title: 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.
authors.affiliation: Hospital for Special Surgery, 535 East 70th Street, New York, New York 10021, USA. sue@hss.edu
authors.forename: E P
authors.initials: EP
authors.lastname: Su
authors.forename: M
authors.initials: M
authors.lastname: Perna
authors.forename: F
authors.initials: F
authors.lastname: Boettner
authors.forename: D J
authors.initials: DJ
authors.lastname: Mayman
authors.forename: T
authors.initials: T
authors.lastname: Gerlinger
authors.forename: W
authors.initials: W
authors.lastname: Barsoum
authors.forename: J
authors.initials: J
authors.lastname: Randolph
authors.forename: G
authors.initials: G
authors.lastname: Lee
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D019645:Arthroplasty, Replacement, Knee / Q000534:rehabilitation*; D017679:Cryotherapy / Q000295:instrumentation* / Q000379:methods; D004487:Edema / Q000209:etiology / Q000517:prevention & control; D005080:Exercise Test; D006801:Humans; D048228:Intermittent Pneumatic Compression Devices; D007592:Joint Diseases / Q000209:etiology / Q000517:prevention & control; D007719:Knee Joint / Q000502:physiology; D008875:Middle Aged; D020370:Osteoarthritis, Knee / Q000601:surgery*; D010149:Postoperative Pain / Q000517:prevention & control; D011182:Postoperative Care / Q000295:instrumentation* / Q000379:methods; D011183:Postoperative Complications / Q000517:prevention & control*; D011446:Prospective Studies; D016059:Range of Motion, Articular; D020127:Recovery of Function; D016037:Single-Blind Method; D016896:Treatment Outcome; D055815:Young Adult