Study to Evaluate the Safety and Performance of Treatment of Articular Cartilage Lesions Located on the Femoral Condyle With gelrinC

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Regentis Biomaterials
ClinicalTrials.gov Identifier:
NCT00989794
First received: October 4, 2009
Last updated: June 8, 2014
Last verified: June 2014
  Purpose

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.


Condition Intervention Phase
Cartilage Lesion to the Femoral Condyle
Device: GelrinC
Phase 1
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase I/II Study for the Safety and Performance of GELRIN C

Further study details as provided by Regentis Biomaterials:

Primary Outcome Measures:
  • No device related AE, or SAE [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • improvement in status based on questionnaires (KOOS, IKDC, VAS, SF-36) [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • proved in outcome based on MRI (MOCART) [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 56
Study Start Date: September 2009
Estimated Study Completion Date: June 2016
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: GelrinC
GelrinC one step implantation to the femoral condyle lesion
Device: GelrinC
Applied once during surgery

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Males or females 18 and 65 years of age.
  2. Not more than two treatable symptomatic lesions which are NOT posterior; patient must present with pain in the index knee of moderate or severe level (VAS score ≥5)
  3. If Female: Actively practicing a contraception method, or Practicing abstinence, or Surgically sterilized, or Postmenopausal
  4. Understands and voluntarily signs and dates an informed consent document.
  5. Grade 3 or 4 acute (traumatic) or chronic (degenerative) lesion
  6. Willingness to follow standardized rehabilitation procedures.
  7. Willingness and ability to comply with the requirements of this protocol, including returning for evaluation (clinical and imaging) at periodic intervals post-treatment.
  8. Study knee has intact ligaments
  9. Ipsilateral knee compartment has intact menisci (or requires partial meniscectomy resulting in stable menisci)
  10. Contralateral knee is asymptomatic, stable and fully functional.
  11. MRI obtained preoperatively within 3 months of Surgery

    Intraoperative Arthroscopic Confirmation:

  12. one or two symptomatic lesions of the femur rated as ICRS III, or IVA with less than 6 mm of bone loss below the subchondral plate
  13. Individual defect size between 1 cm2 - 6 cm2 after arthroscopic debridement

Exclusion Criteria:

  1. More than two symptomatic lesions
  2. Untreatable Posterior lesions
  3. Lesion greater than 6cm2
  4. ICRS Grade larger than grade II on a surface that directly opposes the defect
  5. Osteoarthritis or avascular necrosis (clinical and/or radiographic diagnosis)
  6. History of autoimmune disease or inflammatory arthropathy, such as rheumatoid arthritis, systemic lupus, active gout, septic or reactive arthritis including any history of a positive ANA blood test.
  7. History of chronic debilitating systemic disease and any other unstable cardiac and pulmonary disorders.
  8. History of current or prior malignancy within the last 5 years.
  9. Patients treated in the affected knee with microfracture in the last 12m months or had prior tendon repair, meniscus repair, ligament repair or realignment surgery in the last 6 months.
  10. Patient with prior total or subtotal meniscectomy.
  11. Body Mass Index (BMI) >32 Kg/m2
  12. `Patients with known HIV, Hepatitis A, B, or C infections or other immunodeficient state.
  13. Patients requiring immunosuppressive medications.
  14. Clinically significant organic disease including clinically significant cardiovascular, pulmonary, neurologic, hepatic or renal disease or other medical condition, serious concurrent illness or extenuating circumstance that, in the opinion of the investigator, make the subject a poor candidate for participation in the study.
  15. Patients received any other investigational products within 6 months prior to study enrollment.

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.

  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00989794

Locations
Belgium
ZOL Campus Andre Dumont
Genk, Belgium
Gent University Clinic
Gent, Belgium
AZ Groeninge
Kortrijk, Belgium
UZ Leuven
Leuven, Belgium
Care To Move
Sint Niklaas, Belgium
Germany
Orthopeadische Klinik Fuer die Universitaet Regensburg
Bad Abbach, Regensburg, Germany, 93077
Zentrum for Gelenk und Wirbelsaulenzentrum
Berlin, Germany
Universitätsklinikum Gießen und Marburg GmbH, Standort Gießen
Giessen, Germany
Orthocentrum Hamburg
Hamburg, Germany
Universitateklinilum f. Chirurgie
Luebeck, Germany
Zentrum fur Gelenk Endoprothesen und Wirbelsaulenchirugie
Olsberg, Germany
Orthopedische Chirurgie
Rheinfelden, Germany
Israel
Rambam Medical Center
Haifa, Israel
Sourasky Medical Center
Tel Aviv, Israel
Dr. Gabriel Ager
Tzrifin, Israel
Netherlands
Academisch Ziekenhuis Maastricht
Maastricht, Netherlands
Poland
Centrum Medycyny Sportowej
Warsaw, Poland
Sponsors and Collaborators
Regentis Biomaterials
  More Information

No publications provided

Responsible Party: Regentis Biomaterials
ClinicalTrials.gov Identifier: NCT00989794     History of Changes
Other Study ID Numbers: CLN 004-00
Study First Received: October 4, 2009
Last Updated: June 8, 2014
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Regentis Biomaterials:
cartilage
implantation
chondrocyte
condyle

ClinicalTrials.gov processed this record on July 20, 2014