OsteoarthritisPhase 2NCT00566826
Perioperative Intervention to Improve Post-TKR Support and Function
A Phase 2 study testing Patient support sessions and Treatment as usual in people with Osteoarthritis and Arthroplasty, Replacement, Knee, run by University of Massachusetts, Worcester at 1 site in United States.
Trial summary
Knee osteoarthritis is one of the most common causes of disability in older adults. Total knee replacement (TRK) surgery is often an effective solution when persistent pain does not sufficiently improve with non-surgical treatment. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Osteoarthritis, Arthroplasty, Replacement, Knee
- What is being tested?
- Patient support sessions and Treatment as usual
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 196 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2008to Aug 2012
- Phase
- Phase 2
- 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Scheduled for TKR surgery with one of University of Massachusetts Memorial Health Center's surgeons prior to study entry
Who cannot join
- TKR due to fracture, malignancy, infection, or failure of a previous knee replacement surgery
- Inability to return home during the rehabilitation period
- Co-existing conditions that would negate functional improvement with surgery and exercise
- TKR surgery scheduled on an emergency basis
- Scheduled for TKR surgeries of both knees at the same time
- Terminal illness with a life expectancy of less than 1 year
Show all 9Show fewer
- Inability to provide informed consent due to dementia or cognitive impairment
- Planning another TKR or THR surgery within 6 months of study entry
- Unavailable to complete study procedures (i.e., will be out of the region during the rehabilitation period)
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Massachusetts Memorial Health Center; Arthritis and Total Joint Center
Worcester, Massachusetts, 01655
About this study
Knee osteoarthritis is one of the most common causes of disability in older adults. Total knee replacement (TRK) surgery is often an effective solution when persistent pain does not sufficiently improve with non-surgical treatment. Although most TKR surgeries are a success, an estimated 15% to 30% of patients report no clinically significant improvement in function 12 months after a TKR. This study will evaluate the effectiveness of a patient support program in increasing physical function after a TKR surgery.
Read the detailed description
Each year, more than 350,000 adults elect to have TKR surgery to eliminate knee pain and associated disabilities that persist despite ample medical treatment. Common knee problems of people who undergo TKR surgery include osteoarthritis, rheumatic diseases, and sudden or gradual joint injury. Most people who undergo TKR surgery experience immediate and significant decrease in pain, improved joint function, and increased physical activity. However, not all people who undergo TKR surgery report improvement, and there is no one factor that contributes to this variation in functional gain. With the rapid growth in the number of people electing to have TKR surgery and in the number of candidates eligible for TKR, optimal surgical results are both a clinical and public health priority. This study will evaluate the effectiveness of a patient support program emphasizing exercise and emotional health in increasing physical function after TKR surgery.
Participants in this study will be randomly assigned to a TKR patient support program or treatment as usual. The intervention patients will receive a program designed to complement the intensive physical rehabilitation period.
Sessions will aim to help participants enhance their self-management skills for behavior change.
- Conditions
- Osteoarthritis, Arthroplasty, Replacement, Knee
- Being tested
- Patient support sessions, Treatment as usual
- Keywords
- Physical Function, Total Knee Replacement, Physical Activity, Behavioral Support, Arthroplasty, Function, Self-Care
- Medical subject headings
- Osteoarthritis, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patient support sessionsBehavioural
Patient support sessions aim to enhance patient self-care for independent exercise and physical activity.
Treatment as usualBehavioural
Treatment as usual includes standard care for TKR surgery rehabilitation.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Patient support treatment sessions Receives: Behavioral: Patient support sessions |
| 2 | Active comparator | Treatment as usual Receives: Behavioral: Treatment as usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
Physical function (SF36, WOMAC)
Measured: Measured at Months 6 and 12
Secondary outcomes (1)
Physical activity and exercise
Measured: Measured at Months 6 and 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2007 (estimated)
- Study startJun 2008
- Primary completionAug 2012
- Study completionAug 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for OsteoarthritisStudies of the same condition, open and under way.
- More trials run by University of Massachusetts, WorcesterThe 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 196 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Massachusetts, Worcester
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
- Responsible party
- Principal investigator, Patricia Franklin, University of Massachusetts, Worcester
- Investigators
- Patricia D. Franklin, MD, Principal investigator, University of Massachusetts, WorcesterMilagros C. Rosal, PhD, Study director, University of Massachusetts, Worcester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00566826
- Sponsor's protocol ID
- R01AR054479
- Other IDs
- R01AR054479, H 12601
- Status last verified
- Aug 2023
- First submitted
- 30 Nov 2007
- Last updated
- 6 Sep 2023
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Ayers DC, Li W, Oatis C, Rosal MC, Franklin PD. Patient-reported outcomes after total knee replacement vary on the basis of preoperative coexisting disease in the lumbar spine and other nonoperatively treated joints: the need for a musculoskeletal comorbidity index. J Bone Joint Surg Am. 2013 Oct 16;95(20):1833-7. doi: 10.2106/JBJS.L.01007.
PubMed 24132356Zheng H, Rosal MC, Li W, Borg A, Yang W, Ayers DC, Franklin PD. A Web-Based Treatment Decision Support Tool for Patients With Advanced Knee Arthritis: Evaluation of User Interface and Content Design. JMIR Hum Factors. 2018 Apr 30;5(2):e17. doi: 10.2196/humanfactors.8568.
PubMed 29712620Oatis CA, Johnson JK, DeWan T, Donahue K, Li W, Franklin PD. Characteristics of Usual Physical Therapy Post-Total Knee Replacement and Their Associations With Functional Outcomes. Arthritis Care Res (Hoboken). 2019 Sep;71(9):1171-1177. doi: 10.1002/acr.23761.
PubMed 30281207Rosal 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.
PubMed 21981909
Study at a glance
From the registry record, last updated by the sponsor on 6 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Perioperative Intervention to Improve Post-TKR Support and Function
- ClinicalTrials.gov ID
- NCT00566826
- Acronym / sponsor ID
- R01AR054479
- Conditions
- Osteoarthritis, Arthroplasty, Replacement, Knee
- Keywords
- Physical Function, Total Knee Replacement, Physical Activity, Behavioral Support, Arthroplasty, Function, Self-Care
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 196 participants (actual)
- Lead sponsor
- University of Massachusetts, WorcesterUniversity, hospital or other
- Collaborators
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
- Study start
- Jun 2008
- Primary completion
- Aug 2012 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 4 Dec 2007 (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.
Knee osteoarthritis is one of the most common causes of disability in older adults. Total knee replacement (TRK) surgery is often an effective solution when persistent pain does not sufficiently improve with non-surgical treatment. Although most TKR surgeries are a success, an estimated 15% to 30% of patients report no clinically significant improvement in function 12 months after a TKR. This study will evaluate the effectiveness of a patient support program in increasing physical function after a TKR surgery.
Detailed description
Each year, more than 350,000 adults elect to have TKR surgery to eliminate knee pain and associated disabilities that persist despite ample medical treatment. Common knee problems of people who undergo TKR surgery include osteoarthritis, rheumatic diseases, and sudden or gradual joint injury. Most people who undergo TKR surgery experience immediate and significant decrease in pain, improved joint function, and increased physical activity. However, not all people who undergo TKR surgery report improvement, and there is no one factor that contributes to this variation in functional gain. With the rapid growth in the number of people electing to have TKR surgery and in the number of candidates eligible for TKR, optimal surgical results are both a clinical and public health priority. This study will evaluate the effectiveness of a patient support program emphasizing exercise and emotional health in increasing physical function after TKR surgery.
Participants in this study will be randomly assigned to a TKR patient support program or treatment as usual. The intervention patients will receive a program designed to complement the intensive physical rehabilitation period.
Sessions will aim to help participants enhance their self-management skills for behavior change.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Behavioral: Patient support sessionsPatient support treatment sessions |
| 2 | Active comparator | Behavioral: Treatment as usualTreatment as usual |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Scheduled for TKR surgery with one of University of Massachusetts Memorial Health Center's surgeons prior to study entry
Key exclusion criteria (9 listed)
- TKR due to fracture, malignancy, infection, or failure of a previous knee replacement surgery
- Inability to return home during the rehabilitation period
- Co-existing conditions that would negate functional improvement with surgery and exercise
- TKR surgery scheduled on an emergency basis
- Scheduled for TKR surgeries of both knees at the same time
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 |
|---|---|---|
| Patient support sessionsPatient support sessions aim to enhance patient self-care for independent exercise and physical activity. | Behavioural | 1 |
| Treatment as usualTreatment as usual includes standard care for TKR surgery rehabilitation. | Behavioural | 2 |
Primary outcome
Physical function (SF36, WOMAC)
Time frame: Measured at Months 6 and 12
1 secondary outcome
Physical activity and exercise
Time frame: Measured at Months 6 and 12
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Sep 2023.
- Results publication: PubMed 24132356Ayers DC, Li W, Oatis C, Rosal MC, Franklin PD. Patient-reported outcomes after total knee replacement vary on the basis of preoperative coexisting disease in the lumbar spine and other nonoperatively treated joints: the need for a musculoskeletal comorbidity index. J Bone Joint Surg Am. 2013 Oct 16;95(20):1833-7. doi: 10.2106/JBJS.L.01007.
- Results publication: PubMed 29712620Zheng H, Rosal MC, Li W, Borg A, Yang W, Ayers DC, Franklin PD. A Web-Based Treatment Decision Support Tool for Patients With Advanced Knee Arthritis: Evaluation of User Interface and Content Design. JMIR Hum Factors. 2018 Apr 30;5(2):e17. doi: 10.2196/humanfactors.8568.
- Derived from this study: PubMed 30281207Oatis CA, Johnson JK, DeWan T, Donahue K, Li W, Franklin PD. Characteristics of Usual Physical Therapy Post-Total Knee Replacement and Their Associations With Functional Outcomes. Arthritis Care Res (Hoboken). 2019 Sep;71(9):1171-1177. doi: 10.1002/acr.23761.
- Derived from this study: PubMed 21981909Rosal 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.
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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.
Patricia D. Franklin, MD principal investigator
University of Massachusetts, Worcester
Milagros C. Rosal, PhD study director
University of Massachusetts, Worcester
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Patient support sessions and Treatment as usual in people with Osteoarthritis and Arthroplasty, Replacement, Knee, 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 1 inclusion and 9 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 6 Sep 2023. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Physical function (SF36, WOMAC) (time frame: Measured at Months 6 and 12). 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 NCT00566826, which also lists 4 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 6 Sep 2023; AzTrials last refreshed its copy on 6 Nov 2026.