The Effect on Wrist Range of Motion With Perioperative Glucocorticoid Administration in the Treatment of Adult Distal Radius Fractures: A Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- QuickDASH
研究概览
简要总结
The purpose of this investigation is to compare functional outcome measures and range of motion for patients receiving glucocorticoid (GC) injections versus those not receiving GCs for the treatment of distal radius fractures. The investigators hypothesize that patients who receive GC will have improved ROM and functional outcome measures compared to patients who do not receive GC. In addition, this study aims to determine if there is a difference in rates of complications and postoperative pain control between the GC and non-GC groups. In order to accomplish these aims, the investigators will conduct a prospective, randomized, controlled investigation.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient 18 years of age and older.
- •Patients undergoing ORIF with VP fixation of an acute, isolated DRF with or without associated distal ulna fracture and with or without associated carpal tunnel release
排除标准
- •Worker's compensation patient
- •Non-operatively treated fractures
- •Open fractures
- •Preoperative neurovascular injury
- •Coexisting fractures or injuries
- •Diabetes mellitus
- •Allergy or contraindication to GCs
- •Associated non-orthopedic injury that would prohibit the administration of GCs
- •Patients currently incarcerated
- •Pregnant patients
研究组 & 干预措施
Glucocorticoid (GC) group
Intraoperative: Single intraoperative dose of 10 mg intravenous dexamethasone Postoperative: A 6-day oral methylprednisolone (oral GC) taper course. The oral GC taper course begins on the day of surgery and includes 24mg on day 1, 20mg on day 2, 16mg on day 3, 12mg on day 4, 8mg on day 5, and 4mg on day 6
干预措施: Dexamethasone (Drug)
Glucocorticoid (GC) group
Intraoperative: Single intraoperative dose of 10 mg intravenous dexamethasone Postoperative: A 6-day oral methylprednisolone (oral GC) taper course. The oral GC taper course begins on the day of surgery and includes 24mg on day 1, 20mg on day 2, 16mg on day 3, 12mg on day 4, 8mg on day 5, and 4mg on day 6
干预措施: Methylprednisolone (Drug)
结局指标
主要结局
QuickDASH
时间窗: 0-12 months
best 0-100 worst; functional outcome score for disabilities of the arm, shoulder, and hand
Visual Analog Scale Pain Score
时间窗: 0-12 months
best 0-10 worst; continuous scale to measure current pain level
PROMIS Self-Efficacy Manage Symptoms
时间窗: 0-12 months
best 0-100 worst; measures a patient's ability to cope with their symptoms related to the procedure
PROMIS Pain Interference
时间窗: 0-12 months
best 0-100 worst; measures the effects of a patient's pain on their daily activities and lifestyle
PROMIS Upper Extremity
时间窗: 0-12 months
worst 0-100 best; measures physical function of upper extremities
次要结局
未报告次要终点
研究者
C. Liam Dwyer
Staff Physician
Geisinger Clinic