Some newspapers and websites have covered research that, it is suggested, calls into question the value of some orthopaedic surgery. Headlines, such as “Joint surgery may be no more useful than physiotherapy,” might lead people to believe that surgical interventions they have had could have been replaced with physiotherapy or medication. The media attention was prompted by a study in which claimed benefits of some joint and bone surgery, were not backed up by quality evidence.
However, the actual report, published in the British Medical Journal, does not draw that conclusion. Instead, it highlights the need for further research, and the importance of basing clinical decisions on the available evidence, whether that’s research or a strong body of observational experience.
What was the research?
The research, conducted by a team led by University of Bristol professor and surgeon Anthony Blom, analysed studies which compared the clinical effectiveness of 10 procedures by comparing the outcomes with no treatment, placebo or non-operative care such as physiotherapy and drugs.
The 10 procedures were:
Common elective orthopaedic procedures and indications
|Arthroscopic anterior cruciate ligament reconstruction||Anterior cruciate ligament rupture|
|Arthroscopic meniscal repair of the knee||Traumatic meniscal tears|
|Arthroscopic partial meniscectomy of the knee||Degenerative meniscal tears|
|Arthroscopic rotator cuff repair||Acute rotator cuff tears|
|Arthroscopic subacromial decompression||Subacromial impingement syndrome|
|Carpal tunnel decompression||Carpal tunnel syndrome|
|Lumbar spine decompression||Spinal canal stenosis|
|Lumbar spine fusion||Degenerative disc disease|
|Total hip replacement||End stage osteoarthritis|
|Total knee replacement||End stage osteoarthritis|
Table 1 Source: https://www.bmj.com/content/374/bmj.n1511
The research was an umbrella study of meta-analyses. This means that the team did not directly conduct their own research — although between them, they have a considerable body of research to their names — but instead reviewed the research published by others.
A meta-analysis is a piece of research that reviews the findings from other researchers who have directly investigated the topic. For example, a meta-analysis of knee surgery research might combine the findings of individual researchers from Europe, America, and Australia. The meta-analysis would look at how their results and use accepted methods in an attempt to draw them together.
While this might seem a sensible way to improve the quantity and quality of research, there are many things that can affect the validity of a meta-analysis. The individual studies included will not be researching exactly the same thing. Researchers in one country might, for example, exclude cases that were included in another, or one might have only included slightly different procedures in their analysis. This means that, despite the well-established methods to minimise the effects of these differences, meta-analyses need to be considered with that in mind. This is even more important in a case like this, which is effectively a meta-analysis of meta-analyses.
What does the report actually say?
In the study three key points were noted:
- Most common elective orthopaedic interventions are not backed up by readily available high-quality evidence, mostly owing to a lack of definitive randomised controlled trials
- Of the procedures studied, carpal tunnel decompression and total knee replacement showed superiority over non-operative care
- An urgent need exists to prioritise research into common elective orthopaedic interventions compared with no treatment, placebo, and non-operative treatment
The report concludes that, for many operative procedures, there is no high-quality research evidence that they are effective (with the exception being carpal tunnel decompression and total knee replacements). However, it does not conclude that they are ineffective, or that other interventions may be more effective.
Indeed, it recognises that for many procedures there is strong observational evidence that the procedures are safe and effective. For example, the team found no studies looking at the effectiveness of hip replacement, a common procedure. However, there is a large body of experience and observational evidence, from both medical professionals and patients, that would suggest surgical hip replacement is the most effective treatment.
Does this matter?
The research was looking for randomised control trials on the procedures. These trials are considered the gold standard of academic research. In them, patients are allocated to groups at random, with some receiving the treatment that is the subject of the research. Other patients will be allocated to different control groups depending on the research design, and might get no treatment, an alternative, or a placebo. The idea is to see how outcomes differ between the group to ensure the treatment is effective.
However, although these trials are the gold standard, there are times when they are not used. The most common is when the treatment benefits are so clear, there is not thought to be any need to research the effectiveness. A famous example of this is vaccination. Although individual vaccines are the subject of a rigorous series of tests and randomised control trials, the concept of vaccination as a treatment itself was never trialled.
There have, however, been examples where widely accepted medical practice has been found to be no more effective than alternatives. One study, in which patients received arthroscopy for osteoarthritis of the knee, or underwent a simulated procedure which included an incision, found that the outcomes were identical for both groups. This suggests that the benefits of an expensive surgery were actually the result of a placebo effect rather than the actual operation.
Perhaps the most famous example, although in a different field, of accepted medical practice being wrong was in stomach ulcers. For many years ulcers were linked with diet and stress, and, in some cases, surgery used to treat them. It was not until the 1980s that research showed they were caused by bacteria and could usually be treated with a simple antibiotic.
What does this mean for doctors and patients?
The study concludes that, for some procedures, more research is necessary to establish how effective they are and calls on doctors and researchers to fill the evidence gaps. However, it does not suggest that those procedures should not be carried out, or that any alternatives are better, simply that no research has been done. Instead, the report’s conclusion calls on doctors to make decisions based on the best evidence available. This should be research if it has been undertaken, but if none exists, to “base their judgment on observational evidence, acknowledging that this may be imperfect.”
Commenting after the report had been covered in the media, Professor Blom stressed that an absence of research did not make any difference to whether a procedure worked. Using hip replacement as an example, he highlighted that, like vaccination, “the observational evidence may be so overwhelming that trials would be deemed unethical or redundant.”
In essence, the research evidence, or lack of it, should be considered an element of informed consent. Anyone, medical professional or patient, considering surgery should always weigh the evidence. Whether that’s a rigorous randomised control trial that shows the procedure works, or millions of people who have successfully had an operation, so they can make the decision that is right for them.
Patient consent and joint surgery
According to statistics published by the NHS there are more than 200 musculoskeletal conditions which:
- affect 1 in 4 of the adult population
- account for 30% of GP consultations, in England (Department of Health (2006), A Joint Responsibility: doing it differently, pp 16);
- have an enormous impact on the quality of life of millions of people in the UK; 10.8 million days are lost as a consequence of musculoskeletal conditions (Graham Stringer (2011), Hansard, col: 1347)
- are associated with a large number of co-morbidities, including diabetes, depression and obesity (Arthritis Research UK (2013), Musculoskeletal Health: a public health approach);
- account for over 25% of all surgical interventions in the NHS, and this is set to rise significantly over the next ten years (Arthritis Research UK (2013, Musculoskeletal Health: a public health approach);
- account for £4.76 billion of NHS spending each year (Department of Health (2011), Programme Budgeting Data 2009-10, June).
With so many patients undergoing procedures such as joint replacements does this lack of clear evidence affect patient consent? According to the BMJ study a lack of high-quality evidence on their clinical effectiveness, (mainly because of a lack of definitive trials) “forces patients and clinicians to make decisions based solely on observational evidence”. And with the subsequent financial burden on the NHS and the risk of patients being subjected to unnecessary joint and bone surgery (which carry their own risks) – should orthopaedic surgeons be carrying out these procedures on such a wide scale?
The complications of orthopaedic surgery
Surgery always carries some risk and the risks and complications of bone or joint surgery could include:
- Deep vein thrombosis
- Pulmonary embolism
- Joint Instability and Dislocation
- Vascular Complications
- Nerve Injuries
- Periprosthetic Fractures
- Heterotopic Ossification
- Complex Regional Pain Syndrome
- Acute Compartment Syndrome
Other risks include failure to treat or improve a condition and untreated pressure sores.
Was your joint replacement surgery necessary?
Not all patients are properly advised on the costs and benefits of bone and joint replacement. They are often told about the risks of complications when things might go wrong [see list already in article], but they don’t always talk about the fact that some bone/joint replacements just don’t take/resolve the issue. Also, there are some things that are guaranteed to happen – the pain of surgery, the need for rehabilitative physiotherapy, the need for future revision surgery, etc.
Importantly, what this research shows is that clinicians are often relying on their own experience and expertise when advising on a course of action, and not always on objective evidence. And whilst many clinicians may have experience about the effectiveness of certain surgical procedures, the research suggests they may not necessarily appreciate the potential effectiveness of other more conservative measures.
They should be more proactive in explaining to patients that more conservative forms of treatment, like physiotherapy, carry fewer costs and risks, and may avoid the need for surgery altogether.
A previous client of ours underwent an unnecessary knee replacement followed by two revisions of the surgery. The replacement and two revisions of the knee replacement were unnecessary and the surgery should not have taken place at all. Our orthopaedic claims experts obtained £700K compensation for the patient.
Compensation for incorrect advice associated with joint replacement surgery
Our experts have supported clients all over the UK by securing compensation for orthopaedic negligence. Whether the negligence was associated with missed fractures, negligent surgery or treatment, unnecessary joint replacement surgery, failure to explain the risks of orthopaedic or joint replacement surgery or other area of negligence, we work hard to make sure that you receive the compensation you need to live as full a life as possible.