A Randomized Controlled Trial Comparing No Reduction to Closed Reduction for Distal Radius Fractures in Patients 65 Years and Older (DISCLOSE Trial): A Study Protocol
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 532
- 试验地点
- 14
- 主要终点
- PRWE
研究概览
简要总结
DISCLOSE trial is a randomized controlled trial including 532 participants with low-energy distal radius fractures. The primary objective is to evaluate whether casting without prior closed reduction is equivalent to casting following closed reduction with respect to wrist-related pain and disability, as measured by the Patient-Rated Wrist Evaluation (PRWE) score at 12 months, in patients aged 65 years or older with a displaced distal radius fracture.
- Primary endpoint will be PRWE at 12 months
- Follow-up visits are scheduled at 3 and 12 months. 5-year follow-up will be considered as an exploratory endpoint
详细描述
Interventions:
No reduction: In the no reduction group, a dorsal cast is applied to the patient's wrist after the initial radiograph. Following casting, a control radiograph will be taken. Active range of motion exercises for the fingers and light use of the hand are recommended immediately.
Closed reduction: Distal radius fracture reduction is performed in the emergency department under local anaesthetic, with lidocaine infiltrated into the fracture site. Closed reduction is performed by the on-call physician who is responsible for the patient's treatment. Post-reduction radiographs are then taken to assess fracture alignment, although the findings do not influence the treatment of the patient. The follow-up visits, cast removal, and exercise protocol are identical to those inof the no reduction group.
In both groups, the cast will be removed after 5 weeks at either the health center or the hospital's outpatient clinic, in accordance with the local treatment protocol. Following cast removal, patients will be advised to resume everyday use of the injured wrist without restrictions. No radiographs will be taken during the casting period or before the 3-month follow-up.
Observational arm (not part of the randomised equivalence trial): Eligible patients who decline participation in the randomisation will be offered the opportunity to join an observational group. The patients will receive standard care (closed reduction and casting) and will provide consent for follow-up. Reduction of the DRF is performed in the emergency department and post-reduction radiographs will be taken. The observational groups will be treated according to local treatment protocols. Patients in the observational cohort will be followed at the same time points using the same outcome measures as the randomised group. Study follow-up of the observational group will be organized remotely.
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
- Double (Investigator, Outcomes Assessor)
盲法说明
To minimize the risk of biased interpretation, the trial results will be analyzed using a blinded data interpretation process, in which the statistician will remain masked to the group allocations.
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 65 years or older
- •Independent living patients
- •Displaced distal radius fracture (AO/OTA 23A/23C) with 15-40 degree dorsal angulation, and/or of shortening of the radius for more than 2 mm.
- •Associated ulnar styloid fracture is permitted
- •Low energy injury, (fall from <1 m)
排除标准
- •Patient unable to provide consent
- •Patients who are actively working in a paid position
- •Volar angulation, partial articular fractures (AO/OTA 23B)
- •Concomitant fracture of the ulna proximal to the base of the styloid process
- •Associated fracture or dislocation in any other body part that would affect the use of the injured distal radius
- •Distal radius fractures in both arms
- •Open injury, Gustilo 2 or higher
- •No bony contact between the main fragments
- •High energy injuries
研究组 & 干预措施
Closed Reduction
Closed reduction and casting after distal radius fracture
干预措施: Casting (Other)
Closed Reduction
Closed reduction and casting after distal radius fracture
干预措施: Closed Reduction (Procedure)
No Reduction
Casting without reduction after distal radius fracture
干预措施: No reduction (Procedure)
No Reduction
Casting without reduction after distal radius fracture
干预措施: Casting (Other)
结局指标
主要结局
PRWE
时间窗: 12 months
Primary outcome will be the Patient Rated Wrist Evaluation (PRWE) at 12 months. PRWE is a 15-item questionnaire designed to measure wrist pain and disability in activities of daily living. The questionnaire consists of two subscales (pain and function), and the score ranges from 0 (no disability) to 100 (severe disability).
次要结局
- Pain (NRS)(3 months and 12 months)
- PASS(3 months and 12 months)
- EQ-5D-5L- Quality of life(3 months and 12 months)
- Serious adverse events(3 months and 1 year)
- Cosmesis(3 months)