Knee Replacement, TotalPAS-TKANCT04090125
Improving Physical Activity and Gait Symmetry After Total Knee Arthroplasty
A study testing PAS Intervention in people with Knee Replacement, Total and Knee Arthroplasty, Total, run by University of North Carolina, Chapel Hill at 1 site in United States.
Trial summary
The purpose of this pilot study is to examine the effectiveness of the Physical Activity and Symmetry (PAS) program, compared to an attention (ATT)control group, for patients with post-total knee arthroplasty (TKA). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Knee Replacement, Total, Knee Arthroplasty, Total
- What is being tested?
- PAS Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Nov 2019to 26 Jul 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Patients receiving post-total knee arthroplasty (TKA) physical therapy (PT) at a University of North Carolina (UNC) Healthcare System clinic
Who cannot join
- significant cognitive impairment
- neurological disorders affecting gait
- systemic rheumatic disease
- hospitalization for a cardiovascular condition the past six months
- psychosis
- substance abuse disorder
- lower extremity surgery in the past year
- any other health conditions determined to be contraindications to a home exercise program
Trial locations and contacts
1 site in 1 country.
United States1 site
UNC Thurston Arthritis Research Center
Chapel Hill, North Carolina, 27599
About this study
The purpose of this pilot study is to examine the effectiveness of the Physical Activity and Symmetry (PAS) program, compared to an attention (ATT)control group, for patients with post-total knee arthroplasty (TKA). The investigators hypothesize that the PAS treatment will result in meaningful improvements in physical activity (PA) and joint loading symmetry compared to the ATT group.
Read the detailed description
Background and Significance: Total knee arthroplasty (TKA) has been shown to decrease pain and to improve range of motion and some aspects of physical function. However, accumulating evidence shows that patients have persistent deficits in other critical outcomes following TKA. First, the majority of patients do not substantially increase physical activity beyond levels prior to TKA, remaining well below Department of Health and Human Services recommendations and levels of healthy individuals. This has serious negative implications for both joint health and overall health. Second, studies show that gait asymmetries are common following TKA, such that patients continue to load the non-surgical leg more heavily during walking, even when the post-surgical leg is pain free. This places the contralateral limb at risk for developing or worsening osteoarthritis. Other research shows there is large variability in post-TKA rehabilitation, along with sub-optimal exercise content. Collectively, these findings emphasize the critical need to improve the post-TKA rehabilitation process. However, there are currently no evidence-based approaches to improve overall physical activity and deficits in joint loading symmetry that have been identified following TKA.
Study Aims: This research project will provide important preliminary information on the novel post-TKA PAS program through achieving the following specific aims: 1) Obtain preliminary data on the efficacy of the PAS program with respect to the change in objectively assessed physical activity, measured via accelerometers; 2) Obtain preliminary data on the efficacy of the PAS program with respect to change in peak load symmetry during walking, measured by a novel 3-sensor insole device; 3) Assess the feasibility and acceptability of the PAS program following TKA.
Study Description: Investigators will conduct an exploratory randomized controlled study, with n=60 patients >=18 years receiving post-TKA physical therapy (PT) at a UNC Healthcare System clinic. Patients will be equally allocated to the PAS intervention or an attention (ATT) control group.
- Conditions
- Knee Replacement, Total, Knee Arthroplasty, Total
- Being tested
- PAS Intervention, Attention Control
- Keywords
- knee, total knee replacement, physical therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PAS InterventionBehavioural
The PAS program will be initiated during the final usual care PT visits. The PAS content will be included within the last two routine PT visits (Sessions 1 and 2). Session 1 will emphasize the importance of PA in TKA recovery, work with participants to establish SMART goals regarding overall PA and provide community-based and other resources to support overall PA. Session 2 will include balance exercise content to improve joint loading symmetry and home exercises will be assigned. Then, PAS participants will receive a follow-up phone call after 4 weeks (to assist with activity progression and problem-solving) and an additional in-person visit after 8 weeks (to visually monitor exercise performance and re-assess proportional weight-bearing ability).
Attention ControlBehavioural
This will include usual in-person post TKA PT followed by 2 additional contacts (Session 1 and 2) with the physical therapist. Session 1 (phone) will review recovery benchmarks, assessment of participants' daily activities and reminders about symptoms that should trigger contacting a medical professional. Session 2 (in-person) will involve physical performance tests and comparison to appropriate normative values.
| Study group | Role | What they receive |
|---|---|---|
| Physical Activity and Symmetry (PAS) Intervention | Experimental | Participants assigned to the PAS intervention will receive 4 sessions on balance training and physical activity coaching delivered by a physical therapist, in addition to their usual post-TKA physical therapy (PT) care. Receives: Behavioral: PAS Intervention |
| Attention Control | Placebo comparator | Participants assigned to the ATT group will receive usual post-TKA physical therapy (PT) care, followed by two additional sessions with their physical therapist. Receives: Behavioral: Attention Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline to Month 3 in Objectively Assessed Physical Activity (Accelerometer)
Minutes of moderate to vigorous intensity PA (MVPA) per week measured via accelerometer.
A log transformation was applied due to superior diagnostics relative to untransformed values in statistical modeling; transformed values are presented here.
Measured: Baseline, Month 3
Change From Baseline to Month 6 in Objectively Assessed Physical Activity (Accelerometer)
Minutes of moderate to vigorous intensity PA (MVPA) per week measured via accelerometer.
A log transformation was applied due to superior diagnostics relative to untransformed values in statistical modeling; transformed values are presented here.
Measured: Baseline, Month 6
Change From Baseline to Month 3 in Peak Joint Load Symmetry During Walking
Participants will complete a 10 meter walking test while load beneath each foot is recorded using an instrumented insole. Loading symmetry (peak ground reaction force) will be assessed using the limb symmetry index (LSI (|Surgical/Non-Surgical|*100), values lower than 100% indicate less loading of the surgical limb.
A log transformation was applied due to superior diagnostics relative to untransformed values in statistical modeling; transformed values are presented here.
Measured: Baseline, Month 3
Change From Baseline to Month 6 in Peak Joint Load Symmetry During Walking
Participants will complete a 10 meter walking test while load beneath each foot is recorded using an instrumented insole. Loading symmetry (peak ground reaction force) will be assessed using the limb symmetry index (LSI (|Surgical/Non-Surgical|*100), values lower than 100% indicate less loading of the surgical limb.
A log transformation was applied due to superior diagnostics relative to untransformed values in statistical modeling; transformed values are presented here.
Measured: Baseline, Month 6
Secondary outcomes (16)
Change From Baseline to Month 3 in Self-Reported Physical Activity.
Self-Reported Physical Activity will be assessed using the Modified version of the CHAMPS (Community Health Activities Model Program for Seniors) Physical Activity Measure. Data from the questionnaire is used to determine variety, frequency, and minutes per week from physical activity. This outcome pertains to minutes of physical activity of moderate or greater intensity (metabolic equivalents ≥ 3.0). A square root transformation was applied due to superior diagnostics relative to untransformed values in statistical modeling; transformed values are presented here.
Measured: Baseline, Month 3
Change From Baseline Month 6 in Self-Reported Physical Activity.
Self-Reported Physical Activity will be assessed using the Modified version of the CHAMPS (Community Health Activities Model Program for Seniors) Physical Activity Measure. Data from the questionnaire is used to determine variety, frequency, and minutes per week from physical activity. This outcome pertains to minutes of physical activity of moderate or greater intensity (metabolic equivalents ≥ 3.0). A square root transformation was applied due to superior diagnostics relative to untransformed values in statistical modeling; transformed values are presented here.
Measured: Baseline to Month 6
Change From Baseline to Month 3 in Steps Per Day
Step counts measured via accelerometer. A log transformation was applied due to superior diagnostics relative to untransformed values in statistical modeling; transformed values are presented here.
Measured: Baseline, Month 3
Change From Baseline to Month 6 in Steps Per Day
Step counts measured via accelerometer. A log transformation was applied due to superior diagnostics relative to untransformed values in statistical modeling; transformed values are presented here.
Measured: Baseline, Month 6
Change From Baseline to Month 3 in Minutes of Any Physical Activity (PA)
Minutes of any PA measured via accelerometer. A log transformation was applied due to superior diagnostics relative to untransformed values in statistical modeling; transformed values are presented here.
Measured: Baseline, Month 3
Change From Baseline to Month 6 in Minutes of Any Physical Activity (PA)
Minutes of any PA measured via accelerometer. A log transformation was applied due to superior diagnostics relative to untransformed values in statistical modeling; transformed values are presented here.
Measured: Baseline, Month 6
Change From Baseline to Month 3 in Sedentary Minutes
Minutes of sedentary activity per day, measured via accelerometer
Measured: Baseline, Month 3
Change From Baseline to Month 6 in Sedentary Minutes
Minutes of sedentary activity per day, measured via accelerometer
Measured: Baseline, Month 6
Change From Baseline to Month 3 in Berg Balance Scale
Berg Balance Scale includes 14 tests of static and dynamic balance. Each item is scored along a 5-point scale, ranging from 0 to 4. Zero indicates the lowest level of function and 4 the highest level of function. The total score ranges from 0 to 56. Lower scores indicate reduced functional mobility.
Measured: Baseline, Month 3
Change From Baseline to Month 6 in Berg Balance Scale
Berg Balance Scale includes 14 tests of static and dynamic balance. Each item is scored along a 5-point scale, ranging from 0 to 4. Zero indicates the lowest level of function and 4 the highest level of function. The total score ranges from 0 to 56. Lower scores indicate reduced functional mobility.
Measured: Baseline, Month 6
Change From Baseline to Month 3 in Brief Balance Evaluation Systems Test
Brief Balance Evaluation Systems includes 8 tasks across 6 domains. Each item is scored: 0-3 points (0 representing severe impairment and 3 representing no balance impairment), score range is 0-24). Lower scores indicate higher levels of balance impairment.
Measured: Baseline, Month 3
Change From Baseline to Month 6 in Brief Balance Evaluation Systems Test
Brief Balance Evaluation Systems includes 8 tasks across 6 domains. Each item is scored: 0-3 points (0 representing severe impairment and 3 representing no balance impairment), score range is 0-24. Lower scores indicate higher levels of balance impairment.
Measured: Baseline, Month 6
Change From Baseline to Month 3 in Knee Injury and Osteoarthritis Outcome Score (KOOS)
The KOOS is a patient-reported outcome measurement instrument, developed to assess the patient's opinion about their knee and associated problems. Five KOOS subscale scores were administered: Pain (9 items), Symptoms (7 items), Function in daily living (17 items), Function in Sport and Recreation (5 items), and knee-related Quality of Life (4 items). All items are scored on 5-point Likert scales. A normalized score (100 indicating no symptoms and 0 indicating extreme symptoms) is calculated for each subscale.
Measured: Baseline, Month 3
Change From Baseline to Month 6 in Knee Injury and Osteoarthritis Outcome Score (KOOS)
The KOOS is a patient-reported outcome measurement instrument, developed to assess the patient's opinion about their knee and associated problems. Five KOOS subscale scores were administered: Pain (9 items), Symptoms (7 it4ems) Function in daily living (17 items), Function in Sport and Recreation (5 items), and knee-related Quality of Life (4 items). All items are scored on 5-point Likert scales. A normalized score (100 indicating no symptoms and 0 indicating extreme symptoms) is calculated for each subscale.
Measured: Baseline, Month 6
Change From Baseline to Month 3 in Tampa Scale for Kinesiophobia
The Tampa Scale of Kinesiophobia is a 17 item scale for assessing fear of movement. The scale specifically assesses activity avoidance due to pain-related fear of movement. All items are measured on a 4-point scale from "strongly agree" to "strongly disagree." A score of 17 is the lowest possible score, and indicates no kinesiophobia or negligible. A score of 68 is the highest possible score and indicates extreme fear of pain with movement.
Measured: Baseline, Month 3
Change From Baseline to Month 6 in Tampa Scale for Kinesiophobia
The Tampa Scale of Kinesiophobia is a 17 item scale for assessing fear of movement. The scale specifically assesses activity avoidance due to pain-related fear of movement. All items are measured on a 4-point scale from "strongly agree" to "strongly disagree." A score of 17 is the lowest possible score, and indicates no kinesiophobia or negligible. A score of 68 is the highest possible score and indicates extreme fear of pain with movement.
Measured: Baseline, Month 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2019
- Study start8 Nov 2019
- Primary completion26 Jul 2023
- Study completion26 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Knee Replacement, TotalStudies of the same condition, open and under way.
- More trials run by University of North Carolina, Chapel HillThe 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
- Responsible party
- Sponsor
- Investigators
- Kelli D Allen, PhD, Principal investigator, University of North Carolina, Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04090125
- Sponsor's protocol ID
- 19-0568
- Other IDs
- R21AR074149-01A1
- Acronym
- PAS-TKA
- Status last verified
- Dec 2022
- First submitted
- 12 Sep 2019
- Last updated
- 5 Mar 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Deidentified individual data that supports the results will be shared following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with UNC.
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Physical Activity and Gait Symmetry After Total Knee Arthroplasty
- ClinicalTrials.gov ID
- NCT04090125
- Acronym / sponsor ID
- PAS-TKA / 19-0568
- Conditions
- Knee Replacement, Total, Knee Arthroplasty, Total
- Keywords
- knee, total knee replacement, physical therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
- Study start
- 8 Nov 2019 (actual)
- Primary completion
- 26 Jul 2023 (actual)
- Study completion
- 26 Jul 2023 (actual)
- First posted
- 16 Sep 2019 (actual)
- Results
- Posted 5 Mar 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this pilot study is to examine the effectiveness of the Physical Activity and Symmetry (PAS) program, compared to an attention (ATT)control group, for patients with post-total knee arthroplasty (TKA). The investigators hypothesize that the PAS treatment will result in meaningful improvements in physical activity (PA) and joint loading symmetry compared to the ATT group.
Detailed description
Background and Significance: Total knee arthroplasty (TKA) has been shown to decrease pain and to improve range of motion and some aspects of physical function. However, accumulating evidence shows that patients have persistent deficits in other critical outcomes following TKA. First, the majority of patients do not substantially increase physical activity beyond levels prior to TKA, remaining well below Department of Health and Human Services recommendations and levels of healthy individuals. This has serious negative implications for both joint health and overall health. Second, studies show that gait asymmetries are common following TKA, such that patients continue to load the non-surgical leg more heavily during walking, even when the post-surgical leg is pain free. This places the contralateral limb at risk for developing or worsening osteoarthritis. Other research shows there is large variability in post-TKA rehabilitation, along with sub-optimal exercise content. Collectively, these findings emphasize the critical need to improve the post-TKA rehabilitation process. However, there are currently no evidence-based approaches to improve overall physical activity and deficits in joint loading symmetry that have been identified following TKA.
Study Aims: This research project will provide important preliminary information on the novel post-TKA PAS program through achieving the following specific aims: 1) Obtain preliminary data on the efficacy of the PAS program with respect to the change in objectively assessed physical activity, measured via accelerometers; 2) Obtain preliminary data on the efficacy of the PAS program with respect to change in peak load symmetry during walking, measured by a novel 3-sensor insole device; 3) Assess the feasibility and acceptability of the PAS program following TKA.
Study Description: Investigators will conduct an exploratory randomized controlled study, with n=60 patients >=18 years receiving post-TKA physical therapy (PT) at a UNC Healthcare System clinic. Patients will be equally allocated to the PAS intervention or an attention (ATT) control group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Physical Activity and Symmetry (PAS) Intervention | Experimental | Behavioral: PAS InterventionParticipants assigned to the PAS intervention will receive 4 sessions on balance training and physical activity coaching delivered by a physical therapist, in addition to their usual post-TKA physical therapy (PT) care. |
| Attention Control | Placebo comparator | Behavioral: Attention ControlParticipants assigned to the ATT group will receive usual post-TKA physical therapy (PT) care, followed by two additional sessions with their physical therapist. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients receiving post-total knee arthroplasty (TKA) physical therapy (PT) at a University of North Carolina (UNC) Healthcare System clinic
Key exclusion criteria (8 listed)
- significant cognitive impairment
- neurological disorders affecting gait
- systemic rheumatic disease
- hospitalization for a cardiovascular condition the past six months
- psychosis
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 |
|---|---|---|
| PAS InterventionThe PAS program will be initiated during the final usual care PT visits. The PAS content will be included within the last two routine PT visits (Sessions 1 and 2). Session 1 will emphasize the importance of PA in TKA recovery, work with participants to establish SMART goals regarding overall PA and provide community-based and other resources to support overall PA. Session 2 will include balance exercise content to improve joint loading symmetry and home exercises will be assigned. Then, PAS participants will receive a follow-up phone call after 4 weeks (to assist with activity progression and problem-solving) and an additional in-person visit after 8 weeks (to visually monitor exercise performance and re-assess proportional weight-bearing ability). | Behavioural | Physical Activity and Symmetry (PAS) Intervention |
| Attention ControlThis will include usual in-person post TKA PT followed by 2 additional contacts (Session 1 and 2) with the physical therapist. Session 1 (phone) will review recovery benchmarks, assessment of participants' daily activities and reminders about symptoms that should trigger contacting a medical professional. Session 2 (in-person) will involve physical performance tests and comparison to appropriate normative values. | Behavioural | Attention Control |
Primary outcome
Change From Baseline to Month 3 in Objectively Assessed Physical Activity (Accelerometer)
Time frame: Baseline, Month 3
Minutes of moderate to vigorous intensity PA (MVPA) per week measured via accelerometer. A log transformation was applied due to superior diagnostics relative to untransformed values in statistical modeling; transformed values are presented here.
Change From Baseline to Month 6 in Objectively Assessed Physical Activity (Accelerometer)
Time frame: Baseline, Month 6
Minutes of moderate to vigorous intensity PA (MVPA) per week measured via accelerometer. A log transformation was applied due to superior diagnostics relative to untransformed values in statistical modeling; transformed values are presented here.
Change From Baseline to Month 3 in Peak Joint Load Symmetry During Walking
Time frame: Baseline, Month 3
Participants will complete a 10 meter walking test while load beneath each foot is recorded using an instrumented insole. Loading symmetry (peak ground reaction force) will be assessed using the limb symmetry index (LSI (|Surgical/Non-Surgical|*100), values lower than 100% indicate less loading of the surgical limb. A log transformation was applied due to superior diagnostics relative to untransformed values in statistical modeling; transformed values are presented here.
Change From Baseline to Month 6 in Peak Joint Load Symmetry During Walking
Time frame: Baseline, Month 6
Participants will complete a 10 meter walking test while load beneath each foot is recorded using an instrumented insole. Loading symmetry (peak ground reaction force) will be assessed using the limb symmetry index (LSI (|Surgical/Non-Surgical|*100), values lower than 100% indicate less loading of the surgical limb. A log transformation was applied due to superior diagnostics relative to untransformed values in statistical modeling; transformed values are presented here.
16 secondary outcomes
Change From Baseline to Month 3 in Self-Reported Physical Activity.
Time frame: Baseline, Month 3
Change From Baseline Month 6 in Self-Reported Physical Activity.
Time frame: Baseline to Month 6
Change From Baseline to Month 3 in Steps Per Day
Time frame: Baseline, Month 3
Change From Baseline to Month 6 in Steps Per Day
Time frame: Baseline, Month 6
Change From Baseline to Month 3 in Minutes of Any Physical Activity (PA)
Time frame: Baseline, Month 3
Change From Baseline to Month 6 in Minutes of Any Physical Activity (PA)
Time frame: Baseline, Month 6
Change From Baseline to Month 3 in Sedentary Minutes
Time frame: Baseline, Month 3
Change From Baseline to Month 6 in Sedentary Minutes
Time frame: Baseline, Month 6
Change From Baseline to Month 3 in Berg Balance Scale
Time frame: Baseline, Month 3
Change From Baseline to Month 6 in Berg Balance Scale
Time frame: Baseline, Month 6
Change From Baseline to Month 3 in Brief Balance Evaluation Systems Test
Time frame: Baseline, Month 3
Change From Baseline to Month 6 in Brief Balance Evaluation Systems Test
Time frame: Baseline, Month 6
Change From Baseline to Month 3 in Knee Injury and Osteoarthritis Outcome Score (KOOS)
Time frame: Baseline, Month 3
Change From Baseline to Month 6 in Knee Injury and Osteoarthritis Outcome Score (KOOS)
Time frame: Baseline, Month 6
Change From Baseline to Month 3 in Tampa Scale for Kinesiophobia
Time frame: Baseline, Month 3
Change From Baseline to Month 6 in Tampa Scale for Kinesiophobia
Time frame: Baseline, Month 6
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. Deidentified individual data that supports the results will be shared following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with UNC.
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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.
Kelli D Allen, PhD principal investigator
University of North Carolina, Chapel Hill
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PAS Intervention in people with Knee Replacement, Total and Knee Arthroplasty, Total, run by University of North Carolina, Chapel Hill 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 8 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 5 Mar 2024. 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. Some participants in this study may receive a placebo. 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?
Yes. Results are posted in the registry (first posted 5 Mar 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change From Baseline to Month 3 in Objectively Assessed Physical Activity (Accelerometer) (time frame: Baseline, Month 3). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Mar 2024.