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

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.

Study Overview

• Status: Recruiting
• Conditions: Pelvic Fractures; Weight Bearing
• Intervention / Treatment: Other: Immediate Partial Weight Bearing

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Hager Emad Abdelzaher, Masters Candidate; Phone Number: 00201555726135; Email: Hager.Emad@med.aun.edu.eg
• Study Contact Backup: Name: Mariam I. Abdelazim, PHD; Phone Number: 01001539399; Email: Mariam.A.ibrahim@med.aun.edu.eg

Study Locations

• Egypt
  • Asyut Governorate
    • Asyut, Asyut Governorate, Egypt, 71511
      • Recruiting
      • Trauma Hospital, Assiut University
      • Contact: Hager Emad Abdelzaher, Maters Candidate; Phone Number: +201555726135; Email: Hager.Emad@med.aun.edu.eg
      • Contact: Mariam Ibrahim Abdelazim, PHD; Phone Number: 01001539399; Email: Mariam.A.ibrahim@med.aun.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: weight bearing; immediate partial weight bearing	Other: Immediate Partial Weight Bearing; Immediate Partial Weight Bearing
No Intervention: non-weight bearing; Late weight bearing

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Functional status	Functional status will be evaluated with the Majeed Pelvic Score	at 12 weeks and at 18 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
core and hip muscle strength	core and hip muscle strength, trunk (flexors, extensors and lateral flexors) and hip (extensors and abductors) using VALD handheld dynamometer	at 6 weeks and at 12 weeks
Pain level	Pain rating using numerical pain rating scale (NPRS)	1st day, 6 weeks , 12 weeks, 18 weeks
Gait	Gait by (Functional Gait Assessment)	At 18 weeks
Radiological outcome	Radiological outcome, loss of reduction, by x-ray	1st day post-operative, 6 weeks, 12 weeks, 18 weeks
Patient Quality of life	Patient Quality of life using short form (SF)12	at 18 weeks

Collaborators and Investigators

• Sponsor: Assiut University
• Investigators: Study Director: Osama Ahmed Farouk, MD, Professor of Orthopedic and Trauma surgeries; Study Director: Alaaedien A. Kheiredien, PHD, Assistant Professor of Orthopedic Physiotherapy

Study record dates

Study Major Dates

• Study Start (Actual): August 31, 2025
• Primary Completion (Estimated): May 1, 2026
• Study Completion (Estimated): June 1, 2026

Study Registration Dates

• First Submitted: November 17, 2025
• First Submitted That Met QC Criteria: April 13, 2026
• First Posted (Actual): April 20, 2026

Study Record Updates

• Last Update Posted (Actual): April 20, 2026
• Last Update Submitted That Met QC Criteria: April 13, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Immediate weight bearimg; pelvic fracture rehabilitation; unstalbe pelvic fractures
• Additional Relevant MeSH Terms: Wounds and Injuries; Leg Injuries; Fractures, Bone; Femoral Fractures; Hip Injuries; Hip Fractures
• Other Study ID Numbers: 04-2025-300685

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No