Results from STAR

The Study of the Treatment of Articular Repair (STAR) was designed to determine the safety and efficacy of CARTICEL in patients who had an inadequate response to a prior repair procedure. It was a four-year, prospective, multicenter study of 154 patients at 29 participating sites.1

Study Results

In a clinically challenging patient population who suffered moderate-to-large chondral defects and who failed at least one prior cartilage treatment, CARTICEL demonstrated long-term durability and statistically significant and clinically meaningful reductions in pain and improvements in function.

A Challenging Patient Population

STAR enrolled young adult patients with large chondral defects who reported significant symptoms of pain and functional limitation.

  • Average age was 34.5 years old (17-67 years).
  • Defects were moderate to large (mean defect size 4.6 cm2).
  • 19% of patients had CARTICEL implanted in more than one defect.
  • On the Modified Cincinnati Knee Rating System, overall knee condition score at baseline was 3.3.
  • 26% of patients had osteochondritis dissecans (OCD).
  • 88% of patients reported their knee condition at baseline as “poor to fair.”
  • Average number of all surgeries prior to CARTICEL implantation was 1.9.2
  • Average number of surgeries in which a cartilage repair procedure was performed prior to CARTICEL implantation was 1.5.

Significant Reduction of Pain and Other Symptoms

In this challenging patient population, CARTICEL significantly reduced pain and other symptoms.

  • CARTICEL demonstrated sustained and significant improvements in knee function as early as 6 months and out to 4 years.
  • 78% of evaluable patients reported a follow-up score of “good” to “excellent.”
  • 50% of all evaluable patients reported “very good” or “excellent” results, indicating few or no limitations participating in sports.

Safety Outcomes

The safety reporting in STAR is consistent with the known CARTICEL safety profile.

Patients in STAR presented with many clinical challenges and, as expected, subsequent surgical procedures (SSPs) were reported.

  • 49% (N=76) of patients underwent an SSP irrespective of relationship to CARTICEL.
  • Of the patients who underwent an SSP, 83% underwent an arthroscopy or manipulation under anesthesia only.
  • Lysis of adhesions was the most frequent surgical intervention performed in the first 6 months. Cartilage debridement was the most frequently performed intervention after 6 months.
  • The most frequent serious adverse events (≥ 5% of patients) include arthrofibrosis/joint adhesions, graft overgrowth, chondromalacia or chondrosis, cartilage injury, graft complication, meniscal lesion, graft delamination and osteoarthritis.
  • Subsequent surgical procedures were not indicative of treatment failure in STAR.
  • Majority of patients (61%) did not meet the study definition of treatment failures.
  • Patients reported statistical improvements in clinical outcomes.
References
1. Data on file at Genzyme Corporation, Cambridge, MA.
2. Zaslav K, et al. A prospective study of autologous chondrocyte implantation in patients with failed prior treatment for articular cartilage defect of the knee: Results of the Study of the Treatment of Articular Repair (STAR) clinical trial. Am J Sports Med. 2009;37:42-55. doi:10.1177/0363546508322897.

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Important Safety Information

CARTICEL is for autologous use and is indicated for the repair of symptomatic, cartilage defects of the femoral condyle (medial, lateral or trochlea), caused by acute or repetitive trauma, in patients who have had an inadequate response to a prior arthroscopic or other surgical repair procedure (e.g., debridement, microfracture, drilling/abrasion arthroplasty, or osteochondral allograft/autograft). CARTICEL should only be used in conjunction with debridement, placement of a periosteal flap and rehabilitation. The independent contributions of the autologous cultured chondrocytes and other components of the therapy to outcome are unknown. It is not indicated for the treatment of cartilage damage associated with generalized osteoarthritis. It is not recommended for patients whose knee meniscus has been surgically removed unless the patient has undergone surgical reconstruction prior to or concurrent with CARTICEL implantation.

Pre-existing conditions including meniscal tears, joint instability or malalignment of the joint should be corrected prior to or concurrent with CARTICEL implantation. It should not be used in patients with a known history of hypersensitivity to gentamicin, other aminoglycosides or materials of bovine origin. CARTICEL is not routinely tested for transmissible infectious diseases and may transmit disease to the healthcare provider handling CARTICEL. In addition, it should not be used in patients who have previously had cancer in the bones, cartilage, fat or muscle of the treated limb. Use in children, patients over age 65, or in joints other than the knee has not yet been assessed.

The occurrence of subsequent surgical procedures (SSPs), primarily arthroscopy, following CARTICEL implantation is common. In the Study of the Treatment of Articular Repair (STAR), forty-nine percent (49%) of patients underwent an SSP on the treated knee, irrespective of their relationship to CARTICEL, during the 4-year follow up. The most common serious adverse events (≥5% of patients), derived from STAR, include arthrofibrosis/joint adhesions, graft overgrowth, chondromalacia or chondrosis, cartilage injury, graft complication, meniscal lesion, graft delamination, and osteoarthritis.

For more information on CARTICEL, please see the Package Insert (PDF).