A Dearth of Evidence Supports Elective Orthopedic Surgeries

Are elective orthopedic procedures such as knee and hip replacements or shoulder repair surgery more effective than non-operative care?

According to a meta-analysis from the U.K., there is a dearth of evidence from clinical trials supporting these procedures.

In fact, only two procedures—carpal tunnel decompression and total knee replacement—garnered randomized controlled study evidence to support their superiority over non-operative care, Ashley W. Blom, MD, PhD, from the National Institute for Health Research Bristol Biomedical Research Center, University Hospitals Bristol and Weston NHS Foundation Trust and the University of Bristol, U.K., and colleagues reported in The BMJ.

Blom and colleagues undertook an umbrella review of meta-analyses of randomized controlled trials and—in cases where there were no randomized trials—looked at other study designs to determine if elective orthopedic procedures were superior to no treatment, placebo, or non-operative care and what impact these studies had on clinical guidelines. Their study looked at the ten most common elective orthopedic procedures—arthroscopic anterior cruciate ligament reconstruction, arthroscopic meniscal repair of the knee, arthroscopic partial meniscectomy of the knee, arthroscopic rotator cuff repair, arthroscopic subacromial decompression, carpal tunnel decompression, lumbar spine decompression, lumbar spine fusion, total hip replacement, and total knee replacement.

“Of the 10 procedures, no randomized controlled trials have compared total hip replacement and meniscal repair for acute tears with non-operative care,” Blom and colleagues wrote. “The other eight procedures have been studied in such trials, and some evidence supports the superiority of total knee replacement and strongly supports carpal tunnel decompression over non-operative care.”

The study authors also noted that randomized studies of anterior cruciate ligament reconstruction, arthroscopic partial meniscectomy, arthroscopic repair for acute rotator cuff tears, arthroscopic subacromial decompression, lumbar spinal decompression for spinal canal stenosis, and spinal fusion for degenerative disc disease had trial outcomes comparable to non-operative care.

But what do the guidelines recommend?

The researchers found that:

• “The American Academy of Orthopedic Surgeons (AAOS) recommends using arthroscopic anterior cruciate ligament reconstruction in certain subgroups of patients, as well as using either rotator cuff repair or non-operative care for rotator cuff tears.
• “The 2018 arthroscopic meniscal surgery treatment guidance from the British Association for Surgery of the Knee (BASK) recommends using arthroscopic meniscal repair to treat meniscal lesions of the knee in some patients, while acknowledging that no high quality level 1 evidence is available to support this.
• “The NICE guideline recommendation is to use lumbar spine decompression when non-operative treatment has failed.
• “NICE and other guideline bodies, on the basis of observational data, recommend total hip replacement for end-stage osteoarthritis of the hip.”

Blom and colleagues were encouraged, however, in that many of the recommendations do “reflect the current body of evidence.”

“Consensus statements from guideline societies do not recommend arthroscopic partial meniscectomy in patients with knee pain and a meniscal tear, strongly recommend against the use of subacromial decompression surgery for subacromial impingement syndrome support using open or endoscopic decompression for carpal tunnel syndrome, recommend against lumbar spine decompression for people with low back pain, and recommend total knee replacement for end stage osteoarthritis of the knee,” they wrote.

Their search for studies ran from inception of the study to September 2020, and they assessed the quality of the studies using the Assessment of Multiple Systematic Reviews instrument. To determine which studies had the best evidence, Blom et al used the Jadad decision algorithm, as well as the National Institute for Health and Care Excellence Evidence search to determine whether recommendations for procedures reflected the current body of evidence.

These results are important, they noted, in that surgery is not only expensive but fraught with morbidity, complication risks, and excess mortality. Therefore, solid evidence for the surgical route is needed, as is shared decision making between the physician and patient.

“When high level evidence shows that nonoperative care is equivalent, surgeons and patients should carefully consider what would be achieved by doing surgery,” Blom and colleagues wrote. “A cogent argument can be made for surgery being used as a second line treatment when non-surgical measures have failed or in certain subgroups of patients who have been identified as ’responders’ to surgical treatment. However, trials first need to be done to show the efficacy of surgery in these scenarios and to define the period of treatment with non-surgical interventions that is appropriate before surgery is undertaken.”

The study authors concluded that “surgeons and research funding bodies should actively contribute to filling the key knowledge gaps by enabling and participating in well constructed pragmatic randomized controlled trials” to fill the knowledge gaps for elective orthopedic surgeries.

Limitations of the study include its design and the use of the UK NICE guidelines in their search, even though the search did find guidelines from Europe and the United States.

1. According to a meta-analysis from the U.K., there is a dearth of evidence from clinical trials supporting these procedures.

2. Only two procedures—carpal tunnel decompression and total knee replacement—garnered randomized controlled study evidence to support these procedures’ superiority over non-operative care.

Candace Hoffmann, Managing Editor, BreakingMED™

Cat ID: 438

Topic ID: 437,438,438,730,192,925