Total Knee Arthroplasty Functional Outcomes Study Research Design

restor3d

Status: Terminated

Conditions: Osteoarthritis of the Knee

Treatments: Device: Total knee arthroplasty patients

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT02228538

13-003

Details and patient eligibility

About

The purpose of this study is to obtain patient oriented and clinically oriented physical function outcomes both pre-operatively and post-operatively in patients receiving a total knee arthroplasty.

Full description

This study aims to use up to 75 patients at 3 centers to determine a baseline short-term post-operative physical function status of patients undergoing a total knee arthroplasty through patient and clinically based assessments. The KOOS score will collect data on the patient's physical function, stiffness and pain. The BERG balance, TUG, and TUDS tests will be used quantitatively to assess the patient's ability to conduct activities of daily living like walking for an extended period of time, standing from a seated position, and maintaining balance while performing a series of actions.

Enrollment: 7 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Patient is male or non-pregnant female age 18 years or older at time of study
• Patient is a candidate for a total knee arthroplasty
• Patient is willing and able to comply with postoperative scheduled clinical and radiographic evaluations and rehabilitation

Exclusion criteria

• Patients with a primary diagnosis other than osteoarthritis of the knee as determined by an orthopedic surgeon
• Patients who have had any previous lower extremity procedure
• Patients with a BMI greater than or equal to 40
• Patients with an active infection within the affected knee joint
• Patients with a neuromuscular or neurosensory deficiency that may limit the ability of the patient to evaluate the safety and efficacy of the device
• Patients diagnosed with systemic disease or metabolic disorder leading to progressive bone deterioration (e.g. Lupus Erythematosus, Paget's disease)
• Patients immunologically suppressed or receiving chronic steroids in excess of normal physiological requirements (e.g. greater than 30 days)
• Patients with a known sensitivity to device materials
• Non-English speaking patients
• Patient is a prisoner

Trial design

7 participants in 1 patient group

Total knee arthroplasty patients

Description:

ConforMIS iTotal (CR) knee implant system and off-the-shelf knee implant systems from various manufacturers

Treatment:

Device: Total knee arthroplasty patients