OsteoarthritisNCT02364011
Outcomes Following Total Knee Arthroplasty
An observational study of Osteoarthritis, run by University of Utah at 1 site in United States.
Trial summary
The purpose of this investigation is to determine both patient-reported and performance-based outcomes, specifically muscle function and kinematic/kinetic outcomes, between four different surgical total knee prostheses in individuals following TKA. Read more about this study
- Who is it for?
- Ages 40 to 90 years
- Conditions the study is for
- Osteoarthritis
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2014to 10 Jun 2025
- 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who present to the University of Utah for TKA surgical procedure
Who may be able to join
- adults > 40 years of age that are scheduled for primary TKA
- if they have had a previous TKA, it needs to have been performed on the opposite leg at least 3 months prior to the current TKA
- willing to return for follow-up visits and should be willing and able to be transported from the UOC to the Skeletal Muscle Exercise Research Facility (SMERF), in the Department of Physical Therapy study site for scheduled research follow-up appointments
Who cannot join
- adult with previous additional orthopaedic, neurological, visual or surgical conditions that may affect gait or balance
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Utah Orthopaedic Center
Salt Lake City, Utah, 84108
About this study
Official title: Clinical and Biomechanical Outcomes Following Total Knee Arthroplasty
The purpose of this investigation is to determine both patient-reported and performance-based outcomes, specifically muscle function and kinematic/kinetic outcomes, between four different surgical total knee prostheses in individuals following TKA. Change scores will be determined based on patient-reported outcomes, kinematic/kinetic data, knee extension strength/power, static/dynamic balance control, mobility measures and functional performance testing during functional tasks (i.e. walking, ascending/descending stairs, sit-to-stand). After evaluating the pattern of change in lower-extremity function, the investigators will be better prepared to address residual functional impairments and prognostic factors linked to maximal recovery over two years.
- Conditions
- Osteoarthritis
- Keywords
- Biomechanics, Primary Total Knee Arthroplasty, TKA Bearings, Osteoarthritis, Total Knee Replacement
- Medical subject headings
- Osteoarthritis
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Reported Outcome Scores following TKA
Measured: Follow Up Visits up to 2-Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2015 (estimated)
- Study startNov 2014
- Primary completion10 Jun 2025
- Study completion10 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteoarthritisStudies of the same condition, open and under way.
- More trials run by University of UtahThe 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
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Utah
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christopher Pelt, University of Utah
- Investigators
- Christopher Pelt, MD, Principal investigator, University of Utah
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02364011
- Sponsor's protocol ID
- 75446
- Status last verified
- Nov 2025
- First submitted
- 9 Feb 2015
- Last updated
- 18 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Biomechanical Outcomes Following Total Knee Arthroplasty
- ClinicalTrials.gov ID
- NCT02364011
- Acronym / sponsor ID
- 75446
- Conditions
- Osteoarthritis
- Keywords
- Biomechanics, Primary Total Knee Arthroplasty, TKA Bearings, Osteoarthritis, Total Knee Replacement
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- University of UtahUniversity, hospital or other
- Study start
- Nov 2014
- Primary completion
- 10 Jun 2025 (actual)
- Study completion
- 10 Jun 2025 (actual)
- First posted
- 16 Feb 2015 (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.
The purpose of this investigation is to determine both patient-reported and performance-based outcomes, specifically muscle function and kinematic/kinetic outcomes, between four different surgical total knee prostheses in individuals following TKA. Change scores will be determined based on patient-reported outcomes, kinematic/kinetic data, knee extension strength/power, static/dynamic balance control, mobility measures and functional performance testing during functional tasks (i.e. walking, ascending/descending stairs, sit-to-stand). After evaluating the pattern of change in lower-extremity function, the investigators will be better prepared to address residual functional impairments and prognostic factors linked to maximal recovery over two years.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 40 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who present to the University of Utah for TKA surgical procedure
Key inclusion criteria (3 listed)
- adults > 40 years of age that are scheduled for primary TKA
- if they have had a previous TKA, it needs to have been performed on the opposite leg at least 3 months prior to the current TKA
- willing to return for follow-up visits and should be willing and able to be transported from the UOC to the Skeletal Muscle Exercise Research Facility (SMERF), in the Department of Physical Therapy study site for scheduled research follow-up appointments
Key exclusion criteria (1 listed)
- adult with previous additional orthopaedic, neurological, visual or surgical conditions that may affect gait or balance
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
Patient Reported Outcome Scores following TKA
Time frame: Follow Up Visits up to 2-Years
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 18 Nov 2025.
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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.
Christopher Pelt, MD principal investigator
University of Utah
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 Osteoarthritis, run by University of Utah 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 1 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 18 Nov 2025. 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?
Patient Reported Outcome Scores following TKA (time frame: Follow Up Visits up to 2-Years). 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 18 Nov 2025; AzTrials last refreshed its copy on 6 Nov 2026.