Total knee replacement surgery was found to improve pain, functioning and quality of life, compared with non-surgical intervention, in a recent study published in the New England Journal of Medicine.
While total knee replacement for patients with knee osteoarthritis is thought to be an effective treatment, relatively few clinical trials have compared its effectiveness with non-surgical treatments, leading researchers from Denmark to conduct a randomised controlled trial of total knee replacement in patients with osteoarthritis.
Patients with osteoarthritis who were eligible for total knee replacement surgery were enrolled in the study. The patients were randomised to a non-surgical treatment group, consisting of exercise, education, dietary advice, insoles, and pain medication, or to a total knee replacement treatment group.
While the researchers reported clinically relevant improvements in patients assigned to the non-surgical treatment group, improvements in pain relief, functioning and quality of life were found to be greater in the total knee replacement group. Serious adverse events were also more frequent in the knee replacement group, compared with the non-surgical intervention group. Although treatment outcomes were better in the knee replacement group, only 26% of participants in the non-surgical group went on to have knee replacement surgery in the following year.
Another knee replacement clinical trial, being conducted by researchers from the University of Texas Health Science Center and ConforMIS, Inc., is currently recruiting participants with osteoarthritis of the knee. The trial is assessing the long-term outcomes of the ConforMIS iTotal® (CR) Knee Replacement System. This system is a customized knee implant that is designed to specifically fit a patients’ knee. By customizing the implant, there is a greater potential for reduced long-term pain following surgery. In addition, the iTotal CR is designed to simulate the natural shape of the knee, resulting in a more natural feel and movement. The trial is currently recruiting participants at centers across the United States.
Søren T. Skou, Ewa M. Roos, Mogens B. Laursen, Michael S. Rathleff, Lars Arendt-Nielsen, Ole Simonsen, and Sten Rasmussen. “A Randomized, Controlled Trial of Total Knee Replacement” N Engl J Med 2015; 373:1597-1606
clinicaltrials.gov “A Prospective, Multicenter Study to Evaluate the ConforMIS iTotal® (CR) Knee Replacement System” Available from: https://www.clinicaltrials.gov/ct2/show/NCT01820650?term=knee+replacement+AND+osteoarthritis&rank=12 Last Accessed: October 23, 2015.
Conformis Website: http://www.conformis.com/customized-knee-implants/products/itotal/ Last Accessed: October 23, 2015.
Written by Deborah Tallarigo, PhD