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Completed

NCT Number: NCT03671954

Total Knee Arthroplasty Biomechanics

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.

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Key information

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UF & Shands Orthopaedics and Sports Medicine Institute, Gainesville, Florida, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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:
  • Age 49-85 years
  • Healthy with no signs or symptoms of lower limb arthritis or injury
  • 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

Treatment and study plan

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.

Other names: Hip abductor strengthening program

Standard physical therapy

Other

Physician determined standard of care for individual TKA patients.

Preoperative Assessments

Other

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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

University of Florida

Other

Collaborators

  • Orthosensor, Inc.

Registry information

Official study 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

Important dates

Study start
2019
Primary completion
2023
Study completion
2023
First posted
Sep 14, 2018
Registry last updated
Nov 30, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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