Preoperative Delay & Education Benefits Arthroplasty Patients Save

Having patients waiting for knee arthroplasty undergo a preoperative program of weight loss, exercise, and other interventions gave them modestly improved pain, function, and quality of life, a small randomized trial showed.

The main point of this pilot study, however, was simply to establish that the program was feasible and acceptable to patients, and by that yardstick it was a smashing success, according to A. Hamish R.W. Simpson, BCh, DM, of the University of Edinburgh in Scotland, and colleagues.

Median adherence to the personalized, multimodal regimen was 94% (interquartile range 79.5%-100%), with mean weight loss of 11.2 kg (24.6 lb) in the 40-person intervention group versus 1.3 kg (2.9 lb) among the study's 20 controls, researchers reported in Lancet Rheumatology. Recruitment also matched the initial target and most patients remained in the study until its scheduled completion.

Clinical outcomes, designated as secondary endpoints, were also improved with the program when evaluated just prior to scheduled surgery. Health-related quality of life scores were significantly higher and measures of pain and physical function trended toward greater improvement in the intervention group. Four of 40 intervention patients had enough improvement that they decided to cancel the scheduled surgery.

"This feasibility study showed that delivery of a complex, non-operative package of care to individuals with severe osteoarthritis and multiple long-term conditions waiting for knee replacement surgery is possible," Simpson and colleagues wrote. "The findings also showed that patients will enroll in a randomized study, adhere well to the intervention, and remain in the study until completion. Overall, participants found the intervention acceptable and beneficial."

Considerable research has been devoted to the question of whether joint replacement outcomes can be made even better with preoperative preparation and training. Most patients report reduced pain and improved function after surgery, but not everyone does. There is also the question of speeding recovery as well as maximizing its ultimate potential. Weight loss for overweight and obese patients has repeatedly been shown to help, but results have been mixed for various exercise regimens and other approaches.

As a first step, Simpson and colleagues sought to conduct a feasibility study before going ahead with a "fully powered effectiveness trial." They enrolled a total of 60 osteoarthritis patients on knee arthroplasty waiting lists in Edinburgh and Leeds in the U.K., randomizing them 2:1 to the intervention or usual National Health Service care.

The intervention covered weight loss (for those with body mass index values ≥30 at baseline), exercise, cushioning insoles for their shoes, and adjustments to patients' analgesic medications. The weight loss program was centered on an 810-calorie/day diet replacement. The exercise intervention was reserved for patients with serious functional deficits, such as an inability to stand up from a chair, and consisted of leg strength training. All patients not already using cushioning insoles were given some, and pain management regimes were reviewed for those not using standard analgesics, with an eye to optimizing use of over-the-counter drugs such as acetaminophen. Overall, the intervention was meant to last 16 weeks, with most evaluations performed 1 week before patients' scheduled surgery.

Some 70% of patients had BMI values of 30 or above. Mean age was about 67; 63% of the intervention group and 45% of controls were women. Most patients received several but not all of the four intervention components; only 45% needed new insoles and 55% had the analgesics review.

Since the study was meant to determine whether a larger trial could be attempted, primary outcome measures covered rates of recruitment and retention and compliance with the intervention. The latter was measured with questionnaires and, for obese participants, weight loss. More open-ended interviews were conducted with participants and study personnel, too, to help assess the intervention's feasibility in a trial setting.

Clinical outcomes included pain and functional assessments with the Oxford Knee Score, the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), the Timed Up and Go test, and questionnaires on self-efficacy and quality of life.

Recruitment started in September 2018; the goal was to have 60 participants by the following summer and it was achieved. Only five patients overall, including four in the intervention group, withdrew from the study prematurely. Thirty-six of the 40 participants in the intervention indicated afterward that they were "satisfied" or "very satisfied" with it.

Health-related quality of life measured with the EQ-5D-5L utility index, which runs from -0.59 to 1.0 (the latter representing perfect health), increased by 0.078 points on average -- "greater than the minimum clinically important difference," the authors observed -- with the intervention when assessed just before surgery, versus 0.006 points among controls. WOMAC scores for pain, stiffness, function, and overall just prior to surgery also improved more with the program. Similarly, Oxford scores and Timed Up and Go results also favored the intervention.

Evaluations conducted again 90 days after surgery were more of a mixed bag. WOMAC and Oxford scores at that point actually showed more improvement among controls -- by 10 points on the overall WOMAC score -- while Timed Up and Go and quality-of-life results were similar between groups.

All in all, Simpson and colleagues argued, the results warrant a larger effectiveness trial. They noted that the need for effective preoperative care for knee replacement candidates has increased with the COVID-19 pandemic, as "waiting times now are more than 1 year" in Britain.

"A full-scale study would be able to determine if the improvement in the health-related quality of life for the intervention group persisted for a year while patients were awaiting surgery and also the number of patients wanting to cancel surgery," the group wrote, and could also better determine the intervention's cost-effectiveness.

Limitations included a sample size too small to establish the intervention's effects on surgical outcomes, including post-operative complications.

Also, fewer than half of patients screened and considered eligible ultimately agreed to join the trial, a point highlighted in an accompanying editorial by two researchers at the University of Melbourne in Australia.

"Telehealth might enhance accessibility," wrote doctoral student Travis Haber and Michelle Hall, PhD, "but it is worth considering whether more people would participate in, and benefit sooner, from a comparable non-surgical package offered before this stage of care."

Overall, though, Haber and Hall were encouraged by the results. "This treatment package warrants evaluation in a full-scale trial. However, potentially important questions remain about how such an intervention package is delivered, with tension between wanting to deliver treatments to those most likely to benefit and the paucity of robust criteria to guide this process."

Source Reference: https://www.thelancet.com/journals/lanrhe/article/PIIS2665-9913(23)0033…