Joint ArthroplastyNCT03933969
Functional Predictive Value of Collective Outcome Measure(s) Status Post Total Hip/Knee Arthroplasty
An observational study of Joint Arthroplasty and Knee and Hip, run by Mayo Clinic at 1 site in United States.
Trial summary
Researchers are trying to assess a predictive value or correlation of outcome measures results on subjects following a total knee or total hip arthroplasty in order to better predict the time frame taken to achieve certain functional milestones that are pertinent to subject population. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Joint Arthroplasty, Knee and Hip
- How many people
- 26 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Jun 2019to 23 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subjects status post total hip and total knee arthroplasty that will undergo standard inpatient and outpatient physical therapy evaluation following total joint surgery.
Who may be able to join
- Patient's 18 years or older
- Patients who recently underwent a primary total hip or total knee arthroplasty
- Patient who recently underwent a total hip or total knee revision
Who cannot join
- Patients who lack the ability to provide informed consent
- Patients with previous total joint replacement within the last 6 months
- Patients with complications following surgery such as DVT/PE/Infection
Trial locations and contacts
1 site in 1 country.
About this study
Researchers are trying to assess a predictive value or correlation of outcome measures results on subjects following a total knee or total hip arthroplasty in order to better predict the time frame taken to achieve certain functional milestones that are pertinent to subject population.
Read the detailed description
Subjects will undergo testing for a normal physical therapy clinical assessment that is standard of care for anyone who has a total hip or total knee surgery. Researchers will be using the data obtained from standard therapy care and see if correlations exist from that data and the time taken to complete specific functional tasks.
- Conditions
- Joint Arthroplasty, Knee and Hip
What is being measured
The primary outcome is the main question the study is designed to answer.
Assistive Device Weaning
Number of days to weaning from all assistive devices
Measured: Approximately 3 months
Secondary outcomes (1)
Weaning from pain medication, ability to reciprocally use steps, ability to walk 1 mile or 30 minutes consecutively
Number of days taken to achieve milestones
Measured: Approximately 3-6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2019
- Study start11 Jun 2019
- Primary completion23 Dec 2022
- Study completion23 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Joint ArthroplastyStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe 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
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ryan C. McCoy, Mayo Clinic
- Investigators
- Ryan C McCoy, PT, DPT, OCS, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03933969
- Sponsor's protocol ID
- 18-009437
- Status last verified
- Jan 2023
- First submitted
- 30 Apr 2019
- Last updated
- 17 Jan 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 17 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Functional Predictive Value of Collective Outcome Measure(s) Status Post Total Hip/Knee Arthroplasty
- ClinicalTrials.gov ID
- NCT03933969
- Acronym / sponsor ID
- 18-009437
- Conditions
- Joint Arthroplasty, Knee and Hip
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 11 Jun 2019 (actual)
- Primary completion
- 23 Dec 2022 (actual)
- Study completion
- 23 Dec 2022 (actual)
- First posted
- 1 May 2019 (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.
Researchers are trying to assess a predictive value or correlation of outcome measures results on subjects following a total knee or total hip arthroplasty in order to better predict the time frame taken to achieve certain functional milestones that are pertinent to subject population.
Detailed description
Subjects will undergo testing for a normal physical therapy clinical assessment that is standard of care for anyone who has a total hip or total knee surgery. Researchers will be using the data obtained from standard therapy care and see if correlations exist from that data and the time taken to complete specific functional tasks.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects status post total hip and total knee arthroplasty that will undergo standard inpatient and outpatient physical therapy evaluation following total joint surgery.
Key inclusion criteria (3 listed)
- Patient's 18 years or older
- Patients who recently underwent a primary total hip or total knee arthroplasty
- Patient who recently underwent a total hip or total knee revision
Key exclusion criteria (3 listed)
- Patients who lack the ability to provide informed consent
- Patients with previous total joint replacement within the last 6 months
- Patients with complications following surgery such as DVT/PE/Infection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Assistive Device Weaning
Time frame: Approximately 3 months
Number of days to weaning from all assistive devices
1 secondary outcome
Weaning from pain medication, ability to reciprocally use steps, ability to walk 1 mile or 30 minutes consecutively
Time frame: Approximately 3-6 months
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 17 Jan 2023.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
- 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.
Ryan C McCoy, PT, DPT, OCS principal investigator
Mayo Clinic
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 Joint Arthroplasty and Knee and Hip, run by Mayo Clinic 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 3 inclusion and 3 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 17 Jan 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?
Assistive Device Weaning (time frame: Approximately 3 months). 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 17 Jan 2023.