Primary hip repIacement prostheses and their evidence

base: systematic review of Iiterature

OPEN ACCESS
F Kynaston-Pearson specialist registrar
1
, A M Ashmore orthopaedic fellow
2
, T T Malak clinical
research fellow
2
, I Rombach statistician
2
, A Taylor consultant orthopaedic surgeon
2
, D Beard
professor of musculoskeletal sciences
2
, N K Arden professor of rheumatology
2 3
, A Price professor
of orthopaedic surgery
2
, D Prieto-Alhambra senior clinical research fellow
2
, A Judge senior
statistician
2 3
, A J Carr Nuffield professor of orthopaedic surgery
2
, S Glyn-Jones senior lecturer and
consultant orthopaedic surgeon
2
1
University Hospitals Birmingham NHS Foundation Trust, The Old Queen Elizabeth Hospital, Edgbaston, Birmingham B15 2TH, UK;
2
Oxford NIHR
Musculoskeletal Biomedical Research Unit, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of
Oxford, Oxford OX3 7FF, UK;
3
MRC Lifecourse Epidemiology Unit, University of Southampton, Southampton SO16 6YD, UK
Abstract
Objective To determine the extent to which prostheses with no readily
available evidence to support their use are being implanted in primary
total hip arthroplasty.
Design Systematic review of the literature.
Data sources The 9th annual report of the National Joint Registry of
England and Wales (NJR) was analysed to identify prostheses with an
Orthopaedic Data Evaluation Panel rating of unclassified or pre-entry
used in primary total hip arthroplasty in 2011. A systematic review of
those prostheses was carried out using PubMed, Cochrane, Embase,
OVID, and Google databases.
Study seIection Prostheses used in primary total hip arthroplasty as
published in the NJRs 9th annual report were analysed. Only literature
that included the name of the prosthesis was included. Literature yielded
in the search results was excluded if it reported animal, non-orthopaedic,
non-total hip arthroplasty, or non-device related studies.
ResuIts The systematic review found that 24% (57/235) of all hip
replacement implants available to surgeons in the UK have no evidence
for their clinical effectiveness. It also shows that 10 617 (7.8%) of the
136 593 components used in primary hip replacements in 2011 were
implanted without readily identifiable evidence of clinical effectiveness.
These comprised 157 cemented stems (0.5%of 34 655 implanted), 936
(2.8% of 33 367) uncemented stems, 1732 (7.1% of 24 349) cemented
cups, and 7577 (17.1% of 44 222) uncemented cups.
ConcIusions This study shows that a considerable proportion of
prostheses available to orthopaedic surgeons have no readily available
evidence of clinical effectiveness to support their use. Concern exists
about the current systemof device regulation, and the need for a revised
process for introducing new orthopaedic devices is highlighted.
Introduction
Medical device regulation has been the subject of recent
debate.
1-4
Both professional and public confidence in the system
is at a lowpoint. This is particularly true in orthopaedics, where
the premature failure of some metal-on-metal hip replacements
has added considerably to the global burden of hip revision. As
a result, the British Orthopaedic Association has been at the
forefront of demanding that a good evidence base accompanies
each orthopaedic treatment. In addition, the associations
practice strategy document Restoring your Mobility has joined
others in calling for radical change in the way medical devices
are regulated in the European Union.
5 6
In the United States, the regulation of medical devices falls
under a single agency, the Food and Drug Agency, in much the
same way as drugs are regulated by the European Medicines
Agency in the EU. However, medical devices in Europe are
evaluated for safety and reliability through any one of 76 notified
bodies, which then issue a Conformit Europenne mark,
allowing that device to be marketed in Europe.
7
All hip
replacement prostheses are considered class III devices, which
means that the application for approval must include some
human clinical investigations,
8
although this need not be new
research specific to the device if the manufacturer is claiming
similarity to an existing product.
Although no clear list of which class III devices have been
cleared for use in the United Kingdom or Europe is available,
Correspondence to: S Glyn-Jones, Botnar Centre, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University
of Oxford, Oxford OX3 7LD, UK [email protected]
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Research
RESEARCH
in the case of hip replacement prostheses agencies exist that
allow some comparison of available devices. One of these is
the National Joint Registry (NJR). This was established in 2001
by the Department of Health and the Welsh Assembly
Government to collect information on all hip and knee
replacement operations in England and Wales and to monitor
the performance of the prostheses used. In April 2011 reporting
became mandatory for all National Health Service hospitals,
and this now captures data from most of such operations, with
compliance rates per hospital varying between 93% and 100%
in the NJRs latest report.
9
A second agency is the Orthopaedic Data Evaluation Panel
(ODEP), set up as part of the NHS to assess follow-up data for
different primary hip replacement prostheses. Manufacturers
are requested, but not required, to submit data on their product
by using a pro-forma. Prostheses are then classified by the
number of years post-implantation that the evidence spans (3,
5, 7, or 10) and by the quality of the data supplied (level Abeing
strong evidence, level Breasonable evidence, and level Cweak
evidence); 10A is the highest rating available.
10
To achieve this
10A benchmark, the prosthesis must have a failure rate of 10%
or less at 10 years, a cohort study of more than 500 joints at its
start, Kaplan-Meier survivorship data at 10 years, and registry
data supporting its use.
Products with less than three years of evidence are classified as
pre-entry as long as the manufacturers keep the ODEP
informed of the post-marketing surveillance data. Inclusion in
this pre-entry category does not require evidence from peer
reviewed literature at either the pre-clinical or clinical stages of
development. Therefore, any data, regardless of whether it has
been peer reviewed or not, can be submitted. Prostheses termed
unclassified have had no evidence submitted by the
manufacturers. How many of these unclassified and
pre-entry implants actually have peer reviewed evidence to
support their use is unclear, but many are widely available for
implantation by any orthopaedic surgeon.
This study aimed to establish the number of primary hip
replacement prostheses that have no readily available evidence
of clinical effectiveness to support their use and how many are
being implanted in clinical practice.
Methods
We analysed the NJRs 9th annual report (2012) to group
primary hip replacement prostheses according to their ODEP
rating (fig 1). For prostheses with an ODEP rating of pre-entry
or unclassified, we did a systematic review of the literature by
using PubMed, Cochrane, Embase, OVID, and Google databases
to look for peer reviewed papers of any evidence level relating
to the prosthesis in question. We did not search for custom,
revision, or discontinued prostheses.
The search terms and protocol used were prosthesis name
ANDhip. The prosthesis name was that given in the NJRs
report as the brand name and compared with the manufacturer
official website. If a discrepancy in the name was found, we
used both names individually for the literature search. We did
an additional search for each of the prostheses excluding
generalised words from the brand name given in the NJRs
report, such as cementless or stem, to avoid missing
potentially relevant articles.
Two researchers (FK-P and TTM) did the literature research
and independently reviewed all results to establish the highest
level of evidence for each of the prostheses; a third researcher
(AMA) resolved any discrepancies. Titles and abstracts were
reviewed, and those that were potentially relevant to the device
in question were included. We defined evidence as peer
reviewed publications in which the clinical effectiveness of a
particular device was assessed. We excluded animal,
non-orthopaedic, non-primary hip arthroplasty, and non-device
specific studies (fig 1).
We then gave the selected papers an evidence level rating
according to the simplified evidence level table fromthe Centre
for Evidence-Based Medicine, Oxford (box 1),
11
and we
established the highest level evidence available for each device.
If no suitable evidence could be identified, we contacted the
manufacturers and asked them to provide some data on their
prosthesis. Those that responded with papers were rated; if some
data were provided (for example, details of tensile strength or
principles to support the devices use), this would earn a level
5 evidence rating (expert opinion without explicit critical
appraisal/pre-clinical biomechanical data).
We then analysed the collected evidence to determine the
number of brands implanted with no evidence of clinical
effectiveness and, additionally, the number implanted with no
evidence at any level. Those implants with only level 5 data
were excluded from the analysis, as we believed this level to
be inadequate for clinical decision making. We then cross
referenced this information with the published NJR9 prostheses
tables to find the numbers of prostheses actually implanted into
patients in each of these two categories.
StatisticaI methods
Statistical analysis in this study focused on descriptive statistics.
We tabulated frequencies for the appropriate implants. We
calculated percentages by using the total number of medical
devices in the relevant population as the denominator. We report
the findings according to the PRISMA guidelines.
12
ResuIts
Data from 9th annuaI NJR report (2012)
The NJRs report shows that 142 different brands of femoral
stems (57 cemented, 85 uncemented) and 119 different brands
of acetabular cups (48 cemented, 71 cementless) were used in
primary total hip replacement procedures in 2011 (table 1).
The proportion of components implanted that achieved the
optimal ODEP rating of 10Avaried between the different types
of prosthesis; 85% of cemented stems implanted achieved a
10A rating, dropping to 72% of cementless stems, 40% of
cemented cups, and only 3% of cementless cups (table 2).
Forty eight per cent (126/261) of prosthesis brands implanted
in primary hip replacements in 2011 were categorised as having
an ODEP rating of pre-entry or unclassified. On closer
inspection of the published NJR prostheses tables, we
determined eight of these brands to be revision implants, leaving
118 unrated primary prosthesis brands included for further
analysis (table 1).
AvaiIabIe evidence for pre-entry and
uncIassified components
A literature search was conducted for these 118 brands of
prosthesis. In total, 8111 papers were reviewed by title and
abstract. After application of exclusion criteria, 368 papers were
reviewed in full and a further 211 were then discarded, leaving
157 relevant papers. These were classified according to the level
of evidence they contained (fig 2). Four of 157 papers had a
discrepancy in the level of evidence between the two initial
researchers, which were resolved by a third researcher. The
inter-observer correlation between the researchers who did the
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RESEARCH
Box 1 Evidence IeveIs, Centre for Evidence-Based Medicine, Oxford
11
1a: Systematic reviews of randomised controlled trials
1b: Individual randomised controlled trials
1c: All or none randomised controlled trials
2a: Systematic reviews of cohort studies
2b: Individual cohort study or low quality randomised controlled trials
2c: Outcomes research; ecological studies
3a: Systematic review of case-control studies
3b: Individual case-control study
4: Case series
5: Expert opinion without explicit critical appraisal/pre-clinical biomechanical data
systematic review was 97%. Unpublished data subsequently
provided by manufacturers changed the evidence base rating
on one cemented stem, two uncemented stem, and three
uncemented cup brands.
We could identify no evidence of clinical effectiveness for 48%
(57/118) of pre-entry and unclassified prosthesis brands.
Excluding custom, revision, and discontinued implants, these
accounted for 24% (57/235) of the total number of primary hip
replacement prostheses brands listed in the NJRs report (box
2; fig 3). If we counted level 5 evidence (for example,
biomechanical data showing equivalence to pre-existing
devices), this still left 42% (49/118) of the pre-entry and
unclassified prosthesis brands and 21% (49/235) of all brands
used bereft of any identifiable evidence to support their use.
Use of component with no avaiIabIe evidence
Applying the results of our systematic review to the NJRs 9th
report data showed that 10 617 prostheses without available
evidence of clinical effectiveness to support their use were
implanted into patients in 2011 (7.8%of the 136 593 prostheses
included in the report) (table 2). This number comprised 157
cemented stems, 936 uncemented stems, 1732 cemented cups,
and 7577 uncemented cups.
Cemented stems represented the group with the lowest
proportion of devices implanted without available evidence of
clinical effectiveness (0.5%; 157/34 655), followed by
uncemented stems (2.8%; 936/33 367). Higher numbers of cups
were implanted without such evidence; 7.1% (1732/24 349) of
cemented cups, and 17.1% (7577/44 222) of cementless cups
had no available evidence of clinical effectiveness to support
their use (table 3; fig 3).
Discussion
This systematic review of the literature shows that 8% of all
primary hip replacement prostheses implanted in 2011 and
recorded by the National Joint Registry (NJR) had no readily
available evidence relating to their safety or effectiveness. This
is likely to be an underestimation of the true problem, as much
of the evidence that does exist for the other unrated prostheses
is of low quality or relates to short term outcomes only. This is
of great concern, particularly in light of the widespread publicity
surrounding recent safety problems with regard to some
resurfacing and other large diameter metal-on-metal joint
replacements.
13
Evidence ratings
The ODEP system of grading primary hip components offers
clinicians a simplified, device specific rating for clear
comparison of devices performance on relevant clinical criteria.
It is troubling to note that 45% of the brands available for
primary hip replacement have no ODEP rating, meaning,
according to the ODEP guidelines, that they should be implanted
only as part of a trial. What is more heartening is that despite
the large number of unrated brands available, the most widely
used prostheses are highly rated by the ODEP system, implying
that most orthopaedic surgeons use prostheses that are supported
by a good evidence base.
Why some surgeons would choose to use prostheses with no
available evidence to support their use outside of a research
study is not clear. Possible reasons include the introduction of
new prostheses by manufacturers who have well established
and trusted implants available. These new products are then
judged, perhaps erroneously, to be of the same high standard in
terms of longevity and clinical outcome. Another situation may
arise whereby a well established prosthesis is improved by
way of a minor modification. Unfortunately, numerous examples
exist of minor design changes having disastrous effects on
implants longevity.
14 15
Murray, Carr, and Bulstrode reviewed the evidence for total hip
replacement in 1995.
16
They found that only 30% of hip
replacements available had any evidence supporting their use.
16
At the time, they advocated the need for greatly improved
collection of evidence and proposed improvements in the
regulation of implants and devices. Despite the recommendations
of this and other groups,
4 17
the evidence base in relation to hip
replacements has improved only marginally over the past 18
years. The reasons for this are unclear. It may be related to the
rapid expansion in the number of devices introduced onto the
market during the past two decades as demand for hip
arthroplasty increases worldwide. In 1996 there were 62 primary
hip replacement components on the market in the UK; in 2011
there were 261.[9 ]
16
In addition, the quality of studies in the
orthopaedic literature is of a generally low standard. Our study
has identified only six randomised control trials in the literature,
compared with the 265 implants currently available. Most of
the studies identified were case series. Properly conducted
randomised controlled trials are more difficult to run with
orthopaedic implants than with drugs or other interventions,
and this may also have contributed to the paucity of good quality
evidence in this sphere.
Although the ODEP already provides implant ratings based on
levels of evidence, manufacturers are not required to submit
published negative evidence in the case of either pre-entry or
unclassified prostheses. Therefore, a device could sit in either
category despite several negative peer reviewed publications.
This systematic review has shown that 64% of unclassified
prostheses have published peer reviewed evidence that may not
have been submitted to the ODEP.
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RESEARCH
Box 2 List of prostheses impIanted in 2011 with no readiIy avaiIabIe evidence of cIinicaI effectiveness
Unclassified devices
Cemented stem
Excia Cemented (B Braun/Aesculap)
Kinectiv Cemented (Zimmer)
Edinburgh* (Implants International)
Trilliance (B Braun/Aesculap)
Answer (Biomet)
CTI Cemented Stem (Corin); no longer available
Response (DePuy)
Wroblewski Resection (DePuy)
Kinectiv Cemented (Zimmer)
Uncemented stem
H-Max (Lima)
FH Modular (FH Orthopaedics)
MiniMax (Medacta UK Ltd)
Harmony (Symbios SA)
Lima SL (Lima)
LPS (DePuy)
Euros Cementless (Euros)
Cemented cup
Exeter RimFit (Stryker)
CMK Cemented Cup (Biomet)
Exceed ABT Cemented (Biomet)
CCB (Implants International)
Edinburgh Cup* (Implants International)
Alfa Cemented Cup (B Braun/Aesculap); discontinued 2008
PE (Symbios SA)
Luna (Amplitude)
Charnley KS (DePuy)
Cone Cup (Medacta UK Ltd)
Snap Fit (Waldemar Link)
Uncemented cup
April (Symbios SA)
Gyros (DePuy)
Regenerex Ringloc + (Biomet)
Novation (Exatech)
Beta Cup (Waldemar Link)
Split Cup (Surgicraft)
Restoration ADM Cup (Stryker)
MMC Cup (Zimmer)
Maxera (Zimmer)
Dynasty (Wright Medical UK Ltd)
Sirius Cementless Cup (Euros)
Pre-entry devices
Cemented stem
Corail Cemented (DePuy)
Uncemented stem
Metafix Stem* (Corin)
MiniHip* (Corin)
Silent (DePuy)
Amoda (Comis Orthopaedics)
Trabecular Cementless Stem (Zimmer)
Novation Element Stem (Exactech)
Novation Stem (Exactech)
Cemented cup
Apollo (Biomet)
Polarcup Cemented (Endo Plus (UK) Ltd)
Uncemented cup
CSF plus* (Joint Replacement Instrumentation Ltd)
Continuum (Zimmer)
Trinity* (Corin)
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RESEARCH
Procotyl (Wright Medical)
DeltaMotion* (DePuy)
Versafit* (Medacta UK Ltd)
seleXys PC (Mathys Orthopaedics Ltd)
seleXys TH (Mathys Orthopaedics Ltd)
DeltaMotion (Lima)
seleXys TPS (Mathys Orthopaedics Ltd)
*Awarded 3A status in NJR10 (2013)
Manufacturer states under post-marketing surveillance
Awarded 5A status in NJR10 (2013)
ReguIatory process
The regulation process also seems to be entirely inadequate.
The award of a Conformit Europenne mark is conditional on
a device meeting a series of laboratory based standards that may
not equate to the safety or effectiveness of an implant in patients.
A Conformit Europenne mark may also be awarded in cases
of existing similarity, where the newdevice closely resembles
an existing design. However, as discussed above, small changes
in design have been shown to have major deleterious effects on
an implants clinical effectiveness or lifespan.
14 15
The NJR is effective in auditing current practice but was
designed to monitor the success of implants in relation to when
and how often they need to be replaced or revised. Thus,
although patient reported outcome measures are due to be
introduced as part of the annual report, in its current form the
NJRs report does not recognise problems with implants until
they are revised and so may not be the best tool for evaluating
newprostheses. Most implants are typically introduced in small
numbers initially, which makes outliers difficult or impossible
to detect.
18
This is shown by the recent problems with some
metal-on-metal joint replacements, which were identified in
single centre cohort studies more than three years before the
NJR identified them as outliers,
19 20
Arguably, well designed
controlled studies would have identified the problemeven more
quickly with fewer patients experiencing the adverse
consequences of a substandard design. In addition, the NJRlists
only implants that are in open use and for which reports are
submitted. Consequently, devices that are available to some
surgeons but have not yet been made available on the open
market do not appear in the NJRs report. These factors can lead
to a delay in the identification of failing implants. The National
Institute for Health and Care Excellence (NICE) suggests that
the use of more refined outcome measures such as
radiostereometric analysis, which aims to identify early
loosening of implants by using bi-planar radiographs, may help
to detect early problems.
The phased introduction of devices, combined with the use of
surrogate outcome measures, has been called for to provide
early identification of poorly performing implants.
18
This
correlates with the IDEAL framework ensuring that the
introduction of new devices is controlled and regulated in
phases. The future of medical device regulation needs to be a
careful balance between the requirement to facilitate innovation
and the imperative to safeguard patients. Following the example
of pharmaceutical regulation by implementing a phased
introduction of new orthopaedic implants would seem prudent.
It has been proposed that innovative technologies should be
made available in a fewspecialist units, where the evidence can
be objectively gathered and any problems with implants
resilience identified quickly using surrogate outcome measures.
17
The counter argument debates the damage over-regulation can
do to innovation and development in the field of medicine.
21
The cost of medical implants and devices may also rise if they
are required to undergo lengthy pre-clinical and clinical testing.
However, significant cost savings may accrue if the number of
devices on the market were limited to only those devices with
a solid evidence base for their use. Tackling this question
requires a delicate balance.
Many of the concerns in this process relate to the evidence
required to market an implant or device. Public availability of
a list of current medical implants and devices, including
pre-marketing data and peer reviewed publications, is needed.
This may improve transparency in the early stages of implant
introduction, allowing surgeons and patients to make more
informed decisions.
Limitations of study
A major limitation to our study relates to the requirement that
a prosthesis be specifically named in a publication to meet our
inclusion criteria. Relevant published evidence may therefore
not have been identified, for instance, if a specific implant was
simply referred to as an uncemented acetabular cup or as a
proximal loading femoral stem. However, we felt that the
explicit naming of a prosthesis is necessary if surgeons or
commissioners are to locate evidence that can inform their
decision making as to the use of a particular prosthesis.
Nevertheless, evidence for some implants may have been missed
if the device had undergone a change of brand name since
evidence was published. However, in all cases in which no
evidence could be found, we contacted the manufacturers
directly to request supportive data for the use of their implant,
which gave the opportunity for missed evidence to be brought
to our attention.
Another limitation is that the evidence for some early phase
implants will not have been detected if they are part of ongoing
prospective cohort studies or randomised controlled trials that
have yet to report. We have included, where identified,
pre-entry devices in our analysis, and these prostheses are
likely to be undergoing prospective studies and so would not
yet have published evidence available in the literature. However,
the number of prostheses implanted as part of prospective and
unreported clinical studies is likely to represent only a small
proportion of the 10 617 devices implanted with no available
evidence.
The evidence presented in this study relates to prostheses
implanted in the UK. However, we believe the results of this
study can be applied to other healthcare settings, given that most
of the prostheses in our systematic review are available in most
other developed countries, in Europe, Australasia, and the United
States.
ConcIusion
NICE has set a clear benchmark of an ODEP rating of 10C as
the minimum clinical standard it recommends for general
implantation.
22
Our review has determined that only 49%
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RESEARCH
(118/261) of prostheses implanted overall achieved a 10A/B/C
rating and that almost one in four prosthesis brands available
to surgeons have no evidence to support their use. Although
these brands are used relatively infrequently, at least 7% of all
prostheses implanted lack evidence of clinical effectiveness or
longevity. This study shows that the need still exists for an
improved and more rigorous approach to regulation of devices
to avoid devices with no available evidence being used in a
widespread and uncontrolled manner.
Contributors: FK-P, AMA, TTM, IR, DB, AJ, and SG-J contributed to
study design, method design, data/statistical analysis, and data
interpretation. FK-P, AMA, TTM, and SG-J did the literature search and
systematic review. FK-P, AMA, TTM, IR, AT, BD, NKA, AP, DP-A, AJC,
and SG-J drafted the article. All authors critically revised the article for
important intellectual content. SG-J is the guarantor.
Funding: Support was received from the NIHR Musculoskeletal
Biomedical Research Unit, University of Oxford, to provide staff,
resources, and consumables.
Competing interests:. All authors have completed the ICMJE uniform
disclosure form at www.icmje.org/coi_disclosure.pdf (available on
request from the corresponding author) and declare: support for this
work was received from the NIHR Oxford Musculoskeletal Biomedical
Research Unit; AT has received payment for a lecture from Stryker and
for education training fromZimmer; NKA has received consultancy fees
from Merck, Roche, Smith and Nephew, Q-Med, Nicox, and Flexion;
DP-A has been awarded a grant from Bioberica, Amgen and received
a payment for giving a lecture from Bioberica; SGJ has received grants
from Corin and Zimmer; no other relationships or activities that could
appear to have influenced the submitted work.
Ethical approval: Not needed.
Data sharing: No additional data available
Declaration of transparency: The lead author affirms that this manuscript
is an honest, accurate, and transparent account of the study being
reported; that no important aspects of the study have been omitted; and
that any discrepancies from the study as planned (and, if relevant,
registered) have been explained.
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18 Nelissen RG, Pijls BG, Karrholm J, Malchau H, Nieuwenhuijse MJ, Valstar ER. RSA and
registries: the quest for phased introduction of new implants. J Bone Joint Surg Am
2011;93(suppl 3):62-5.
19 Glyn-Jones S, Pandit H, Kwon YM, Doll H, Gill HS, Murray DW. Risk factors for
inflammatory pseudotumour formation following hip resurfacing. J Bone Joint Surg Br
2009;91:1566-74.
20 Smith AJ, Dieppe P, Howard PW, Blom AW, for the National Joint Registry for England
and Wales. Failure rates of metal-on-metal hip resurfacings: analysis of data from the
National Joint Registry for England and Wales. Lancet 2012;380:1759-66.
21 Di Mario C, James S, Dudek D, Sabate M, Degertekin M. Commentary: The risk of
over-regulation. BMJ 2011;342:d3021.
22 National Institute for Health and Clinical Excellence. Guidance on the selection of
prostheses for primary total hip replacement. NICE, 2000.
Accepted: 05 November 2013
Cite this as: BMJ 2013;347:f6956
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RESEARCH
What is aIready known on this topic
The high failure rate of some metal-on-metal hip replacements has highlighted the need for an adequate evidence base for orthopaedic
implants
Many implants are available to orthopaedic surgeons, but how many of these have evidence of clinical effectiveness to support their
use is not known
What this study adds
A quarter of prostheses available to the surgeon for use in primary total hip arthroplasty in the UK have no available evidence of clinical
effectiveness to support their use
Almost 8% of all primary hip replacement prostheses implanted in 2011 had no readily available evidence relating to their safety or
effectiveness
TabIes
TabIe 1| Breakdown of Orthopaedic Data EvaIuation PaneI`s rating for each device category from 9th NationaI Joint Registry of EngIand
and WaIes report. VaIues are numbers (percentages)
TotaI (n=261) Uncemented cup (n=71) Cemented cup (n=48) Uncemented stem (n=85) Cemented stem (n=57)
ODEP rated
50 9 11 16 14 10A
6 2 1 1 2 10B
5 1 0 2 2 10C
11 4 1 3 3 7A
4 1 0 1 2 7B
23 12 2 4 5 5A
3 0 2 1 0 5B
14 2 1 7 4 3A
1 1 0 0 0 3B
117 (45) 32 18 35 32 Total
Unrated
94 24 23 33 14 Unclassified
32 13 3 13 3 Pre-entry
18 2 4 4 8 Custom/revision/discontinued
144 (55) 39 30 50 25 Total
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RESEARCH
TabIe 2| Numbers (percentages) of prostheses impIanted, 2011
TotaI Uncemented cup Cemented cup Uncemented stem Cemented stem Rating
65 891 1531 (3.5) 9751 (40.0) 23 920 (71.7) 30 689 (88.6) 10A
743 (0.6) 35 (0.1) 41 (0.2) 147 (0.4) 520 (1.5) 10B
329 (0.2) 69 (0.2) 0 (0) 142 (0.4) 118 (0.3) 10C
19 344 (14.2) 18 639 (42.1) 223 (0.9) 222 (0.7) 260 (0.8) 7A
3684 (2.7) 6 (<0.1) 0 (0) 3514 (10.5) 164 (0.5) 7B
23 008 (16.9) 10 530 (23.8) 8436 (34.6) 1870 (5.6) 2172 (6.3) 5A
1220 (0.9) 0 (0) 1171 (4.8) 49 (0.1) 0 (0) 5B
6198 (4.5) 3405 (7.7) 1735 (7.1) 639 (1.9) 419 (1.2) 3A
7 (<0.1) 7 (<0.1) 0 (0) 0 (0) 0 (0) 3B
5445 (4.0) 1434 (3.2) 2746 (11.3) 1061 (3.2) 204 (0.6) Unclassified
10 617 (7.8) 8552 (19.3) 206 (0.8) 1775 (5.3) 84 (0.2) Pre-entry
107 (0.1) 14 (<0.1) 40 (0.2) 28 (0.1) 25 (0.1) Custom/revision/discontinued
136 593 (100) 44 222 (100) 24 349 (100) 33 367 (100) 34 655 (100) Total
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RESEARCH
TabIe 3| Summary of highest IeveI of evidence found for unrated (uncIassified and pre-entry) brands by prosthesis type. VaIues in parentheses
are numbers impIanted
TotaI Uncemented cup Cemented cup Uncemented stem Cemented stem Evidence IeveI
1A
6 (285) 3 (47) 2 (218) 1 (20) 1B
1C
2A
5 (1,765) 2 (1,213) 3 (552) 2B
1 (1) 1 (1) 2C
3A
3 (194) 1 (149) 1 (9) 1 (36) 3B
42 (3941) 7 (1726) 11 (1069) 18 (956) 6 (190) 4
57 (10 617); 20 pre-entry;
37 unclassified
21 (7577); 10 pre-entry; 11
unclassified
13 (1732); 2 pre-entry; 11
unclassified
14 (936); 7 pre-entry; 7
unclassified
9 (157); 9 unclassified No of prostheses available
with no evidence
7.8% of those implanted
(10 617 of 136 593)
17.1% of those implanted
(7577 of 44 222)
7.1% of those implanted
(1732 of 24 349)
2.8% of those implanted
(936 of 33 367)
0.5% of those implanted
(157 of 34 655)
No of prostheses
implanted with no
evidence
Revision devices have been excluded (2 cemented stems, 3 uncemented stems, and 3 uncemented cups).
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RESEARCH
Figures
Fig 1 Process used to identify unrated devices and determine evidence levels. NJR=National Joint Registry;
ODEP=Orthopaedic Data Evaluation Panel
Fig 2 Flow chart of literature search and evidence level classification
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RESEARCH
Fig 3 Percentage of available prosthesis brands with no evidence of clinical effectiveness in 2011 (top) and percentage of
prostheses implanted with no evidence of clinical effectiveness in 2011 (bottom)
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RESEARCH