Case Study: Medial Femoral Condyle Cartilage Repair
Important Safety Information
Full Prescribing Information
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Case Study: Medial Femoral Condyle Cartilage Repair

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See a recent case study to learn how an 18-year-old recreational athlete was able to resume her active lifestyle following an accident and left knee medial femoral condyle cartilage repair with MACI, which offers the flexibility to treat cartilage defects in multiple areas of the knee.

The Patient

  • 18-year-old female patient
  • Recreational athlete

Patient’s Knee History

  • Left knee pain resulting from a motor vehicle accident
  • Conservative management was initially recommended: activity modification, and a home exercise program

Arthroscopy findings from an 18-year-old patient revealing central grade III chondromalacia about the femoral condyle measuring 15 x 11 mm and corresponding grade II chondromalacia about the central weight-bearing portion of the tibial plateau measuring 12 x 15 mm.

Surgical Approach

  • Arthroscopy revealed central grade III chondromalacia about the femoral condyle measuring 15 x 11 mm
  • Corresponding grade II chondromalacia about the central weight-bearing portion of the tibial plateau measuring 12 x 15 mm
  • Initial surgical approach was for tricompartmental synovectomy and Stage I ACI harvest
  • At 6-weeks post-op, patient was progressing well; the decision was made to continue PT and follow up for re-evaluation
  • Patient noted some recurrence of symptoms 12-month post-op
  • At 19-month post-op symptoms had worsened significantly and decision was made to proceed with MACI implantation of the medial femoral condyle

Surgical step-by-step showing MACI implantation into a patient’s knee

Rehab

  • 12-week rehab protocol with return to low impact activity in months 6-9
  • Resume running program and dynamic recreational activities in months 9-12

Outcome

  • At 9 months post-op, patient rated at 91% on SANE Score

Learn more about surgical best practices for MACI knee cartilage repair here.

Individual results may vary.

 

Please see below for full indication and ISI. Blog posts are intended to provide educational information only and do not constitute medical advice.

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Indication and Important Safety Information

Important Safety Information

Contraindications: MACI is contraindicated in patients with a known history of hypersensitivity to gentamicin, other aminoglycosides, products of porcine or bovine origin; in patients with severe osteoarthritis of the knee, inflammatory arthritis, inflammatory joint disease, or uncorrected congenital blood coagulation disorders; 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; or in patients unable to cooperate with a physician-prescribed post-surgical rehabilitation program.

Warnings and Precautions:
  • Malignancy: The risk of MACI in patients with malignancy in the area of cartilage biopsy or implant is unknown. Expansion of malignant or dysplastic cells present in biopsy tissue during manufacture and subsequent implantation may be possible.
  • Transmissible infectious diseases: Because patients undergoing procedures associated with MACI are not routinely tested for transmissible infectious diseases, cartilage biopsy and MACI implant may carry risk of transmitting infectious diseases.
  • Presurgical Comorbidities: Local inflammation or active infection in the bone, joint, and surrounding soft tissue, meniscal pathology, cruciate ligament instability, and misalignment should be assessed and treated prior to or concurrent with MACI implantation.
  • Product Sterility: Final sterility test results are not available at the time of shipping.

Adverse Reactions: 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.

Specific Populations:
  • Use of MACI in pediatric patients (younger than 18 years of age) or in patients over 65 years of age has not been established.
  • The MACI implant is not recommended during pregnancy. For implantations post-pregnancy, the safety of breastfeeding to an infant has not been determined.

To report negative side effects, contact Vericel Corporation at 1-800-453-6948 or FDA at 1-800-FDA-1088 (1-800-332-1088) or www.fda.gov/medwatch.

Please see Full Prescribing Information.

Indication

MACI® is an autologous cellularized scaffold product indicated for the repair of single or multiple symptomatic, full-thickness cartilage defects of the knee with or without bone involvement in adults.

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

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.