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Total Knee Arthroplasty Biomechanics

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ClinicalTrials.gov Identifier: NCT03671954
Recruitment Status : Not yet recruiting
First Posted : September 14, 2018
Last Update Posted : February 8, 2019
Sponsor:
Information provided by (Responsible Party):
University of Florida

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.

Condition or disease Intervention/treatment Phase
Total Knee Arthroplasty (TKA) Behavioral: Home Strengthening Exercises Other: Standard Physical Therapy Other: Preoperative Assessments Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 110 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
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.
Masking: None (Open Label)
Masking Description: Participant, outcome assessor
Primary Purpose: Supportive Care
Official Title: Determining the Effects of Implant Design, Soft Tissue Balance, Neuromuscular Adaptations, and Rehabilitation Strategies on Functional Outcomes and Patient Satisfaction After Total Knee Arthroplasty
Estimated Study Start Date : April 10, 2019
Estimated Primary Completion Date : December 30, 2020
Estimated Study Completion Date : December 30, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Knee Replacement

Arm Intervention/treatment
Experimental: TKA Intervention Group
The TKA intervention group will perform unsupervised home strengthening exercises for the hip abductors in addition to standard physical therapy.
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 Name: Hip abductor strengthening program

Other: Standard Physical Therapy
Physician determined standard of care for individual TKA patients.

Active Comparator: TKA Control Group
The TKA control group will receive standard physical therapy alone.
Other: Standard Physical Therapy
Physician determined standard of care for individual TKA patients.

Active Comparator: Healthy Control Group
The Healthy Control Group, aged 49-85 years without any signs of degenerative joint, disease will undergo the preoperative assessments only.
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)




Primary Outcome Measures :
  1. Top declined walking speed before and after TKA. [ Time Frame: 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.

  2. Bilateral isometric quadriceps, hamstrings, and gluteus medius strength before and after TKA [ Time Frame: 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.



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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Patients requiring unilateral TKA for knee osteoarthritis
  • Contralateral knee with Kellgren-Lawrence grade ≤1
  • 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
  • History of lower limb or spinal surgery
  • 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
  • Diagnosed anxiety or depressive disorders
  • Presence of vestibular disorder
  • Pregnancy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03671954


Locations
United States, Florida
UF & Shands Orthopaedics and Sports Medicine Institute
Gainesville, Florida, United States, 32607
UF Health at the University of Florida
Gainesville, Florida, United States, 32610
UF Health Cancer Hospital Not yet recruiting
Gainesville, Florida, United States, 32610
Sponsors and Collaborators
University of Florida
Investigators
Principal Investigator: MaryBeth Horodyski, EdD University of Florida

Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT03671954     History of Changes
Other Study ID Numbers: IRB201801019
OCR18180 ( Other Identifier: University of Florida )
First Posted: September 14, 2018    Key Record Dates
Last Update Posted: February 8, 2019
Last Verified: February 2019

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University of Florida:
knee osteoarthritis
rehabilitation strategies
soft tissue balance