Total Knee Arthroplasty Biomechanics

Sponsor

University of Florida (Other)

Overall Status

Recruiting

CT.gov ID

NCT03671954

Collaborator

Orthosensor, Inc. (Industry)

110

Enrollment

Locations

Arms

Anticipated Duration (Months)

27.5

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Total Knee Arthroplasty (TKA)	Behavioral: Home Strengthening Exercises Other: Standard Physical Therapy Other: Preoperative Assessments	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

110 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

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.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.

Masking:

None (Open Label)

Masking Description:

Participant, outcome assessor

Primary Purpose:

Supportive Care

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

Actual Study Start Date :

May 1, 2019

Anticipated Primary Completion Date :

Aug 1, 2021

Anticipated Study Completion Date :

Aug 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: TKA Intervention Group The TKA intervention group will perform unsupervised home strengthening exercises for the hip abductors in addition to standard physical therapy.	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 Names: Hip abductor strengthening program Other: Standard Physical Therapy Physician determined standard of care for individual TKA patients.
Active Comparator: TKA Control Group The TKA control group will receive standard physical therapy alone.	Other: Standard Physical Therapy Physician determined standard of care for individual TKA patients.
Active Comparator: Healthy Control Group The Healthy Control Group, aged 49-85 years without any signs of degenerative joint, disease will undergo the preoperative assessments only.	Other: 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)

Arm

Intervention/Treatment

Experimental: TKA Intervention Group

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 Names:

Hip abductor strengthening program

Other: Standard Physical Therapy

Physician determined standard of care for individual TKA patients.

Active Comparator: TKA Control Group

The TKA control group will receive standard physical therapy alone.

Other: Standard Physical Therapy

Physician determined standard of care for individual TKA patients.

Active Comparator: Healthy Control Group

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

Other: 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)

Outcome Measures

Primary Outcome Measures

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.
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 90 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	UF & Shands Orthopaedics and Sports Medicine Institute	Gainesville	Florida	United States	32607
2	UF Health Florida Surgical Center	Gainesville	Florida	United States	32607
3	UF Health at the University of Florida	Gainesville	Florida	United States	32610
4	UF Health Cancer Hospital	Gainesville	Florida	United States	32610

Sponsors and Collaborators

University of Florida
Orthosensor, Inc.

Investigators

Principal Investigator: MaryBeth Horodyski, EdD, University of Florida

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University of Florida

ClinicalTrials.gov Identifier:

NCT03671954

Other Study ID Numbers:

IRB201801019
OCR18180

First Posted:

Sep 14, 2018

Last Update Posted:

Jun 30, 2021

Last Verified:

Jun 1, 2021

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by University of Florida

knee osteoarthritis

rehabilitation strategies

soft tissue balance

Study Results

No Results Posted as of Jun 30, 2021