Total Knee Arthroplasty Biomechanics

NCT03671954 | Completed

• 2 other identifiers: IRB201801019OCR18180
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 4

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.

Conditions

Total Knee Arthroplasty (TKA)

Keywords

knee osteoarthritis; rehabilitation strategies; soft tissue balance

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (3)

TKA Intervention Group

EXPERIMENTAL

The TKA intervention group will perform unsupervised home strengthening exercises for the hip abductors in addition to standard physical therapy.

Behavioral: Home Strengthening Exercises; Other: Standard Physical Therapy

TKA Control Group

ACTIVE COMPARATOR

The TKA control group will receive standard physical therapy alone.

Other: Standard Physical Therapy

Healthy Control Group

ACTIVE COMPARATOR

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

Other: Preoperative Assessments

Interventions

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.

Also known as: Hip abductor strengthening program

TKA Intervention Group

Standard Physical Therapy OTHER

Physician determined standard of care for individual TKA patients.

TKA Control Group; TKA Intervention Group

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)

Healthy Control Group

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Florida: lead
• Orthosensor, Inc.: collaborator

Study Sites (4)

UF & Shands Orthopaedics and Sports Medicine Institute

Gainesville, Florida, 32607, United States

Location

UF Health Florida Surgical Center

Gainesville, Florida, 32607, United States

Location

UF Health at the University of Florida

Gainesville, Florida, 32610, United States

Location

UF Health Cancer Hospital

Gainesville, Florida, 32610, United States

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• MaryBeth Horodyski, EdD

  University of Florida

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Participant, outcome assessor
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: August 31, 2018
• First Posted: September 14, 2018
• Study Start: May 1, 2019
• Primary Completion: November 16, 2023
• Study Completion: November 16, 2023
• Last Updated: November 30, 2023

Record last verified: 2023-11

Locations

US (4)