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
| Type | Name | Description |
|---|---|---|
| BEHAVIORAL | Home Strengthening Exercises | The 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. |
| OTHER | Standard Physical Therapy | Physician determined standard of care for individual TKA patients. |
| OTHER | Preoperative Assessments | Assessments 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.