Status:
TERMINATED
Total Knee Arthroplasty Functional Outcomes Study Research Design
Lead Sponsor:
Restor3D
Collaborating Sponsors:
Ochsner Health System
Conditions:
Osteoarthritis of the Knee
Eligibility:
All Genders
18+ years
Brief Summary
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.
Detailed 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 cl...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2013
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
September 1 2016
Estimated Enrollment :
7 Patients enrolled
Trial Details
Trial ID
NCT02228538
Start Date
October 1 2013
End Date
September 1 2016
Last Update
October 25 2023
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Ochsner Clinic Foundation
New Orleans, Louisiana, United States, 70121