López-Vidriero Emilio, Olivé-Vilas Ramón, López-Capapé David, Varela-Sende Luisa, López-Vidriero Rosa, Til-Pérez Luís
ISMEC, Sevilla, Spain.
CST Consorci Sanitari de Terrassa, Barcelona, Spain.
Orthop J Sports Med. 2019 Feb 27;7(2):2325967119827237. doi: 10.1177/2325967119827237. eCollection 2019 Feb.
New biologic strategies are arising to enhance healing and improve the clinical outcome of anterior cruciate ligament (ACL) reconstruction.
To evaluate the efficacy of a new oral nutritional supplement (Progen) that contains hydrolyzed collagen peptides and plasma proteins, a hyaluronic acid-chondroitin sulfate complex, and vitamin C.
Randomized controlled trial; Level of evidence, 2.
The study included patients who underwent ACL reconstruction with hamstring autografts using the same fixation method. All patients received the same analgesia and physical therapy (PT) protocol and were randomized to receive either the nutritional supplement (supplemented group) or no additional therapy (control group). Patients were followed up at days 7, 30, 60, and 90. Pain was assessed by use of a visual analog scale (VAS) and by analgesic consumption. Clinical outcome was assessed via International Knee Documentation Committee (IKDC) score and the number of PT sessions. Perceived efficacy and tolerability were rated on a 5-point Likert scale. Graft maturation was assessed by a blinded musculoskeletal radiologist using magnetic resonance imaging. The number of adverse events (AEs) was recorded.
The intention-to-treat analysis included 72 patients, 36 allocated to the supplemented group and 36 to the control group, with no significant differences regarding demographic and preoperative characteristics. Both groups showed significant improvement in pain and function (measured by VAS and IKDC scores) during the 90-day follow-up period ( < .001 for both), without significant differences between groups. The supplemented group had fewer patients that needed analgesics (8.5% vs 50.0%; < .05) and attended fewer PT sessions (38.0 vs 48.4 sessions; < .001) at 90 days and had a higher IKDC score at 60 days (62.5 vs 55.5; = .029) compared with the control group. Patient- and physician-perceived efficacy was considered significantly higher in the supplemented group at 60 and 90 days ( < .05). Perceived tolerability of the overall intervention was better in the supplemented group at 30, 60, and 90 days ( < .05). Graft maturation showed more advanced degrees (grades 3 and 4) in the supplemented group at 90 days (61.8% vs 38.2%; < .01). No intolerance or AEs associated with the nutritional supplement treatment were reported.
The combination of the nutritional supplement and PT after ACL reconstruction improved pain, clinical outcome, and graft maturation. Nutritional supplementation showed higher efficacy during the second month of recovery, without causing AEs.
NCT03355651 (ClinicalTrials.gov identifier).
新的生物策略正在兴起，以促进前交叉韧带（ACL）重建的愈合并改善临床结果。
评估一种新型口服营养补充剂（Progen）的疗效，该补充剂含有水解胶原蛋白肽和血浆蛋白、透明质酸 - 硫酸软骨素复合物以及维生素C。
随机对照试验；证据等级，2级。
该研究纳入了使用相同固定方法进行自体腘绳肌腱ACL重建的患者。所有患者均接受相同的镇痛和物理治疗（PT）方案，并随机分为接受营养补充剂组（补充组）或不接受额外治疗组（对照组）。在第7、30、60和90天对患者进行随访。通过视觉模拟量表（VAS）和镇痛药消耗量评估疼痛。通过国际膝关节文献委员会（IKDC）评分和PT疗程次数评估临床结果。使用5点李克特量表对感知疗效和耐受性进行评分。由一名盲法肌肉骨骼放射科医生使用磁共振成像评估移植物成熟度。记录不良事件（AE）的数量。
意向性分析纳入了72例患者，36例分配至补充组，36例分配至对照组，两组在人口统计学和术前特征方面无显著差异。在90天的随访期内，两组的疼痛和功能（通过VAS和IKDC评分测量）均有显著改善（两组均P <.001），组间无显著差异。与对照组相比，补充组在90天时需要镇痛药的患者较少（8.5%对50.0%；P <.05），参加的PT疗程较少（38.0次对48.4次；P <.001），且在60天时IKDC评分较高（62.5对55.5；P = 0.029）。在60天和90天时，补充组患者和医生感知的疗效被认为显著更高（P <.05）。在30、60和90天时，补充组对整体干预的感知耐受性更好（P <.05）。在90天时，补充组移植物成熟显示出更高级别（3级和4级）（61.8%对38.2%；P <.01）。未报告与营养补充剂治疗相关的不耐受或AE。
ACL重建后营养补充剂与PT联合使用可改善疼痛、临床结果和移植物成熟度。营养补充在恢复的第二个月显示出更高的疗效，且未引起AE。
NCT03355651（ClinicalTrials.gov标识符）
