A Biologic Joint Replacement Strategy to Treat Patients With Severe Knee Trauma and Post-Traumatic Osteoarthritis (Expansion)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 14
- 试验地点
- 2
- 主要终点
- VAS Pain Score (Visual Analog Scale)
研究概览
简要总结
Participants will be enrolled in a prospective clinical trial to assess outcomes in 2 cohorts of patients undergoing unicompartmental versus more extensive biologic OCA transplantation of the knee using MOPSTM-preserved allografts (including menisci), anatomically-shaped allografts, autogenous bone marrow aspirate concentrate (BMC)-treated donor bone, and treatment-specific postoperative rehabilitation.
详细描述
With IRB approval, patients will be enrolled in a prospective clinical trial to assess outcomes in 2 cohorts of patients undergoing unicompartmental versus more extensive biologic OCA transplantation of the knee using MOPSTM-preserved allografts (including menisci), anatomically-shaped allografts, autogenous bone marrow aspirate concentrate (BMC)-treated donor bone, and treatment-specific postoperative rehabilitation. Demographic and operative data will be collected. Outcome assessments will include VAS pain, IKDC, SANE, Tegner and PROMIS Mobility for knee at 6 months and yearly after surgery. In addition, serial limb alignment measurements, ultrasonographic assessments of meniscal location and integrity, quantitative MRIs for cartilage composition, and serum and urine biomarkers for treatment monitoring will be performed. All complications and re-operations will be recorded. OCA survival will be determined based on maintenance of acceptable levels of pain and function and/or need for revision surgery or total knee arthroplasty.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Grade IV changes in the articular cartilage of the femoral condyle and tibial plateau and meniscal pathology in the medial or lateral femorotibial joint (unicompartmental) or unicompartmental and other femoral condyle, tibial plateau, trochlea and/or patella.
- •Between the age of 18-55
排除标准
- •Acute injury to any other part of the affected lower extremity
- •Inability to comply with protocol
- •BMI greater than 40
- •The subject is either pregnant or a prisoner
- •Currently involved in worker's compensation case at the time of enrollment
结局指标
主要结局
VAS Pain Score (Visual Analog Scale)
时间窗: 12 Months
This pain score is between 0 and 10, with 0 being no pain and 10 being the worst pain
次要结局
- International Knee Documentation Committee Score (IKDC)(12 Months)
- Single Assessment Numeric Evaluation (SANE) score(12 Months)
- PROMIS Mobility(12 Months)
研究者
James Stannard
Professor, Orthopedic Surgery
University of Missouri-Columbia