LifeCell Corporation (an Allergan affiliate), Research and Development Department, Bridgewater, NJ, USA.
J Orthop Surg (Hong Kong). 2020 Jan-Apr;28(2):2309499020939737. doi: 10.1177/2309499020939737.
The use of human tissue-derived autografts and allografts continues to be the gold standard in anterior cruciate ligament (ACL) repair. However, autografts and allografts have their own set of associated risks. Many alternative options, including synthetic replacements, have failed to demonstrate long-term success. In this study, sterile acellular porcine bone-tendon-bone (BTB) xenografts were created using a proprietary process and tested against BTB autografts in goats for 13 and 52 weeks. At 13 weeks, all xenograft-implanted animals ( = 9) had subjective hind leg motor function (HLMF) that was categorized as either normal (score = 0) or a slight limp (score = 1) compared with two of nine autograft-implanted animals having a moderate limp (score = 2). At 39 weeks, there was HLMF improvement with each autograft-implanted and xenograft-implanted animal having normal HLMF or only a slight limp. At 13 weeks, six of nine animals in each group achieved normal anterior drawer scores, which increased to nine of nine animals in each group by 39 weeks. Both autografts and xenografts exhibited minimal inflammation with excellent integration of the fibrous tendon portion of the graft to host bone, as evidenced histologically by Sharpey's fiber formation. At 52 weeks, maximum mechanical load at failure for xenografts was 1092.0 ± 586.4 N compared with 1037.0 ± 422.6 N for autografts. These results demonstrate that a sterile acellular porcine BTB xenograft can perform equivalently to BTB autograft in a caprine model of ACL repair.
使用人组织来源的自体移植物和同种异体移植物仍然是前交叉韧带(ACL)修复的金标准。然而,自体移植物和同种异体移植物都有其自身的一系列相关风险。许多替代方案,包括合成替代品,都未能证明长期成功。在这项研究中,使用专有的方法创建了无菌脱细胞猪骨-肌腱-骨(BTB)异种移植物,并在山羊中对 BTB 自体移植物进行了 13 周和 52 周的测试。在 13 周时,所有异种移植物植入动物(=9)的后腿主观运动功能(HLMF)均被归类为正常(评分=0)或轻度跛行(评分=1),而 9 只自体移植物植入动物中有 2 只存在中度跛行(评分=2)。在 39 周时,每个自体移植物和异种移植物植入动物的 HLMF 都有所改善,所有动物的 HLMF 均正常或仅轻度跛行。在 13 周时,每组 9 只动物中有 6 只的前抽屉评分正常,到 39 周时每组动物的前抽屉评分均为 9 只正常。自体移植物和异种移植物均表现出最小的炎症反应,移植物的纤维肌腱部分与宿主骨结合良好,组织学上表现为Sharpey 纤维形成。在 52 周时,异种移植物的失效最大机械载荷为 1092.0±586.4 N,而自体移植物的失效最大机械载荷为 1037.0±422.6 N。这些结果表明,在 ACL 修复的山羊模型中,无菌脱细胞猪 BTB 异种移植物可以与 BTB 自体移植物等效发挥作用。