Quantitative and Clinical Assessment of Flexor Tendon Gliding Following Application of a Bioresorbable Hydrogel: A Prospective, Randomized Study in Patients Undergoing Distal Radius Fracture Repair.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 4
- 主要终点
- Range of Motion: Thumb Interphalangeal and Index Finger Distal Interphalangeal Joints
研究概览
简要总结
The investigators will be evaluating the use of versawrap in the setting of distal radius fractures by placing membrane between plate and flexor tendons. Investigators will then evaluate tendon gliding morphology and number of tendon ruptures
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Cognitively able to converse in English or in native language supported by a certified medical interpreter;
- •Diagnosed with a closed, distal radius fracture treated with open reduction and internal fixation using a volar distal radius plating system.
排除标准
- •open injury;
- •concomitant injury to the contralateral wrist;
- •history of flexor tendon repair involving one or both hands or wrists;
- •use of a trans-carpal fixation device (bridge plate or external fixator) that would preclude wrist motion post-operatively;
- •concomitant fracture / injury to the thumb or index finger of one or both hands;
- •concomitant carpal tunnel release.
结局指标
主要结局
Range of Motion: Thumb Interphalangeal and Index Finger Distal Interphalangeal Joints
时间窗: 6 months
Standardized clinical examination (relative to wrist and digital positioning): active and passive range of motion for thumb interphalangeal and index finger distal interphalangeal joints.
Range of Motion: Thumb and Index Finger
时间窗: 6 months
Standardized clinical examination (relative to wrist and digital positioning): active and passive composite digital range of motion for thumb and index fingers
Range of Motion: Wrist
时间窗: 6 months
Standardized clinical examination (relative to wrist and digital positioning): active and passive wrist range of motion.
Ultrasound Assessment of Flexor Pollicis Longus and Index Finger Flexor Digitorum Profundus Tendon Excursion
时间窗: 6 Months
Tendons in the volar forearm will be directly visualized with ultrasound. The distance the tendons are able to travel (excursion) within the forearm will be reported.
次要结局
- Complications(6 months)
- Patient-Rated Wrist Evaluation (PRWE)(6 Months)
- Quick Disabilities of the Arm, Shoulder and Hand (QuickDASH)(6 Months)
- Visual Analog Scale (VAS) pain scores(6 Months)
- Subjective Reporting Specific to Tendon Function(6 Months)
- Key Pinch(6 Months)
- Three-Jaw Pinch(6 Months)
- Grip Strength(6 Months)
- Soong Classification(6 Months)
- Ultrasound Assessment of Flexor Pollicis Longus and Index Finger Flexor Digitorum Profundus Tendon Morphology(6 Months)