A Cohort Comparison Study Comparing Platelet Rich Plasma vs Hyaluronic Acid Intra-articular Knee Injections for Early Cartilage Defects in the Knee
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Clinical outcome
研究概览
简要总结
Study Title: A cohort comparison study Comparing Platelet Rich Plasma vs Hyaluronic Acid Intra-articular Knee Injections for Early Cartilage Defects in the knee.
Study hypothesis: We start with the hypothesis that both treatments are equally effective.
Trial Design: The participating patients will be divided into two groups, each group receiving either one of the treatment modalities. This study will be randomised. Both procedures will be done at the Spire Alexandra Hospital by Professor A. A Shetty. The post-operative rehabilitation process will be the same for both groups.
Trial Participants: All participants will be from patients attending Professor Shetty's clinic at the Spire Alexandra Hospital.
Planned Sample Size: 50 patients in each group
Follow-up duration: The participating patients will be followed up at 2 weeks, 6 weeks, 3 months following the surgery by visits to the clinic and assessed clinically. The surgical outcomes will be measured by by IKDC, KOOS and Lysholm scores.
Planned Trial Period: Two to three years
Primary Objective: To establish superiority, if any, of either procedure over the other by studying pain relief, improvement in function.
Primary Endpoint: At the end of the 2 year follow up for all participating patients.
详细描述
Osteoarthritis and early degenerative cartilage lesions has a significant impact on our society. People are both living and are more active for longer and so their demands are greater. This is having a direct effect on our economy from days missed off work and greater dependency on state resources.
The limited regenerative capacity of cartilage is part of this problem. Existing degenerative lesions lead to accelerated deterioration of the articular (joint) surface leading to end-stage arthritis. Any solution that can delay or reverse this process is therefore desirable. A number of non-invasive solutions do exist to treat painful knees that improve functionality but with varying rates of success. Two of the more promising agents are hyaluronic acid (HA) and platelet rich plasma (PRP). HA is widely applied in clinical practice with good results in many studies. HA forms part of the inflammatory process that can lead to the regeneration of cartilage in defective areas of the knee.
PRP uses reparative growth factors taken from the patient's own blood to create an environment in the knee conducive to wound healing that can fill cartilage defects. It's autologous origin, easy preparation and safety profile makes it a potentially ground breaking treatment option for knee cartilage defects and osteoarthritis.
These solutions work to improve the localised environment of morbidity and so for this reason are best administered as intra-articularly. As PRP is still in the earlier stages of its development, its exact dosage is still to be determined. HA has also recently been prepared as a higher concentration solution to test if there are any benefits to this.
Trials have compared these two products. No randomised controlled trials exist making our proposed research important.
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
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participant is willing and able to give informed consent for participation in the study.
- •Male or Female, aged 18 years or above.
- •Diagnosed with either early degenerative cartilage lesions (Grade 1-3) as determined by plain radiograph, MRI or intra-operatively (categorised as per Outerbridge/ICRS classification).
- •The patient must have more than a four month history of knee pain or swelling whether continuous or intermittent.
排除标准
- •Female participants who are pregnant, lactating or planning pregnancy during the course of the study.
- •Systemic disorders- DM, RA, SLE
- •Major axial deviation (varus>5˚, valgus>5˚)
- •Patients suffering from haematological disorders (coagulopathy)
- •Patients with severe cardiovascular disease
- •Active infection
- •Immuno-suppressed patients
- •Patients taking anticoagulants such warfarin or low molecular weight heparin
- •Haemoglobin levels below 11g/dl
- •Platelet count below 150000/mmc
- •Participants who have participated in another research study involving an investigational product in the past 12 weeks
结局指标
主要结局
Clinical outcome
时间窗: 3 months
The participating patients will be followed up at 2 weeks, 6 weeks and finally at 3 months following the injection by visits to the clinic and assessed clinically. The surgical outcomes will be measured by by KOOS score.
次要结局
- Change in VAS Score at 3 months(3 months)