Steadman J Richard, Rodkey William G
Steadman Hawkins Clinic, Vail, Colorado, USA.
Arthroscopy. 2005 May;21(5):515-25. doi: 10.1016/j.arthro.2005.01.006.
In this feasibility study, a 5- to 6-year clinical follow-up evaluation was conducted on 8 patients who had undergone reconstruction of 1 injured medial meniscus with a tissue-engineered collagen meniscus implant. The hypothesis was that these patients would show significant clinical improvement over their preoperative status and would have maintained their status determined at the 2-year follow-up evaluation.
Prospective longitudinal feasibility study follow-up evaluation.
Eight patients underwent arthroscopic placement of a collagen meniscus implant by a single surgeon to reconstruct and restore the irreparably damaged medial meniscus of 1 knee. All patients returned for clinical, radiographic, magnetic resonance imaging, and arthroscopic examinations an average of 5.8 years (range, 5.5-6.3 y) after collagen meniscus implant placement.
Lysholm scores improved significantly (P = .045) from 75 preoperatively to 88 at most recent follow-up evaluation. Average Tegner activity scores improved significantly (P = .001) from 3 to 6. Patient self-assessment improved significantly (P = .046) from 2.4 to 1.9 (1 = normal, 4 = severely abnormal). Pain scores improved from 23 to 11 (0 = no pain, 100 = worst pain). Imaging studies confirmed that the chondral surfaces of the medial compartment had not degenerated further since the placement of the implant 5.8 years earlier. Relook arthroscopy with direct measurement of the newly generated tissue revealed 69% defect filling. Histologic assessment of tissue biopsy specimens from 3 patients showed the presence of fibrocartilage with a uniform extracellular matrix.
The meniscus-like tissue that developed after collagen meniscus implant placement has maintained its structure and functioned without negative effects for more than 5 years. The hypothesis was affirmed that these patients were improved significantly compared with their preoperative status and unchanged compared with 2-year evaluations.
Level IV.
在本可行性研究中，对8例接受组织工程胶原蛋白半月板植入物修复1例内侧半月板损伤的患者进行了5至6年的临床随访评估。假设是这些患者与术前状态相比临床症状将有显著改善，并且将维持在2年随访评估时所确定的状态。
前瞻性纵向可行性研究随访评估。
8例患者由同一外科医生通过关节镜植入胶原蛋白半月板植入物，以重建和修复1例膝关节不可修复的内侧半月板损伤。所有患者在植入胶原蛋白半月板植入物后平均5.8年（范围5.5 - 6.3年）返回进行临床、影像学、磁共振成像和关节镜检查。
Lysholm评分从术前的75分显著提高（P = 0.045）至最近一次随访评估时的88分。平均Tegner活动评分从3分显著提高（P = 0.001）至6分。患者自我评估从2.4分显著改善（P = 0.046）至1.9分（1 = 正常，4 = 严重异常）。疼痛评分从23分改善至11分（0 = 无疼痛，100 = 最严重疼痛）。影像学研究证实，自5.8年前植入植入物以来，内侧间室的软骨表面未进一步退变。再次关节镜检查并直接测量新生成组织显示缺损填充率为69%。对3例患者的组织活检标本进行组织学评估显示存在具有均匀细胞外基质的纤维软骨。
胶原蛋白半月板植入后形成的半月板样组织在5年多的时间里保持了其结构和功能，且无不良影响。假设得到证实，即这些患者与术前状态相比有显著改善，与2年评估时相比无变化。
IV级。
