Volunteers in the surgery group gained an average of 32.5 points versus 16.0 points for people who received nonsurgical therapy. All started off with a score of about 48 on a 101-point assessment scale.
Individual measures of pain, symptoms, activities of daily living, quality of life, and sports and recreation all showed significant improvement with surgery.
But while there were just six instances of serious adverse events in the 50 patients who didn’t receive surgery, there were four times as many among the 50 assigned to have a knee replaced. One third of the problems involved the replaced knee, including three cases each of unacceptable stiffness and deep vein thrombosis requiring anticoagulation, and one case each of deep infection and leg fracture.
Thirteen of the 50 patients assigned to the no-surgery group ended up having their knee replaced anyway during the 12-month, follow-up period.
“We’ve had some patients who had the surgery who did not improve in pain and, in some cases, had worse pain,” Skou said. They may improve with longer followup, but, he said, “what struck me is, if you do not go through surgery, you could always have the surgery later.”
Pollak said he doesn’t think the study will change U.S. attitudes about the surgery because it only followed patients for a year and cultural differences between U.S. patients the ones studied in Denmark may play a role in how the two treatments play out.
Of 108 eligible patients, 100 agreed to be randomly assigned to the surgery or non-surgery group. “Most health care providers in the U.S. couldn’t imagine where 100 of 108 patients would decide whether to have the operation based on the flip of a coin,” Pollak said.
Ultimately, what the new study tells patients, he said, “is what many doctors have been telling them right along. ‘You don’t have to have a knee replacement. It’s an option for you. But your quality of life will improve if you have it.'”