Results from the Study of the Treatment of Articular Repair (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
In a clinically challenging patient population who suffered moderate-to-large chondral defects and who failed at least 1 prior cartilage treatment, Carticel demonstrated long-term durability out to 4 years (duration of study) 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.
- Mean age was 34.5 years old.
- Defects were moderate to large (mean defect size 4.6 cm2).
- 19% of patients had Carticel implanted in more than 1 defect.
- 26% of patients had osteochondritis dissecans (OCD).
- 88% of patients reported their knee condition at baseline as “poor to fair,” indicating a 4 or less on the Overall Modified Cincinnati Knee Scale.
- Mean number of all surgeries prior to Carticel implantation was 1.9.2
- Mean number of surgeries in which a cartilage repair procedure was performed prior to Carticel implantation was 1.5.
Reduction of Pain and Other Symptoms
In this challenging patient population, Carticel reduced pain and other symptoms.
- Carticel demonstrated sustained improvements in knee function as early as 12 months and out to 4 years (duration of the study).
- At 48 months post-treatment, 77% of evaluable patients reported “good” to “excellent” overall knee condition (an overall score of 6 or better on the Modified Cincinnati Knee Rating System), which indicates they have some limitations with sports but can participate with minimal compensation.
- 50% of all evaluable patients reported “very good” or “excellent” results, indicating few or no limitations participating in sports.
76% of patients treated with Carticel did not meet the definition of treatment failure by the 4-year follow-up.
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% (63/76) 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 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.
- Subsequent surgical procedures were not indicative of treatment failure in STAR.
- Of the patients who required an SSP, 61% (46/76) did not meet the study definition of treatment failure (e.g., graft delamination or surgical procedure violating the subchondral bone).
- Patients reported statistical improvements in clinical outcomes.