MACI Surgical Technique

LIVE CASE VIDEOS DEMONSTRATING THE USE OF MACI IN THE TREATMENT OF CARTILAGE DEFECTS OF THE KNEE

Kai Mithoefer, M.D. demonstrates a live MACI surgery on a 42 year old male with multiple cartilage defects on the lateral femoral condyle and trochlea following an ACL reconstruction.

PATIENT PROFILE

Dr. Mithoefer addresses his treatment approach for a 42 year old male with multiple cartilage defects

SURGICAL APPROACH

Dr. Mithoefer discusses exposure for a trochlear defect and a posterior LFC defect

ASSESSMENT AND DEBRIDEMENT

Dr. Mithoefer uses the MACI custom cutters to prepare the defects for MACI

MACI IMPLANTATION

Dr. Mithoefer secures the MACI implants and discusses the post-op plan

Tom Minas, M.D. performs the MACI procedure and a tibial tubercle osteotomy on a patient with chronic patella subluxation and multiple cartilage defects.

Patient Case Description

Tom Minas, M.D. reviews the case including history of previous surgeries

Surgical Approach

Tom Minas, M.D. demonstrates his surgical incision and discusses his operative plan

Exposure And Approach

Tom Minas, M.D. discusses his cuts for a tibial tubercle osteotomy

Defect Preparation

Tom Minas, M.D. prepares the cartilage defects for MACI implantation

Sizing And Shaping

Tom Minas, M.D. templates the MACI implants for multiple defects

MACI Implantation

Tom Minas, M.D. places and secures the MACI implants to the patella, trochlea, and MFC

Fixation And Closure

Tom Minas, M.D. fixates the tibial tubercle and discusses his closure technique

Wayne Gersoff, M.D. performs the MACI procedure on a cartilage defect located in the medial femoral condyle.

Patient Profile

Wayne Gersoff, M.D. presents the case outline for this demonstration

Preparing the Defect

Wayne Gersoff, M.D. prepares a cartilage defect for MACI

Sizing and Shaping

Wayne Gersoff, M.D. fits the MACI implant to the defect

Implantation

Wayne Gersoff, M.D. affixes the MACI implant

Kevin Freedman, M.D. demonstrates the use of MACI in thetreatment of a defect located in the lateral femoral condyle.

Biopsy procurement

Kevin Freedman, M.D. describes the tools and techniques for obtaining the cartilage biopsy

Patient profile

Kevin Freedman, M.D. describes the case outline, including location and size of lesion

Surgical approach

Kevin Freedman, M.D. prepares the knee and exposes the defect

Assessment and debridement

Kevin Freedman, M.D. prepares the defect for MACI implantation

Shaping the implant

Kevin Freedman, M.D. creates an exact fit by templating the MACI implant

Implantation of MACI

Kevin Freedman, M.D. inserts the implant into the defect and secures it with fibrin adhesive

PP.US.MAC.0751

Indication

MACI^® (autologous cultured chondrocytes on porcine collagen membrane) is an autologous cellularized scaffold product that is indicated for the repair of single or multiple symptomatic, full-thickness cartilage defects of the adult knee, with or without bone involvement.

MACI is intended for autologous use and must only be administered to the patient for whom it was manufactured. The implantation of MACI is to be performed via an arthrotomy to the knee joint under sterile conditions.

The amount of MACI administered is dependent upon the size (surface in cm²) of the cartilage defect. The implantation membrane is trimmed by the treating surgeon to the size and shape of the defect, to ensure the damaged area is completely covered, and implanted cell-side down.

Limitations of Use

Effectiveness of MACI in joints other than the knee has not been established.

Safety and effectiveness of MACI in patients over the age of 55 years have not been established.

Important safety information

MACI is contraindicated in patients with a known history of hypersensitivity to gentamicin, other aminoglycosides, or products of porcine or bovine origin. MACI is also contraindicated for patients with severe osteoarthritis of the knee, inflammatory arthritis, inflammatory joint disease, or uncorrected congenital blood coagulation disorders. MACI is also not indicated for use in patients who have undergone prior knee surgery in the past 6 months, excluding surgery to procure a biopsy or a concomitant procedure to prepare the knee for a MACI implant.

MACI is contraindicated in patients who are unable to follow a physician-prescribed post-surgical rehabilitation program.

The safety of MACI in patients with malignancy in the area of cartilage biopsy or implant is unknown. Expansion of present malignant or dysplastic cells during the culturing process or implantation is possible.

Patients undergoing procedures associated with MACI are not routinely tested for transmissible infectious diseases. A cartilage biopsy and MACI implant may carry the risk of transmitting infectious diseases to healthcare providers handling the tissue. Universal precautions should be employed when handling the biopsy samples and the MACI product.

Final sterility test results are not available at the time of shipping. In the case of positive sterility results, health care provider(s) will be contacted.

To create a favorable environment for healing, concomitant pathologies that include meniscal pathology, cruciate ligament instability and joint misalignment, must be addressed prior to or concurrent with the implantation of MACI.

Local treatment guidelines regarding the use of thromboprophylaxis and antibiotic prophylaxis around orthopaedic surgery should be followed. Use in patients with local inflammations or active infections in the bone, joint, and surrounding soft tissue should be temporarily deferred until documented recovery.

The MACI implant is not recommended during pregnancy. For implantations post-pregnancy, the safety of breast feeding to infant has not been determined.

Use of MACI in pediatric patients (younger than 18 years of age) or patients over 65 years of age has not been established.

The most frequently occurring adverse reactions reported for MACI (≥5%) were arthralgia, tendonitis, back pain, joint swelling, and joint effusion.

Serious adverse reactions reported for MACI were arthralgia, cartilage injury, meniscus injury, treatment failure, and osteoarthritis.

Please see Full Prescribing Information for more information

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