Centeno-Schultz Clinic, 403 Summit Blvd Suite 201, Broomfield, CO, 80021, USA.
Regenexx, LLC, Des Moines, IA, 50321, USA.
J Transl Med. 2018 Sep 3;16(1):246. doi: 10.1186/s12967-018-1623-3.
Bone marrow concentrate (BMC) has shown promise in the treatment of several orthopedic conditions. This registry study investigated the use of autologous BMC and platelet products for percutaneous anterior cruciate ligament (ACL) treatment.
Twenty-nine patients presenting to a single outpatient interventional musculoskeletal and pain practice with symptomatic grade 1, 2, or 3 ACL tears with less than 1 cm retraction were enrolled. Patients were treated with a percutaneous ACL injection of autologous BMC and platelet products using fluoroscopic guidance. Pre- and post-treatment magnetic resonance imaging analysis was completed for 23 patients using ImageJ software for an objective quantitative analysis of pixel density as a proxy for ACL integrity. Subjective clinical outcome measures collected pre-treatment and at 1, 3, 6, 12, 18, 24, and 36 months post-treatment include the Numerical Pain Scale (NPS), the Lower Extremity Functional Scale (LEFS), the International Knee Documentation Committee (IKDC) form, and a modified version of the Single Assessment Numeric Evaluation.
Seventy-seven percent of patients treated with BMC injections into the ACL showed significant improvement (p < 0.01) in objective measures of ACL integrity at an average of 8.8 months (median 4.7 months). The mean of last patient-reported improvement was 72% (SD = 35) at an average of 23 (SD = 10) months post-treatment. Mean scores were found to be significantly different (p < 0.05) for the NPS at 6, 18, and 24 months, and LEFS and IKDC at all time points (i.e. 1, 3, 6, 12, 18, 24, and 36 months) relative to baseline.
In symptomatic patients with grade 1, 2, or even grade 3 tears with minimal retraction, ACL treatment with percutaneous injection of BMC and platelet products shows promise as a non-surgical alternative. However, a larger randomized controlled trial is warranted to confirm these findings. Trial registration NCT03011398. A Clinical Registry of Orthobiologics Procedures. https://clinicaltrials.gov/ct2/show/NCT03011398?term=orthobiologics&rank=1 . Registered 29 December 2016. Enrollment 1 December 2011-retrospectively registered.
骨髓浓缩物（BMC）在治疗多种骨科疾病方面显示出良好的效果。本注册研究调查了自体 BMC 和血小板产品在经皮前交叉韧带（ACL）治疗中的应用。
29 名患者因有症状的 ACL 1 级、2 级或 3 级撕裂且回缩小于 1cm 而到一家单门诊介入肌肉骨骼和疼痛治疗中心就诊，接受了经皮 ACL 自体 BMC 和血小板产品注射治疗。23 名患者在治疗前后均使用磁共振成像（MRI）进行分析，使用 ImageJ 软件对像素密度进行客观定量分析，作为 ACL 完整性的替代指标。在治疗前和治疗后 1、3、6、12、18、24 和 36 个月时收集了主观临床结局指标，包括数字疼痛量表（NPS）、下肢功能量表（LEFS）、国际膝关节文献委员会（IKDC）表单和改良的单项评估数字评估。
77%的接受 BMC 注射治疗的 ACL 患者在 ACL 完整性的客观测量中显示出显著改善（p<0.01），平均为 8.8 个月（中位数 4.7 个月）。最后一次患者报告改善的平均值为 72%（SD=35），平均为 23 个月（SD=10 个月）。与基线相比，NPS 在 6、18 和 24 个月，LEFS 和 IKDC 在所有时间点（即 1、3、6、12、18、24 和 36 个月）的平均得分均有显著差异（p<0.05）。
在有症状的 1 级、2 级甚至 3 级撕裂且回缩最小的患者中，经皮注射 BMC 和血小板产品治疗 ACL 具有作为非手术替代方案的潜力。然而，需要更大的随机对照试验来证实这些发现。试验注册 NCT03011398。骨科生物制剂治疗的临床注册。https://clinicaltrials.gov/ct2/show/NCT03011398?term=orthobiologics&rank=1。注册于 2016 年 12 月 29 日。招募于 2011 年 12 月 1 日-回顾性注册。
