lists annually.

A profound criticism by industry on the strict categorisa-tion of medical devices is the risk of obstructing innovation. New implants will not find their way to the market. We do not agree with this criticism. It is fair to reveal to patients that an implant is experimental because no long-term information is available. In the past few years several authors have discussed a stepwise introduction of new implants to the market, before large-scale use (5-9). The background of this stepwise intro-duction is to obtain improvements while preventing disas-trous complications for our patients (10). As was shown with former RSA studies, some prostheses performed better with

respect to mean survival in national registries compared to non-RSA studied implants (8). However, only long-term clini-cal follow-up (as completed in registry studies) can prove that an implant is genuinely safe. Despite excellent preclinical data and short-term RSA data, unforeseen mechanism failure, like tissue reactions from metal debris can occur. The large head metal-on-metal problems illustrate this excellently. A recent study showed that 24% of all hip implants in the UK available to the surgeons and more importantly almost 8% of the im-planted hip components have no evidence for their clinical effectiveness (11).

Rationale

Orthopaedic surgeons should obviously protect the well-being of their patients. Therefore they should collaborate with patients, inform them optimally and accept a leading role in the stepwise introduction of implants. This will help regain trust from the general public and most importantly from our patients. Our NOV lists of well-functioning implants is based on survival data of implants in registries with at least 90% inclu-sion of all selected national data or large cohort studies (ODEP). This list may serve as an international reference with which to

Poolman et al 137


compare new implants. Most importantly we offer patients in-sights in known quality of the implants by sharing the results of our implant review. This will facilitate shared decision making by empowering patients in their knowledge on available hip arthroplasties. Using new implants without rigorous evaluation should be discouraged. Utilising a stepwise introduction will ensure patient safety and act as a platform for real innovation using sound study methodology. For this reason the "Beyond compliance" initiative has been launched in the UK. (http://www.beyondcompliance.org.uk/About/AboutBeyondCompli-ance.aspx). The Dutch Orthopaedic Association is currently working on a scientific programme focusing on issues relevant to society and supports research consortia. New implant can still be used if these new designs are implanted in research setting following a protocol approved by an Ethical Committee. Still “seeding trials” are discouraged.

NOV criteria categorising hip implants (2013)

Annual update with admissible data up to November first 2013.

NOV 1A: Full acceptance (Benchmark)

A hip implant (stem or cup) with a mean revision percent-age of 10% or less at 10 years with revision for any reason as end point. For this purpose, revision is defined as revision-surgery of any prosthesis components.

Substantiation: supporting data originating from any of the public national registries that have open access Internet, use a comparable methodology for data validation and data presen-tation, and are full members of ISAR (International Society of Arthroplasty Registries) (http://www.isarhome.org/directory) with at least 10 years of follow-up on at least 500 implants or those which have an ODEP rating (Orthopaedic Data Evalua-tion Panel) (http://www.supplychain.nhs.uk/odep/) of 10A.

NOV 1B: Conditional acceptance (Entry benchmark)

A hip implant (stem or cup) with a mean revision percent-age of 5% or less at 5 years with revision for any reason as end point.

Substantiation: supporting data originating from one of the above defined registries with at least 5 years of follow-up on at least 500 implants or an ODEP-rating of 5A or 7A.

NOV 2: New implants

Prostheses that do not meet or do not yet meet the above mentioned criteria may only be implanted in a research pro-gramme which has been approved by the institutions medical ethics review board.

Categories 1A and 1B differ with regard to the period dur-ing which the prostheses were monitored (at least 10 or 5 years, respectively) and the maximum revision percentage

at this point in time (10 and 5, respectively). An annual up-date will be published in February with a reference date of November 1st of the previous year. Implants that meet the requirements set for 1A or 1B but are contrary to applicable NOV advices, will not be included. It concerns components for a regular indication total hip prosthesis, without unusual anatomic abnormality like substantial post traumatic or con-genital deformity of the acetabulum and/or femur.

The manufacturers were allowed to remove some of their components from the lists (e.g. production stopped, not for Dutch market) and/or comment on the proposed list. All com-ments were gathered, evaluated by the DHTF and a decision was made.

AcknowledgementsLoes van Beers provided help with the literature search and catego-rization of the implants.

DisclosuresFinancial support: None.Conflict of interest: None.Meeting presentation: This article was presented in abstract form at the Dutch Orthopedic Association Annual Meeting, Amsterdam, The Netherlands, 7-8 February 2013.

References1. Cohen D. Revision rates for metal on metal hip joints are dou-

ble that of other materials. BMJ. 2011;343:d5977.2. Cohen D. Patients are let down by poor device regulation, warn

surgeons. BMJ. 2012;345:e7221.3. Verheyen CC, Verhaar JA. Failure rates of stemmed metal-on-

metal hip replacements. Lancet. 2012;380(9837):105, author reply 106.

4. Hamilton DF, Howie CR. Selecting the right hip replacement. BMJ. 2014;348:g46.

5. McCulloch P, Altman DG, Campbell WB, et al; Balliol Collabo-ration. No surgical innovation without evaluation: the IDEAL recommendations. Lancet. 2009;374(9695):1105-1112.

6. Huiskes R. Failed innovation in total hip replacement. Diagno-sis and proposals for a cure. Acta Orthop Scand. 1993;64(6): 699-716.

7. Malchau H, Bragdon CR, Muratoglu OK. The stepwise introduc-tion of innovation into orthopedic surgery: the next level of dilemmas. J Arthroplasty. 2011;26(6):825-831.

8. Nelissen RG, Pijls BG, Kärrholm J, Malchau H, Nieuwenhuijse MJ, Valstar ER. RSA and registries: the quest for phased introduc-tion of new implants. J Bone Joint Surg Am. 2011;93(Suppl 3): 62-65.

9. Schemitsch EH, Bhandari M, Boden SD, et al. The evidence-based approach in bringing new orthopaedic devices to mar-ket. J Bone Joint Surg Am. 2010;92(4):1030-1037.

10. Sedrakyan A. Metal-on-metal failures-in science, regulation, and policy. Lancet. 2012;379(9822):1174-1176.

11. Kynaston-Pearson F, Ashmore AM, Malak TT, et al. Primary hip replacement prostheses and their evidence base: systematic review of literature. BMJ. 2013;347:f6956.

Finding the right hip implant for patient and surgeon: the Dutch strategy – empowering patients

Documents

Transcript of Finding the right hip implant for patient and surgeon: the Dutch strategy – empowering patients