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| ID | Type | Description | Link |
|---|---|---|---|
| OCR18180 | Other Identifier | University of Florida |
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| Name | Class |
|---|---|
| Orthosensor, Inc. | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TKA Intervention Group | Experimental | The TKA intervention group will perform unsupervised home strengthening exercises for the hip abductors in addition to standard physical therapy. |
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| TKA Control Group | Active Comparator | The TKA control group will receive standard physical therapy alone. |
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| Healthy Control Group | Active Comparator | The Healthy Control Group, aged 49-85 years without any signs of degenerative joint, disease will undergo the preoperative assessments only. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Home Strengthening Exercises | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Top declined walking speed before and after TKA. | Top walking speed is defined as the maximum speed a patient feels that they can safely walk without running. Patients will walk on an instrumented treadmill declined at seven degrees. | Tested preoperatively, and once during the two to four months after TKA |
| Bilateral isometric quadriceps, hamstrings, and gluteus medius strength before and after TKA | Maximum isometric quadriceps, hamstrings, and gluteus medius strength as measured by a dynamometer. | Tested preoperatively, and once during the two to four months after TKA |
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Inclusion Criteria:
Patients requiring unilateral TKA for knee osteoarthritis
No osteoarthritis symptoms in contralateral knee
Radiographic coronal deformity ≤ 15°
Preoperative flexion ≥ 90°
Receiving one of four implants used by UF Orthopaedic surgeons
Able to walk for a short distance without the use of ambulatory aids
Healthy Participants:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| MaryBeth Horodyski, EdD | University of Florida | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UF & Shands Orthopaedics and Sports Medicine Institute | Gainesville | Florida | 32607 | United States | ||
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| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
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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. Subjects will be assigned to one of two groups by block randomization, such that patients receiving each different implant design comprise each block.
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Participant, outcome assessor
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| Standard Physical Therapy | Other | Physician determined standard of care for individual TKA patients. |
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| Preoperative Assessments | Other | Assessments will include:
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| UF Health Florida Surgical Center |
| Gainesville |
| Florida |
| 32607 |
| United States |
| UF Health at the University of Florida | Gainesville | Florida | 32610 | United States |
| UF Health Cancer Hospital | Gainesville | Florida | 32610 | United States |
| D012216 |
| Rheumatic Diseases |