NCT00864877Unknown不适用
A Randomised, Prospective Clinical Investigation to Compare Post-Operative Fracture Healing and Complication Rate After the Fixation of Ankle Fractures Using the Inion OTPS FreedomPlate Biodegradable Fixation System Versus Conventional Metal Screws and Plates.
适应症
试验速览
- 阶段
- 不适用
- 发起方
- Inion Oy
- 试验地点
- 2
- 主要终点
- The functional performance will be primarily determined by the Olerud and Molander Ankle Score
研究概览
简要总结
A randomised, prospective clinical investigation to compare post-operative fracture healing and complication rate after the fixation of ankle fractures using the Inion OTPS FreedomPlateTM Biodegradable Fixation System versus conventional stainless steel metal screws and plates.
The objectives of the investigation are
- to compare post-operative fracture healing (union rates, time-to-union), and the complication rates (hardware failure, infection) between the two Plating Systems (biodegradable INION OTPS FreedomPlateTM vs. Stainless Steel 3.5 Reconstruction or DCP plate, or 1/3 Semitubular plates) at the clinical setting of Ankle fractures
- to study the safety of the clinical application of the biodegradable plating system of Inion OTPS FreedomPlateTM at the acute Ankle fracture setting.
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient is willing and able to understand, sign and date the study-specific, Institutional Review Board/Ethics Committee approved patient informed consent and applicable privacy regulations.
- •Patient must require surgical treatment of a ankle fracture, with a distal fibular (i.e., lateral malleolus) fracture (isolated, closed, unilateral, non-comminuted) including either instable/dislocated Weber class B or any Weber class C fracture that cannot be anatomically reconstructed accurately without open procedure, or bimalleolar fracture with lateral malleolus fracture (as described above) and medial malleolus fracture (closed, unilateral, non-comminuted), or trimalleolar fracture with lateral and medial malleolus fractures as described above and posterior malleolus fracture with less than ¼ of the articular surface fractured
- •Fresh/acute fractures (seen within seventy-two hours of the injury)
- •Aged between 18 to 60 years
- •Skeletally mature
- •Willingness to accept randomisation either to the test or control group
- •Willingness and ability to comply with all investigation procedures pre- and post-operation.
排除标准
- •Contraindications of operative internal plate fixations
- •Contraindications for the Inion OTPS FreedomPlateTM Biodegradable Fixation System:
- •active or potential infection
- •patient's conditions, including limited blood supply, insufficient quantity or quality of bone, and where patient cooperation cannot be guaranteed (e.g., alcoholism, drug abuse)
- •high-load bearing applications
- •Multiple trauma, head injury, bilateral lower extremity fractures, upper extremity fractures
- •Any concomitant painful or disabling disease of the lower limb that would interfere with evaluation of the affected ankle
- •Previous ankle fracture
- •Patients who most likely will not learn to walk with crutches (e.g., due to being severely overweight)
- •Bone malignancy
- •Osteomyelitis
结局指标
主要结局
The functional performance will be primarily determined by the Olerud and Molander Ankle Score
时间窗: at 2, 6 and 12 weeks, and 12 and 24 months post-operatively
次要结局
未报告次要终点
研究者
研究点 (2)
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