AAOS-American Association of Orthopedic Surgeons
Value of total joint registries:
The jury is in
By Norman A. Johanson, MD
Current evidence makes a compelling case for a
national registry
Registries for hip and knee replacement
procedures are a world-wide reality with growing importance. Many of the preeminent
registries—such as those in Sweden, Finland, Norway, Australia, Denmark, and
New Zealand—have more than 10 years of experience and are currently collecting
data on more than 90 percent of procedures nationally.
Registries are also growing in the complexity of
data collected. The minimum recommended data set
(http://www.ear.efort.org/E/03/01-03.asp) includes patient, surgeon, and
hospital identifiers; core surgical data, date of surgery, diagnostic and
treatment codes, laterality, and implant information. This may be augmented to
include comorbidity and patient-administered questionnaires. Registries also
address important issues such as prophylactic antibiotic and anticoagulant
administration by measuring their impact on the incidence of infection and
thromboembolic events. Published evidence from registries can now potentially
guide important clinical decision-making.
A snapshot of clinical practices
A
distinguishing feature of registries is that, with several thousand consecutive
patients entered, they have no exclusions—a characteristic of methodologically
sophisticated clinical trials. What is sacrificed in terms of potential bias
inherent in inappropriate group comparisons, however, is offset by the breadth
of applicability of the findings.
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Most significantly, registries provide a snapshot
of the realities of current clinical practices and real-time assessment of the
associated outcomes. The timely feedback of these observations to surgeons may
result in significant behavioral change, particularly if a practice pattern can
be clearly associated with a desirable or adverse outcome.
National registries, by virtue of their
inclusiveness, can detect significant risks to patient health associated with a
particular procedure. For example, registry data show that pulmonary embolism
(PE) following total hip or knee replacement is rare. In total hip arthroplasty
(THA), the 90-day rate of nonfatal PE has been reported to be 0.93 percent in
58,521 Medicare patients who underwent primary THA with or without prophylaxis
during 1995 and 1996. Death following PE in THA is very rare, with a 90-day
death rate of just 0.22 percent, according to an analysis of 44,785 patients in
the Scottish Morbidity Record from 1992 to 2001.
Nonfatal and fatal PE following total knee
arthroplasty (TKA) are even less common. A survey of a California discharge
database (222,684 patients who had undergone TKA from 1991 to 2001) found a 90-day
nonfatal PE rate of 0.41 percent. The rate of fatal PE in 27,000 TKA patients
in the Scottish Morbidity Record was 0.15 percent.
Most importantly, registries show that, despite
significant changes in venous thromboembolism prophylaxis and surgical techniques
over the past 10 to 15 years, the rates of PE and PE-related mortality are
remarkably stable. Based on these findings, one might question both the current
stereotype of all orthopaedic patients being at high risk for serious
thromboembolic complications and the real value of using the newer and more
expensive pharmacologic agents for routine thromboprophylaxis in all THA and
TKA patients.
Is a U.S. registry needed?
In
March 2008, the AAOS presented a symposium on the value of national registries,
inviting representatives of several registries to discuss the real and
potential benefit of total hip and knee registries. In his introductory
comments, William J. Maloney, MD, underscored the following threefold
value of registries:
•
They provide an early warning system for early
implant failure.
•
They provide evidence that, if delivered to
physicians in a timely and understandable fashion, will positively influence
physician behavior to the benefit of patients and society.
•
They have the power to ultimately decrease the
burden of disease and cost associated with surgical morbidity and mortality,
and reduce the volume of premature revision procedures.
The remainder of the symposium contained ample
evidence to support these claims, lending weight to arguments for the absolute
necessity of developing the American Joint Replacement Registry.
Registries as early warning systems
Early
implant failure has not been adequately addressed through the traditional
follow-up and publication strategy. Registries have proven more effective in
identifying problems with particular implants or new surgical procedures used
for implantation.
The Kaiser-Permanente Total Joint Registry, along
with several national registries around the world, demonstrates the proficiency
of this function by providing data on unicondylar knee replacement, an
increasingly popular procedure. Data from multiple registries, however,
demonstrate that the aseptic loosening rates of unicondylar knees is
significantly higher than those of total knee replacements. At Kaiser,
reporting this finding to its physicians led to a decrease in the rate of
unicondylar replacements.
After the higher rates of loosening were found to
be concentrated among surgeons who performed a lower volume of unicondylar
replacements, a subsequent redistribution of the procedures toward higher
volume surgeons was noted. The procedure itself was not discredited, but the
need to refine the procedure’s indications and surgeon’s qualifications was
underscored.
Impact on physicians
During
the past several years, minimal incision surgery (MIS) for THA has been
aggressively promoted as leading to more rapid recovery times and better
short-term outcomes when compared to conventional THA. Much of this promotional
information passed from the implant manufacturers directly to the public.
The Kaiser Registry was used to track the
increase in volume and the outcomes of this new procedure. Within a few years
of its inception in 2001, the registry detected a higher complication rate and
compromise in early clinical outcomes associated with two-incision MIS THA. In
addition, MIS TKA was found to produce increased pain and a decrease in patient
satisfaction during the early postoperative period. When surgeons were informed
of these observations, the number of these procedures performed dropped
dramatically.
Registries in patient selection
The
Australian National Joint Replacement Registry was used to study the impact of
the rapid rise in resurfacing hip replacement during the past decade. An
analysis of 5-year cumulative data found a significantly higher revision rate
for resurfaced hips compared to total hip replacement. Women were found to have
more than twice the risk for revision than men.
On further analysis, a femoral head size of less
than 50 mm was found to be the primary risk factor. This finding has helped to
clarify the population that may be most suitable for undergoing hip
resurfacing: Men younger than 65 years old, with osteoarthritis, who require a
femoral head size of 50 mm or more.
Reducing the burden of disease
In
calling attention to the compelling case for a national total joint registry, David
G. Lewallen, MD, chairman of the AAOS American Joint Replacement Registry
Project Oversight Board, made the following observations:
During the life of the Swedish Hip and Knee
Registries, the revision burden has been reduced from 17 percent to 7 percent.
In 1 year, the Australian National Joint
Replacement Registry reported a 0.6 percent decrease in revision knee surgery
at a savings value of $8.7 million. Using the volume of revision hip and knee
replacements performed in the United States during 2003, a mere 1 percent
reduction in the revision rate would have resulted in a 1-year savings of $30
million.
The evidence presented at the AAOS Symposium
documented the value of national registries and made an excellent case for
moving ahead in cooperation with the international orthopaedic community in
developing a national total joint replacement registry in the US. The ability
of registries to realize value has been amply demonstrated. A rapidly growing,
evidence-based argument favors action now to avoid unnecessary injury to our
patients, to promote improved clarity and rationale in developing clinical
practice guidelines, and to facilitate the most cost-effective use of our
progressively limited healthcare resources.
Norman A. Johanson, MD, is a member of the
Evidence-Based Practice Committee. His disclosure information is available at www.aaos.org/disclosure
More information about the Evidence-Based
Practice Committee and evidence-based medicine can be found at www.aaos.org/Research/Committee/Evidence/ebpc.asp
Read more...Joshua J. Jacobs, MD, leads a
roundtable discussion on "Building a national joint replacement
registry"
References
1.
Katz JN, Losina E, Barrett J, et al: Association
between hospital and surgeon procedure volume and outcomes of total hip
replacement in the United States Medicare population. J Bone Joint Surg Am 2001;83(A):1622-1629.
2.
Howie C, Hughes H, Watts AC: Venous
thromboembolism associated with hip and knee replacement over a ten-year
period: A population-based study. J Bone Joint Surg Br
2005;87:1675-1680.
3.
SooHoo NF, Lieberman JR, Ko CY, Zingmond DS:
Factors predicting complication rates following total knee replacement. J
Bone Joint Surg Am 2006;88:480-485.
4.
Lie SA, Engesaeter LB, Havelin LI, Furnes O,
Vollset SE. Early postoperative mortality after 67,548 total hip replacements:
Causes of death and thromboprophylaxis in 68 hospitals in Norway from 1987 to
1999. Acta Orthop Scand 2002;73:392-399.
5.
American Academy of Orthopaedic Surgeons clinical
guideline on prevention of symptomatic pulmonary embolism in patients
undergoing total hip or knee arthroplasty. Rosemont, IL: American Academy of
Orthopaedic Surgeons (AAOS); 2007.
6.
Proceedings of the 75th Annual Meeting of
the AAOS, San Francisco, March 5-9, 2008, pp 190-205.
AAOS Now
August 2008 Issue
http://www.aaos.org/news/aaosnow/aug08/research1.asp
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