Tassinari Enrico, Minerba Andrea, Basile Tommaso, Bucciarelli Alessio, Traina Francesco, Grigolo Brunella, Zaffagnini Stefano, Olivotto Eleonora
2nd Orthopaedic and Traumatologic Clinic IRCCS Istituto Ortopedico Rizzoli Bologna Italy.
Orthopaedic-Traumatology and Prosthetic Surgery and Revisions of Hip and Knee IRCCS Istituto Ortopedico Rizzoli Bologna Italy.
J Exp Orthop. 2025 Jan 31;12(1):e70158. doi: 10.1002/jeo2.70158. eCollection 2025 Jan.
This study aimed to compare the use of cortisone (C), intra-articular injected at the end of hip arthroscopy in patients with femoroacetabular impingement (FAI), to a new Class III medical device based on hydrolyzed collagen peptides 'PEPTYS' (P) and, to investigate potential associations among preoperative symptoms and hip function, outcomes after arthroscopic surgery and presence of inflammatory biomarkers in synovial fluids (SFs) at basal condition.
The two treatments were administrated to patients scheduled for arthroscopy with simple blind randomization sampling. Based on the sample size calculation, the number necessary to recruit was at least 20 patients for the C group and 20 for the P group. SFs, when available, were obtained by aspiration just prior to surgical intervention. At the baseline, osteoarthritis (OA) severity was assessed with a radiographic scoring system (Tönnis classification). Physical examination and clinical assessment using the Hip disability and Osteoarthritis Outcome Score (HOOS) and visual analogue scale (VAS) score for pain were performed at the time of surgery and at 1 and 6 months of follow-up. At the time of surgery, chondral (Outerbridge score) and labral pathology based on direct arthroscopic visualization were also evaluated.
Forty-seven FAI patients were enroled, with a median age of 35 years with a standard deviation (SD) of 10.6 and a body mass index of 24.3kg/m² with an SD of 4.5. 24 patients were treated with C and 23 with P. Both treatments did not show any statistically significant difference in hip function and pain. High expression of inflammatory molecules in SFs was correlated with the worst post-operative articular function.
Our study showed that the use of P was completely comparable to cortisone. Therefore, PEPTYS might be a valuable candidate to improve early recovery, in terms of pain and function, from arthroscopic FAI treatment.
Level III, comparative and randomized study.
本研究旨在比较在股骨髋臼撞击症（FAI）患者髋关节镜检查结束时关节内注射可的松（C）与基于水解胶原蛋白肽的新型III类医疗器械“PEPTYS”（P）的使用情况，并研究术前症状与髋关节功能、关节镜手术后的结果以及基础状态下滑液（SF）中炎症生物标志物的存在之间的潜在关联。
通过简单的盲法随机抽样，将两种治疗方法应用于计划进行关节镜检查的患者。根据样本量计算，C组至少需要招募20名患者，P组至少需要招募20名患者。如有可用的SF，则在手术干预前通过抽吸获取。在基线时，使用放射学评分系统（Tönnis分类）评估骨关节炎（OA）的严重程度。在手术时以及随访的1个月和6个月时，使用髋关节残疾和骨关节炎结果评分（HOOS）以及疼痛视觉模拟量表（VAS）评分进行体格检查和临床评估。在手术时，还基于直接关节镜观察评估软骨（Outerbridge评分）和盂唇病变。
47例FAI患者入组，中位年龄为35岁，标准差（SD）为10.6，体重指数为24.3kg/m²，SD为4.5。24例患者接受C治疗，23例接受P治疗。两种治疗在髋关节功能和疼痛方面均未显示出任何统计学上的显著差异。SF中炎症分子的高表达与术后最差的关节功能相关。
我们的研究表明，P的使用与可的松完全可比。因此，就疼痛和功能而言，PEPTYS可能是改善关节镜下FAI治疗早期恢复的有价值的候选药物。
III级，比较性随机研究。
