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

NCT07538726 | Recruiting

• 1 other identifier: 04-2025-300685
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pelvic Fractures; Weight Bearing

Keywords

Immediate weight bearimg; pelvic fracture rehabilitation; unstalbe pelvic fractures

Outcome Measures

Primary Outcomes (1)

• Functional status

  Functional status will be evaluated with the Majeed Pelvic Score

  at 12 weeks and at 18 weeks

Secondary Outcomes (5)

• 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

Study Arms (2)

weight bearing

EXPERIMENTAL

immediate partial weight bearing

Other: Immediate Partial Weight Bearing

non-weight bearing

NO INTERVENTION

Late weight bearing

Interventions

Immediate Partial Weight Bearing OTHER

Immediate Partial Weight Bearing

weight bearing

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Trauma Hospital, Assiut University

Asyut, Asyut Governorate, 71511, Egypt

RECRUITING

MeSH Terms

Conditions

Hip Fractures

Condition Hierarchy (Ancestors)

Femoral Fractures; Fractures, Bone; Wounds and Injuries; Hip Injuries; Leg Injuries

Study Officials

• Osama Ahmed Farouk, MD

  Professor of Orthopedic and Trauma surgeries

  STUDY DIRECTOR

• Alaaedien A. Kheiredien, PHD

  Assistant Professor of Orthopedic Physiotherapy

  STUDY DIRECTOR

Central Study Contacts

Hager Emad Abdelzaher, Masters Candidate

CONTACT

00201555726135; Hager.Emad@med.aun.edu.eg

Mariam I. Abdelazim, PHD

CONTACT

01001539399; Mariam.A.ibrahim@med.aun.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physical therapist of Orthopedics and Trauma Surgeries

Study Record Dates

• First Submitted: November 17, 2025
• First Posted: April 20, 2026
• Study Start: August 31, 2025
• Primary Completion: May 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: April 20, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share

Locations

EG (1)