An observational study in Osteoarthritis, Knee, sponsored by Restor3D. Terminated at 2 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-10-25.
Sponsored by Restor3D · Observational
This is a prospective multicenter study located in the United States. Subjects will be implanted with an iTotal Identity Knee Replacement System and followed for 10 years post implantation.
3,303 studies on the registry are indexed under Osteoarthritis, Knee; 608 are open to participants now.
This study's enrollment of 22 is below the median of 100 across 473 observational studies indexed under Osteoarthritis, Knee.
Browse Osteoarthritis, Knee studies →Restor3D is the lead sponsor of 23 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients with clinical condition indicated in the approved Instructions for Use for the Conformis iTotal Identity Knee Replacement System
Exclusion Criteria:
The iTotal® Identity KRS is a tri-compartmental semi-constrained knee prosthesis composed of three components: a Femoral Component, a Tibial Component, and a Patellar Component.Using patient imaging, a patient-specific implant is designed that best meets the geometric and anatomic requirements of the specific patient. The treatment allows for the placement of a cemented metallic device designed from the patient's natural bone geometry. This process allows definition of the shape and size of the femoral and tibial components of the implant, as well as the disposable instrumentation.
Pain and function
Measured by 2011 Knee Society Clinical Rating Score (objective knee score 0-125, function score 0-100, satisfaction score 0-40, expectation score 0-15 with higher scores meaning better outcome)
Time frame: 2 years post implantation
Revision rate
Time frame: Post implantation up to 10 years
Incidence of major procedure-related and device-related complications, including infection rate
Time frame: Post implantation up to 10 years
Post-operative hip-knee-ankle limb alignment (with 180 degrees being the expected outcome, plus or minus 5 degrees), if long leg x-rays available
Time frame: Post implantation up to 10 years
Number of patients demonstrating radiographic loosening, radiolucency
Review of x-rays to subjectively determine evidence of implant disassociation with bone
Time frame: Post implantation up to 10 years
Length of procedure
Time frame: Implant procedure from time the patient enters the operating room til time the surgery is complete and patient exits the operating room (up to 6 hours)
Length of hospital stay in hours
Time frame: Time from patient admission to hospital before surgery til discharge from hospital (up to 72 hours)
blood loss during surgery
Time frame: Implant procedure from time the patient enters the operating room til time the surgery is complete and patient exits the operating room (up to 6 hours)
blood transfusion rates
Time frame: Implant procedure from time the patient enters the operating room til time the surgery is complete and patient exits the operating room (up to 6 hours)
Plan to share: No
No publications or documents are linked to this record.
This study is terminated, as verified in Oct 2023. You cannot join it, but the record below documents what was studied.
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Restor3D