Below-Elbow Versus Initial Above-Elbow Casting After Closed Reduction of Distal Radius Fractures: 12-Week Isokinetic and 5-Year Functional Outcomes of a Prospective Randomized Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 93
- 试验地点
- 1
- 主要终点
- Isokinetic Peak Torque Normalized to Body Weight at 12 Weeks
研究概览
简要总结
The goal of this clinical trial was to compare two casting strategies for adults with a broken wrist, also called a distal radius fracture. The study included people whose treating team had determined that treatment without surgery was appropriate. Their fracture was first put back into position without surgery.
The main questions were:
- Does starting treatment with a below-elbow cast or an above-elbow cast affect how well the fracture stays in position?
- Does cast length affect early elbow or shoulder pain and stiffness?
- Does it affect grip strength, arm and wrist muscle recovery, wrist function, or long-term disability?
Researchers compared a below-elbow cast used from the start with an above-elbow cast used for the first 2 weeks and then changed to a below-elbow cast.
Participants:
- were randomly assigned to one of the two casting strategies
- wore a cast for 4 weeks, followed by a splint and rehabilitation
- had x-rays and clinical assessments during the first 12 weeks
- were scheduled for bilateral grip-strength and machine-based muscle-strength testing at cast removal and at 12 weeks
- were invited to complete a clinical and functional follow-up assessment at approximately 5 years
详细描述
Distal radius fractures that are suitable for nonsurgical care are commonly treated with closed reduction and cast immobilization. Whether the elbow should be immobilized during the early treatment period remains uncertain. Above-elbow casting may restrict forearm rotation and theoretically improve fracture stability, but it may also cause elbow and shoulder discomfort or stiffness. Below-elbow casting preserves elbow movement and may reduce this treatment burden.
This was a single-center, prospective, randomized, parallel-group clinical trial involving adults aged 18 to 70 years with eligible AO/OTA distal radius fractures. After the treating team established that nonsurgical treatment was indicated, participants underwent closed reduction and were assigned by web-based block randomization to one of two cast-immobilization strategies. Randomization therefore occurred after the indication for nonsurgical treatment had been established, not after nonsurgical treatment had been completed.
Participants assigned to the below-elbow casting group received a below-elbow cast immediately after reduction. Participants assigned to the initial above-elbow casting group received an above-elbow cast immediately after reduction. At 2 weeks, the above-elbow cast was converted to a below-elbow cast. Cast immobilization ended at 4 weeks in both groups, followed by wrist splinting and rehabilitation.
At the initial injury assessment on Day 1, grip-strength testing and Cybex isokinetic testing were performed only on the uninjured contralateral upper extremity. Bilateral grip-strength and Cybex assessments were performed at cast removal, 4 weeks after closed reduction, and again at 12 weeks. Cybex measurements included raw peak torque, peak torque normalized to body weight, raw work per repetition, work per repetition normalized to body weight, and range of motion during elbow flexion and extension, wrist flexion and extension, and forearm supination and pronation. Side-to-side deficits were derived from the bilateral assessments at 4 and 12 weeks.
Radiographic follow-up included measurement of radial inclination, radial height, ulnar variance, and volar tilt immediately after reduction, at 4 weeks, and at 12 weeks. Maintenance of reduction was evaluated as within-participant change in these radiographic parameters through 12 weeks. Early clinical outcomes included elbow or shoulder pain and stiffness at cast removal, grip-strength recovery, and patient-reported wrist and upper-extremity function. Complications, additional treatment, and conversion to surgery were monitored through the 12-week follow-up period.
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
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 to 70 years
- •Closed distal radius fracture for which the treating team determined that nonsurgical treatment with closed reduction and cast immobilization was appropriate
- •AO/OTA distal radius fracture classified as 2R3A2, 2R3A3, 2R3B2, 2R3B3, 2R3C1, 2R3C2, or 2R3C3
排除标准
- •AO/OTA distal radius fracture classified as 2R3A1 or 2R3B1
- •Open distal radius fracture
- •History of an allergic reaction to cast material
- •Previous surgery involving the wrist or elbow
- •Distal radius fracture judged to require operative treatment at the initial evaluation
结局指标
主要结局
Isokinetic Peak Torque Normalized to Body Weight at 12 Weeks
时间窗: 12 weeks after closed reduction
Peak torque measured by bilateral Cybex isokinetic dynamometry was normalized to body weight and expressed as a percentage for elbow flexion, elbow extension, wrist flexion, wrist extension, forearm supination, and forearm pronation. Values were recorded separately for the affected and unaffected upper extremities. Higher values indicate greater strength relative to body weight.
次要结局
- Raw Isokinetic Peak Torque at Cast Removal(At cast removal, 4 weeks after closed reduction)
- Raw Isokinetic Peak Torque at 12 Weeks(12 weeks after closed reduction)
- Isokinetic Peak Torque Normalized to Body Weight at Cast Removal(At cast removal, 4 weeks after closed reduction)
- Raw Isokinetic Work per Repetition at Cast Removal(At cast removal, 4 weeks after closed reduction)
- Isokinetic Work per Repetition Normalized to Body Weight at Cast Removal(At cast removal, 4 weeks after closed reduction)
- Isokinetic Range of Motion at Cast Removal(At cast removal, 4 weeks after closed reduction)
- Affected-to-Unaffected Isokinetic Deficit at Cast Removal(At cast removal, 4 weeks after closed reduction)
- Bilateral Grip Strength at Cast Removal(At cast removal, 4 weeks after closed reduction)
- Raw Isokinetic Work per Repetition at 12 Weeks(12 weeks after closed reduction)
- Isokinetic Work per Repetition Normalized to Body Weight at 12 Weeks(12 weeks after closed reduction)
- Isokinetic Range of Motion at 12 Weeks(12 weeks after closed reduction)
- Affected-to-Unaffected Isokinetic Deficit at 12 Weeks(12 weeks after closed reduction)
- Bilateral Grip Strength at 12 Weeks(12 weeks after closed reduction)
- Change in Affected-Hand Grip Strength From 4 to 12 Weeks(4 and 12 weeks after closed reduction)
- Patient-Rated Wrist and Hand Evaluation Total Score at 4 Weeks(At cast removal, 4 weeks after closed reduction)
- Change in Radial Inclination From Post-Reduction to 12 Weeks(Immediately after closed reduction and 12 weeks after closed reduction)
- Change in Radial Height From Post-Reduction to 12 Weeks(Immediately after closed reduction and 12 weeks after closed reduction)
- Change in Ulnar Variance From Post-Reduction to 12 Weeks(Immediately after closed reduction and 12 weeks after closed reduction)
- Change in Volar Tilt From Post-Reduction to 12 Weeks(Immediately after closed reduction and 12 weeks after closed reduction)
- Elbow or Shoulder Pain and Stiffness at Cast Removal(At cast removal, 4 weeks after closed reduction)
- Patient-Rated Wrist and Hand Evaluation Total Score at 12 Weeks(12 weeks after closed reduction)
- Quick Disabilities of the Arm, Shoulder and Hand Total Score at 4 Weeks(At cast removal, 4 weeks after closed reduction)
- Quick Disabilities of the Arm, Shoulder and Hand Total Score at 12 Weeks(12 weeks after closed reduction)
- Number of Participants With Complications or Additional Treatment Through 12 Weeks(From closed reduction through 12 weeks after closed reduction)
- Patient-Rated Wrist and Hand Evaluation Total Score at 5 Years(5 years after closed reduction)
- Quick Disabilities of the Arm, Shoulder and Hand Total Score at 5 Years(5 years after closed reduction)
- Treatment Satisfaction Score at 5 Years(5 years after closed reduction)
研究者
Alper Sukru Kendirci
Assistant Professor of Orthopaedics and Traumatology
Istanbul University