A Phase 1/2 interventional study of GelrinC in Cartilage Lesion to the Femoral Condyle, sponsored by Regentis Biomaterials. Status unknown. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2017-10-09.
Sponsored by Regentis Biomaterials · Phase 1/2, Interventional, and Treatment
This is a single arm, open label multi-center study to determine safety and the performance of the treatment of cartilage lesions located on the femoral condyle with GelrinC.
Patients meeting inclusion/exclusion criteria at screening will be enrolled into the study, and will receive treatment implantation into their cartilage lesions.
Treatment will consist of GelrinC implantations at the symptomatic lesion of femur rated as ICRS III, or IVA with less than 6 mm of bone loss below the subchondral plate.
The patients will undergo a rehabilitation program during the follow up period.
Regentis Biomaterials is the lead sponsor of 2 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
MRI obtained preoperatively within 3 months of Surgery
Intraoperative Arthroscopic Confirmation:
Exclusion Criteria:
17.Taking specific OA drugs such as chondroitin sulfate, diacerein, n-glucosamine, piascledine, capsaicin within 2 weeks of the screening 18.Is receiving prescription pain medication other than NSAIDs or acetaminophen for conditions unrelated to the index knee condition, chronic use of anticoagulant, or taking corticosteroids 19.Uncontrolled diabetes 20.Any concomitant painful or disabling disease of the spine, hips or lower limbs that would interfere with evaluation of the afflicted knee 21.Any clinically significant or symptomatic vascular or neurologic disorder of the lower extremities 22.Any evidence of the following diseases in the target joint : septic arthritis, inflammatory joint disease, gout, recurrent episodes of pseudogout, Paget's disease of bone, ochronosis, acromegaly, hemochromatosis, Wilson's disease, primary osteochondromatosis, heritable disorders, collagen gene mutation 23.Current diagnosis of osteomyelitis 24.Liver enzymes (SGOT, SGPT, Alkaline Phosphatase) of more than two times the upper limit of normal or any other result that is clinically important according to the Investigator 25.CRP > 10 mg/l 26.Clinically significant abnormal finding on screening laboratory parameters. 27.Clinically relevant compartment malalignment (> 5 degrees) as measured from the mechanical axis verified by clinical assessment or radiographic imaging when required 28.Patients with a history of bleeding disorders, patients receiving anti-platelet therapy or other anticoagulant medication use within 10 days prior to the beginning of the study, or patients in whom antiplatelet or other anticoagulant medication use is anticipated during the course of the study. However, patients on low-dose aspirin may be included in the study if aspirin therapy is interrupted at least 10 days before the treatment and not resumed until at least 2 weeks after the treatment.
GelrinC one step implantation to the femoral condyle lesion
Device: GelrinC
Applied once during surgery
No device related AE, or SAE
Time frame: 1 year
Improvement in KOOS over baseline
Time frame: 18 months
improvement in outcome based on questionnaires (KOOS, IKDC, VAS, SF-36)
Time frame: 2 years
improvement in outcome based on MRI (MOCART)
Time frame: 2 years
No study locations are listed for this record.
This study is status unknown, as verified in Oct 2017. You cannot join it, but the record below documents what was studied.
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