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.
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
- Conditions the study is for
- Recovery Following Primary Total Knee Arthroplasty
- 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
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 group | Role | What they receive |
|---|---|---|
| Formal Rehabilitation Therapy | Active comparator | Patients 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 Cohort | Experimental | 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 knee. Receives: Procedure: Independent Exercise Cohort |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
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
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
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.
- First posted8 Apr 2013 (estimated)
- Study startJul 2014
- Primary completion23 Oct 2015
- Study completion23 Oct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for Recovery Following Primary Total Knee ArthroplastyStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kevin J. Bozic, MD, MBA, Principal investigator, University of California, San Francisco
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 18676897Khan 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 18425906Shepperd 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 16034853Mahomed 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 10914863Shepperd 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 9624068Kurtz 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 17403800Dorr 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 17545416Munin 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 9515999Nilsdotter 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 12777182Roos 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 12801417Nilsdotter 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 19091604Hurst 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 9734677Terwee 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 21251989Bellamy 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 3068365Collins 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
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Independent Exercise Compared With Formal Rehabilitation Following Primary Total Knee Replacement
- ClinicalTrials.gov ID
- NCT01826305
- Acronym / sponsor ID
- 12-09642
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 23 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Study start
- Jul 2014
- Primary completion
- 23 Oct 2015 (actual)
- Study completion
- 23 Oct 2015 (actual)
- First posted
- 8 Apr 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Formal Rehabilitation Therapy | Active comparator | Procedure: Formal Rehabilitation TherapyPatients randomized to the formal rehabilitation therapy cohort will receive a prescription for therapy for twelve weeks following their primary knee replacement. |
| Independent Exercise Cohort | Experimental | Procedure: Independent Exercise CohortPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- scheduled for primary total knee arthroplasty
- an age of eighteen years or older
- English speaking
- have a computer with access to the Internet
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Formal Rehabilitation TherapyAlso: Physical TherapyPatients 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. | Procedure or surgery | Formal Rehabilitation Therapy |
| Independent Exercise CohortThe 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. | Procedure or surgery | Independent Exercise Cohort |
Primary outcome
Knee Function
Time frame: up to 12 months post-operatively
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.
3 secondary outcomes
General physical and mental health
Time frame: up to 12 months post-operatively
Activity Level
Time frame: up to 12 months post-operatively
Knee and Osteoarthritis Outcome Score (KOOS)
Time frame: up to 12 months post-operatively
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2020.
- Background: PubMed 18676897Mahomed 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.
- Background: PubMed 18425906Khan 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.
- Background: PubMed 16034853Shepperd 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.
- Background: PubMed 10914863Mahomed 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.
- Background: PubMed 9624068Shepperd 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.
- Background: PubMed 17403800Kurtz 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.
- Background: PubMed 17545416Dorr 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.
- Background: PubMed 9515999Munin 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.
- Background: PubMed 12777182Nilsdotter 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.
- Background: PubMed 12801417Roos 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.
- Background: PubMed 19091604Nilsdotter 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.
- Background: PubMed 9734677Hurst 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kevin J. Bozic, MD, MBA principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
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.