Assessment of the accuracy of Total Knee Replacement's (TKR's) performed using patient matched technology by computed tomography

Not Applicable

• Conditions: Osteoarthritis; Musculoskeletal - Osteoarthritis

• Registration Number: ACTRN12613000936729
• Lead Sponsor: Dr. Arash Nabavi

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-08-26
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

1.The individual has read and understood the patient information statement (PIS) and signed a consent form specific to this study.
2.The individual is over 18 years of age.
3.The individual has been given a primary diagnosis of osteoarthritis.
4.The individual clinically qualifies for total knee arthroplasty surgery based on physical examination and medical history.
5.The individual is physically and mentally willing and able to comply with scheduled clinical and radiographic evaluations (i.e., not currently being treated for a psychiatric disorder, senile dementia, Alzheimer’s disease, alcohol or substance abuse).
6.The individual does not have a systemic disease that would affect their welfare or the overall outcome of the study, is not immunologically suppressed, or receiving steroids in excess of physiologic dose requirements.
7.The individual is skeletally mature.

Exclusion Criteria

1.The individual is unable or unwilling to read the patient information statement (PIS) and sign the consent form specific to this study.
2.The individual has had a previous fracture of the femoral condyles, tibia plateau, or femora/tibial shaft.
3.The individual has had a previous osteotomy around the knee.
4.The individual is physically or mentally compromised (i.e., is currently being treated for a psychiatric disorder, senile dementia, Alzheimer’s disease, alcohol or substance abuse), and is unable to comply with scheduled clinical and radiographic evaluations.
5.The individual has a neuromuscular or neurosensory deficiency which limits their ability to evaluate the safety and effectiveness of the device.
6.The individual has an active infection within the affected joint.
7.The individual has had a previous total knee replacement.
8.The individual is pregnant.

Study & Design

• Study Type: Interventional
• Study Design: Not specified