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Total Knee Arthroplasty Biomechanics

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University of Florida

Status

Completed

Conditions

Total Knee Arthroplasty (TKA)

Treatments

Other: Standard Physical Therapy
Other: Preoperative Assessments
Behavioral: Home Strengthening Exercises

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT03671954
IRB201801019
OCR18180 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment

38 patients

Sex

All

Ages

18 to 90 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

38 participants in 3 patient groups

TKA Intervention Group
Experimental group
Description:
The TKA intervention group will perform unsupervised home strengthening exercises for the hip abductors in addition to standard physical therapy.
Treatment:
Behavioral: Home Strengthening Exercises
Other: Standard Physical Therapy
TKA Control Group
Active Comparator group
Description:
The TKA control group will receive standard physical therapy alone.
Treatment:
Other: Standard Physical Therapy
Healthy Control Group
Active Comparator group
Description:
The Healthy Control Group, aged 49-85 years without any signs of degenerative joint, disease will undergo the preoperative assessments only.
Treatment:
Other: Preoperative Assessments

Trial contacts and locations

4

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Data sourced from clinicaltrials.gov

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