Total Knee ReplacementNCT05900453
Novel Strategies for Personalized Clinical Decisions in Knee Arthroplasty
An observational study of Total Knee Replacement, run by University of Colorado, Denver at 1 site in United States.
Trial summary
This study will compare the postoperative recovery of two patient cohorts who attended outpatient physical therapy at two clinics in the Greenville, South Carolina area. The Usual Care cohort received care according to each clinic's pre-existing care guidelines. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Total Knee Replacement
- What is being tested?
- Clinical decision support (CDS) tool
- How many people
- 675 participants
- Where
- 1 siteUnited States
- Study dates
- 15 May 2018to 30 Dec 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who attend post-TKA rehabilitation at the participating outpatient physical therapy clinics in the Greenville, SC area.
Who may be able to join
- Patient underwent TKA for primary knee osteoarthritis
- Patient underwent postoperative TKA rehabilitation at one of the two participating physical therapy clinics in the Greenville, SC area
Who cannot join
- Patients < 40 years old
- Patients whose total episode of care length in outpatient physical therapy was < 21 days
- Patients who attended < 3 outpatient physical therapy visits throughout their episode of care
- Outcomes collected > 6 months after surgery (except for visit utilization, which can include data up to 1 year after surgery)
- Patients who were not exposed to the CDS tool, but were treated by a clinician who was trained to use the CDS tool
Trial locations and contacts
1 site in 1 country.
United States1 site
ATI Physical Therapy
Greenville, South Carolina, 29601
About this study
This study will compare the postoperative recovery of two patient cohorts who attended outpatient physical therapy at two clinics in the Greenville, South Carolina area. The Usual Care cohort received care according to each clinic's pre-existing care guidelines. The CDS Cohort received care informed by a new clinical decision support (CDS) tool.
Read the detailed description
In this cohort study, the investigators will use regression to examine whether CDS tool exposure was associated with patient outcomes after total knee replacement. Linear mixed effect models will be used for continuous outcomes that have multiple assessment points per patient. For count outcomes (e.g., visit utilization), the investigators will use Poisson/negative binomial regression or linear regression with appropriate outcome transformations.
- Conditions
- Total Knee Replacement
- Being tested
- Clinical decision support (CDS) tool
- Keywords
- precision medicine, prognosis, patient-centered care, Decision Support Systems, Clinical
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clinical decision support (CDS) toolOther
The web-based clinical decision support (CDS) tool uses patient information (e.g., age, sex, BMI, perioperative status) to create personalized predictions of recovery following knee replacement. The CDS tool predicts range of motion, physical function, and pain recovery. Clinicians can use these predictions to (1) inform patients of their expected prognosis, (2) monitor patients' recovery against their predicted recovery, and (3) tailor treatments according to individual patients' needs.
Clinicians were provided with basic training for how to use the CDS tool, and were given examples of how to integrate it into clinical care. However, the CDS tool did not dictate any treatment decisions; clinicians were free to use the CDS tool at their discretion to inform decision making.
| Study group | Role | What they receive |
|---|---|---|
| Usual Care TKA rehabilitation | This cohort of patients received Usual Care TKA rehabilitation at two outpatient physical therapy clinics in the Greenville, South Carolina, USA area. These patients received treatment guided by their clinician's professional judgment and the clinic's best practice guidelines for TKA. | |
| CDS tool TKA rehabilitation | This cohort of patients received TKA rehabilitation at the same two outpatient physical therapy clinics in the Greenville, South Carolina, USA area. These patients also received treatment guided by their clinician's professional judgement and the clinic's best practice guidelines. Additionally, this cohort of patients was exposed to the CDS tool (i.e., clinicians used the tool to view personalized information about the patient at least once during the patient's episode of care). Receives: Other: Clinical decision support (CDS) tool |
What is being measured
The primary outcome is the main question the study is designed to answer.
Knee Injury and Osteoarthritis Outcome Score - Joint Replacement (KOOS-JR)
The KOOS-JR is a patient-reported measure of physical function developed specifically for patients with total knee arthroplasty (TKA). The KOOS-JR is scored on a 100-point scale with 0 representing complete knee disability and 100 representing perfect knee health. It can be completed quickly (only 7 items) and has established validity, reliability, and responsiveness in the TKA population.
Measured: KOOS-JR was assessed postoperatively up to 6 months after surgery
Secondary outcomes (4)
Outpatient Physical Therapy Visit Utilization
The total number of outpatient physical therapy visits attended by each patient during the year immediately following their TKA will be extracted from the electronic medical record. Only visits associated with the patient's episode of care for TKA will be included.
Measured: All visits from initial evaluation to discharge up to 1 year after surgery
Time Up and Go (TUG)
The TUG is a basic measure of mobility and balance that consists of rising from a seated position, walking three meters, and pivoting and returning to the original seated position. The TUG is responsive to change with adequate reliability in the acute recovery period after TKA.
Measured: TUG was assessed postoperatively up to 6 months after surgery
Surveys of patients' perceived knowledge of their recovery and engagement in their rehabilitation.
Patients completed surveys regarding their perceived knowledge of their postoperative recovery and their engagement in rehabilitation decision making. The surveys were scored on a 5-point Likert scale ranging from 0 (strongly disagree) to 4 (strongly agree).
Measured: Surveys were assessed postoperatively up to 6 months after surgery
Knee range of motion (ROM)
Knee flexion and extension ROM was measured manually by goniometry, which is a valid and reliable technique for measuring knee mobility. Recovery of ROM after TKA is necessary for many functional activities and is emphasized in rehabilitation after TKA.
Measured: ROM was assessed postoperatively up to 6 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2023
- Study start15 May 2018
- Primary completion30 Dec 2022
- Study completion30 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Total Knee ReplacementStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 675 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Collaborators
- ATI Physical Therapy
- Responsible party
- Sponsor
- Investigators
- Jennifer E Stevens-Lapsley, PhD, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05900453
- Sponsor's protocol ID
- 18-1246
- Status last verified
- Sep 2023
- First submitted
- 15 May 2023
- Last updated
- 28 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Novel Strategies for Personalized Clinical Decisions in Knee Arthroplasty
- ClinicalTrials.gov ID
- NCT05900453
- Acronym / sponsor ID
- 18-1246
- Conditions
- Total Knee Replacement
- Keywords
- precision medicine, prognosis, patient-centered care, Decision Support Systems, Clinical
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 675 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Collaborators
- ATI Physical Therapy
- Study start
- 15 May 2018 (actual)
- Primary completion
- 30 Dec 2022 (actual)
- Study completion
- 30 Dec 2022 (actual)
- First posted
- 12 Jun 2023 (actual)
- 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.
This study will compare the postoperative recovery of two patient cohorts who attended outpatient physical therapy at two clinics in the Greenville, South Carolina area. The Usual Care cohort received care according to each clinic's pre-existing care guidelines. The CDS Cohort received care informed by a new clinical decision support (CDS) tool.
Detailed description
In this cohort study, the investigators will use regression to examine whether CDS tool exposure was associated with patient outcomes after total knee replacement. Linear mixed effect models will be used for continuous outcomes that have multiple assessment points per patient. For count outcomes (e.g., visit utilization), the investigators will use Poisson/negative binomial regression or linear regression with appropriate outcome transformations.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Usual Care TKA rehabilitation | – | –This cohort of patients received Usual Care TKA rehabilitation at two outpatient physical therapy clinics in the Greenville, South Carolina, USA area. These patients received treatment guided by their clinician's professional judgment and the clinic's best practice guidelines for TKA. |
| CDS tool TKA rehabilitation | – | Other: Clinical decision support (CDS) toolThis cohort of patients received TKA rehabilitation at the same two outpatient physical therapy clinics in the Greenville, South Carolina, USA area. These patients also received treatment guided by their clinician's professional judgement and the clinic's best practice guidelines. Additionally, this cohort of patients was exposed to the CDS tool (i.e., clinicians used the tool to view personalized information about the patient at least once during the patient's episode of care). |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who attend post-TKA rehabilitation at the participating outpatient physical therapy clinics in the Greenville, SC area.
Key inclusion criteria (2 listed)
- Patient underwent TKA for primary knee osteoarthritis
- Patient underwent postoperative TKA rehabilitation at one of the two participating physical therapy clinics in the Greenville, SC area
Key exclusion criteria (5 listed)
- Patients < 40 years old
- Patients whose total episode of care length in outpatient physical therapy was < 21 days
- Patients who attended < 3 outpatient physical therapy visits throughout their episode of care
- Outcomes collected > 6 months after surgery (except for visit utilization, which can include data up to 1 year after surgery)
- Patients who were not exposed to the CDS tool, but were treated by a clinician who was trained to use the CDS tool
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 |
|---|---|---|
| Clinical decision support (CDS) toolThe web-based clinical decision support (CDS) tool uses patient information (e.g., age, sex, BMI, perioperative status) to create personalized predictions of recovery following knee replacement. The CDS tool predicts range of motion, physical function, and pain recovery. Clinicians can use these predictions to (1) inform patients of their expected prognosis, (2) monitor patients' recovery against their predicted recovery, and (3) tailor treatments according to individual patients' needs. Clinicians were provided with basic training for how to use the CDS tool, and were given examples of how to integrate it into clinical care. However, the CDS tool did not dictate any treatment decisions; clinicians were free to use the CDS tool at their discretion to inform decision making. | Other | CDS tool TKA rehabilitation |
Primary outcome
Knee Injury and Osteoarthritis Outcome Score - Joint Replacement (KOOS-JR)
Time frame: KOOS-JR was assessed postoperatively up to 6 months after surgery
The KOOS-JR is a patient-reported measure of physical function developed specifically for patients with total knee arthroplasty (TKA). The KOOS-JR is scored on a 100-point scale with 0 representing complete knee disability and 100 representing perfect knee health. It can be completed quickly (only 7 items) and has established validity, reliability, and responsiveness in the TKA population.
4 secondary outcomes
Outpatient Physical Therapy Visit Utilization
Time frame: All visits from initial evaluation to discharge up to 1 year after surgery
Time Up and Go (TUG)
Time frame: TUG was assessed postoperatively up to 6 months after surgery
Surveys of patients' perceived knowledge of their recovery and engagement in their rehabilitation.
Time frame: Surveys were assessed postoperatively up to 6 months after surgery
Knee range of motion (ROM)
Time frame: ROM was assessed postoperatively up to 6 months after surgery
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 28 Sep 2023.
- Individual participant dataSharing planned: No
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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.
Jennifer E Stevens-Lapsley, PhD principal investigator
University of Colorado, Denver
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Total Knee Replacement, run by University of Colorado, Denver 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 2 inclusion and 5 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 28 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.
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?
Knee Injury and Osteoarthritis Outcome Score - Joint Replacement (KOOS-JR) (time frame: KOOS-JR was assessed postoperatively up to 6 months after surgery). 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 28 Sep 2023.