NCT06636695已完成3 期
Clinical Efficacy of Platelet-Rich Plasma and Hyaluronic Acid Versus Hyaluronic Acid for Knee Osteoarthritis with MRI Analysis: a Randomized Controlled Trial
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 58
- 试验地点
- 2
- 主要终点
- Pain score
研究概览
简要总结
The study hypothesizes that the combination of Cellular Matrix PRP-HA is superior to Hyaluronic Acid (HA) alone, specifically from the Orthovisc Kit, in relieving pain and function associated with knee osteoarthritis.
The primary objective is to assess pain reduction following treatment. The secondary objectives, includes assessing the treatment's impact on function, stiffness, and overall quality of life for patients. In addition, non-invasive MRI will be employed at baseline and 12 months to evaluate changes in bone marrow edema, cartilage structure, and joint effusion. The study also aims to compare the safety of Cellular Matrix PRP-HA and HA.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants fulfilling all of the inclusion criteria, listed below, are eligible to participate in this study:
- •Patients between 40 and 80 years (inclusive) of age
- •Femoro-tibial knee osteoarthritis defined
- •OA grade 2-3 according to the Kellgren & Lawrence grading scale, as defined on knee radiographs (less than 6 months old: Antero-posterior view; lateral view and skyline view)
- •Symptomatic knee osteoarthritis of a unilateral knee, characterized by pain at walking VAS ≥40 on a 0 to 100mm scale
- •*Bilateral knee osteoarthritis is allowed, provided the contralateral knee is characterized by a maximum pain at walkingof 30 on a 0 to 100 mm scale and doesn't require systemic analgesic treatment, with the exception of paracetamol up to the maximum dose of 4 g per day
- •Outpatient capableof walking 50 meters without assistance
- •Signature of the informed consent form
- •Capable of understanding the study's imperatives, as well as written instructions
排除标准
- •Grade < 2 or > 3 OA according to the Kellgren & Lawrence gradingscale
- •Viscosupplementation in the treatment site within the past 3 months
- •Patients suffering from femoropatellar osteoarthritis
- •Use of NSAIDs within the past 7 days
- •Corticosteroid injection in the treatment site within the past 3 months
- •Chronic use of corticosteroids (except those that are inhaled) or level III analgesics in the past 3 months and NSAID during the past month2 weeks
- •PRP or PRP/HA injection in the past 12 months
- •Any surgery of the knee planned within the next 12 months
- •Unstable knee injury
- •Systemic use of level III analgesics in the past 3 months
- •History of allergy to HA
- •Rheumatological disorders(exceptKOA)
- •Clinical evidence of local inflammation such as redness or heat of the joint
- •Current or medical history of autoimmunediseases
- •Surgery or arthroscopy surgery in the affected knee within the past 3 months
- •Local infection in the affected knee
- •Haematologic or clotting disorders (thrombocytopenia platelet count <150,000 platelets/µ) or blood coagulation (deficit-blood dyscrasia)
- •Anaemia (Haemoglobin <10g/dl)
- •Anticoagulant treatment or Antiaggregant treatment
- •Acute infection
- •Immunosuppressive states
- •Malignant disease
- •Recent fever (within previous 2 weeks) or serious disorders (liver disease, active gastroduodenal ulcer, digestive haemorrhage, etc.)
- •Pregnancy or breastfeeding or planning to become pregnant during the course of the study
- •Uncontrolled diabeted
- •Participation ongoing or in the past 3 months in another clinical trial
- •Participation in another OA clinical study in the past year
- •Refusal to sign or inability to give Informed Consent Inability to understand or comply with the requirements of the study
结局指标
主要结局
Pain score
时间窗: Baseline, Month 1, Month 2, Month 6, Month 12
Visual Analogue Score (VAS) on a scale of 0 to 10. 10 being the worst possible pain.
次要结局
- Quality of life(Baseline, Month 1, Month 2, Month 6, Month 12)
- MRI(Baseline and Month 12)
- Function Score(Baseline, Month 1, Month 2, Month 6, Month 12)
研究者
研究点 (2)
Loading locations...
相似试验
已完成
不适用
Comparison of Hyaluronic Acid and Platelet-rich Plasma InjectionsKnee OsteoarthritisNCT03761472Bezmialem Vakif University40
已完成
3 期
Comparison of Autologous Platelet-rich Plasma With Hyaluronic Acid for the Treatment of Osteoarthritis of the Knee JointOsteoarthritis, KneeNCT02211521Samsung Medical Center110
Unknown
不适用
PRP vs HA Intra-articular Knee Injections for Cartilage DefectsOsteoarthritisNCT02012530Shetty-Kim Research Foundation100
尚未招募
3 期
The Effect of Platelet-rich Plasma Nasal Injection in the Treatment of Traumatic Olfactory DysfunctionTraumatic Olfactory Nerve Injury With Anosmia (Diagnosis)Effect of DrugNCT06290219Taichung Veterans General Hospital80
Unknown
不适用
Platelet Rich Fibrin VS Hyaloronic Acid in Management of Pain After Harvesting a Free Gingival GraftPain, PostoperativeNCT03814707mostafa soliman26