Anatomical Single-Bundle Anterior Cruciate Ligament Reconstruction Using a Calcium Phosphate-Hybridized Tendon Graft with More than an Average of 5 Years of Follow-Up: A Follow-Up Study of a Randomized Controlled Trial.

Abstract

Calcium phosphate (CaP)-hybridized tendon grafting using an alternate soaking process improves tendon-to-bone healing in anterior cruciate ligament (ACL) reconstructions. This study aimed to compare bone tunnel enlargement, knee osteoarthritis, and clinical results between CaP-hybridized tendon grafting and conventional grafting in anatomical single-bundle ACL reconstruction. This study was a follow-up of a randomized controlled trial. Between July 2011 and December 2015, 90 patients underwent unilateral anatomical single-bundle ACL reconstructions and were randomly assigned to the CaP-hybridized tendon grafting (CaP group, n = 45; age, 27.1 [14-54] years; sex, 21 males and 24 females) or conventional grafting (control group, n = 45; age, 22.9 [13-58] years; sex, 26 males and 19 females). The randomization was performed according to the days of the week when the patients first visited the outpatient. The CaP-hybridized tendon grafting was created intraoperatively. The tendon grafts were soaked in a calcium solution for 30 s. After that, the tendon grafts were soaked in a NaHPO4 solution for 30 s. This soaking cycle between the calcium solution and the NaHPO4 solution was repeated 10 times. The bone tunnel enlargement, osteoarthritis grade, clinical score, and sports level were evaluated in patients who could be followed up for >3 years (CaP group, n = 20, average follow-up period 6.0 [5.1-6.9] years; control group, n = 15, average follow-up period 5.6 [4.3-6.9] years). Clinical scores, sports levels, and osteoarthritis grades were analyzed using a generalized linear mixed model (GLMM) based on repeated measurement data from preoperative and final observations, with time, group, sex, age, and BMI as fixed effects and the effect of individual differences as variable effects. In addition, bone-tunnel enlargements were analyzed using generalized linear models (GLM) with group, sex, age, and BMI as the main effects. Compared with the control group, the CaP group exhibited significantly reduced bone-tunnel enlargement on the femoral side (anteroposterior diameter; CaP group, 7.9% [-1.1-16.8] vs. control group, 29.2% [17.9-40.5], p = 0.004, MCID 16.05, proximal-distal diameter; CaP group, 7.9% [-1.9-17.8] vs. control group, 22.8% [10.9-34.7], p = 0.062, MCID 15.00). The osteoarthritis grades progressed in both groups (p < 0.001). The clinical scores and sports levels were not significantly different between the groups. This study suggests that the calcium phosphate-hybridized tendon graft reduces femoral bone-tunnel enlargement after anatomical single-bundle anterior cruciate ligament reconstruction in an average >5-year follow-up period. A longer follow-up period is necessary to reveal the clinical effects of the calcium phosphate-hybridized tendon grafts in anterior cruciate ligament reconstruction.