Biological Response of Stage IV Knee Osteoarthritis to Serial 12.5% Dextrose Injections Without Weight Bearing Restriction: A Double Arthroscopic Assessment
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 6
- 试验地点
- 1
- 主要终点
- Quality of cartilage growth
研究概览
简要总结
Dextrose injection in end-stage knee arthritis will cause growth of cartilage cells in a particular area of complete cartilage loss. Dextrose concentration will be 12.5%. Cartilage status will be monitored by pre and post treatment arthroscopy views with specialized (methylene blue) staining for cartilage.
详细描述
Historical, compliance, examination,anesthetic injection, radiographic and arthroscopic screening will be completed. One month after arthroscopy completion, the intervention phase will begin.
INTERVENTION
- Injection of 12.5% dextrose at 0, 1 and 2 months.
- Stand up without using only the non-injected leg for 3 days after each injection.
- Avoid running and squatting as feasible.
- Ensure that the injected knee descends stairs first ascends stairs last for 3 days.
- May take Acetaminophen.
- No NSAIDS for 2 days before and 10 days after a treatment. PRN NSAIDs only.
- No glucosamine or chondroitin should be taken.
SECOND ARTHROSCOPY TIMING
- A minimum of 4 months after first arthroscopy, when schedulable.
- After a minimum of 3 monthly injections of dextrose 12.5% .
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Weight ≤ 90 kilos.
- •Available for clinic any day.
- •Agreeable to keep coming if pain stops.
- •More than one phone number.(close relative ok)
- •Willing to wait 6 months prior to considering a TKA.
- •Good strength in arms to help stand.
- •Knee flexion more than 100 degrees.
- •90% reduction of standing, walking and sitting pain 5 minutes after intraarticular injection of 9 ml of 0.25% dextrose.
- •XRay repeat with camera at knee height confirms bone on bone status in the medial compartment.
排除标准
- •No dementia.
- •No radiating back pain.
- •No systemic inflammatory conditions.
- •No history of knee fracture or infection.
- •No cancer history.
- •No blood thinners.
- •No daily narcotic.
- •No walking limitation from another cause.
- •Repetitive squatting or stair use on job.
- •Inability to use one arm to help come to stand.
- •Painful hip ROM or imitative of patient's pain.
- •Knee extension lacking more than 15 degrees on each side.
- •Any degree of valgus.
- •Varus of 20 degree or more.
- •A painful Baker's cyst.
- •Visible bone shift when walking
- •Meniscal tear seen on arthroscopy that could block motion and needs trimming.
- •Significant loose bodies seen on arthroscopy.
- •Severe synovitis seen on arthroscopy.
- •More than 1 outerbridge lesion in the medial compartment of the femur.
结局指标
主要结局
Quality of cartilage growth
时间窗: 0 to 3 months
A Jamshidi needle biopsy will be obtained at 45 degrees in the area of maximum cartilage growth and analyzed for quality/type of cartilage if such growth is seen.
Number of sections of medial condyle with loss, no change or growth of cartilage.
时间窗: 7.5 month mean
Arthroscopy of all 9 sections of the medial condyle for each of 6 knees will be viewed by each of 3 arthroscopers who will render their opinion for each section. They will compare sections from 1st and 2nd arthroscopy side by side, and will be asked to indicate loss of cartilage no change or growth of cartilage for each of sections on each of 6 knees. Still photos of the biopsy study site wiThe photo of the Out IV lesion will be analyzed in a blinded fashion for a visual or computerized assessment of the percentage of lesion size covered by cartilage buds.
次要结局
- Walking pain(0 to 3 years)
- Flexion range of motion(0 to 3 months)
- WOMAC(7.5 Months)
研究者
Gastón Andrés Topol
Principle Investigator
Universidad Nacional de Rosario