Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
38 participants
INTERVENTIONAL
2019-05-01
2023-11-16
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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TKA Intervention Group
The TKA intervention group will perform unsupervised home strengthening exercises for the hip abductors in addition to standard physical therapy.
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.
Standard Physical Therapy
Physician determined standard of care for individual TKA patients.
TKA Control Group
The TKA control group will receive standard physical therapy alone.
Standard Physical Therapy
Physician determined standard of care for individual TKA patients.
Healthy Control Group
The Healthy Control Group, aged 49-85 years without any signs of degenerative joint, disease will undergo the preoperative assessments only.
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)
Interventions
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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.
Standard Physical Therapy
Physician determined standard of care for individual TKA patients.
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)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
90 Years
ALL
Yes
Sponsors
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Orthosensor, Inc.
INDUSTRY
University of Florida
OTHER
Responsible Party
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Principal Investigators
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MaryBeth Horodyski, EdD
Role: PRINCIPAL_INVESTIGATOR
University of Florida
Locations
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UF & Shands Orthopaedics and Sports Medicine Institute
Gainesville, Florida, United States
UF Health Florida Surgical Center
Gainesville, Florida, United States
UF Health at the University of Florida
Gainesville, Florida, United States
UF Health Cancer Hospital
Gainesville, Florida, United States
Countries
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Other Identifiers
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OCR18180
Identifier Type: OTHER
Identifier Source: secondary_id
IRB201801019
Identifier Type: -
Identifier Source: org_study_id