Total Knee Arthroplasty (TKA)
Conditions
Keywords
knee osteoarthritis, rehabilitation strategies, soft tissue balance
Brief 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.
Interventions
BEHAVIORALHome 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.
OTHERStandard Physical Therapy
Physician determined standard of care for individual TKA patients.
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)
Sponsors
Orthosensor, Inc.
University of Florida
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Masking description
Participant, outcome assessor
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
Yes
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: 1. Age 49-85 years 2. Healthy with no signs or symptoms of lower limb arthritis or injury 3. Able to walk for a short distance without the use of ambulatory aids
Exclusion criteria
* BMI \> 40 kg/m2 * Presence of knee, hip, or ankle prosthesis for either limb * Presence of hip prosthesis in surgical limb (TKA only subjects) * History of lower limb or spinal surgery within the last year * Presence of neurologic or orthopaedic disorders that could affect gait or balance * Chronic opioid or illicit drug use * Poorly controlled diabetes (HbA1C \> 7 percent) * Chronic pain syndrome * Chronic back pain * Presence of vestibular disorder * Pregnancy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Top declined walking speed before and after TKA. | Tested preoperatively, and once during the two to four months 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. |
| Bilateral isometric quadriceps, hamstrings, and gluteus medius strength before and after TKA | Tested preoperatively, and once during the two to four months after TKA | Maximum isometric quadriceps, hamstrings, and gluteus medius strength as measured by a dynamometer. |
Countries
United States
Outcome results
None listed