TY - JOUR
T1 - Innovative Devices Did Not Provide Superior Total Knee Arthroplasty Outcomes in Post-Operative Rehabilitation
T2 - Results From a Four-Arm Randomized Clinical Trial
AU - DeJong, Gerben
AU - Hsieh, Chinghui Jean
AU - Vita, Michele T.
AU - Zeymo, Alexander
AU - Boucher, Henry R.
AU - Thakkar, Savyasachi C.
N1 - Funding Information:
The funding for this study was provided by a joint venture between MedStar National Rehabilitation Network and Suburban Hospital, DC (Johns Hopkins Medicine); Peninsula Regional Medical Center of the Peninsula Regional Health System, MD; and Accelerated Care Plus Corporation (ACP), NV. In-kind support was provided by AlterG (in the form of discount price anti-gravity treadmills); Accelerated Care Plus Corporation (in the form of portable PENS units); and MedStar Health Physical Therapy administrative and clinical staff. Neither of the companies, AlterG and ACP, whose devices were represented in the study, had any involvement over the course of the study apart from an initial review of the proposed study design and protocol. They were, however, apprised of study participant enrollment progress. Neither company saw the study findings until after this manuscript was prepared. Neither sponsor was involved in the collection, analysis, and interpretation of data; and in the decision to submit the article for publication. MedStar Health Physical Therapy was involved throughout but had no vested or financial interest in the outcome. The authors acknowledge the enormous internal support for the study within MedStar Nationsl Rehabilitation Network Rehabilitation Network and MedStar Health Health Physical Therapy and 15 of its outpatient centers without which this study would not have been possible: John Rockwood, MS, President; John Brickley, PT, MA, VP, Ambulatory Operations & Network Development; Linda Briggs Hawkins, EdD, Assistant Vice president for Business Development; all KAROS clinical coordinators, treating physical therapists, and their therapy center support staff; and MedStar Health patient care coordinators and specialists. The authors also acknowledge the following MedStar Health orthopedic surgeons who referred patients to the study: Dr James Tozzi, Dr Evan Argintar, Dr David Johnson, Dr Wiemi Douoguih, Dr Brian Evans, Dr Mark Zawadsky, Dr John Klimkiewicz, Dr James (“Ryan”) Macdonell, Dr Frank Ebert, Dr Robert McKinstry, Dr Richard Levine, Dr Richard Hinton, Dr Allison Fillar, Dr John O'Donnell, Dr Kenneth Tepper, Dr Jason Hammond, and Dr. Michael Jacobs.
Publisher Copyright:
© 2020 Elsevier Inc.
PY - 2020/8
Y1 - 2020/8
N2 - Background: Orthopedic surgeons face an increasing array of post-TKA (total knee arthroplasty) rehabilitation interventions that entail innovative equipment and devices, but their relative effectiveness remains unknown. The study compared patient outcomes among primary unilateral TKA patients participating in one of 4 post-TKA rehabilitation interventions—a standard-of-care intervention and 3 more recently developed physical therapy interventions. Methods: The Knee Arthroplasty Rehabilitation Outcomes Study is a 4-arm randomized clinical trial conducted across 15 outpatient rehabilitation clinics. The trial evaluated 4 alternative interventions: (1) a stationary recumbent bike (control intervention); (2) a body weight-adjustable treadmill; (3) a recumbent bike and use of a patterned electrical neuromuscular stimulation device; and (4) a body weight-adjustable treadmill and a patterned electrical neuromuscular stimulation device. The study's outcome measures were patient walking speed and the Knee injury and Osteoarthritis Outcome Score (KOOS) measured at therapy discharge and at follow-up. Results: The study enrolled 363 TKA patients with 90-92 patients in each of the 4 study arms. Participants were similar across the 4 groups: They were about 63 years old, 61% female, 67% white, living at home, overweight (mean body mass index = 31.6), with mostly private insurance (61%) or Medicare (32%). Walking speed was similar at admission and discharge; KOOS scores were similar at admission, discharge, and follow-up across the 4 intervention groups. Conclusion: The study found no statistical or clinically meaningful differences across the 4 study arms in walking speed or KOOS outcomes. Clinicians, payers, and policy makers will want to encourage providers and patients to use the least expensive intervention since each provide similar outcomes. Trial Registration: NCT02426190; https://clinicaltrials.gov/ct2/show/NCT02426190?term=NCT02426190&cntry=US&rank=1.
AB - Background: Orthopedic surgeons face an increasing array of post-TKA (total knee arthroplasty) rehabilitation interventions that entail innovative equipment and devices, but their relative effectiveness remains unknown. The study compared patient outcomes among primary unilateral TKA patients participating in one of 4 post-TKA rehabilitation interventions—a standard-of-care intervention and 3 more recently developed physical therapy interventions. Methods: The Knee Arthroplasty Rehabilitation Outcomes Study is a 4-arm randomized clinical trial conducted across 15 outpatient rehabilitation clinics. The trial evaluated 4 alternative interventions: (1) a stationary recumbent bike (control intervention); (2) a body weight-adjustable treadmill; (3) a recumbent bike and use of a patterned electrical neuromuscular stimulation device; and (4) a body weight-adjustable treadmill and a patterned electrical neuromuscular stimulation device. The study's outcome measures were patient walking speed and the Knee injury and Osteoarthritis Outcome Score (KOOS) measured at therapy discharge and at follow-up. Results: The study enrolled 363 TKA patients with 90-92 patients in each of the 4 study arms. Participants were similar across the 4 groups: They were about 63 years old, 61% female, 67% white, living at home, overweight (mean body mass index = 31.6), with mostly private insurance (61%) or Medicare (32%). Walking speed was similar at admission and discharge; KOOS scores were similar at admission, discharge, and follow-up across the 4 intervention groups. Conclusion: The study found no statistical or clinically meaningful differences across the 4 study arms in walking speed or KOOS outcomes. Clinicians, payers, and policy makers will want to encourage providers and patients to use the least expensive intervention since each provide similar outcomes. Trial Registration: NCT02426190; https://clinicaltrials.gov/ct2/show/NCT02426190?term=NCT02426190&cntry=US&rank=1.
KW - clinical trial
KW - physical therapy
KW - rehabilitation
KW - total knee arthroplasty
KW - total knee replacement
KW - treatment outcome
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U2 - 10.1016/j.arth.2020.03.048
DO - 10.1016/j.arth.2020.03.048
M3 - Article
C2 - 32360105
AN - SCOPUS:85084035234
SN - 0883-5403
VL - 35
SP - 2054
EP - 2065
JO - Journal of Arthroplasty
JF - Journal of Arthroplasty
IS - 8
ER -