Short Leg Walking Plaster Cast Versus Walking Foot Cast for Jones Fracture: An Open Label Randomized Controlled Trial.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 122
- 试验地点
- 2
- 主要终点
- Fracture Union Rate
研究概览
简要总结
This study is an open-label, randomized controlled trial comparing the effectiveness of two plaster cast methods-Short Leg Walking Plaster Cast and Walking Foot Plaster Cast-for treating Jones fractures, a common fracture at the base of the fifth metatarsal in the foot. This trial will be conducted at Lady Reading Hospital Peshawar. The study will evaluate differences in fracture healing and functional outcomes between these two treatment approaches. Findings from this trial may guide more evidence-based treatment protocols for Jones fractures, potentially improving patient mobility and recovery without requiring surgical intervention.
详细描述
Jones fractures represent 26.3% of fractures at the base of the fifth metatarsal and are commonly treated conservatively through various weight-bearing casts. The lack of consensus on the optimal casting method for Jones fractures necessitates further study, particularly given the absence of published guidelines. This trial, unique in its randomized and prospective approach within Pakistan, aims to compare Short Leg Walking Plaster Casts and Walking Foot Plaster Casts specifically for Jones fractures.
Patients meeting the inclusion criteria will be randomly assigned to one of the two treatment groups, with the primary endpoints being fracture healing (union) and functional outcomes at six weeks, assessed via radiographs and the American Orthopaedic Foot and Ankle Score (AOFAS). This study seeks to produce robust evidence to inform treatment guidelines, allowing patients, especially in low- and middle-income settings, to continue daily activities with minimal disruption during recovery.
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
盲法说明
No masking due to the visible nature of the interventions (type of plaster cast), but the outcomes assessor is blinded to treatment assignment when evaluating follow-up outcomes.
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
- •Both genders
- •18 years and above
- •Jones fractures that are un-displaced or minimally displaced (less than 2 mm)
- •Fractures presented within 7 days of injury
排除标准
- •Significant foot swelling
- •Open fractures
- •Ipsilateral foot, ankle, or lower limb soft tissue pathology or fractures
- •Pathological fractures
结局指标
主要结局
Fracture Union Rate
时间窗: 6 weeks after cast application.
Measurement of fracture healing defined by callus formation and obliteration of the fracture line in 2 out of 3 cortices (lateral, medial, plantar) on X-ray, and absence of pain and tenderness at the fracture site, assessed by a senior orthopedic consultant.
Delayed Union Rate
时间窗: 6 weeks, with further assessment at 8 weeks if needed.
Defined by insufficient callus in fewer than 2 cortices and persistent pain and tenderness at the fracture site. This assessment determines cases where additional casting or intervention may be necessary.
Nonunion Rate
时间窗: 8 weeks post-cast application.
Nonunion is confirmed if there is insufficient callus formation in fewer than 2 cortices, with persistent pain and tenderness at the fracture site.
Functional Outcome (American Orthopaedic Foot and Ankle Score - AOFAS)
时间窗: 6 weeks after cast removal.
Functional outcome assessed via the AOFAS scoring system, which includes pain (40 points), function (50 points), and alignment (10 points), with higher scores indicating better function.
次要结局
- Complication(Throughout the study duration up to 8 weeks.)