External Fixation Versus Volar Locking Plate for Unstable Intraarticular Distal Radius Fractures: a Prospective Comparative Study of the Functional Outcomes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- Functional Outcomes Assessed by the Green and O'Brien Scoring System Modified by Cooney
研究概览
简要总结
The goal of this prospective comparative clinical trial is to evaluate the effectiveness of external fixation versus volar locking plates in the management of unstable intra-articular distal radius fractures in adults over 18 years old. The main questions it aims to answer are:
Does the use of a volar locking plate result in better functional outcomes, as measured by the Green and O'Brien scoring system modified by Cooney, compared to external fixation? What are the differences in intraoperative and postoperative parameters, including complications, between the two methods? Researchers will compare outcomes in two groups: one receiving external fixation and the other undergoing open reduction and internal fixation with volar locking plates.
Participants will:
Undergo surgical intervention (external fixation or ORIF with volar plates) performed by experienced orthopedic surgeons.
Follow a postoperative rehabilitation plan, including active and passive range of motion exercises.
Attend follow-ups at 6, 12, and 24 weeks to assess pain, range of motion, fracture union, and complications.
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
- •Patients aged 18 years or older.
- •Diagnosed with recent (<1 week) intra-articular distal end radius fractures.
- •Willing and able to provide informed consent.
排除标准
- •Open fractures classified as Gustilo grade II or higher.
- •Fracture avulsion or dislocation.
- •Vascular injury associated with the fracture.
- •Extra-articular fractures of the distal radius.
- •Preexisting joint or carpal bone disease affecting rehabilitation.
- •Patients unwilling to provide consent.
研究组 & 干预措施
External Fixation
Patients in this arm will undergo external fixation for unstable intra-articular distal radius fractures. The procedure involves the placement of an external fixator to stabilize the fracture, followed by postoperative care including pin tract cleaning and removal of the fixator after radiological confirmation of bone healing (6-8 weeks). Functional outcomes, fracture union, and complications will be assessed at regular intervals.
干预措施: External Fixation (Procedure)
Volar Locking Plate
Patients in this arm will undergo open reduction and internal fixation (ORIF) using a volar locking plate for unstable intra-articular distal radius fractures. This method provides stable fixation, allowing early mobilization. Postoperative outcomes, including functional scores, union rates, and complications, will be evaluated at follow-up visits.
干预措施: Open Reduction and Internal Fixation (ORIF) with Volar Locking Plate (Procedure)
结局指标
主要结局
Functional Outcomes Assessed by the Green and O'Brien Scoring System Modified by Cooney
时间窗: 24 weeks post-surgery
The primary outcome will be the functional outcome of the wrist assessed using the Green and O'Brien scoring system modified by Cooney. This scoring system evaluates four components: pain, function, range of motion, and grip strength, each weighted appropriately to provide a composite score. Scores will be compared between the external fixation and volar plating groups to determine the superiority of either intervention in restoring wrist function.
次要结局
未报告次要终点
研究者
Sabir Kumar Khadka
Junior Resident
B.P. Koirala Institute of Health Sciences