Physical Therapy Components for Maximum TKR Outcome

Knee Osteoarthritis Clinical Trial

Official title:

Defining Components of Physical Therapy Achieving Maximum Function After Total Knee Replacement

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03120052
• Other study ID #: NIH 1 R01 AR071048-01
• Secondary ID: 1R01AR071048-01
• Status: Completed
• Start date: January 8, 2018
• Est. completion date: December 8, 2020

Study information

• Verified date: March 2021
• Source: University of Massachusetts, Worcester
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 161
• Est. completion date: December 8, 2020
• Est. primary completion date: December 8, 2020
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Knee Osteoarthritis
• Knee Replacement
• Osteoarthritis
• Osteoarthritis, Knee

Locations

Country	Name	City	State
United States	University of Massachusetts Medical SChool	Worcester	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
University of Massachusetts, Worcester	National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Country where clinical trial is conducted

United States, 

References & Publications (31)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. Epub 2007 Sep 20. Review. — View Citation

Moffet H, Tousignant M, Nadeau S, Mérette C, Boissy P, Corriveau H, Marquis F, Cabana F, Ranger P, Belzile ÉL, 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. — View Citation

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. — View Citation

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. Review. — View Citation

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. pii: 002. Epub 2014 Apr 22. — View Citation

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. — View Citation

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. — View Citation

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. Review. — View Citation

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. — View Citation

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. Review. — View Citation

Roos EM. Effectiveness and practice variation of rehabilitation after joint replacement. Curr Opin Rheumatol. 2003 Mar;15(2):160-2. Review. — View Citation

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. — View Citation

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. — View Citation

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. Review. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 31 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Differences in knee specific functional gain at 6 months	Differences in pre-operative to 6 month post-operative functional gain, using the Knee Injury and Osteoarthritis Outcome Score (KOOS) Activities of Daily Living (ADL) by physical therapy regimen.	6 month follow-up
Secondary	Differences in knee performance measures at 6 months	Differences in pre-operative to 6-month post -operative knee performance measures using the Physical Therapy Performance Measures (includes a 5 minute stair climbing exercise, a 6 minute walking exercise and a sit to stand exercise) by physical therapy regimen.	6 month follow-up