A prospective, multi-center, randomised trial to evaluate the efficacy of a cryopneumatic device on total knee arthroplasty recovery

Abstract

Pain, swelling and inflammation are expected during the recovery from total knee arthroplasty (TKA) surgery. The severity of these factors and how a patient copes with them may determine the ultimate outcome of a TKA. Cryotherapy and compression are frequently used modalities to mitigate these commonly experienced sequelae. However, their effect on range of motion, functional testing, and narcotic consumption has not been well-studied. A prospective, multi-center, randomised trial was conducted to evaluate the effect of a cryopneumatic device on post-operative TKA recovery. Patients were randomised to treatment with a cryopneumatic device or ice with static compression. A total of 280 patients were enrolled at 11 international sites. Both treatments were initiated within three hours post-operation and used at least four times per day for two weeks. The cryopneumatic device was titrated for cooling and pressure by the patient to their comfort level. Patients were evaluated by physical therapists blinded to the treatment arm. Range of motion (ROM), knee girth, six minute walk test (6MWT) and timed up and go test (TUG) were measured pre-operatively, two- and six-weeks post-operatively. A visual analog pain score and narcotic consumption was also measured post-operatively. At two weeks post-operatively, both the treatment and control groups had diminished ROM and function compared to pre-operatively. Both groups had increased knee girth compared to pre- operatively. There was no significant difference in ROM, 6MWT, TUG, or knee girth between the 2 groups. We did find a significantly lower amount of narcotic consumption (509 mg morphine equivalents) in the treatment group compared with the control group (680 mg morphine equivalents) at up to two weeks postop, when the cryopneumatic device was being used (p < 0.05). Between two and six weeks, there was no difference in the total amount of narcotics consumed between the two groups. At six weeks, there was a trend toward a greater distance walked in the 6MWT in the treatment group (29.4 meters versus 7.9 meters, p = 0.13). There was a significant difference in the satisfaction scores of patients with their cooling regimen, with greater satisfaction in the treatment group (p < 0.0001). There was no difference in ROM, TUG, VAS, or knee girth at six weeks. There was no difference in adverse events or compliance between the two groups. A cryopneumatic device used after TKA appeared to decrease the need for narcotic medication from hospital discharge to 2 weeks post-operatively. There was also a trend toward a greater distance walked in the 6MWT. Patient satisfaction with the cryopneumatic cooling regimen was significantly higher than with the control treatment.