Clinical trial NCT03671954: Total Knee Arthroplasty Biomechanics
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Total Knee Arthroplasty (TKA)
Keywords: knee osteoarthritis
rehabilitation strategies
soft tissue balance
Lead sponsor: University of Florida
Sponsor class: OTHER
Collaborators: name: Orthosensor, Inc.
First posted: 2018-09-14
Enrollment: 38
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Top declined walking speed before and after TKA.
timeFrame: Tested preoperatively, and once during the two to four months after TKA
measure: Bilateral isometric quadriceps, hamstrings, and gluteus medius strength before and after TKA
timeFrame: Tested preoperatively, and once during the two to four months after TKA
Secondary outcomes:
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: UF & Shands Orthopaedics and Sports Medicine Institute
state: Florida
city: Gainesville
country: United States
facility: UF Health Florida Surgical Center
state: Florida
city: Gainesville
country: United States
facility: UF Health at the University of Florida
state: Florida
city: Gainesville
country: United States
facility: UF Health Cancer Hospital
state: Florida
Study officials:
affiliation: University of Florida
name: MaryBeth Horodyski, EdD
role: PRINCIPAL_INVESTIGATOR
References: