RecruitingNot ApplicableNCT07538726
Early Partial Weight-bearing May Improve Functional Recovery Without Increasing Complications Despite This Potential, Limited Randomized Studies Have Evaluated Early Weight-bearing After Pelvic Fixation Surgeries
Immediate Versus Delayed Weight Bearing After Fixation of Pelvic Ring Injuries: Randomized Control Trial
Sponsor
Assiut University
Enrollment
50 participants
Start Date
Aug 31, 2025
Study Type
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Min Age: 18 YearsMax Age: 55 Years
Inclusion Criteria6
- 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.
Exclusion Criteria14
- 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
- Cancer
- 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
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Interventions
OTHERImmediate Partial Weight Bearing
Immediate Partial Weight Bearing
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT07538726