IRB Number: 2014-384
Institutional Review Board, Hospital for Special Surgery
October 06, 2015
The safety of study participants is our top priority. The trial is approved and periodically reviewed by an Institutional Review Board (IRB), which includes doctors, administrators, ethicists, and members of the general public. The safety of clinical trials is reviewed by the U.S. Food and Drug Administration.
Before enrolling in a clinical trial, the investigator will explain the purpose of the trial, its expected benefits, any possible risks or side effects, and what your role will be. This is the time to ask questions! If you want to join the trial, you must sign the informed consent documents. You can leave a clinical trial at any time without penalty.
For further information, see Understanding Clinical Trials.
Riley J. Williams, MD
The purpose of this company-sponsored Phase 3 study is to learn about the safety and potential efficacy of an investigational cartilage tissue implant, NeoCart®, compared to microfracture, the current standard of care surgery for articular cartilage defects of the knee. Dr. Williams, as one of the investigating physicians, is currently screening patients who may qualify for this study. If you are between the ages of 18 and 59 years old, are suffering from knee pain, and have been told that microfracture may be a treatment option, you may be eligible for this study. An estimated 25 patients will enroll and the follow-up duration will last for 3 years.
Any patient who meets all of the following criteria may be included into this study. The patient must be:
- Able and willing to give informed consent.
- 18 years to 59 years of age.
- Symptomatic with knee pain indicative of an articular cartilage injury of the distal femur and/or trochlea. Baseline KOOS pain score must be <80 and baseline IKDC Subjective score must be <70.
- Medically able to undergo arthroscopy, arthrotomy for NeoCart® implantation, and serial MRIs.
- Females must be post-menopausal or practicing an acceptable form of birth control.
Pre-Procedure Exclusion Criteria
Any patient who meets any of the following criteria will not be included into this study. The patient cannot have:
- Any previous surgical treatment of the study defect (such as abrasion arthroplasty, abrasion chondroplasty, multiple drilling or microfracture). Prior debridement or shaving of the articular cartilage/chondroplasty of the study lesion is permitted but must have been performed >3 months prior to the study arthroscopy.
- Meniscal repair on either knee within three months prior to arthroscopy.
- Partial meniscectomy on the study knee within 3 months prior to study arthroscopy.
- Body Mass Index (BMI) > 35 kg/m2.
- Radiographic evidence of osteoarthritis, Kellgren-Lawrence Grade 3 or greater.
- Malalignment greater than 3 degrees outside the mechanical axis from the contralateral knee, or malalignment requiring surgical correction.
- Symptomatic pathology of the contralateral knee.
- Surgery (with the exception of ligament reconstruction or meniscal repair addressed separately) on the contralateral knee within the 3 months prior to the scheduled arthroscopy.
- Any form of inflammatory arthritis.
- Ankylosing spondylitis.
- Synovioma, hemangioma, pigmented villonodular synovitis (PVNS), or other neoplasms in the knee.
- Any condition requiring chemotherapy.
- Positive pregnancy test or intention to become pregnant during the year following treatment.
- Known history of allergy to bovine products or gentamycin.
- Any autoimmune disease.
- Human immunodeficiency virus (HIV), chronic hepatitis B or C viral infection.
- Insulin-dependent diabetes.
- Clinically significant or symptomatic vascular or neurologic disorder of the lower extremities.
- Current drug or alcohol abuse.
- Ligament reconstruction on either knee within three months prior to study arthroscopy.
- Evidence suggesting inability to comply with the Protocol.
- Smoking habit of more than 1 pack of cigarettes per week and/or are frequent users (>1/week) of chewing tobacco. The number of smokers will be limited to 10% of the enrolled patients.
- Any concomitant painful or disabling disease of the hips or lower limbs that would interfere with the evaluation of the afflicted knee.
- Treatment with specific osteoarthritis drugs, such as chondroitin sulfate, diacerein, n-glucosamine, piascledine, and capsaicin, within the last two weeks.
- Corticosteroid therapy by systemic or intra-articular route within the last month of baseline or intramuscular or oral corticosteroids within the last two weeks.
- Intra-articular injections of hyaluronic acid into the afflicted knee within the last six months.
- Status as a participant in an investigational research trial within the last three months.
Gregory T. Mahony