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Recovery Following Primary Total Knee ArthroplastyNCT01826305

Independent Exercise Compared With Formal Rehabilitation Following Primary Total Knee Replacement

A study testing Formal Rehabilitation Therapy and Independent Exercise Cohort in people with Recovery Following Primary Total Knee Arthroplasty, run by University of California, San Francisco at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

In this study we plan to compare the efficacy of independent exercises performed by the patients at home to formal rehabilitation therapy following primary total knee replacement. Patients will be randomized to these two cohorts at enrollment into the study and followed prospectively. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Formal Rehabilitation Therapy and Independent Exercise Cohort
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
23 participants
Where
1 siteUnited States
Study dates
Jul 2014to 23 Oct 2015
Phase
Interventional
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • scheduled for primary total knee arthroplasty
  • an age of eighteen years or older
  • English speaking
  • have a computer with access to the Internet

Who cannot join

  • any knee arthroplasty other than total knee
  • patients not planning to return for follow up care
  • patients relying on others for basic functioning
  • do not speak English
  • do not have a computer with access to the Internet
  • prior physical therapy

Trial locations and contacts

1 site in 1 country.

United States1 site
  • University of California, San Francisco

    San Francisco, California, 94143

Other trials in United States

About this study

In this study we plan to compare the efficacy of independent exercises performed by the patients at home to formal rehabilitation therapy following primary total knee replacement. Patients will be randomized to these two cohorts at enrollment into the study and followed prospectively. Patients randomized to the formal rehabilitation cohort will receive a prescription for therapy for twelve weeks. Patients randomized to the independent exercise cohort will receive online access to a twelve-week protocol of exercises to perform at home to strengthen and improve function of the replaced joint.

At enrollment, a baseline evaluation will be conducted to capture demographics, height, weight, primary diagnosis, medical comorbidities, and social supports as well as completion of the selected outcome measure, American Knee Society (AKS) Score, Knee and Osteoarthritis Outcome Score (KOOS). Secondary outcomes will include the measurement of health status with use of the Short Form-12v2 (SF-12v2) and activity level with the University of California, Los Angeles (UCLA) Activity Score. At the twelve-week, six-month and twelve-month follow-up visits, the study subjects will complete the KOOS, SF-12v2, and UCLA Activity Score questionnaires. Statistical analysis will be performed to compare the outcomes between the two cohorts.

Read more

Hypothesis:

There will be no difference in outcomes between formal rehabilitation and independent exercises at twelve months after primary total knee replacement surgery using the American Knee Society (AKS) Knee Score.

Read the detailed description

We will randomize patients who are scheduled to have primary total knee arthroplasty to receive either a prescription for formal physical therapy (PT) or instructions for independent exercises. Inclusion criteria will be: scheduled for primary total knee arthroplasty, an age of eighteen years or older, speak English, and have a computer with access to the Internet. Exclusion criteria will be: any knee arthroplasty other than total knee, patients not planning to return for follow up care, patients relying on others for basic functioning, do not speak English, and do not have a computer with access to the Internet. Enrollment will occur at the initial clinic visit in the surgeon's office.

Informed consent will be received from patients who will participate in the study at the initial clinic visit and these patients will be randomized equally to either the PT/OT or independent exercise cohort using the REDCap website randomization feature. REDCap is a secure, web-based application for building and managing online surveys and databases that will be utilized for this study for data management. Patients that will be randomized to PT cohort will be prescribed formal therapy for twelve weeks with supervised exercises to regain knee strength and range of motion. Therapists will not be involved in the study design and therapists will not be informed that patients are participating in this study. The content, frequency, and duration of the rehabilitation program will be at the discretion of the treating therapist, consistent with usual practice.

The patients who will be in the independent exercises cohort will be registered on www.careforpatients.com, an online rehabilitation resource that provides computer aided rehabilitative exercises. Patients will follow a prepared 12-week protocol of exercises to perform postoperatively to gradually regain their knee strength and range of motion.

Post-operative weeks 0 - 1, the patients will perform three sets of ten repetitions everyday of: supine ankle pumps, supine heel slides, seated quad sets, supine glut sets, and supine hip abduction/adduction. The patient will also perform three sets of patella mobilization for one minute each and three sets of one repetition of supine knee extension.

Post-operative weeks 1 - 2, the patients will perform three sets of ten repetitions everyday of: supine heel slides, prone knee flexion, supine knee extension, supine SLR flexion, sidelying SLR abduction, prone SLR extension, sidelying SLR adduction. The patient will also perform three sets of patella mobilization for one minute each and three sets of one repetition of supine knee extension with weight.

Post-operative weeks 2 - 4, the patients will perform three sets of ten repetitions everyday of: standing knee extension, standing knee flexion, standing SLR flexion, standing SLR abduction, standing SLR extension, standing SLR adduction. The patient will also perform three sets of patella mobilization for one minute each, three sets of sitting hamstring stretch for thirty seconds each, prone quad stretch for thirty seconds each, and three sets of single leg stance for thirty seconds each.

Post-operative weeks 4 - 8, the patients will perform three sets of ten repetitions everyday of: bilateral mini squats, standing SLR flexion, standing SLR abduction, standing SLR extension, standing SLR adduction. The patient will also perform three sets of sitting hamstring stretch for thirty seconds each and prone quad stretch for thirty seconds each.

Post-operative weeks 8 - 12, the patients will perform three sets of ten repetitions everyday of: bilateral wall squats, forward step-ups, and side step-ups. The patient will also perform three sets of sitting hamstring stretch for thirty seconds each and prone quad stretch for thirty seconds each. Patients will be advised to perform these exercises as often as possible, but at least once a day.

All patients will have regularly scheduled follow-up visits per usual practice at six-weeks post-operatively, six-months post-operatively, and 12-months post-operatively where a physical exam will be performed to check the range of motion of the knee, gait, and lower leg muscle strength.

The primary outcome of the trial will be to evaluate the efficacy of formal therapy compared with independent exercises at twelve months after surgery with use of the American Knee Society (AKS) Knee Score. Secondary outcomes will include the Knee and Osteoarthritis Outcome Score (KOOS) the measurement of health status with use of the Short Form-12v2 (SF-12v2) and activity level with the University of California, Los Angeles (UCLA) Activity Score.

At enrollment, a baseline evaluation will be conducted to capture demographics, height, weight, primary diagnosis, medical comorbidities, and social supports as well as completion of the selected outcome measures, AKS, KOOS, SF-12v2, and UCLA Activity Score. At the twelve-week, six-month and twelve-month follow-up visits, the study subjects will complete the AKS, KOOS, SF-12v2, and UCLA Activity Score questionnaires during their clinic visit or will be contacted by telephone or mail to complete the questionnaires if they do not have appointments for twelve-week, six-month or twelve-month follow-ups.

Being tested
Formal Rehabilitation Therapy, Independent Exercise Cohort

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Formal Rehabilitation TherapyProcedure or surgery

    Also called Physical Therapy

    Patients that will be randomized to the formal rehabilitation therapy cohort will be prescribed formal therapy for twelve weeks with supervised exercises to regain knee strength and range of motion. Therapists will not be involved in the study design and therapists will not be informed that patients are participating in this study. The content, frequency, and duration of the rehabilitation program will be at the discretion of the treating therapist, consistent with usual practice.

  • Independent Exercise CohortProcedure or surgery

    The patients who will be in the independent exercises cohort will be registered on www.careforpatients.com, an online rehabilitation resource that provides computer aided rehabilitative exercises. Patients will follow a prepared 12-week protocol of exercises to perform post-operatively to gradually regain their knee strength, flexion, extension, abduction, and adduction.

Study groups in NCT01826305
Study groupRoleWhat they receive
Formal Rehabilitation TherapyActive comparatorPatients randomized to the formal rehabilitation therapy cohort will receive a prescription for therapy for twelve weeks following their primary knee replacement.
Receives: Procedure: Formal Rehabilitation Therapy
Independent Exercise CohortExperimentalPatients randomized to the independent exercise cohort will receive online access to a twelve-week protocol of exercises to perform at home to strengthen and improve function of the replaced knee.
Receives: Procedure: Independent Exercise Cohort

What is being measured

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

  1. Knee Function

    The American Knee Society Score (AKS) consists of two parts. The first is the Knee Score, which considers pain, stability and range of motion as the main parameters, with deductions for flexion contractures, extension lag and malalignment. The second part, the Function Score, utilizes walking distance and stair climbing as the main parameters with deductions for the use of a walking aid.

    Measured: up to 12 months post-operatively

Secondary outcomes (3)
  1. General physical and mental health

    The Short Form 12v2 (SF-12v2) is an abbreviated version of the Short Form-36 (SF-36) that includes the physical and emotional limitations that are placed on work and social activities. The SF-12v2 measures how individuals value their current health state. It has been shown to be reliable (Pearson r > 0.70), valid (highly correlated with SF-36), and responsive for the measurements of health status in many patient populations.

    Measured: up to 12 months post-operatively

  2. Activity Level

    The UCLA Activity Score assesses an individual's level of activity. The evaluation has ten descriptive activity levels ranging from wholly inactive and dependent on others (level 1), to moderate activities such as unlimited housework and shopping (level 6), to regular participation in impact sports such as jogging or tennis (level 10). The individual is asked to pick the statement that best describes their activity level.

    Measured: up to 12 months post-operatively

  3. Knee and Osteoarthritis Outcome Score (KOOS)

    The KOOS is a self-administered 40-item questionnaire used to assess patient-relevant outcomes in five separate subscales related to the knee (pain, symptoms, activity of daily living, sport and recreation function and knee related quality of life). The KOOS contains all Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) questions in unchanged form, so a WOMAC score can be calculated from the KOOS. The WOMAC is used to assess pain, function, and stiffness of the knee.

    Measured: up to 12 months post-operatively

Timeline

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

  1. First posted8 Apr 2013 (estimated)
  2. Study startJul 2014
  3. Primary completion23 Oct 2015
  4. Study completion23 Oct 2015

Resources

More details

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

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
23 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01826305
Sponsor's protocol ID
12-09642
Status last verified
Jan 2020
First submitted
3 Apr 2013
Last updated
18 Jan 2020
Results posted
No

Publications

  • Mahomed NN, Davis AM, Hawker G, Badley E, Davey JR, Syed KA, Coyte PC, Gandhi R, Wright JG. Inpatient compared with home-based rehabilitation following primary unilateral total hip or knee replacement: a randomized controlled trial. J Bone Joint Surg Am. 2008 Aug;90(8):1673-80. doi: 10.2106/JBJS.G.01108.

    PubMed 18676897
  • Khan F, Ng L, Gonzalez S, Hale T, Turner-Stokes L. Multidisciplinary rehabilitation programmes following joint replacement at the hip and knee in chronic arthropathy. Cochrane Database Syst Rev. 2008 Apr 16;2008(2):CD004957. doi: 10.1002/14651858.CD004957.pub3.

    PubMed 18425906
  • Shepperd S, Iliffe S. Hospital at home versus in-patient hospital care. Cochrane Database Syst Rev. 2005 Jul 20;(3):CD000356. doi: 10.1002/14651858.CD000356.pub2.

    PubMed 16034853
  • Mahomed NN, Koo Seen Lin MJ, Levesque J, Lan S, Bogoch ER. Determinants and outcomes of inpatient versus home based rehabilitation following elective hip and knee replacement. J Rheumatol. 2000 Jul;27(7):1753-8.

    PubMed 10914863
  • Shepperd S, Harwood D, Jenkinson C, Gray A, Vessey M, Morgan P. Randomised controlled trial comparing hospital at home care with inpatient hospital care. I: three month follow up of health outcomes. BMJ. 1998 Jun 13;316(7147):1786-91. doi: 10.1136/bmj.316.7147.1786.

    PubMed 9624068
  • Kurtz S, Ong K, Lau E, Mowat F, Halpern M. Projections of primary and revision hip and knee arthroplasty in the United States from 2005 to 2030. J Bone Joint Surg Am. 2007 Apr;89(4):780-5. doi: 10.2106/JBJS.F.00222.

    PubMed 17403800
  • Dorr LD, Maheshwari AV, Long WT, Wan Z, Sirianni LE. Early pain relief and function after posterior minimally invasive and conventional total hip arthroplasty. A prospective, randomized, blinded study. J Bone Joint Surg Am. 2007 Jun;89(6):1153-60. doi: 10.2106/JBJS.F.00940.

    PubMed 17545416
  • Munin MC, Rudy TE, Glynn NW, Crossett LS, Rubash HE. Early inpatient rehabilitation after elective hip and knee arthroplasty. JAMA. 1998 Mar 18;279(11):847-52. doi: 10.1001/jama.279.11.847.

    PubMed 9515999
  • Nilsdotter AK, Lohmander LS, Klassbo M, Roos EM. Hip disability and osteoarthritis outcome score (HOOS)--validity and responsiveness in total hip replacement. BMC Musculoskelet Disord. 2003 May 30;4:10. doi: 10.1186/1471-2474-4-10. Epub 2003 May 30.

    PubMed 12777182
  • Roos EM, Toksvig-Larsen S. Knee injury and Osteoarthritis Outcome Score (KOOS) - validation and comparison to the WOMAC in total knee replacement. Health Qual Life Outcomes. 2003 May 25;1:17. doi: 10.1186/1477-7525-1-17.

    PubMed 12801417
  • Nilsdotter AK, Toksvig-Larsen S, Roos EM. A 5 year prospective study of patient-relevant outcomes after total knee replacement. Osteoarthritis Cartilage. 2009 May;17(5):601-6. doi: 10.1016/j.joca.2008.11.007. Epub 2008 Nov 21.

    PubMed 19091604
  • Hurst NP, Ruta DA, Kind P. Comparison of the MOS short form-12 (SF12) health status questionnaire with the SF36 in patients with rheumatoid arthritis. Br J Rheumatol. 1998 Aug;37(8):862-9. doi: 10.1093/rheumatology/37.8.862.

    PubMed 9734677
  • Terwee CB, Bouwmeester W, van Elsland SL, de Vet HC, Dekker J. Instruments to assess physical activity in patients with osteoarthritis of the hip or knee: a systematic review of measurement properties. Osteoarthritis Cartilage. 2011 Jun;19(6):620-33. doi: 10.1016/j.joca.2011.01.002. Epub 2011 Jan 18.

    PubMed 21251989
  • Bellamy N, Buchanan WW, Goldsmith CH, Campbell J, Stitt LW. Validation study of WOMAC: a health status instrument for measuring clinically important patient relevant outcomes to antirheumatic drug therapy in patients with osteoarthritis of the hip or knee. J Rheumatol. 1988 Dec;15(12):1833-40.

    PubMed 3068365
  • Collins NJ, Misra D, Felson DT, Crossley KM, Roos EM. Measures of knee function: International Knee Documentation Committee (IKDC) Subjective Knee Evaluation Form, Knee Injury and Osteoarthritis Outcome Score (KOOS), Knee Injury and Osteoarthritis Outcome Score Physical Function Short Form (KOOS-PS), Knee Outcome Survey Activities of Daily Living Scale (KOS-ADL), Lysholm Knee Scoring Scale, Oxford Knee Score (OKS), Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), Activity Rating Scale (ARS), and Tegner Activity Score (TAS). Arthritis Care Res (Hoboken). 2011 Nov;63 Suppl 11(0 11):S208-28. doi: 10.1002/acr.20632. No abstract available.

    PubMed 22588746

Questions about this trial

What is this clinical trial studying?

A study testing Formal Rehabilitation Therapy and Independent Exercise Cohort in people with Recovery Following Primary Total Knee Arthroplasty, run by University of California, San Francisco 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 4 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: stopped early, as of the sponsor's last update on 18 Jan 2020. 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 was stopped early. Results are not available in the source record.

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?

Knee Function (time frame: up to 12 months post-operatively). 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 NCT01826305, which also lists 15 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 18 Jan 2020.

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