Scandinavian Humeral diAphyseal Fracture Trial - A Pragmatic Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 287
- 试验地点
- 25
- 主要终点
- Disabilities of the Arm, Shoulder and Hand (DASH) score
研究概览
简要总结
This pragmatic multicenter randomized controlled trial (RCT) includes adult participants with an acute humeral shaft fracture to compare surgical fixation of humeral shaft fracture to non-surgical treatment with early identification and treatment of delayed union by a patient-reported outcome after 52 weeks. The trial population of 287 participants The trial population is divided in two age-groups due to the changes in DASH score by age. The definition of delayed union differs in the young and elderly population to consider dissimilarity in bone healing rates and the timepoint for crossover is therefor different between the groups. Participants will be randomized 1:1 between non-surgical treatment and surgical treatment. The primary outcome is the Disability of Arm, Shoulder and Hand (DASH) score at 52 weeks, and is assessor blinded. The secondary outcomes are DASH score earlier than 52 weeks, EQ-5D-5L, pain assessed by visual analogue score, Constant-Murley score including elbow range of motion and anchor-questions collected at all timepoints throughout the trial. All complications will be reported including; infection, nerve or vascular injury, surgical revisions (implant malpositioning, hardware failure, aseptic loosening and peri-implant fracture), major adverse cardiovascular events, other major adverse events and mortality. SHAFT will provide information on the effectiveness of two standard treatments for humeral shaft fractures, while taking the dilemmas within the population into account.
详细描述
We will conduct a pragmatic multicenter, randomized, controlled, outcome assessor-blinded, clinical superiority trial. The objective is to compare surgical fixation of humeral shaft fracture to non-surgical treatment with early identification and treatment of delayed union by a patient-reported outcome after 52 weeks. .
Null-hypothesis:
The DASH score at 52 weeks after surgical treatment is not superior to non-surgical treatment with the option of early crossover surgery in patients with humeral shaft fractures
The trial population is divided in two age-groups due to the changes in DASH score by age. The definition of delayed union differs in the young and elderly population to consider dissimilarity in bone healing rates:
- SHAFT-Y for the young with an age cut-off of 18 to 64 years. The early identification and treatment of delayed union is set to 6 to 12 weeks
- SHAFT-E for the elder with an age cut-off +65 years. The early identification and treatment of delayed union is set to 12 to 26 weeks
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 (Outcomes Assessor)
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
- •Fracture types 12A-C (OTA/AO classification)
- •a. Includes minimal displaced extra-articular fracture extensions to the proximal humerus (less than a 1 cm or 45 degree angulation)
- •Treatment within 14 days from trauma
- •Age 18-64 years for SHAFT-Y and ≥65 years for SHAFT-E
- •Patients must understand the information given and be able to read and speak Danish, Swedish or Norwegian to complete the study paperwork
- •All fracture extensions involving the distal humerus and displaced fracture extensions involving the proximal humerus will not be included. Isolated fractures to the proximal or the distal end of the humerus are not eligible for screening. The proximal and distal end segments of the humerus are defined by squares of which the sides are the widest length of the epiphysis/metaphysis in question on the anterior-posterior view.
排除标准
- •Inability to give informed consent
- •Undisplaced shaft fracture (less than a cortex-wide displacement in all radiographic plane)
- •Vascular injury in ipsilateral arm
- •Polytrauma (defined as a trauma with one or more concurrent fractures to the upper extremities or other trauma absolute indications for surgical intervention)
- •Pathological fracture
- •Open fracture
- •Health conditions preventing either treatment
结局指标
主要结局
Disabilities of the Arm, Shoulder and Hand (DASH) score
时间窗: 52 weeks
A patient-reported outcome measure specific for physical function and symptoms of the upper limb (Disability of Arm, Shoulder and Hand-DASH). Scores range from 0 (no disability) to 100 (most severe disability)
次要结局
- EuroQol-5 Domain (EQ-5D-5L)(Pre-Injury, 6 weeks, 12 weeks, 26 weeks, 52 weeks)
- Constant-Murley score(6 weeks, 12 weeks, 26 weeks, 52 weeks)
- Elbow range of motion(6 weeks, 12 weeks, 26 weeks, 52 weeks)
- Rate of complications(Up to 52 weeks)
- Visual Analogue Scale (VAS)(Baseline, 6 weeks, 12 weeks, 26 weeks, 52 weeks)
- Anchor question(6 weeks, 12 weeks, 26 weeks, 52 weeks)
- Disabilities of the Arm, Shoulder and Hand (DASH) score(Pre-injury, 6 weeks, 12 weeks, 26 weeks)