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

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.

Study Overview

• Status: Completed
• Conditions: Total Knee Arthroplasty (TKA)
• Intervention / Treatment: Behavioral: Home Strengthening Exercises; Other: Standard Physical Therapy; Other: Preoperative Assessments

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
• Enrollment (Actual): 38
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Gainesville, Florida, United States, 32607
      • UF & Shands Orthopaedics and Sports Medicine Institute
    • Gainesville, Florida, United States, 32610
      • UF Health at the University of Florida
    • Gainesville, Florida, United States, 32607
      • UF Health Florida Surgical Center
    • Gainesville, Florida, United States, 32610
      • UF Health Cancer Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / 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 Names: 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: University of Florida
• Collaborators: Orthosensor, Inc.
• Investigators: Principal Investigator: MaryBeth Horodyski, EdD, University of Florida

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2019
• Primary Completion (Actual): November 16, 2023
• Study Completion (Actual): November 16, 2023

Study Registration Dates

• First Submitted: August 31, 2018
• First Submitted That Met QC Criteria: September 13, 2018
• First Posted (Actual): September 14, 2018

Study Record Updates

• Last Update Posted (Actual): November 30, 2023
• Last Update Submitted That Met QC Criteria: November 28, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: knee osteoarthritis; rehabilitation strategies; soft tissue balance
• Other Study ID Numbers: IRB201801019; OCR18180 (Other Identifier: University of Florida)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No