Anterior cruciate ligament reconstruction with BPTB autograft, irradiated versus non-irradiated allograft: a prospective randomized clinical study.

The effect of using gamma irradiation to sterilize bone-patellar tendon-bone (BPTB) allograft on the clinical outcomes of anterior cruciate ligament (ACL) reconstruction with irradiated allograft remains controversial. Our study was aimed to analyze the clinical outcomes of arthroscopic ACL reconstruction with irradiated BPTB allograft compared with non-irradiated allograft and autograft. All BPTB allografts were obtained from a single tissue bank and the irradiated allografts were sterilized with 2.5 Mrad of irradiation prior to distribution. A total of 102 patients undergoing arthroscopic ACL reconstruction were prospectively randomized consecutively into three groups. The same surgical technique was used in all operations done by the same senior surgeon. Before surgery and at the average of 31 months follow-up (range 24-47 months) patients were evaluated by the same observer according to objective and subjective clinical evaluations. Of these patients, 99 (autograft 33, non-irradiated allograft 34, irradiated allograft 32) were available for full evaluation. When compared the irradiated allograft group to non-irradiated allograft group or autograft group at 31 months follow-up by the Lachman test, ADT, pivot shift test and KT-2000 arthrometer testing, statistically significant differences were found. Most importantly, 87.8% of patients in the Auto group, 85.3% in the Non-Ir-Auto group and just only 31.3% in the Ir-Allo group had a side-to-side difference of less than 3 mm according to KT-2000. The failure rate of the ACL reconstruction with irradiated allograft (34.4%) was higher than that with autograft (6.1%) and non-irradiated allograft (8.8%). The anterior and rotational stability decreased significantly in the irradiated allograft group. According to the overall IKDC, functional, subjective evaluations and activity level testing, no statistically significant differences were found between the three groups. However, there was a trend that the functional and activity level decreased and the patients felt uncomfortable more often in the irradiated allograft group. The statistical analysis showed no significant difference between the non-irradiated allograft group and the autograft group according to the aforementioned evaluations, except that patients in the allograft group had a shorter operation time and a longer duration of postoperative fever. When comparing the postoperative duration of fever of the two allograft groups, there was also a trend that the irradiated allograft group was longer than the non-irradiated allograft group, but no significant difference was found. When the patients had a fever, the laboratory examinations of all patients were almost normal (Blood routine was normal, the values of ESR were 5 - 16 mm/h, CRP were 3 - 10 mg/l). On the basis of our study, we concluded that patients undergoing ACL reconstruction with BPTB non-irradiated allograft or autograft had similar clinical outcomes. Non-irradiated BPTB allograft is a reasonable alternative to autograft for ACL reconstruction. While the short term clinical outcomes of the ACL reconstruction with irradiated BPTB allograft were adversely affected with an increased failure rate. The less than satisfactory results led the senior authors to discontinue the use of irradiated BPTB allograft in ACL surgery and not to advocate that gamma irradiation be used as a secondary sterilizing method. Further research into alternatives to gamma irradiation is needed.

RCT Entities:   Population Interventions Outcomes