Patel Sandeep, Gahlaut Shivam, Thami Tarkik, Chouhan Devendra Kumar, Jain Ashish, Dhillon Mandeep Singh
Department of Orthopedic Surgery, Post Graduate Institute of Medical Education & Research (PGIMER), Chandigarh, India.
Department of Transfusion Medicine, Post Graduate Institute of Medical Education & Research (PGIMER), Chandigarh, India.
Orthop J Sports Med. 2024 Feb 26;12(2):23259671241227863. doi: 10.1177/23259671241227863. eCollection 2024 Feb.
Confusion persists regarding the ideal dosage of platelet-rich plasma (PRP) injection for knee osteoarthritis (OA).
PURPOSE/HYPOTHESIS: The purpose of the study was to compare the efficacy of 2 different single-injection PRP dosages in patients with early knee OA-a conventional 4 mL dose and a superdose of 8 mL. It was hypothesized that 8 mL of PRP would be superior to 4 mL of PRP in this patient population.
Randomized clinical trial; Level of evidence, 1.
Patients with early knee OA (Kellgren-Lawrence grades 1 and 2) who met the inclusion criteria were randomly divided into 2 groups: Group A (n = 50 knees) received a 4-mL PRP injection, and group B (n = 49 knees) received an 8-mL PRP injection, both prepared using the same procedure. Patients were evaluated at the baseline, 6 weeks, 3 months, and 6 months using the Western Ontario and McMaster Universities Arthritis Index (WOMAC), the WOMAC-Pain subscale, the visual analog scale for pain, the Knee injury and Osteoarthritis Outcome Score, and patient satisfaction, and results were compared between the groups.
The baseline characteristics of the 2 groups were comparable (group A: mean age, 51.96 ± 6.93 years; group B: mean age, 49.12 ± 9.8 3 years). Leucocyte-depleted PRP with 3.5 times concentration (final product platelet concentration, 706.74 × 10-μL) was injected. The mean absolute platelet count injected was 2.82 ± 0.0012 billion in group A and 5.65 ± 0.0022 billion in group B. All patient-reported outcome scores improved significantly in both groups from the baseline to the final follow-up ( < .001), with overall trends and results significantly better in group B than in group A ( < .001). Patient satisfaction at the 6-month follow-up was also better in group B (96%) compared with group A (68%). Short (2 to 7 days) self-limiting complications, such as pain and stiffness, occurred more often in group B ( < .001).
Patients with early knee OA had significantly better improvement in pain and function when treated with an 8-mL injection of PRP compared with a 4-mL injection of PRP. The larger dose of PRP had approximately twice the number of platelets.
CTRI/2020/02/023403 (Clinical Trials Registry-India identifier).
对于膝骨关节炎(OA)患者,富血小板血浆(PRP)注射的理想剂量仍存在争议。
目的/假设:本研究旨在比较两种不同单次注射PRP剂量对早期膝OA患者的疗效,即传统的4 mL剂量和8 mL超大剂量。假设在该患者群体中,8 mL PRP的疗效优于4 mL PRP。
随机临床试验;证据等级为1级。
符合纳入标准的早期膝OA(Kellgren-Lawrence分级为1级和2级)患者被随机分为两组:A组(n = 50膝)接受4 mL PRP注射,B组(n = 49膝)接受8 mL PRP注射,两组均采用相同方法制备。在基线、6周、3个月和6个月时,使用西安大略和麦克马斯特大学骨关节炎指数(WOMAC)、WOMAC疼痛子量表、视觉模拟疼痛量表、膝关节损伤和骨关节炎疗效评分以及患者满意度对患者进行评估,并比较两组结果。
两组的基线特征具有可比性(A组:平均年龄51.96±6.93岁;B组:平均年龄49.12±9.83岁)。注射了浓度为3.5倍的去白细胞PRP(最终产品血小板浓度为706.74×10⁶/μL)。A组注射的平均绝对血小板计数为28.2±0.0012亿,B组为56.5±0.0022亿。从基线到最终随访,两组所有患者报告的结局评分均显著改善(P <.001),B组的总体趋势和结果显著优于A组(P <.001)。B组在6个月随访时的患者满意度(96%)也高于A组(68%)。B组更常出现短期(2至7天)自限性并发症,如疼痛和僵硬(P <.001)。
与4 mL PRP注射相比,8 mL PRP注射治疗早期膝OA患者时,疼痛和功能改善明显更好。较大剂量的PRP所含血小板数量约为前者的两倍。
CTRI/2020/02/023403(印度临床试验注册标识符)