Clinical Trials Directory

Trials / Completed

CompletedNCT03671954

Total Knee Arthroplasty Biomechanics

Determining the Effects of Implant Design, Soft Tissue Balance, Neuromuscular Adaptations, and Rehabilitation Strategies on Functional Outcomes and Patient Satisfaction After Total Knee Arthroplasty

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
38 (actual)
Sponsor
University of Florida · Academic / Other
Sex
All
Age
18 Years – 90 Years
Healthy volunteers
Accepted

Summary

In total knee arthroplasty (TKA), the relationship between implant design, soft tissue balance, neuromuscular contributions, and rehabilitation strategies on patient satisfaction and functional outcomes is highly complex and poorly understood. The investigators will prospectively study the effects of these factors using in vivo assessments preoperatively, and postoperatively. Computer simulation models will also be used to analyze lower extremity biomechanics.

Detailed description

Total knee arthroplasty (TKA) is the primary treatment for end-stage knee osteoarthritis and effectively relieves pain and improves function after surgery. Nevertheless, as many as 1 in 5 patients are dissatisfied with the postoperative outcome, and knee instability remains one of the top indications for revision surgery. Implant design, soft tissue balance, neuromuscular capabilities, and rehabilitation strategies can all influence postoperative outcomes. However, the relationship between these factors and the most effective therapeutic approach for total knee arthroplasty has yet to be identified. The investigators will study preoperative and postoperative functional measures and patient satisfaction along with implant design and specific intraoperative data, which may help inform a targeted approach for optimal outcomes after total knee arthroplasty and improve future care of patients.

Conditions

Interventions

TypeNameDescription
BEHAVIORALHome Strengthening ExercisesThe intervention group will perform unsupervised home strengthening exercises for the hip abductors in addition to standard physical therapy, while the control group will receive standard physical therapy alone.
OTHERStandard Physical TherapyPhysician determined standard of care for individual TKA patients.
OTHERPreoperative AssessmentsAssessments will include: * TUG (timed up and go test) \>12 sec indicates increased fall risk * Tandem balance test \< 10 sec indicates increased fall risk * Sit to Stand test (age based norms) * Knee Range Of Motion (ROM) * Quadriceps and hamstring strength (MMT or hand held dynamometer) * Lower Extremity Functional Score (LEFS questionnaire)

Timeline

Start date
2019-05-01
Primary completion
2023-11-16
Completion
2023-11-16
First posted
2018-09-14
Last updated
2023-11-30

Locations

4 sites across 1 country: United States

Source: ClinicalTrials.gov record NCT03671954. Inclusion in this directory is not an endorsement.

Total Knee Arthroplasty Biomechanics (NCT03671954) · Clinical Trials Directory