Total Knee Arthroplasty Biomechanics

Not Applicable

Completed

• Conditions: Total Knee Arthroplasty (TKA)
• Interventions: Other: Preoperative Assessments; Other: Standard Physical Therapy; Behavioral: Home Strengthening Exercises

• Registration Number: NCT03671954
• Lead Sponsor: 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.

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2018-08-31
• Study First Submitted QC: 2018-09-13
• Study First Posted: 2018-09-14
• Study Start: 2019-05-01
• Status Verified: 2023-11
• Primary Completion: 2023-11-16
• Study Completion: 2023-11-16
• Last Update Submitted: 2023-11-28
• Last Update Posted: 2023-11-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 38

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Bilateral isometric quadriceps, hamstrings, and gluteus medius strength before and after TKA	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.
Top declined walking speed before and after TKA.	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.

Trial Locations

Locations (4)

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