Department of Orthopaedics and Traumatology, Samsun Training and Research Hospital, İlkadım, 55139, Samsun, Turkey.
Department of Orthopaedics and Traumatology, Ondokuz Mayis University Faculty of Medicine, Samsun, Turkey.
Arch Orthop Trauma Surg. 2022 Oct;142(10):2755-2768. doi: 10.1007/s00402-021-04230-2. Epub 2021 Oct 27.
The primary purposes of this study were to prove the efficacy of PRP injection therapy on knee pain and functions by comparing patients with mild to moderate OA with a placebo control group, and also to understand the effectiveness of multiple doses compared to a single dose. It was hypothesized that PRP would lead to more favorable results than the placebo at 1, 3, 6, 12 and 24 months after treatment.
237 patients diagnosed with OA were randomly separated into 4 groups, who were administered the following: single dose of PRP (n: 62), single dose of sodium saline (NS) (n: 59), three doses of PRP (n: 63), and three doses of NS (n: 53). Clinical evaluations were made pre-treatment and at 1, 3, 6, 12 and 24 months post-treatment, using the Knee Injury and Osteoarthritis Result Score (KOOS), Kujala Patellofemoral Score, knee joint range of motion (ROM), measurements of knee circumference (KC), and mechanical axis angle (MAA) and a Visual Analog Scale (VAS) for the evaluation of pain.
The better score values in the groups were recorded at 3 and 6 months. Patients treated with PRP maintained better scores at 3, 6 and 12 months compared to the NS groups (p < 0.05). Multiple doses of PRP were seen to be more effective than single-dose PRP at 6 and 12 months (p < 0.05). At the end of 24 months, there was no significant score difference across all the groups. The most positive change in scores was found in stage 2 OA, and the most positive change in ROM was in stage 3 OA patients. In the PRP groups, KC decreased more at 1 and 6 months (p < 0.05). Compared to other age groups, patients aged 51-65 years scored better at 6 months (p < 0.05). A negative correlation was determined with MAA scores (r = - 0.508, p < 0.001).
In comparison to the placebo (NS), leukocyte-rich PRP treatment was determined to be effective in the treatment of OA. Multiple doses of PRP increase the treatment efficacy and duration. Of all the patients treated with PRP, the best results were obtained by patients aged 51-65 years, with lower MAA, and by K/L stage 2 OA patients.
Randomized controlled trial; Level of evidence, 1.
NCT04454164 (ClinicalTrials.gov identifier).
本研究的主要目的是通过与安慰剂对照组比较，证明 PRP 注射疗法对轻度至中度 OA 患者的膝关节疼痛和功能的疗效，并了解与单次剂量相比多次剂量的效果。假设 PRP 治疗后 1、3、6、12 和 24 个月，其效果将优于安慰剂。
将 237 名被诊断为 OA 的患者随机分为 4 组，分别接受以下治疗：单次 PRP 剂量（n=62）、单次生理盐水（NS）剂量（n=59）、3 次 PRP 剂量（n=63）和 3 次 NS 剂量（n=53）。治疗前和治疗后 1、3、6、12 和 24 个月，采用膝关节损伤和骨关节炎结果评分（KOOS）、Kujala 髌股评分、膝关节活动度（ROM）、膝关节周长（KC）测量值、机械轴角度（MAA）和视觉模拟评分（VAS）评估疼痛。
在第 3 和 6 个月，各组记录到更好的评分值。与 NS 组相比，接受 PRP 治疗的患者在 3、6 和 12 个月时保持更好的评分（p<0.05）。与单次 PRP 相比，多次 PRP 治疗在 6 和 12 个月时更有效（p<0.05）。在 24 个月结束时，所有组之间的评分无显著差异。在 2 期 OA 中，评分的变化最明显，在 3 期 OA 患者中，ROM 的变化最明显。在 PRP 组中，KC 在 1 和 6 个月时下降更多（p<0.05）。与其他年龄组相比，51-65 岁的患者在 6 个月时评分更好（p<0.05）。MAA 评分与 KC 呈负相关（r=-0.508，p<0.001）。
与安慰剂（NS）相比，富含白细胞的 PRP 治疗被证明对 OA 有效。多次 PRP 剂量可提高治疗效果和持续时间。在接受 PRP 治疗的所有患者中，51-65 岁、MAA 较低、K/L 2 期 OA 患者的疗效最佳。
随机对照试验；证据水平，1。
NCT04454164（ClinicalTrials.gov 标识符）。
