Below-elbow or Above-elbow Cast for Conservative Treatment of Extra-articular Distal Radius Fractures With Dorsal Displacement: a Prospective Randomized Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 74
- 试验地点
- 1
- 主要终点
- To measure the maintenance of fracture reduction according to radial height (Long plaster casts Vs Short plaster casts)
研究概览
简要总结
The aim of this prospective randomised study was to shed more light on the issue by comparing the capacity of long plaster casts (above-elbow, LC) and short plaster casts (below-elbow, SC) to maintain the reduction of extra-articular distal radius fractures with dorsal displacement (2R3A2.2, according to the AO/OTA classification). The initial hypothesis was that the short cast would be equally as effective as the long cast in treating this type of fracture. The secondary objective of the study was to determine whether or not there is a direct correlation between radiological parameters and functional outcomes in such patients.
详细描述
Distal radial fractures are common traumatic injuries, but their management remains controversial, Hence, we conducted a two-arm, parallel-group, prospective randomised trial to compare the capacity of long casts (above-elbow) and short casts (below-elbow) to maintain the reduction of extra-articular distal radius fractures with dorsal displacement (AO/OTA classification: 2R3A2.2). Eligible patients with AO/OTA 2R3A2.2 fractures treated with closed reduction and cast immobilization were randomized to the long cast group or to the short cast group. Baseline radiological parameters, radial inclination (RI), radial height (RH), ulnar variance (UV) and palmar tilt (PT) were taken, and compared with clinical (DASH, Mayo Wrist and Mayo Elbow) and radiological scores taken at 7-10 days, 4 weeks and 12 weeks. Furthermore, to evaluate correlations between radiological parameters and functional outcomes, patients were divided into two groups according to whether or not their radiological parameters at Follow-ups 2 and 3 were acceptable, i.e. within the range 11-12 mm for RH, 16°-28° for IR, -4-+2 mm for UV, and 0°-22° for PT.
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)
盲法说明
randomised trial
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •extra-articular fractures of the distal radius with dorsal displacement (type 2R3A2.2 according to the AO classification).
- •eligible for conservative treatment with plaster
排除标准
- •open fractures
- •extra-articular distal radius fracture with volar displacement
- •a history of allergy to the cast material
- •patients scheduled for surgical treatment
研究组 & 干预措施
Long plaster casts for type AO 2R3A2.2
Closed reduction of the fracture and immobilization with long plaster casts (above-elbow, Long plaster casts).
干预措施: plaster cast (Device)
Short plaster casts for type AO 2R3A2.2
Closed reduction of the fracture and immobilization with short plaster casts (below-elbow, Short plaster casts)
干预措施: plaster cast (Device)
结局指标
主要结局
To measure the maintenance of fracture reduction according to radial height (Long plaster casts Vs Short plaster casts)
时间窗: compared at baseline, at 7-10 days, at 4 weeks and at 12 weeks
Radial height: distance between two parallel lines drawn perpendicular to the long axis of the radial shaft, one from the tip of the radial styloid and the other from the ulnar corner of the lunate fossa, normal 11-12 mm
To measure the maintenance of fracture reduction according to palmar tilt (Long plaster casts Vs Short plaster casts)
时间窗: compared at baseline, at 7-10 days, at 4 weeks and at 12 weeks
Palmar tilt: can be measured by obtaining the angle of intersection between a line drawn tangentially across the most distal points of the radial articular surface and a perpendicular to the midshaft of the radius, normal 0°-22°
To measure the maintenance of fracture reduction according to ulnar variance (Long plaster casts Vs Short plaster casts)
时间窗: compared at baseline, at 7-10 days, at 4 weeks and at 12 weeks
Ulnar variance: refers to the relative lengths of the distal articular surfaces of the radius and ulna, normal -4-+2 mm
To measure the maintenance of fracture reduction according to radial inclination (Long plaster casts Vs Short plaster casts)
时间窗: compared at baseline, at 7-10 days, at 4 weeks and at 12 weeks
Radial inclination: angle of the distal radial surface with respect to a line perpendicular to the shaft, a normal 16° - 18°
次要结局
- Correlation RX parameters Vs functional outcomes(twelve weeks)