Early partial weight-bearing to improve recovery after pelvic fixation
Immediate Versus Delayed Weight Bearing After Fixation of Pelvic Ring Injuries: Randomized Control Trial
This trial will test whether starting partial weight-bearing right away instead of waiting helps adults (18–55) recover function, pain, walking ability, and quality of life after pelvic fixation surgery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 18 Years to 55 Years |
| Sex | All |
| Sponsor | Assiut University Academic / other |
| Locations | 1 site (Asyut, Asyut Governorate) |
| Trial ID | NCT07538726 on ClinicalTrials.gov |
What this trial studies
This is a randomized trial comparing immediate partial weight-bearing with delayed weight-bearing in adults who had surgical fixation for traumatic pelvic fractures. Participants will be adults 18 to 55 with Type B fractures or Type C fractures with stable fixation and an excellent-to-good radiologic reduction. Primary outcomes include function, pain, gait, muscle strength, radiographic quality of reduction, and quality of life, with monitoring for complications. The trial is conducted at the Trauma Hospital, Assiut University, and excludes patients with bilateral unstable pelvic disruptions after fixation, concomitant lower-limb fractures that prevent weight-bearing, spinal cord injury, or active bone infection.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18–55 with traumatic pelvic fractures fixed to a stable construct (Types B or select Type C) with excellent-to-good radiologic reduction and no other injuries or infections that prevent weight-bearing.
Not a fit: Patients unlikely to benefit include those with bilateral unstable pelvis after fixation, associated lower-extremity fractures that limit weight-bearing, spinal cord injury, active bone infection, or those outside the 18–55 age range.
Why it matters
Potential benefit: If successful, early partial weight-bearing could speed functional recovery, reduce pain, and improve walking and quality of life without increasing complication rates.
How similar studies have performed: Previous small or nonrandomized studies and a limited number of randomized reports suggest early weight-bearing after pelvic fixation can help recovery, but high-quality randomized evidence remains limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Criteria: * 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
Where this trial is running
Asyut, Asyut Governorate
- Trauma Hospital, Assiut University — Asyut, Asyut Governorate, Egypt (Recruiting)
Study contacts
- Study coordinator: Hager Emad Abdelzaher, Masters Candidate
- Email: Hager.Emad@med.aun.edu.eg
- Phone: 00201555726135
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.