Comparison of Two Volar Plating Systems for Distal Radius Fractures - A Prospective Randomized Single-blinded Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 106
- 试验地点
- 2
- 主要终点
- Patient rated wrist evaluation
研究概览
简要总结
We plan to compare 2 types of plating systems for volar plating of distal radius fractures (Aptus 2.5® Medartis AG, Basel, Switzerland vs. INTEOS 2.5® - Hofer Medical GmbH and Co KG, Austria) in a prospective single-blinded controlled clinical trial.
详细描述
This study represents a prospective randomized clinical trial comparing two different systems of volar plate osteosynthesis in patients with distal radius fractures.
Patients meeting the inclusion criteria will be enrolled in the present study provided they give their consent. Informed written consent will be obtained. Envelopes will be prepared containing equal number of cards representing either the conventional or the novel plating syste. On the morning of the surgery a randomly picked envelope decides allocation one of the study groups. Patients will be blinded to treatment until completion of the study. Patients allocated to the control group receive Aptus 2.5® volar plate for distal radius fractures (Medartis AG, Basel, Switzerland), while patients in the study group will receive the plating system INTEOS 2.5® (Hofer GmbH and Co KG, Austria). In the control group, the pronator quadratus muscle will be cut prior mounting of the plate, while in the treatment group the plate will be inserted underneath the pronator quadratus leaving the muscle intact.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •" Distal radius fracture, Type A2, A3, B1, B2, B3, C1, C2 (according to AO Müller classification3) " Patient age between 18 and 75 years " Closed fracture or I° open fractures (according to Gustilo-Anderson classification6) " Agreement of patient to participate and written informed consent
排除标准
- •" Polytraumatized patients " Severe systemic disorder (ASA 3) " New and/or preexisting fracture/Injury of contralateral forearm " II° and III° open fractures (according to Gustilo-Anderson classification6) " Associated injuries of the ipsilateral wrist (e.g. scapholunate dissociation, concomitant fractures) " Non-compliance to postoperative protocol (e.g. physiotherapy) " Delayed definitive surgical treatment of more than 14 days after injury " Change from temporary procedure (e.g. Fixateur externe) " Complex regional pain syndrome (CRPS, M.Sudeck) " Loss to follow-up
结局指标
主要结局
Patient rated wrist evaluation
时间窗: 12 months
Outcome score based on a standardised questionnaire, 15 items, range 0-100, 0 =best possible score, 100=worst possible score
次要结局
- Mayo wrist score(8 weeks, 3 months, 6 months, 12 months)
- Radiological Outcome(2weeks, 4 weeks, 8 weeks, 3 months, 6 months, 12 months)
- Patient rated wrist evaluation(4 weeks, 8 weeks, 3 months, 6 months)
- strength measurement(4 weeks, 8 weeks, 3 months, 6 months, 12 months)
- Disabilities of the Arm, Shoulder and Hand, Outcome Score - DASH(4 weeks, 8 weeks, 3 months, 6 months, 12 months)
- Volumetric evaluation(4 weeks, 8 weeks, 3 months, 6 months, 12 months)
研究者
Thomas Haider
Principal Investigator
Medical University of Vienna