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NCT Number: 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

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.

Recruiting

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Key information

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Immediate Partial Weight Bearing

Other

Immediate Partial Weight Bearing

Primary outcomes

  1. Functional status

    Time frame: at 12 weeks and at 18 weeks

    Functional status will be evaluated with the Majeed Pelvic Score

Secondary outcomes

  1. core and hip muscle strength

    Time frame: at 6 weeks and at 12 weeks

    core and hip muscle strength, trunk (flexors, extensors and lateral flexors) and hip (extensors and abductors) using VALD handheld dynamometer

  2. Pain level

    Time frame: 1st day, 6 weeks , 12 weeks, 18 weeks

    Pain rating using numerical pain rating scale (NPRS)

  3. Gait

    Time frame: At 18 weeks

    Gait by (Functional Gait Assessment)

  4. Radiological outcome

    Time frame: 1st day post-operative, 6 weeks, 12 weeks, 18 weeks

    Radiological outcome, loss of reduction, by x-ray

  5. Patient Quality of life

    Time frame: at 18 weeks

    Patient Quality of life using short form (SF)12

Study contacts

Contact information is provided by the study sponsor or research team.

Hager Emad Abdelzaher, Masters Candidate

CONTACT

[email protected]

00201555726135

Mariam I. Abdelazim, PHD

CONTACT

[email protected]

01001539399

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Apr 20, 2026
Registry last updated
Apr 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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