Physical Therapy Components for Maximum TKR Outcome

NCT03120052 | Completed

• 2 other identifiers: NIH 1 R01 AR071048-011R01AR071048-01
• Study Type: observational
• Target: 161
• Locations: 1 country
• Sites: 1

Brief Summary

The overall goal of this study is to identify what Physical Therapy care components are associated with the best patient-reported functional outcome after Total Knee Replacement (TKR) surgery. The investigators are specifically looking at outcomes at 6 and 12 months after surgery.

Conditions

Knee Osteoarthritis; Knee Replacement

Outcome Measures

Primary Outcomes (1)

• Differences in overall functional gain at 6 months

  Differences in pre-operative to 6 month post -operative functional gain, using the SF-36 Physical Component Summary (PCS) Score by physical therapy regimen.

  6 month follow-up

Secondary Outcomes (2)

• Differences in knee specific functional gain at 6 months

  6 month follow-up

• Differences in knee performance measures at 6 months

  6 month follow-up

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients electing total knee replacement at one of participating PT sites.

You may qualify if:

• Are scheduled to undergo an elective, unilateral primary total knee replacement due to knee osteoarthritis
• Will receive outpatient PT from a participating physical therapist.
• Agree to record their exercise and activity for specific time points in the study.

You may not qualify if:

• Total knee replacement scheduled for indications other than OA (e.g., fracture, malignancy, infection, or revision or prior implant)
• The inability to obtain informed consent due to cognitive conditions.
• Non-English speakers as the materials used in this project have not yet been tested with non-English speakers
• Individuals who are not yet adults (infants, children, teenagers)
• Pregnant women
• Prisoners

Sponsors & Collaborators

• University of Massachusetts, Worcester: lead
• National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS): collaborator

Study Sites (1)

University of Massachusetts Medical SChool

Worcester, Massachusetts, 01655, United States

Location

Related Publications (31)

• Franklin PD, Li W, Ayers DC. The Chitranjan Ranawat Award: functional outcome after total knee replacement varies with patient attributes. Clin Orthop Relat Res. 2008 Nov;466(11):2597-604. doi: 10.1007/s11999-008-0428-8.

  PMID: 18810570 BACKGROUND

• Han AS, Nairn L, Harmer AR, Crosbie J, March L, Parker D, Crawford R, Fransen M. Early rehabilitation after total knee replacement surgery: a multicenter, noninferiority, randomized clinical trial comparing a home exercise program with usual outpatient care. Arthritis Care Res (Hoboken). 2015 Feb;67(2):196-202. doi: 10.1002/acr.22457.

  PMID: 25220488 BACKGROUND

• Freburger JK, Holmes GM, Ku LJ, Cutchin MP, Heatwole-Shank K, Edwards LJ. Disparities in post-acute rehabilitation care for joint replacement. Arthritis Care Res (Hoboken). 2011 Jul;63(7):1020-30. doi: 10.1002/acr.20477.

  PMID: 21485020 BACKGROUND

• Naylor J, Harmer A, Fransen M, Crosbie J, Innes L. Status of physiotherapy rehabilitation after total knee replacement in Australia. Physiother Res Int. 2006 Mar;11(1):35-47. doi: 10.1002/pri.40.

  PMID: 16594314 BACKGROUND

• Westby MD, Brittain A, Backman CL. Expert consensus on best practices for post-acute rehabilitation after total hip and knee arthroplasty: a Canada and United States Delphi study. Arthritis Care Res (Hoboken). 2014 Mar;66(3):411-23. doi: 10.1002/acr.22164.

  PMID: 24023047 BACKGROUND

• Peter WF, Jansen MJ, Hurkmans EJ, Bloo H, Dekker J, Dilling RG, Hilberdink W, Kersten-Smit C, de Rooij M, Veenhof C, Vermeulen HM, de Vos RJ, Schoones JW, Vliet Vlieland TP; Guideline Steering Committee - Hip and Knee Osteoarthritis. Physiotherapy in hip and knee osteoarthritis: development of a practice guideline concerning initial assessment, treatment and evaluation. Acta Reumatol Port. 2011 Jul-Sep;36(3):268-81.

  PMID: 22113602 BACKGROUND

• Ebert JR, Munsie C, Joss B. Guidelines for the early restoration of active knee flexion after total knee arthroplasty: implications for rehabilitation and early intervention. Arch Phys Med Rehabil. 2014 Jun;95(6):1135-40. doi: 10.1016/j.apmr.2014.02.015. Epub 2014 Mar 3.

  PMID: 24602550 BACKGROUND

• Ruiz D Jr, Koenig L, Dall TM, Gallo P, Narzikul A, Parvizi J, Tongue J. The direct and indirect costs to society of treatment for end-stage knee osteoarthritis. J Bone Joint Surg Am. 2013 Aug 21;95(16):1473-80. doi: 10.2106/JBJS.L.01488.

  PMID: 23965697 BACKGROUND

• Ong KL, Lotke PA, Lau E, Manley MT, Kurtz SM. Prevalence and Costs of Rehabilitation and Physical Therapy After Primary TJA. J Arthroplasty. 2015 Jul;30(7):1121-6. doi: 10.1016/j.arth.2015.02.030. Epub 2015 Feb 28.

  PMID: 25765130 BACKGROUND

• Lingard EA, Berven S, Katz JN; Kinemax Outcomes Group. Management and care of patients undergoing total knee arthroplasty: variations across different health care settings. Arthritis Care Res. 2000 Jun;13(3):129-36.

  PMID: 14635286 BACKGROUND

• Roos EM. Effectiveness and practice variation of rehabilitation after joint replacement. Curr Opin Rheumatol. 2003 Mar;15(2):160-2. doi: 10.1097/00002281-200303000-00014.

  PMID: 12598806 BACKGROUND

• Oatis CA, Li W, DiRusso JM, Hoover MJ, Johnston KK, Butz MK, Phillips AL, Nanovic KM, Cummings EC, Rosal MC, Ayers DC, Franklin PD. Variations in Delivery and Exercise Content of Physical Therapy Rehabilitation Following Total Knee Replacement Surgery: A Cross-Sectional Observation Study. Int J Phys Med Rehabil. 2014;Suppl 5:002. doi: 10.4172/2329-9096.S5-002. Epub 2014 Apr 22.

  PMID: 26594649 BACKGROUND

• Peter WF, Nelissen RG, Vlieland TP. Guideline recommendations for post-acute postoperative physiotherapy in total hip and knee arthroplasty: are they used in daily clinical practice? Musculoskeletal Care. 2014 Sep;12(3):125-31. doi: 10.1002/msc.1067. Epub 2014 Feb 4.

  PMID: 24497426 BACKGROUND

• Dejong G, Horn SD, Smout RJ, Tian W, Putman K, Gassaway J. Joint replacement rehabilitation outcomes on discharge from skilled nursing facilities and inpatient rehabilitation facilities. Arch Phys Med Rehabil. 2009 Aug;90(8):1284-96. doi: 10.1016/j.apmr.2009.02.009.

  PMID: 19651262 BACKGROUND

• DeJong G, Tian W, Smout RJ, Horn SD, Putman K, Smith P, Gassaway J, Davanzo JE. Use of rehabilitation and other health care services by patients with joint replacement after discharge from skilled nursing and inpatient rehabilitation facilities. Arch Phys Med Rehabil. 2009 Aug;90(8):1297-305. doi: 10.1016/j.apmr.2008.12.029.

  PMID: 19651263 BACKGROUND

• Fritz JM, Hunter SJ, Tracy DM, Brennan GP. Utilization and clinical outcomes of outpatient physical therapy for medicare beneficiaries with musculoskeletal conditions. Phys Ther. 2011 Mar;91(3):330-45. doi: 10.2522/ptj.20090290. Epub 2011 Jan 13.

  PMID: 21233306 BACKGROUND

• Artz N, Dixon S, Wylde V, Beswick A, Blom A, Gooberman-Hill R. Physiotherapy provision following discharge after total hip and total knee replacement: a survey of current practice at high-volume NHS hospitals in England and wales. Musculoskeletal Care. 2013 Mar;11(1):31-8. doi: 10.1002/msc.1027. Epub 2012 Jul 9.

  PMID: 22778023 BACKGROUND

• Pozzi F, Snyder-Mackler L, Zeni J. Physical exercise after knee arthroplasty: a systematic review of controlled trials. Eur J Phys Rehabil Med. 2013 Dec;49(6):877-92. Epub 2013 Oct 30.

  PMID: 24172642 BACKGROUND

• Rosal MC, Ayers D, Li W, Oatis C, Borg A, Zheng H, Franklin P. A randomized clinical trial of a peri-operative behavioral intervention to improve physical activity adherence and functional outcomes following total knee replacement. BMC Musculoskelet Disord. 2011 Oct 7;12:226. doi: 10.1186/1471-2474-12-226.

  PMID: 21981909 BACKGROUND

• Petterson SC, Mizner RL, Stevens JE, Raisis L, Bodenstab A, Newcomb W, Snyder-Mackler L. Improved function from progressive strengthening interventions after total knee arthroplasty: a randomized clinical trial with an imbedded prospective cohort. Arthritis Rheum. 2009 Feb 15;61(2):174-83. doi: 10.1002/art.24167.

  PMID: 19177542 BACKGROUND

• Bade MJ, Stevens-Lapsley JE. Early high-intensity rehabilitation following total knee arthroplasty improves outcomes. J Orthop Sports Phys Ther. 2011 Dec;41(12):932-41. doi: 10.2519/jospt.2011.3734. Epub 2011 Sep 30.

  PMID: 21979411 BACKGROUND

• Minns Lowe CJ, Barker KL, Dewey M, Sackley CM. Effectiveness of physiotherapy exercise after knee arthroplasty for osteoarthritis: systematic review and meta-analysis of randomised controlled trials. BMJ. 2007 Oct 20;335(7624):812. doi: 10.1136/bmj.39311.460093.BE. Epub 2007 Sep 20.

  PMID: 17884861 BACKGROUND

• Skoffer B, Dalgas U, Mechlenburg I. Progressive resistance training before and after total hip and knee arthroplasty: a systematic review. Clin Rehabil. 2015 Jan;29(1):14-29. doi: 10.1177/0269215514537093. Epub 2014 Jul 3.

  PMID: 24994766 BACKGROUND

• Zech A, Hendrich S, Pfeifer K. Association Between Exercise Therapy Dose and Functional Improvements in the Early Postoperative Phase After Hip and Knee Arthroplasty: An Observational Study. PM R. 2015 Oct;7(10):1064-1072. doi: 10.1016/j.pmrj.2015.04.008. Epub 2015 Apr 16.

  PMID: 25892356 BACKGROUND

• Moffet H, Tousignant M, Nadeau S, Merette C, Boissy P, Corriveau H, Marquis F, Cabana F, Ranger P, Belzile EL, Dimentberg R. In-Home Telerehabilitation Compared with Face-to-Face Rehabilitation After Total Knee Arthroplasty: A Noninferiority Randomized Controlled Trial. J Bone Joint Surg Am. 2015 Jul 15;97(14):1129-41. doi: 10.2106/JBJS.N.01066.

  PMID: 26178888 BACKGROUND

• Spangehl MJ. Is It Time for Telerehabilitation to Go Mainstream? J Bone Joint Surg Am. 2015 Jul 15;97(14):e55. doi: 10.2106/JBJS.O.00540. No abstract available.

  PMID: 26178897 BACKGROUND

• Kramer JF, Speechley M, Bourne R, Rorabeck C, Vaz M. Comparison of clinic- and home-based rehabilitation programs after total knee arthroplasty. Clin Orthop Relat Res. 2003 May;(410):225-34. doi: 10.1097/01.blo.0000063600.67412.11.

  PMID: 12771834 BACKGROUND

• NIH Consensus Panel. NIH Consensus Statement on total knee replacement December 8-10, 2003. J Bone Joint Surg Am. 2004 Jun;86(6):1328-35. doi: 10.2106/00004623-200406000-00031. No abstract available.

  PMID: 15173310 BACKGROUND

• Goldstein MS, Scalzitti DA, Craik RL, Dunn SL, Irion JM, Irrgang J, Kolobe TH, McDonough CM, Shields RK. The revised research agenda for physical therapy. Phys Ther. 2011 Feb;91(2):165-74. doi: 10.2522/ptj.20100248. Epub 2010 Dec 17. No abstract available.

  PMID: 21169424 BACKGROUND

• White NT, Delitto A, Manal TJ, Miller S. The American Physical Therapy Association's top five choosing wisely recommendations. Phys Ther. 2015 Jan;95(1):9-24. doi: 10.2522/ptj.20140287. Epub 2014 Sep 15. No abstract available.

  PMID: 25223237 BACKGROUND

• Franklin PD, Allison JJ, Ayers DC. Beyond joint implant registries: a patient-centered research consortium for comparative effectiveness in total joint replacement. JAMA. 2012 Sep 26;308(12):1217-8. doi: 10.1001/jama.2012.12568. No abstract available.

  PMID: 23011710 BACKGROUND

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Patricia D Franklin, MD, MBA, MPH

  University of Massachusetts, Worcester

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 11, 2017
• First Posted: April 19, 2017
• Study Start: January 8, 2018
• Primary Completion: December 8, 2020
• Study Completion: December 8, 2020
• Last Updated: March 12, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)