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Recruiting NCT07538726

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

No phase Interventional Pelvic Fractures Weight Bearing

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Immediate Partial Weight Bearing.
Who it may be relevant to
Registry conditions: Pelvic Fractures, Weight Bearing. Basic parameters: 18 years — 55 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Egypt
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Immediate Versus Delayed Weight Bearing After Fixation of Pelvic Ring Injuries: Randomized Control Trial

Overview

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.

Interventions

  • Other Immediate Partial Weight Bearing
    Immediate Partial Weight Bearing

Primary outcome measures

  • Functional status [Time frame: at 12 weeks and at 18 weeks]
Secondary outcome measures (5)
  • core and hip muscle strength [Time frame: at 6 weeks and at 12 weeks]
  • Pain level [Time frame: 1st day, 6 weeks , 12 weeks, 18 weeks]
  • Gait [Time frame: At 18 weeks]
  • Radiological outcome [Time frame: 1st day post-operative, 6 weeks, 12 weeks, 18 weeks]
  • Patient Quality of life [Time frame: at 18 weeks]

Eligibility 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

Egypt · 1 center
  • Trauma Hospital, Assiut University — Asyut

Identifiers

NCT: NCT07538726 · 04-2025-300685

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗