Extract
Rigorous orthopaedic clinical research should not be an oxymoron. The
vitality of the orthopaedic specialty is critically dependent on well-designed
and well-conducted clinical research targeted at the important questions
facing orthopaedic surgeons and their patients. Randomized clinical trials are
widely accepted as the most scientifically valid design for clinical research.
Orthopaedic surgeons recognize this. Most would acknowledge that they search
for high-level evidence-based research at scientific meetings and in journal
publications. Most are sophisticated research evaluators who are aware that
prospective, randomized, blinded data collection with controlled comparison
provides the most valid evaluation of different surgical interventions.
Orthopaedic surgeons can identify the biases and weaknesses of research
reports and factor these into their interpretation of the results. In addition
to using research, many orthopaedic surgeons participate in the conduct of
clinical research. Generally, however, only a small percentage of orthopaedic
surgeons participate in randomized clinical trials.
Rigorous orthopaedic clinical research should not be an oxymoron. The
vitality of the orthopaedic specialty is critically dependent on well-designed
and well-conducted clinical research targeted at the important questions
facing orthopaedic surgeons and their patients. Randomized clinical trials are
widely accepted as the most scientifically valid design for clinical research.
Orthopaedic surgeons recognize this. Most would acknowledge that they search
for high-level evidence-based research at scientific meetings and in journal
publications. Most are sophisticated research evaluators who are aware that
prospective, randomized, blinded data collection with controlled comparison
provides the most valid evaluation of different surgical interventions.
Orthopaedic surgeons can identify the biases and weaknesses of research
reports and factor these into their interpretation of the results. In addition
to using research, many orthopaedic surgeons participate in the conduct of
clinical research. Generally, however, only a small percentage of orthopaedic
surgeons participate in randomized clinical trials.
Although the number of randomized clinical trials published in The
Journal Bone and Joint Surgery (American Volume) has increased over the
last several years, they remain a relatively small percentage of the clinical
research articles. Before 2000, a mere 10% of the studies published in The
Journal were randomized
trials1. In 2005,
articles in The Journal that reported level-I evidence comprised 21%
of the clinical studies. A large number of the articles in The
Journal continue to be designed to provide only the lowest level of
evidence. In 2005, 47% of the clinical studies in The Journal
provided evidence that was rated level IV. Although the United States is the
source of most of the articles published in The Journal, the
proportion of level-I to level-IV studies in 2005 was higher for
investigations performed abroad (44%) than for studies performed in the United
States (38%). A recent review of the literature on surgery for degenerative
lumbar spondylosis found thirty-one randomized clinical trials published
through March 2005. Unfortunately, many of those studies used suboptimal
methodology. However, randomized methods were noted to have improved in the
recent studies, and three of the recent studies were
double-blind2. Taken
together, these observations indicate that orthopaedic randomized clinical
trials are being done only infrequently and that the vast majority of the
orthopaedic literature consists of low-quality evidence. Optimistically, the
trends also indicate that orthopaedic randomized clinical trials can be done
and, indeed, that more of them are being done now than in the past.
In other disciplines, when randomized clinical trials have been performed
more frequently, the studies have substantially improved outcomes for
patients. For example, the decrease in mortality among children with malignant
tumors from 90% to 30% over the past thirty years has been largely attributed
to randomized clinical
trials3. Some past
advances in orthopaedic surgery were so dramatically better than traditional
treatments that case series were able to demonstrate their superiority to
older treatments. Examples include arthroplasty, spinal instrumentation for
scoliosis, arthroscopy, and internal fixation of fractures. In other
treatments that have less obvious benefit, only temporal trends toward
improvement have been
identified4.
However, all of these innovations were developed more than thirty years ago.
Refinements have been and continue to be made, but these smaller-scale changes
have not always been carefully assessed to see whether they improve clinical
outcomes, as has been done in pediatric oncology. Further advances for
patients with orthopaedic conditions will require better designed and more
widespread implementation of randomized trials.
Why are randomized trials perceived as being so difficult in orthopaedics?
An important reason is likely to be a simple lack of training and experience
among orthopaedic surgeons. Although surgical trials pose many unique
challenges, most of these are
surmountable5. Just
as technically challenging orthopaedic procedures can be performed well by
using the right surgical technical skills, so challenging orthopaedic clinical
research can be performed well by using the right research technical
skills.
To be successful in the conduct of clinical research, the surgeon needs to
understand the unique challenges of the task. These challenges differ from
those encountered in basic-science or animal research. The clinical
investigator needs to recognize and address feasibility, methodology,
infrastructure, regulatory and cultural issues, and resource requirements. The
investigator must also be able to handle variables as diverse as experimental
design quality, multi-institutional site coordination, coinvestigator
personality, ego, and bias. Each of these variables creates challenges that
the investigator needs to anticipate, understand, and be willing to work
through.
Recent press related to inappropriately performed research at respected
centers has added a new dimension to the clinical research
challenge—loss of trust in the health care researcher. In the personal
experience of one of the authors (M.J.B.), the largest single reason for
patients to opt out of a study evaluating the efficacy of indomethacin
compared with no treatment (and whether to accept treatment with indomethacin
as the standard of care to reduce heterotopic bone formation following
acetabular surgery) was their lack of trust in clinical research. These same
patients, however, were willing to have the same surgical team they rejected
as clinical researchers perform high-risk trauma surgery.
A good place to start in designing, or deciding whether to participate in,
a randomized clinical trial is to critically evaluate the research question.
Does the project address an unsolved problem? To answer this, the surgeon must
be intimately familiar with prior work in the field. Does the hypothesis
survive the "who cares" question? This often calls for discussion
with colleagues or other objective observers who can provide an unbiased view
of a surgeon's pet project ideas. Is the problem to be solved important enough
to justify the effort? What is the potential impact of the study outcome?
Increasingly, academic institutions are asking their investigators to consider
the market value of their studies. This type of consideration can also be used
to justify a study. The surgeon's ability to articulate the importance of the
clinical problem and the potential impact of the solution being tested becomes
particularly meaningful when financial support for the study is being sought
through a grant or contract funding mechanisms.
Commitment to a clinical research project as a principal or coinvestigator
obligates not only the individual but the department or practice to the
project. This is a long-term commitment. The life cycle of a randomized
clinical trial comprises many phases, each with its own time-frame. Combined,
these generally amount to a period of more than five years
(Fig. 1). Depending on the time
required to recruit enough patients and on the duration of follow-up, study
durations may extend to ten years. The feasibility of such studies is
different for different surgeons and must be decided on before making a
commitment to the study.
The opportunity to shorten the time-frame of randomized clinical trials for
some types of orthopaedic interventions may be provided by the discovery and
validation of surrogate laboratory or imaging markers for orthopaedic
disorders. Many orthopaedic treatments have end points that occur long after
treatment. For example, the treatment of asymptomatic pediatric hip
conditions, such as hip dysplasia, aims to prevent or delay the onset of hip
arthritis from middle age to later in life. The strategy to address this issue
requires surrogate or intermediate outcomes related to the final outcome. For
example, in the treatment of Legg-Calvé-Perthes disease, the shape of
the hip in adolescence is related to the long-term risk of
arthritis6. An early
decline in patient-reported subjective outcome measures may be able to predict
clinical failure. Similarly, radiostereometric analyses may serve as a
surrogate measure related to early loosening of an arthroplasty
component7.
To provide a valid answer to the clinical question, a sufficient number of
patients must enter and then be available at the end of the trial. Although
some conditions of interest to orthopaedic surgeons, such as back pain and
lower extremity osteoarthritis are common, many are relatively rare. For this
reason, the participation of multiple investigators at multiple sites is
necessary to obtain sufficient numbers of subjects for much of the research
that is needed in our field. Patient numbers are influenced by several
factors. For example, once exclusion criteria are applied and patients consent
to participate, the number of enrolled patients may drop below the required
sample size. When confronted with the possibility of too few patients,
investigators can relax the eligibility criteria, improve the consent rate,
prolong the duration of the trial, or recruit multiple sites. In general,
investigators should use as few exclusion criteria as possible. The
feasibility of a randomized clinical trial is improved by using broad
inclusion criteria. Broad inclusion criteria also increase the
generalizability of the final study results.
An important determinant of the success of a study is to ensure that all
eligible patients are asked to participate. Optimizing enrollment requires
that the study not rely solely on house staff and surgeons to approach
patients, as this generally results in low enrollment
rates8. A better
approach is to employ dedicated study personnel at each study
site9. Consent rates
depend in part on the type of study. Trials comparing similar surgical
procedures may have consent rates as high as 70% to 95%. Although trials
comparing surgical and nonsurgical therapy may have consent rates as low as 5%
to 50%, a well-conducted study with close surgeon involvement may achieve
rates higher than this. To enroll sufficient patients in a reasonable
time-period, multiple sites are usually needed and should be planned at the
beginning of the trial.
Clinical trials will be successful only with sufficient infrastructure. A
good starting point is to ensure that experienced investigators are running
the trial. The number of surgeons who have completed advanced training in
biostatistics, epidemiology, and evaluative sciences is low. When surgeons
lack sufficient expertise or experience, they need to collaborate with
appropriate investigators. Failure to partner with a PhD epidemiologist or
research methodologist is probably the largest error that an orthopaedic
surgeon can make in the design of a randomized clinical trial. Such
coinvestigators bring invaluable experience, insight into clinical trials, and
a different and critical skill set to the research team. They also bring few
orthopaedic biases and can help to identify and avoid them in the study.
The investigators must function as a team. Indeed, the investigative team
is the most important component of the infrastructure of a randomized clinical
trial. In a multi-institutional study, each site will require a local
orthopaedic surgeon asprincipal investigator to supervise the project at that
site. Most surgeons interested in clinical research want to be intellectual
partners. As such, these surgeons do not want to be presented with someone
else's approved project and be invited only for their ability to enroll
patients. Instead, the success of the project requires that a core research
team be developed early enough to critically assesses the potential of the
research question and then, as a group, to define, design, and drive the
project.
Selection of the clinical research team is important. A limitation in
surgical studies is often the surgeons themselves. Surgeons with egos that
cannot be checked, or personalities and opinions that are uncompromising, are
poor team candidates. Although seemingly counterintuitive, friends are not
always the best coinvestigators, and the quality of data from large centers
can often be disappointing. All team members need to be assured of the
professionalism, fairness, and attention to everyone's academic career
advancement. The use of committees, including executive, steering, dispute
and/or data adjudication, and publications committees, helps to assure all
investigators of fair project governance. The development team should
recognize the talent and enthusiasm of young investigators. The young
researcher is typically anxious to prove his or her ability, is often less
biased, and tends to be less cynical than older colleagues. The involvement of
young investigators affords the project the opportunity to mentor a junior
clinical researcher and, importantly, to add to the much needed ranks of
experienced orthopaedic clinical scientists.
In the selection of sites to participate in a randomized clinical trial,
there are several site characteristics that investigators need to understand.
For example, what is the site's raw case volume and does it meet the
investigation's entry criteria? What is the site's prior experience with
screening and what is its consent rate? How does the site recruit for, or
market, its trials? Is the site hospitable to the conduct of research and
scientific inquiry, or is research more of an afterthought to clinical
practice?
An additional issue is the need for study personnel. At each site,
dedicated personnel are required to conduct day-to-day operations. The success
of the trial ultimately hinges on their expertise and commitment. Their role
is to recruit patients, organize patient visits, and collect trial data. They
must be skilled in adhering to the requirements of the institutional review
board and the Health Insurance Portability and Accountability Act, following
the informed consent process, complying with protocol details, and ensuring
that reporting is both complete and timely. Surgeons generally do not have the
time or ability to properly monitor all of the components of study progress
even at their own centers. For this reason, it is important to include a
research coordinator as a key member of the research team. This individual can
facilitate communication among the sponsor, investigators, subjects,
institutional review boards, and other stakeholders in the study.
The requirement for study personnel is one of the features of randomized
clinical trials that make them expensive to run. It is, however, a false
economy to leave these positions off the budget as a cost-containment measure.
Appropriate funding is required to support these personnel. Because such
funding is required at the outset of the study, costs will be incurred early
and study planning will need to account for this
(Fig. 2).
Another issue is that certain aspects of trial management should be
centrally coordinated. For example, centrally managed institutional review
board approval substantially aids investigators by reducing duplication of
effort. Data entry is also best performed centrally in order to facilitate
adherence to time lines, to assure standardization, and to maximize
accuracy.
Finally, the creation of a group of experienced investigators as an
established network can substantially ease the burden of running a randomized
clinical trial. Orthopaedic specialty societies have the opportunity to play
an important role in this regard. For example, the Pediatric Orthopaedic
Society of North America established its Clinical Trials Network of
experienced investigators in 1999 as a web-based location for providing
guidelines, monitoring, and learning from orthopaedic clinical
trials9. Other
subspecialty societies can similarly develop the requisite infrastructure and
promote trials in their respective disciplines.
The validity of the results of a randomized clinical trial is determined by
its design. Just as preoperative planning is essential for the smooth
performance of an orthopaedic surgical procedure, so prestudy planning of
design details is essential for the smooth performance of an orthopaedic
randomized clinical trial. Indeed, it is more difficult to change the
experimental design of a randomized clinical trial once it is under way than
it is to move to Plan B in an orthopaedic procedure. To do so may invalidate
the portion of the study already accomplished.
Surgical trials pose specific methodological
challenges5. One of
those challenges is blinding (or masking) the participants. In the absence of
blinding, knowledge of the intervention tends to inflate the benefits of
treatment10.
Blinding of the patient and assessor is usually straightforward in a trial
comparing two similar surgical interventions. For example, in a recent study
comparing a minimally invasive approach and a standard approach to total hip
replacement, the patients and the evaluator were blinded to treatment by
keeping the incision covered by
dressings11. In
such a study, the surgeon and the individual performing the dressing changes,
neither of whom is blinded, are not involved in evaluating the outcome.
In trials comparing surgical and nonsurgical therapy, the patients cannot
be blinded, but the appraiser generally can be. For example, in a randomized
trial of external fixation compared with early application of a hip spica for
pediatric femoral fractures, the clinicians performing the physical
examination were successfully blinded to the intervention by children wearing
tights12. The only
conundrum occurs when patients cannot be blinded, such as surgical compared
with nonsurgical therapy, and the primary outcome is subjective patient
appraisal. Such a design can answer the important question of which treatment
is of greater subjective benefit to the patient, but it cannot distinguish
whether this benefit is due to the treatment or to a placebo effect. If the
surgeon wants to determine the benefit of surgical therapy in this situation,
then a placebo-controlled trial must be used.
Placebo-controlled trials (sham surgery) pose specific ethical issues
whereby patients may have a general anesthetic and skin incisions but no
surgical therapy. The rationale for such trials is that surgery is an
extremely effective placebo and may result in substantial and prolonged
improvement in subjective patient complaints. For example, a randomized trial
comparing sham surgery (in this case, sternotomy) with internal mammary
implantation for ischemic heart disease found that patients had sustained
relief of chest pain six months after the placebo
surgery13. Such
trials are possible in orthopaedics, as illustrated by a randomized clinical
trial that evaluated the usefulness of arthroscopy for osteoarthritis of the
knee14.
In randomized clinical trials that involve new surgical procedures, the
learning curve is an important design consideration that will determine when
to begin the trial. While some have argued that the first patient to receive a
new surgical therapy should be enrolled in a randomized trial, most surgeons
hold the view that individual and collective experience that approaches a
steady state in the learning curve is required before a new surgical treatment
should be
evaluated15.
Evaluation that is done too soon in the learning curve is likely to lead to
the improper conclusion that the procedure is ineffective or has too high a
complication rate. On the other hand, if evaluation is done too late, surgical
interventions often become adopted, sometimes widely, without demonstration of
their superiority or inferiority to standard therapy. By that point, it may be
difficult to recruit surgeons and patients to make this determination.
Orthopaedic randomized clinical trials, particularly those that involve the
use of new products, may be subject to commercial issues. When a treatment or
product has been developed by a corporate entity, it may be promoted as, or
even before, surgeons have fully assessed it. Frequently, such treatments or
products have been developed at considerable effort and expense. Surgeons must
respect the need to avoid undue delay in properly evaluating such treatments.
Surgeons must also take care to avoid the temptation or pressure to cut
corners or otherwise compromise scientific quality in conducting their
studies.
A critical part of the design of any randomized clinical trial is to
develop a manual of operations. This manual clearly defines the scope of the
project, the execution plan, and the responsibilities of each team member,
each committee, and each site. Investigators typically overestimate the
ability and experience of the research sites. It is best to assume that all
sites, all investigators, and all coordinators are new to clinical research.
The design should exclude verbal agreements and reliance on corporate memory
management. All agreements, and any subsequent changes, need to be clearly
detailed, distributed to all investigators, and placed in the manual of
operations.
No project design is perfect. As the design of the randomized clinical
trial is developed, surgeons are at risk for encountering a variety of
pitfalls. A few common examples are illustrated in
Table I. A key to success in
randomized clinical trials is to have the team critically evaluate the study's
process and procedures so as to identify and correct deficiencies. When
adjustments are made, it is important to review and, if necessary, update the
manual of operations accordingly. For these reasons, an early review of the
project's progress should be included in the study's original design.
The project design must incorporate investigator accountability and include
an annual review of enrollment, protocol violations, and data quality. In
addition, because clinical research is a business event, the research team is
responsible for the appropriate and judicious use of funds. If necessary, the
team needs to be willing to cut its losses early in a project. Despite the
care taken in recruiting coinvestigators, multisite randomized clinical trials
often require the team to remove from the study a colleague or a major
institution that is not fulfilling the requirements of the study.
Every clinical research study must be approved by an institutional review
board. Compliance with institutional review board requirements is as critical
as compliance with the protocol. The purpose of the consent is to protect all
of the subjects. A key issue that an institutional review board will address
is the requirement for written informed consent from all subjects
(Table II). Additional subject
protection should be provided by creating a data safety monitoring board, a
group convened by the investigators to help track adverse events and study
outcomes.
Clinical trials in the United States are conducted according to Good
Clinical Practice guidelines. Provided by the United States Food and Drug
Administration, these regulations are intended to ensure the protection of
human research subjects and the integrity of data collected in clinical
trials16. Good
Clinical Practice guidelines govern everything from the role of the
institutional review boards to the process of obtaining informed consent from
human research subjects to financial disclosure procedures for clinical
investigators. Familiarity with Good Clinical Practice guidelines and their
historical framework is important for participants in randomized clinical
trials17,18.
Institutional review board approval is required prior to the initiation of
subject recruitment because the subject recruitment process requires
institutional review board oversight. In the initial stages of marketing a
trial, when the investigators are involved in giving presentations to
professional organizations, writing letters to health professionals, and
making general news releases, institutional review board oversight is not
required. In the later stages of recruitment, when direct advertising is used
to solicit subjects for participation in a trial, institutional review board
approval is
required19.
Marketing a trial to the general public is regarded as the start of the
informed consent process. Marketing cannot be coercive or misleading. The
investigational status of the drug or device under study must be
communicated.
The institutional review board also oversees the process of patient
reimbursement. Federal requirements state that reimbursement is to be provided
to the subjects as the study progresses. Although a small proportion of
reimbursement may be offered to subjects as an incentive for completing the
study, the payment schedule may not be coercive. Subjects cannot be forced to
complete the investigation to receive money. As noted above, the reimbursement
amount and schedule should be stated in the informed consent.
The multiple responsibilities of the institutional review board often
result in a protracted review and approval process. For planning purposes, it
is helpful for an investigator to expect at least one institutional review
board resubmission of the protocol, and that if a trial involves contracting,
the time requirements become even more substantial. Contracting will usually
require the involvement of attorneys, legal clarification of responsibilities,
sharing of intellectual property, and financial understandings. These issues
commonly require dialogue and negotiation between the parties. Close
communication between the investigators and the institutional review board as
the study is developed will enable the investigators to incorporate the
institutional review board requirements into the study design from the
beginning. The alternative of presenting the institutional review board with a
proposal devoid of prior institutional review board input is likely to require
considerably greater effort to revise it after institutional review board
review.
It is important to keep the institutional review board in mind even after
the study is well under way. Investigators should assume that, after the data
collection period is supposed to be over, data analysis will reveal that
additional patient information is needed. For this reason, it is useful to
keep the institutional review board approval for the project renewed to at
least twenty-four months beyond the date of the last patient enrollment.
The most important ingredient in the execution of a large-scale randomized
clinical trial is
communication20.
During a randomized clinical trial, the attention and enthusiasm of the
investigators needs to be maintained for a long time-period. Investigator
meetings that review progress, data quality, and project finances should be
planned at least twice each year. Friendly competition between centers is
often helpful and can be stimulated by monthly enrollment reports. Critical to
the execution of the study is strict adherence to protocol and complete
patient follow-up.
A key component of the execution of any randomized clinical trial is
subject randomization. In a multicenter study, this should be conducted from a
central location with use of statistically and operationally valid methods.
The use of independent personnel, randomly generated numbers, or random-number
tables can be used to avoid bias. By contrast, the use of opaque envelopes,
medical record numbers, day of admission, admitting physician, or other
processes that are discoverable or potentially subject to tampering should be
avoided21.
Although data handling during the execution of a randomized clinical trial
is best handled by a central site, each investigator should be familiar with
the data handling procedures at his or her site to enable interfacing. Data
handling procedures may include checks for data accuracy and protocol
adherence, double data entry, scanning of physical documents, and use of
electronic documents. Data management may involve the use of the Internet and
commercially available software. Adobe Acrobat attachments (Adobe Systems, San
Jose, California) are an example of one software application that can
facilitate data collection. Alternatively, the use of a web server can allow
direct access to the data and can facilitate effective data collection and
processing22.
Important components of data management are to ensure security and to employ
both on-site and off-site data backup.
There is a set of issues affecting orthopaedic clinical research that may
be termed cultural. One such issue is the tendency for orthopaedic surgeons to
not only accept but to sometimes promote widely divergent surgical
recommendations for the same
condition23.
Orthopaedic conferences are frequently organized as debates over different
treatments for a specific problem. The orthopaedic literature is filled with
widely divergent treatment recommendations based on case series. In most
instances, these disagreements reflect conflicting and poor-quality data based
on inadequate experimental evidence. Studies capable of resolving many of the
outstanding questions in orthopaedics simply have not been done. As a result,
arguments over what represents the best treatment for many conditions are
destined to be of limited use. A culture that accepts inferior information as
the basis for treatment decisions serves no one. The patient, the surgeon, and
our society are disadvantaged by inadequate information. Of much greater value
would be a culture that focuses on acquiring high-quality data with which to
answer questions for which answers do not currently exist. An important task
for our specialty is to replace the historical status quo.
This change in culture is already occurring on behalf of orthopaedic
surgeons. Medicine, including orthopaedic surgery, is entering a new era. It
will be characterized by increased accountability. In the not-too-distant
future, surgeons will likely be called on to justify their treatment
decisions. Surgeon accountability may take the form of pay for performance or
another similar connection between treatment and value. Justification for
treatment decisions may be achieved by demonstrating sound evidence in support
of the treatment selected.
Another cultural issue is that many physicians do not acknowledge the
uncertainty that is intrinsic to their current clinical practice. For example,
in 1995, surgeons were surveyed about the patient indications for total knee
replacement24. A
subsequent survey in 2000 demonstrated that variability in surgeon opinion was
unchanged. More concerning was that physicians repeated the survey six weeks
apart, and 50% of the variation in opinion could be attributed to physicians
changing their opinions during that brief interval. Most concerning was the
finding that, despite obvious uncertainty about how patient factors affected
their decision making, less than 10% of the physicians indicated they were
uncertain. Clearly, treatment decisions need to be made. However, orthopaedic
surgeons need to acknowledge the uncertainty that characterizes their decision
making in order to change the current culture. Patients, too, need to be
better empowered to help in the decision-making
process25. Only
with sound clinical data will patients be able to place the current marketing
exposure into proper perspective.
Of equal importance to the specialty of orthopaedics, and particularly to
the patients cared for by orthopaedic surgeons, is the willingness of
orthopaedic surgeons to apply new discoveries from high-quality clinical
research. For example, osteoporosis is a diagnosis that is often first made by
an orthopaedic surgeon. This is because osteoporosis often first manifests
itself as an insufficiency fracture. Virtually all orthopaedic surgeons are
familiar with the demonstration by clinical research that osteoporosis can now
be treated by medical intervention. Yet a recent study has found that only 2%
to 10% of patients with a hip fracture received a drug with clinical trial
evidence supporting its use for treatment of the disease that led to the
patient's
fracture26. This
phenomenon is not restricted to orthopaedic surgeons. Despite the majority of
obstetricians in Ontario stating they were aware of, supported, and had
implemented practice guidelines about Caesarian section, knowledge of the
guidelines and implementation was, in fact,
low27. Orthopaedic
surgeons can add tools to their treatment armamentarium and can cast
themselves in a more favorable light by adopting high-quality evidence when it
is provided by clinical research.
Orthopaedic surgeons have the opportunity not only to participate in
randomized clinical trials themselves but also to use the results of
randomized clinical trials conducted by others. These are opportunities to
create a new culture of progress based on sound evidence. Taking advantage of
these opportunities will be important for the success of individual
orthopaedic surgeons, for the future of the orthopaedic specialty, and for the
well-being of orthopaedic patients.
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