Total Knee Arthroplasty Biomechanics

Total Knee Arthroplasty (TKA) Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03671954
• Other study ID #: IRB201801019
• Secondary ID: OCR18180
• Status: Completed
• Phase: N/A
• Start date: May 1, 2019
• Est. completion date: November 16, 2023

Study information

• Verified date: November 2023
• Source: University of Florida
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: November 16, 2023
• Est. primary completion date: November 16, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Total Knee Arthroplasty (TKA)

Intervention

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:
• Standard Physical Therapy
Physician determined standard of care for individual TKA patients.
• 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)

Locations

Country	Name	City	State
United States	UF & Shands Orthopaedics and Sports Medicine Institute	Gainesville	Florida
United States	UF Health at the University of Florida	Gainesville	Florida
United States	UF Health Cancer Hospital	Gainesville	Florida
United States	UF Health Florida Surgical Center	Gainesville	Florida

Sponsors (2)

Lead Sponsor	Collaborator
University of Florida	Orthosensor, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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