NCT07538726招募中不适用
Immediate Versus Delayed Weight Bearing After Fixation of Pelvic Ring Injuries: Randomized Control Trial
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Functional status
研究概览
简要总结
The goal of this randomized clinical trial is to compare between the effect of immediate weight bearing (WB) versus delayed weight bearing in improving function, pain, gait, quality of reduction radiologically, muscle strength, and quality of life outcomes in individuals who underwent specific pelvic fixation surgeries.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 to 55 years
- •Traumatic fractures indicated for pelvic fixation.
- •All Types B after stable anterior and / or posterior fixation.
- •Type C, Stable fixation:
- •Posterior fixation by triangular osteosynthesis. oTrans-iliac trans-sacral screw fixation or Trans iliac plate or posterior infex combined with anterior fixation.
- •Excellent to good quality of fracture reduction by Matta and Tornetta radiological assessment.
排除标准
- •Associated lower extremity fractures that independently restrict or contraindicate weight-bearing activities.
- •Bilateral unstable after fixation pelvic ring disruption.
- •Patients with associated spinal cord injury, as neurological deficits may alter gait, functional recovery, and weight-bearing capacity, thereby affecting the validity and generalizability of the outcome measures.
- •Current history of acute systemic infection, active Bone inflammatory disease, (e.g., osteomyelitis, chronic non-bacterial osteitis), or malignancy, which may compromise the healing process, confound clinical outcomes, or pose additional medical risks during rehabilitation.
- •Uncontrolled Diabetes
- •Active infection
- •Morbid obesity (BMI > 40)
- •Alcohol use disorder (AUD). Alcohol abuse as defined by the National Institute on Alcohol Abuse and Alcoholism: "Drinking at Low Risk for Developing Alcohol Use Disorder: For women, low-risk drinking is defined as no more than 3 drinks on any single day and no more than 7 drinks per week. For men, it is defined as no more than 4 drinks on any single day and no more than 14 drinks per week. NIAAA research shows that only about 2 in 100 people who drink within these limits have AUD".
- •Claustrophobia
- •Pregnant woman
- •Inability to follow study protocol (e.g., lack of ability to attend visits or comprehend instructions)
- •Any psychiatric illness that would prevent comprehension of the details and nature of the study and interfere with follow-up clinical visits
- •Any clinical finding that would place the patient at health risk, impact the study, or affect the completion of the study
研究组 & 干预措施
weight bearing
Experimental
immediate partial weight bearing
干预措施: Immediate Partial Weight Bearing (Other)
non-weight bearing
No Intervention
Late weight bearing
结局指标
主要结局
Functional status
时间窗: at 12 weeks and at 18 weeks
Functional status will be evaluated with the Majeed Pelvic Score
次要结局
- core and hip muscle strength(at 6 weeks and at 12 weeks)
- Pain level(1st day, 6 weeks , 12 weeks, 18 weeks)
- Gait(At 18 weeks)
- Radiological outcome(1st day post-operative, 6 weeks, 12 weeks, 18 weeks)
- Patient Quality of life(at 18 weeks)
研究者
Hager Emad
Physical therapist of Orthopedics and Trauma Surgeries
Assiut University
研究点 (1)
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