{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,7,17]],"date-time":"2026-07-17T15:33:23Z","timestamp":1784302403973,"version":"3.55.0"},"reference-count":26,"publisher":"Georg Thieme Verlag KG","issue":"04","funder":[{"name":"University of Missouri's Coulter Biomedical Accelerator Program"},{"name":"Department of Orthopaedic Surgery"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["J Knee Surg"],"published-print":{"date-parts":[[2023,3]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:p>This prospective randomized clinical trial assessed a novel device for initial management of knee range of motion (ROM), pain, and function after total knee arthroplasty (TKA). Primary TKA patients with preoperative ROM of at least 5\u00b0 to 115\u00b0 were randomized to initial knee motion management: Mizzou BioJoint Flex\u2014novel motion-assistive device with prescribed physical therapy or standard physical therapy\u2014prescribed physical therapy. ROM, pain score, and knee injury and osteoarthritis score for joint replacement (KOOSjr) were obtained preoperatively and 2 weeks, 6 weeks, and 3 months postoperatively. Patient satisfaction for both cohorts and subjective assessments of the MBF device were assessed at 3 months. Readmissions, reoperations, and complications were assessed through 1 year. Nineteen patients were randomized to each cohort, with no significant preoperative differences in demographics, pain score, KOOSjr score, or ROM. Six SPT (31.6%) and 3 MBF (15.8%) patients failed to regain preoperative ROM (p\u2009=\u20090.044). One SPT (5.3%) and eight MBF (42%) patients exceeded 125\u00b0 ROM (p\u2009=\u20090.019) by 3 months. Total ROM (p\u2009=\u20090.039), pain (p\u2009=\u20090.0068), and function (p\u2009=\u20090.0027) were significantly better for MBF at 3 months. MBF patients reported significantly higher satisfaction (mean, 9.4\u2009\u00b1\u20091.1 vs. 8.0\u2009\u00b1\u20091.8, respectively; p\u2009=\u20090.0084). One patient in each group underwent manipulation under anesthesia. No other readmissions, reoperations, or complications were reported. A novel durable medical equipment device can provide a safe and effective patient-controlled method for initial management of knee ROM, pain, and function after primary TKA with potential clinically meaningful advantages over physical therapy alone. In conjunction with physical therapy, management with this novel knee flexion device more effectively restored knee ROM and early patient function when compared with therapy alone and was associated with higher proportions of patients regaining minimum (115\u00b0) and desired (125\u00b0) levels of knee ROM and clinically meaningful differences in pain scores, knee function, and patient satisfaction. This is a Level 1, prospective trial study.<\/jats:p>","DOI":"10.1055\/s-0041-1735160","type":"journal-article","created":{"date-parts":[[2021,9,16]],"date-time":"2021-09-16T23:45:37Z","timestamp":1631835937000},"page":"424-430","source":"Crossref","is-referenced-by-count":1,"title":["Prospective, Randomized Clinical Trial Comparing a Novel Motion-Assistive Device to Standard Physical Therapy for Initial Management of Knee Range of Motion after Primary Total Knee Arthroplasty"],"prefix":"10.1055","volume":"36","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-0862-995X","authenticated-orcid":false,"given":"James L.","family":"Cook","sequence":"additional","affiliation":[{"name":"Department of Orthopaedic Surgery, University of Missouri, Columbia, Missouri"},{"name":"Department of Orthopaedic Surgery, Thompson Laboratory for Regenerative Orthopaedics, University of Missouri, Columbia, Missouri"},{"name":"Department of Orthopaedic Surgery, Mizzou BioJoint Center, University of Missouri, Columbia, Missouri"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-8627-1500","authenticated-orcid":false,"given":"Kylee","family":"Rucinski","sequence":"additional","affiliation":[{"name":"Department of Orthopaedic Surgery, University of Missouri, Columbia, Missouri"},{"name":"Department of Orthopaedic Surgery, Thompson Laboratory for Regenerative Orthopaedics, University of Missouri, Columbia, Missouri"},{"name":"Department of Orthopaedic Surgery, Mizzou BioJoint Center, University of Missouri, Columbia, Missouri"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Cory R.","family":"Crecelius","sequence":"additional","affiliation":[{"name":"Department of Orthopaedic Surgery, University of Missouri, Columbia, Missouri"},{"name":"Department of Orthopaedic Surgery, Mizzou BioJoint Center, University of Missouri, Columbia, Missouri"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Suzin","family":"Cunningham","sequence":"additional","affiliation":[{"name":"Department of Orthopaedic Surgery, University of Missouri, Columbia, Missouri"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Trent M.","family":"Guess","sequence":"additional","affiliation":[{"name":"Department of Orthopaedic Surgery, University of Missouri, Columbia, Missouri"},{"name":"Department of Physical Therapy, University of Missouri, Columbia, Missouri"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"194","published-online":{"date-parts":[[2021,9,16]]},"reference":[{"issue":"03","key":"ref1","doi-asserted-by":"crossref","first-page":"269","DOI":"10.1016\/j.ocl.2019.02.005","article-title":"Arthrofibrosis after total knee arthroplasty: pathophysiology, diagnosis, and management","volume":"50","author":"R Thompson","year":"2019","journal-title":"Orthop Clin North Am"},{"issue":"01","key":"ref2","doi-asserted-by":"crossref","first-page":"127","DOI":"10.1007\/s11999-012-2533-y","article-title":"Postoperative alignment and ROM affect patient satisfaction after TKA","volume":"471","author":"S Matsuda","year":"2013","journal-title":"Clin Orthop Relat Res"},{"issue":"07","key":"ref3","doi-asserted-by":"crossref","first-page":"1479","DOI":"10.2106\/00004623-200407000-00017","article-title":"Stiffness after total knee arthroplasty. Prevalence of the complication and outcomes of revision","volume":"86","author":"J Kim","year":"2004","journal-title":"J Bone Joint Surg Am"},{"key":"ref4","doi-asserted-by":"crossref","first-page":"71","DOI":"10.1054\/arth.2002.32450","article-title":"The stiff total knee arthroplasty: evaluation and management","volume":"17","author":"W J Maloney","year":"2002","journal-title":"J Arthroplasty"},{"issue":"08","key":"ref5","doi-asserted-by":"crossref","first-page":"896","DOI":"10.1016\/S0883-5403(98)90196-6","article-title":"Relationship between length of stay and manipulation rate after total knee arthroplasty","volume":"13","author":"D R Mauerhan","year":"1998","journal-title":"J Arthroplasty"},{"issue":"02","key":"ref6","doi-asserted-by":"crossref","first-page":"111","DOI":"10.1016\/j.knee.2005.10.001","article-title":"Stiffness after total knee arthroplasty: prevalence, management and outcomes","volume":"13","author":"H S Yercan","year":"2006","journal-title":"Knee"},{"issue":"08","key":"ref7","doi-asserted-by":"crossref","first-page":"1092","DOI":"10.1016\/j.arth.2006.11.009","article-title":"The role of flexion contracture on outcomes in primary total knee arthroplasty","volume":"22","author":"M A Ritter","year":"2007","journal-title":"J Arthroplasty"},{"issue":"03","key":"ref8","doi-asserted-by":"crossref","first-page":"111","DOI":"10.1007\/s10195-009-0054-6","article-title":"Stiffness in total knee arthroplasty","volume":"10","author":"A Schiavone Panni","year":"2009","journal-title":"J Orthop Traumatol"},{"issue":"S 03","key":"ref9","first-page":"59","article-title":"Functional problems and arthrofibrosis following total knee arthroplasty","volume":"89","author":"T M Seyler","year":"2007","journal-title":"J Bone Joint Surg Am"},{"issue":"03","key":"ref10","doi-asserted-by":"crossref","first-page":"159","DOI":"10.1016\/j.bjpt.2017.03.012","article-title":"Hip, knee, and ankle kinematics during activities of daily living: a cross-sectional study","volume":"21","author":"K Hyodo","year":"2017","journal-title":"Braz J Phys Ther"},{"issue":"08","key":"ref11","doi-asserted-by":"crossref","first-page":"273","DOI":"10.2519\/jospt.1988.9.8.273","article-title":"Joint motions of the lower limb during ergometer cycling","volume":"9","author":"M O Ercison","year":"1988","journal-title":"J Orthop Sports Phys Ther"},{"issue":"01","key":"ref12","first-page":"102","article-title":"Comprehensive profile of hip, knee and ankle ranges of motion in professional football players","volume":"59","author":"A L\u00f3pez-Valenciano","year":"2019","journal-title":"J Sports Med Phys Fitness"},{"issue":"460","key":"ref13","doi-asserted-by":"crossref","first-page":"174","DOI":"10.1097\/BLO.0b013e318046ccb7","article-title":"Range of motion correlates with patient perception of TKA outcome","volume":"460","author":"R Padua","year":"2007","journal-title":"Clin Orthop Relat Res"},{"issue":"08","key":"ref14","doi-asserted-by":"crossref","first-page":"2604","DOI":"10.1016\/j.arth.2017.02.005","article-title":"Arthrofibrosis associated with total knee arthroplasty","volume":"32","author":"V A Cheuy","year":"2017","journal-title":"J Arthroplasty"},{"issue":"09","key":"ref15","doi-asserted-by":"crossref","first-page":"2325967118794490","DOI":"10.1177\/2325967118794490","article-title":"Risk factors for manipulation under anesthesia and\/or lysis of adhesions after anterior cruciate ligament reconstruction","volume":"6","author":"J Huleatt","year":"2018","journal-title":"Orthop J Sports Med"},{"key":"ref16","doi-asserted-by":"crossref","first-page":"184","DOI":"10.1186\/1471-2474-12-184","article-title":"Arthrofibrosis after TKA - 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