Prospective Interventional Study on Intraarticular Platelet-Rich Plasma Injection in Patients With Kellgren-Lawrence Grade II and III Knee Osteoarthritis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 59
- 试验地点
- 1
- 主要终点
- Pain intensity
研究概览
简要总结
This prospective single-arm interventional study was designed to assess the short-term clinical outcomes of intra-articular platelet-rich plasma (PRP) injections in patients with Kellgren-Lawrence grade II and III knee osteoarthritis. A total of 59 patients (61 knees) were enrolled and followed for six months. Pain and function were measured using the Visual Analogue Scale (VAS) and Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC). Safety monitoring included documentation of injection-site pain and other adverse events.
详细描述
Osteoarthritis of the knee is a leading cause of disability worldwide. Platelet-rich plasma (PRP) therapy has emerged as a biologic intervention to enhance cartilage repair and reduce inflammation. This study was conducted at KIST Medical College and Teaching Hospital, Lalitpur, Nepal, between November 2022 and November 2023. Patients aged ≥50 years with KL grade II or III knee OA were enrolled. PRP was prepared using a double-spin centrifugation protocol to yield leukocyte-poor PRP, and 5 ml was injected intraarticularly via an inferolateral approach. Outcomes were assessed at baseline, 2, 4, and 6 months using validated instruments (VAS and WOMAC). Adverse events were monitored throughout the follow-up period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age >50 years
- •Persistent knee pain >4 weeks (In the case of patients presenting with bilateral knee pain, the knee with more severe symptoms was selected for study purposes.)
- •Patient must have undergone conservative treatment for at least 4 weeks.
- •Radiologically diagnosed as knee osteoarthritis with Kellgren-Lawrence grading scale, grades 2 and 3
- •Primary osteoarthritis of the knee
排除标准
- •Immunosuppressed patients (Examples: uncontrolled diabetes, HIV, under corticosteroid medication, etc.)
- •History of surgery around the knee joint
- •History of significant knee injury
- •Patients diagnosed with connective tissue disorders, inflammatory disorders of joints, congenital anomalies of the lower extremity, tumors, and metabolic diseases of bone
- •Patients who had received intra-articular steroid injections within the past 6 months
- •Patient who has not attempted conservative treatment.
- •Presence or suspected of infection or ulceration at the injection site.
- •Patients with a platelet count less than 1.5 lakhs/microliters
- •Congenital anomalies of the lower extremity
- •Patients on NSAIDs 2 days before and 2 days after PRP injection.
- •Patients with coexisting backache, hip pain
- •Pregnant or lactating females.
- •Cases where the diagnosis is uncertain.
- •Patients not willing to participate in the study
研究组 & 干预措施
PRP Injection
All participants received a single intraarticular injection of 5 ml leukocyte-poor platelet-rich plasma (PRP). The PRP was prepared using a double-spin centrifugation protocol and injected via an inferolateral approach with the knee flexed to 70°. Post-injection care included ice fomentation and range of motion exercises. NSAIDs were avoided for 2 days before and after injection; paracetamol was permitted for pain relief.
干预措施: Platelet-Rich Plasma (PRP) (Biological)
结局指标
主要结局
Pain intensity
时间窗: Baseline to 6 months
Unabbreviated scale title: Visual Analogue Scale (VAS) for pain Range: 0 to 10 Interpretation: Higher scores indicate worse pain intensity (0 = no pain, 10 = worst imaginable pain).
Functional outcome
时间窗: Baseline to 6 months
Unabbreviated scale title: Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Range: 0 to 96 (total score) Interpretation: Higher scores indicate worse pain, stiffness, and functional limitation (0 = no symptoms, 96 = extreme symptoms).
次要结局
未报告次要终点
研究者
Gaurav Bir Bajracharya
Orthopaedic Consultant and Clinical Researcher, Principal Investigator
KIST Medical and Teaching Hospital