Interventional Orthopedics Foundation Patient Registry Database-A Clinical Registry of Orthobiologics Procedures
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 50,000
- 试验地点
- 28
- 主要终点
- Change in Percent Improvement
研究概览
简要总结
The purpose of the Registry study is to observe the improvement in subject-reported clinical outcomes for percutaneous orthopedic procedures for treatment of musculoskeletal disorders.
详细描述
This Registry was designed to assure that the benefits and knowledge gained by studying clinical outcomes associated with the use of percutaneous orthopedic procedures outweigh the potential risks to the patients. The primary objective of this Registry is to observe the improvements in subject-reported clinical outcomes for these procedures used to treat musculoskeletal disorders. Secondary objectives include evaluating post-treatment complication, adverse events, re-injections, and surgical intervention. Patients receiving percutaneous orthopedic treatments are asked to enroll before receiving treatment and complete a set of baseline questionnaires regarding pain and functionality of the area of the body being treated (i.e. knee, shoulder, spine, etc). Follow-up outcomes are collected at 1 month, 3 months, 6 months, 12 months, 18 months, and annually 2-20 years post-injection. Subjects are withdrawn from the Registry prematurely if a surgical operation occurs.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Candidates must meet ALL of the following:
- •Voluntary signature of the IRB approved Informed Consents,
- •Treated with a Regenexx procedure
- •Have a musculoskeletal condition appropriate for the procedure such as osteoarthritis or internal joint derangement; ligament or tendon injury; intervertebral disc degeneration; protrusion, extrusion, or annular tear; muscle tear
排除标准
- 未提供
结局指标
主要结局
Change in Percent Improvement
时间窗: 1 month, 3 months, 6 months, 12 months, 18 months and annually 2-20 years post treatment
Mean improvement score, where -100=100% worse from baseline and 100=100% better or improved from baseline
次要结局
- Oxford Hip Score(1 month, 3 months, 6 months, 12 months, 18 months and annually 2-20 years post treatment)
- Complications(1 month, 3 months, 6 months, 12 months, 18 months and annually 2-20 years post treatment)
- Number of Re-injections to treated area(1 month, 3 months, 6 months, 12 months, 18 months and annually 2-20 years post treatment)
- Number of Surgical Interventions to treated area(1 month, 3 months, 6 months, 12 months, 18 months and annually 2-20 years post treatment)
- International Knee Documentation Committee form(1 month, 3 months, 6 months, 12 months, 18 months and annually 2-20 years post treatment)
- Disabilities of the Arm, Shoulder and Hand form(1 month, 3 months, 6 months, 12 months, 18 months and annually 2-20 years post treatment)
- Pain Scale(1 month, 3 months, 6 months, 12 months, 18 months and annually 2-20 years post treatment)
- Functional Rating Index(1 month, 3 months, 6 months, 12 months, 18 months and annually 2-20 years post treatment)
- Adverse Events(1 month, 3 months, 6 months, 12 months, 18 months and annually 2-20 years post treatment)
- Lower Extremity Function Scale(1 month, 3 months, 6 months, 12 months, 18 months and annually 2-20 years post treatment)