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Knee OsteoarthritisNCT03120052

Physical Therapy Components for Maximum TKR Outcome

An observational study of Knee Osteoarthritis and Knee Replacement, run by University of Massachusetts, Worcester at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 99 years
Conditions the study is for
Knee Osteoarthritis, Knee Replacement
How many people
161 participants
Where
1 siteUnited States
Study dates
8 Jan 2018to 8 Dec 2020
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 99 years
  • All sexes
  • Adult, Older adult

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

Who may be able to join

  • 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.

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of Massachusetts Medical SChool

    Worcester, Massachusetts, 01655

Other trials in United States

About this study

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

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.

Medical subject headings
Osteoarthritis, Knee

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 6 month follow-up

Secondary outcomes (2)

  1. 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.

    Measured: 6 month follow-up

  2. 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.

    Measured: 6 month follow-up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Apr 2017
  2. Study start8 Jan 2018
  3. Primary completion8 Dec 2020
  4. Study completion8 Dec 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
161 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03120052
Sponsor's protocol ID
NIH 1 R01 AR071048-01
Other IDs
1R01AR071048-01
Status last verified
Mar 2021
First submitted
11 Apr 2017
Last updated
12 Mar 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 18810570

  • 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.

    PubMed 25220488

  • 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.

    PubMed 21485020

  • 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.

    PubMed 16594314

  • 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.

    PubMed 24023047

  • 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.

    PubMed 22113602

  • 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.

    PubMed 24602550

  • 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.

    PubMed 23965697

  • 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.

    PubMed 25765130

  • 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.

    PubMed 14635286

  • 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.

    PubMed 12598806

  • 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.

    PubMed 26594649

  • 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.

    PubMed 24497426

  • 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.

    PubMed 19651262

  • 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.

    PubMed 19651263

Questions about this trial

What is this clinical trial studying?

An observational study of Knee Osteoarthritis and Knee Replacement, run by University of Massachusetts, Worcester at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Differences in overall functional gain at 6 months (time frame: 6 month follow-up). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03120052, which also lists 31 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2021.

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