A Pilot Study to Investigate Biomarkers in ACL Patients and Healthy Controls
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 8
- 试验地点
- 1
- 主要终点
- The change in knee varus/valgus from baseline to 6 months post-ACL reconstruction, measured when performing a single leg squat
研究概览
简要总结
Incident rates of ACL rupture are greatest in 16-39 year olds at almost 1 in 1,000.
Performance Based Investigations (PBIs) can be used to evaluate and select correct approaches to patient treatment, and biochemical, biomechanical and physiological biomarkers in other conditions are sensitive in distinguishing between disease state severities, type of injuries and responsiveness to treatment. Despite the measurement sensitivity of PBIs, these are not widely used possibly owing to their focus postoperatively where benefits are less worthwhile.
This study aims to investigate novel biomarkers as performance based investigations (PBIs) to improve surgical and treatment strategies in anterior cruciate ligament (ACL) patients. The objectives are to identify whether biomarkers, collected before and after operations, can: 1) Assist the surgeon in decision making; 2) Lead to improved prognosis; 3) Be used to predict the outcomes of prognosis, and; 4) Correlate with disease signs/ smoking to help further understand ACL injuries.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •unilateral ACL rupture
- •18 - 45 years old
排除标准
- •combined posterior and ACL rupture
- •multi-ligament instability including medial or lateral collateral ligament injury
- •other lower limb surgery <3mths
- •current significant acute injury affecting other lower extremity joints, or other relevant neurological or musculoskeletal pathology.
研究组 & 干预措施
Operation - No PBI
Patients requiring operation - baseline PBI data not seen by surgeon
Operation - PBI available
Patients requiring operation - baseline PBI data seen by surgeon pre-operatively
干预措施: Surgeons knowledge of pre-operative PBIs (Procedure)
Non-operation
Patients with ACL rupture not requiring operation
Control
Healthy age matched volunteers - No operation
结局指标
主要结局
The change in knee varus/valgus from baseline to 6 months post-ACL reconstruction, measured when performing a single leg squat
时间窗: Baseline, 6 months
The change in anterior-posterior centre of pressure displacement from baseline to 6 weeks post-ACL reconstruction, measured when performing a 10 second standing balance task.
时间窗: Baseline, 6 weeks
The change in knee varus/valgus from baseline to 6 weeks post-ACL reconstruction, measured when performing a single leg squat.
时间窗: Baseline, 6 weeks
The change in anterior-posterior centre of pressure displacement from baseline to 6 months post-ACL reconstruction, measured when performing a 10 second standing balance task.
时间窗: Baseline, 6 months
The change in time taken to complete a sit-to-stand task, from baseline to 6 months post-ACL reconstruction
时间窗: Baseline, 6 months
The change in peak vertical ground reaction force from baseline to 6 weeks post-ACL reconstruction, measured when performing a novel isometric task during sitting.
时间窗: Baseline, 6 weeks
The change in peak vertical ground reaction force from baseline to 6 months post-ACL reconstruction, measured when performing a novel isometric task during sitting.
时间窗: Baseline, 6 months
The change in time taken to complete a sit-to-stand task, from baseline to 6 weeks post-ACL reconstruction
时间窗: Baseline, 6 weeks
次要结局
- The change in Interleukin-6 obtained from blood samples at baseline to 6 months post-ACL reconstruction(6 months post-ACL reconstruction)
- The change in Tegner Activity Score from baseline to 6 months post-ACL reconstruction(6 months post-ACL reconstruction)
- The change in International Knee Documentation Committee subjective knee evaluation form from baseline to 6 months post-ACL reconstruction(baseline to 6 months post-ACL reconstruction)
- The change in Lysholm Knee Scoring Scale from baseline to 6 months post-ACL reconstruction(6 months post-ACL reconstruction)
- The difference in bone morphogenetic protein-7 (BMP-7) between smokers and non-smokers who undergo ACL reconstruction(At time of surgery)