NCT02364011

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2014

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2014

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

February 9, 2015

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 16, 2015

Completed
10.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 10, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 10, 2025

Completed
Last Updated

November 18, 2025

Status Verified

November 1, 2025

Enrollment Period

10.6 years

First QC Date

February 9, 2015

Last Update Submit

November 17, 2025

Conditions

Keywords

BiomechanicsPrimary Total Knee ArthroplastyTKA BearingsOsteoarthritisTotal Knee Replacement

Outcome Measures

Primary Outcomes (1)

  • Patient Reported Outcome Scores following TKA

    Follow Up Visits up to 2-Years

Eligibility Criteria

Age40 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients who present to the University of Utah for TKA surgical procedure

You may qualify if:

  • 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

You may not qualify if:

  • adult with previous additional orthopaedic, neurological, visual or surgical conditions that may affect gait or balance

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Utah Orthopaedic Center

Salt Lake City, Utah, 84108, United States

Location

MeSH Terms

Conditions

Osteoarthritis

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Officials

  • Christopher Pelt, MD

    University of Utah

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principle Investigator

Study Record Dates

First Submitted

February 9, 2015

First Posted

February 16, 2015

Study Start

November 1, 2014

Primary Completion

June 10, 2025

Study Completion

June 10, 2025

Last Updated

November 18, 2025

Record last verified: 2025-11

Locations