Dr. Tejwani and his colleagues sought to examine the association of graft processing techniques, patient characteristics, and graft type with risk of revision surgery after allograft ACLR. Using a large community-based ACLR registry, they identified 5,968 patients (61 percent male; median age = 34 years) who had undergone primary unilateral allograft ACLR between February 2005 and September 2012. Cases with incomplete vendor graft processing information were excluded.
Graft processing techniques included the following:
BioCleanse®, a proprietary technique developed by Regeneration Technologies (n = 367; 6.1 percent)
AlloSource’s AlloTrue™ or LifeNet Health’s AlloWash® (n = 2,278; 38.2 percent)
Irradiation using more than 1.8 Mrad (n = 1,146; 19.2 percent)
Irradiation using less than 1.8 Mrad (n = 3,637; 60.9 percent)
No irradiation at all (n = 1,185; 19.9 percent)
Among the 5,968 patients, 62.9 percent had undergone ACLR with soft tissue, 19.9 percent with Achilles tendon, and 17.2 percent with bone–patellar tendon–bone (BPTB) allograft. The median age of the allograft donors was 50 years. The mean time to follow-up after the initial surgery was 2.1 years.
The aseptic revision rate was 2.6 percent (n = 156). The researchers found statistically significant differences in the distribution of patient age (P < 0.001), allograft type (P = 0.021), and irradiation dosage (P = 0.041) among the cases, with and without revision. After adjusting for patient age, gender, and body mass index, they found that the BioCleanse technique—which sterilizes tissue through oscillating positive and negative pressure in the presence of detergents and sterilants—and irradiation with more than 1.8 Mrad were associated with a higher risk of revision after 1 year, compared to the other graft processing methods.
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Samir G Tejwani, Jason Chen, Tadashi T Funahashi, Rebecca Love, Gregory B Maletis. "Revision Risk After Allograft Anterior Cruciate Ligament Reconstruction: Association With Graft Processing Techniques, Patient Characteristics, and Graft Type." Am J Sports Med. 2015 Nov;43(11):2696-705