Shoulder joint replacement - what can national registries tell us?

The utility of international shoulder joint replacement registries and databases: a comparative analytic review of two hundred and sixty one thousand, four hundred and eighty four cases


These authors indicate that national databases provide an unselected view of shoulder joint replacement within geographical areas that cannot be obtained from case series or prospective studies. They can be particularly helpful in determining which diagnoses, patients, procedures, and prostheses have higher than expected rates of revision.

In an attempt to determine the generalizability of registry data, they analyzed seven national shoulder arthroplasty registries and five publications regarding national shoulder arthroplasty data containing a combined total of 261,484 shoulder arthroplasty cases. 

They found that percentages of hemiarthroplasty, anatomic and reverse total shoulders, the diagnoses leading to arthroplasty, the mean patient age, and the distribution of patient gender varied significantly with geographical location. They suggest that these variations must be considered when comparing outcomes of shoulder arthroplasty from different locations.

In the charts below it can be see that the prevalence of rheumatoid arthritis among patients receiving shoulder arthroplasty varied from 0.9% in the US to 41% in Scotland.

and that the percentage of reverse shoulder arthroplasty varied from 0% in Scotland to 63% in Italy and the Netherlands.

They point out that these national data provide the opportunity to reduce costs by identifying implants and procedures with higher failure rates. Below are examples from the Australian registry.

The establishment and maintenance of a registry that captures an unbiased and complete inclusion of shoulder arthroplasties in a defined patient population is both difficult and expensive. In order to preserve the integrity of these registries, their funding needs to be stable and free of conflicts of interest. Conflict-free funding has been achieved in several instances from either national departments of health or from large health plans. 

The authors conclude that while hundreds of thousands of shoulder arthroplasties are performed each year around the world, reliable data are available on very few of them. Most of the publications on shoulder arthroplasty.

A related article was recently published: International variation in shoulder arthroplasty

These authors assessed international trends in use of shoulder arthroplasty, and described the current state of procedure selection and outcome presentation as documented in nine national and regional joint registries (Norway, Sweden, New Zealand, Denmark, California, Australia, Emilia-Romagna, Germany, and United Kingdom).

They found that shoulder arthroplasty incidence rate in 2012 was 20 procedures/100,000 population with a 6-fold variation between the highest (Germany) and lowest (United Kingdom) country. The annual incidence rate increased 2.8-fold in the past decade. 

Within the indications osteoarthritis, fracture, and cuff-tear arthropathy variations in procedure choice between registries were large. 

These findings point to the wide variation in use of and indications for shoulder arthroplasty. Analysis is complicated by inconsistency in the definitions of diagnoses, procedures, and outcomes.

Nevertheless, registries that are durably funded with encompassing unbiased patient inclusion can provide data that is otherwise unavailable. 

A very real opportunity exists for surgeons from different nations to collaborate on the design, implementation, and support of standardized joint registries.

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The reader may also be interested in these posts:

Healing through joint replacement

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You may be interested in some of our most visited web pages including:shoulder arthritis, total shoulder, ream and run, reverse total shoulder, CTA arthroplasty, and rotator cuff surgery as well as the 'ream and run essentials'

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Shoulder arthroplasty registries - why are the US, France, Germany, Switzerland and others not on the list?

A review of national shoulder and elbow joint replacement registries.

Between 1994 and 2004, 6 shoulder registries; by the end of 2009, the shoulder registries included between 2498 and 7113 replacements. The registries were initiated by orthopedic societies and funded by the government or by levies on implant manufacturers. In some countries, data reporting and patient consent are required. Completeness is assessed by comparing data with the national health authority. All registries use implant survival as the primary outcome. Some registries use patient-reported outcomes as a secondary outcome.

Data from national registries can cause us to re-think our approach.  For example, many surgeons are convinced that total shoulder is superior to hemiarthroplasty, but the Finnish data on revision rates (see below) deserve consideration.

A recent article goes a step further, asking: Is it feasible to merge data from national shoulder registries? A new collaboration within the Nordic Arthroplasty Register Association.

Emerging data from this collaboration enable comparison of survival rates among implants

Comment: Notably NOT on the list of countries with national registries are those performing the largest number of shoulder joint replacements: the United States, France, Germany and Switzerland.  Imagine how much faster we'd learn about what was and what was not working if we followed the example of our Scandinavian and South Pacific colleagues. It is also of interest that the great preponderance of shoulder arthroplasty implants are made in the countries NOT participating in national registries. One would think that the wealth created by implant sales would easily support registries in these countries

For example, the US market for extremity implants in 2015 was $934 million compared to $890 million in 2014. Shoulder implants account for 62% of the extremity market (link). If a fraction of this was used to support a registry......

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Shoulder joint replacement arthroplasty - risk factors for revision surgery from a registry

Risk factors for revision after shoulder arthroplasty: 1,825 shoulder arthroplasties from the Norwegian Arthroplasty Register.

These authors describe the results of shoulder replacement in the Norwegian population (of 4.7 million) over a 12-year period. They found that 1,531 hemiarthroplasties, 69 total shoulder replacements (Neer type TSR), and 225 reversed total shoulder replacement (reversed TSR) operations were reported to the Norwegian Arthroplasty Register between 1994 and 2005.

The 5- and 10-year failure rates for hemiarthroplasties were 6% and 8%. The risk of revision for patients who were 70 years or older was half that of those who were younger. The main reasons for revision of hemiarthroplasties were pain and instability. The risk of revision was highest for patients with sequelae after fracture compared to those with acute fractures.

The 5- and 10-year failure rates for reversed total shoulder replacements they were 10%  and 22%.
The risk of revision was less for women than for men.  The main cause of revision was aseptic loosening of the glenoid component.

Comment: First, thanks to our colleague Mac McElvany for reminding us of this important article.

Secondly, this report points out the value of registry data that include all procedures done within a defined patient population. Third, it points out the need for long-term followup of shoulder arthroplasties - while it may be tempting to dismiss these high revision rates the fact is that we do not have eight to ten year followup on the procedures currently in use. Will this type of registry data be available for what we do now?

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You may be interested in some of our most visited web pages including:shoulder arthritis, total shoulder, ream and run, reverse total shoulder, CTA arthroplasty, and rotator cuff surgery as well as the 'ream and run essentials'

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Shoulder joint replacement arthroplasty - types and revisions

The Kaiser Permanente Shoulder Arthroplasty Registry

Results from 6,336 primary shoulder arthroplasties

These authors analyzed 6336 shoulder arthroplasties entered into the Kaiser Permanente registry between January 2005 and June 2013. Median follow-up time for all primaries was 3.3 years; 461 cases were lost to follow-up by ending of health plan membership. Primary cases were predominantly female (56%) and white (81%), with an average age of 70 years. The most common reason for surgery was osteoarthritis in 60% of cases, followed by acute fracture (17%) and rotator cuff tear arthropathy (15%). In elective shoulder arthroplasty procedures, 200 all-cause revisions (4%) were reported, with glenoid wear being the most common reason.

Revisions were defined as any procedure after the registered index arthroplasty involving the addition, removal or replacement of at least 1 implanted component, so that soft tissue procedures would not be included.

Much of the story can be told by the numbers:

Comment: This is a most impressive overview of a large case series with a very low rate of cases lost to followup.

In interpreting these data it is important to understand that this is NOT a pure comparison of procedures, rather it is a comparison of surgeons electing to perform certain procedures on certain patients with certain diagnoses. We must wonder why surgeons chose to do 818 hemiarthroplasties and 130 resurfacings on patients with osteoarthritis - was it because they were not comfortable with their ability to do a total shoulder in these cases, because the patient did not want a glenoid, or because the surgeon thought the patient had involvement of the humeral side of the joint only (a rarity in glenohumeral arthritis). In any event, we must conclude that there was something different about these cases from those receiving total shoulder arthroplasty. This may explain why there was such a high revision rate for "glenoid wear" following hemiarthroplasty or resurfacing (27% of all revisions). Among elective hemiarthroplasties, the revision rate was 6% with glenoid wear as the reason for revision in 52% of cases, while the revision rate following TSA in particular was only 2%. It is of note that resurfacing arthroplasties had by far the highest revision rate.

So...these investigators have a wonderful opportunity to explore the "4P" factors associated with the need for revision: (1) the problem (diagnosis, the preoperative pathoanatomy of the shoulder), (2) the physician (surgeon identity, training, age), (3) the patient (age, gender of the patient, co-morbidities), and (4) the prosthesis used. In addition, as the authors were careful to point out that implant survival alone fails to capture patients with under performing shoulder arthroplasties who simply decline revision surgery. Thus it is possible that older individuals would be less likely to elect revision even if the outcome of their surgery was unsatisfactory. 

Be sure to click on this link to the Shoulder Arthritis Book.

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Resurfacing hemiarthroplasty for osteoarthritis of the shoulder - is there any advantage?

Outcome, revision rate and indication for revision following resurfacing hemiarthroplasty for osteoarthritis of the shoulder

These authors evaluated patient-reported outcomes, the rate of revision and the indications for revision following resurfacing hemiarthroplasty of the shoulder in patients with osteoarthritis performed between January 2006 and December 2010 from the Danish registry.

A complete Western Ontario Osteoarthritis of the Shoulder questionnaire was returned by 688 patients (82.2%). The mean WOOS at followup was 67 (0 to 100). The preoperative scores were not provided so that the amount of improvement is not known. A total of 63 hemiarthroplasties (7.5%) required revision; the cumulative five-year rate of revision was 9.9%. 

Patients aged < 55 years had a statistically significant inferior clinical outcomes compared with older patients (mean difference 14.2 (8.8; 95% CI 19.6; p < 0.001).

Comment: While some surgeons are attracted to the concept of a resurfacing hemiarthroplasty as a 'conservative' arthroplasty for managing glenohumeral arthritis, it has several shortcomings. (1) The resurfacing hemiathroplasty does not manage the glenoid aspect of glenohumeral arthritis. (2) While a stemmed humeral component allows for modification of the head size, shape and position to optimize shoulder mobility and stability, this is not possible with a resurfacing hemiarthroplasty.

In this retrospective series, the annualized revision rate was 2% per year. The most common reasons for revision were glenoid problems, rotator cuff dysfunction, 'technical failure', pain, infection, loosening, and instability.

We revise quite a few failed resurfacing arthroplasties. Here are the preoperative and postoperative x-rays from a case a few weeks ago that was revised because of pain and stiffness in a 50 year old woman. At the time of her presentation she could perform 0 of the 12 functions of the Simple Shoulder Test.

Two days after her revision to a total shoulder she had assisted elevation to 160 degrees while taking only minimal pain medication.

Contrast this scenario with that shown in the next post.

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Shoulder arthroplasty registries, what do they tell us and what do they not tell us?

Patient-reported outcome and risk of revision after shoulder replacement for osteoarthritis1,209 cases from the Danish Shoulder Arthroplasty Registry, 2006–2010

These authors used patient-reported outcome and risk of revision for hemiarthroplasty vs. total shoulder arthroplasty and for stemmed hemiarthroplasty vs. resurfacing hemiarthroplasty in patients with glenohumeral osteoarthritis.

They included all patients reported to the Danish Shoulder Arthroplasty Registry between January 2006 and December 2010. 1,209 arthroplasties in 1,109 patients were eligible. Western Ontario Osteoarthritis of the Shoulder index (WOOS) was used to evaluate patient-reported outcome 1 year postoperatively. Revision rates were also tabulated.

 There were 113 total shoulders and 1096 hemiarthroplasties (837 resurfacing and 259 stemmed). Patients treated with total shoulder generally had a better WOOS scores.  There were no statistically significant differences in revision rate or in adjusted risk of revision between any of the groups.

Comment: Registries are of interest, but there are inherent problems in interpreting the data. For example in this sample, there were almost 10 times as many hemiarthroplasties as total shoulders. This prompts us to ask 'what factors resulted in patients getting a total shoulder?' - was it the more experienced surgeon, a healthier patient, better shoulder anatomy, or what? For example, it is of interest that 21% of the patients having hemiatrhoplasty had had prior surgery whereas only 12% of those having total shoulders had had prior surgery. It is well recognized that prior surgery is a major risk factor for a less successful outcome.

What would have been a more useful analysis would be the comparison of those shoulders with a good result with a given type of arthroplasty to those with a poor result for the same procedure. In that analysis the factors leading to the decision of arthroplasty type would be controlled so that the authors could evaluate the effects of sex, age, prior surgery, diagnosis, comorbidities, and surgeon experience (i.e. the 4Ps).

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You may be interested in some of our most visited web pages including:shoulder arthritis, total shoulder, ream and run, reverse total shoulder, CTA arthroplasty, and rotator cuff surgery as well as the 'ream and run essentials'

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Impact of implant developers on published outcome and reproducibility of cohort-based clinical studies in arthroplasty. JBJS

Impact of implant developers on published outcome and reproducibility of cohort-based clinical studies in arthroplasty. JBJS

This article is from a year ago, but its message seems more than worthy of a re-vist.

Basically, the authors contrasted the revision rates obtained from case series with those from registries. The bottom line was that revision rates from arthroplasty registry data were significantly higher than those from clinical case series. The authors also noted that in clinical case series, the preponderance of the data came from the institution at which the arthroplasty implant was developed - these data had a major influence on the observed rates of arthroplasty revision. This phenomenon was particularly common for implants developed in the U.S. 

The observation that the attractively low revision rates reported by the implant developers were not replicated by the registry data that reflects 'routine' patient treatment makes two important points: 

(1) data from case series authored by implant developers may not be applicable to the general practice of orthopaedic surgery and 

(2) there is a critical need for arthroplasty implant registries in the U.S. as championed by the American Joint Replacement Registry.

Joint registries give us the best chance to live up to the admonition of Codman: to follow every patient long enough to determine if our treatment was a success and if not to determine why not. They keep us from putting our heads in the sand as shown in his depiction of the goose ostrich, which continues to lay golden eggs even though she cannot see the results.

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You may be interested in some of our most visited web pages including:shoulder arthritis, total shoulder, ream and run, reverse total shoulder, CTA arthroplasty, and rotator cuff surgery.

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Variability in Costs Associated with Total Hip and Knee Replacement Implants. JBJS

Variability in Costs Associated with Total Hip and Knee Replacement Implants. JBJS

The authors point out that the average implant cost per case varied by over 600% ($1797 to $12093) for total knee replacement procedures and by over 400% ($2392 to $12651) for total hip replacement procedures.  These wide variances could not be explained by differences in patient characteristics. The ratio of device cost to total surgical cost for knee and hip arthroplasty can be as high as 87%, with the median ratio being 43%.

The authors point out that data are currently lacking to support the belief that higher cost devices are associated with better outcomes. This is an important article, especially when viewed in the light of the survivorship of some of the more expensive and 'more modern' implants as also shown here. On this basis some have advocated device regulation to assure that new technology is optimally applied.

While we are not aware of similar data for shoulder implants, it is logical to assume that the same phenomenon exists there. We have also seen that the results with newer shoulder implants may not justify the associated expense. Determination of differences in outcome may require quite long term followup.

An interesting commentary on this article was offered: Joint Replacement Costs in the Era of Healthcare Reform: Commentary on an article by James C. Robinson, PhD, MPH, et al.: “Variability in Costs Associated with Total Hip and Knee Replacement Implants” The author of this commentary reminded that orthopaedic implants and procedures are major contributors to the rising cost of healthcare. In spite of the rising number of these procedures performed each year, the cost of these procedures is not following 'economies of scale principles' in which the implant cost per case would drop as the number of cases increased. The author of the commentary suggests several possible approaches to reducing these costs: (1) collective bargaining by Medicare with the implant manufacturers, (2) defining standards on the impact of new devices on cost and outcomes before they come to market, opining that 'there is little evidence that newer and more expensive devices are associated with better functional outcomes', (3) lack of  'gain-sharing' between medical centers and surgeons, which could incentivize surgeons to cut costs without compromising outcomes, and (4) lack of a national joint registry, such as those that exist in other countries, that would provide cost and outcomes data that could inform future decisions on implant selection for particular categories of patients.

The bottom line is that in future we need to pay more attention to the value equation: how much better are the documented results with the new implant divided by how much more it costs than the existing device? If a country wanted to curb the rising cost of joint arthroplasty, would it be better for it to reduce the cost of implants or to reduce the payments to the surgeons implanting them? That choice may be on us sooner rather than later.

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A review of national shoulder and elbow joint replacement registries. JSES

A review of national shoulder and elbow joint replacement registries published by JSES presents an analysis of national shoulder (6) and elbow (5) joint replacement registries. The countries having established such registries include Australia, Denmark, Finland, Norway, Sweden (funded by the respective governments), New Zealand (funded by levies on implants, government agencies, and a private group) and the UK (funded by a levy on implants). No registries were identified in the US or Canada. The authors point to the importance of such registries, which characteristically use revision as the primary outcome.

As was pointed out in a recent post, the revision rates from these registries is often higher than those from published case series - possibly because they reflect data from all surgeons, rather than only from high volume centers. To this point, the recent JSES article shows the revision rates for total shoulder and hemiarthroplasty by year as in the figure below. While the authors suggest that the data shown demonstrate that the results are getting better with time, it appears that for both older and more recent total shoulder arthroplasties, there was a five percent revision rate in the first 2 years. 

These data suggest that revisions are required more commonly than might be suspected from published case series. To understand how the practice of shoulder arthroplasty can be improved, we need data such as these as well as data on the factors associated with higher risks of revision. Risk factor information does not seem to be commonly available from registry data. While the authors suggest that comparison of results with different arthroplasty designs would be an important topic for suggestion, we suggest that other factors, such as age, gender, comorbidities, BMI, diagnosis, prior surgery and surgeon experience might be of even greater interest and would at least be factors that needed to be controlled in comparisons of prostheses.

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Registries, Shoulder arthroplasty, periprosthetic infection in December JBJS

After a winter solstice steelhead, some spectacular views from a remote mountain cabin, and slogging through a heavy snowfall, it's time to get back to work and blogging.

The December 21 JBJS has some articles of interest.

Bill Maloney wrote an editorial on the role of orthopaedic device registries in improving patient outcomes. In it he points to the difficulties in keeping track of which patients have which results with which implants performed by which surgeons. He uses the recent example of the failure of metal-on-metal hips, but there are many other examples of defective implants that might have been recognized earlier had their been a central registry of implants and their clinical performance. Yet the implant is only one of the potential causes of failure of a joint replacement.  Others include poor selection of patients, poor surgical technique, complications and poor rehabilitation. We live in a world where millions of joint replacements are done every year, yet the results of over 95% these arthroplasties are not analyzed so that the knowledge that could potentially be gained from what works and what doesn't work in different circumstances is lost. Since neither industry, nor the government, nor organized medicine can make followup happen, maybe some young person will save the day by designing an "app" called "MyJoint" that will ask the patient to enter the specifics about themself and their arthroplasty and remind them to complete a self assessment each year and post it to a central database.

Javad Parvizi et al reported on the novel idea of using a simple colorimetric strip test to look for the enzyme leukocyte esterase in the joint fluid of knees with a possible joint infection. The test correlated well with the number of neutrophils and with systemic inflammatory markers. It is exciting to see how well this works for knees; however for those of us in the shoulder world most of our infections engender less of an inflammatory response so that the effectiveness of this approach remains to be evaluated.

Sunny Kim et al reported the increasing incidence of shoulder replacements in the US. They found relatively constant growth in the number of hemiarthroplasties from 12,000 in 2000 to 20,000 in 2008, many of these being performed for fracture. The number of total shoulders grew from 8,000 in 2000 to 11,000 in 2003 and then took a sudden leap to over 27,000 in 2008, perhaps in part due to the introduction of the reverse total shoulder in the US in 2003. Unfortunately, this article contains no information on functional outcomes or revision rates.

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