Pelvic FracturesNCT07538726
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
A study testing Immediate Partial Weight Bearing in people with Pelvic Fractures and Weight Bearing, run by Assiut University at 1 site in Egypt.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Pelvic Fractures, Weight Bearing
- What is being tested?
- Immediate Partial Weight Bearing
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 31 Aug 2025to Jun 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 14Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Trauma Hospital, Assiut University
Asyut, Asyut Governorate, 71511
Hager Emad Abdelzaher, Maters Candidate, +201555726135, Hager.Emad@med.aun.edu.eg
Mariam Ibrahim Abdelazim, PHD, 01001539399, Mariam.A.ibrahim@med.aun.edu.eg
About this study
Official title: 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.
- Conditions
- Pelvic Fractures, Weight Bearing
- Being tested
- Immediate Partial Weight Bearing
- Keywords
- Immediate weight bearimg, pelvic fracture rehabilitation, unstalbe pelvic fractures
- Medical subject headings
- Hip Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Immediate Partial Weight BearingOther
Immediate Partial Weight Bearing
| Study group | Role | What they receive |
|---|---|---|
| weight bearing | Experimental | immediate partial weight bearing Receives: Other: Immediate Partial Weight Bearing |
| non-weight bearing | No intervention | Late weight bearing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional status
Functional status will be evaluated with the Majeed Pelvic Score
Measured: at 12 weeks and at 18 weeks
Secondary outcomes (5)
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
Measured: at 6 weeks and at 12 weeks
Pain level
Pain rating using numerical pain rating scale (NPRS)
Measured: 1st day, 6 weeks , 12 weeks, 18 weeks
Gait
Gait by (Functional Gait Assessment)
Measured: At 18 weeks
Radiological outcome
Radiological outcome, loss of reduction, by x-ray
Measured: 1st day post-operative, 6 weeks, 12 weeks, 18 weeks
Patient Quality of life
Patient Quality of life using short form (SF)12
Measured: at 18 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2026
- Study start31 Aug 2025
- Primary completionMay 2026 (estimated)
- Study completionJun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pelvic FracturesStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hager Emad, Assiut University
- Investigators
- Osama Ahmed Farouk, MD, Study director, Professor of Orthopedic and Trauma surgeriesAlaaedien A. Kheiredien, PHD, Study director, Assistant Professor of Orthopedic Physiotherapy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07538726
- Sponsor's protocol ID
- 04-2025-300685
- Status last verified
- Apr 2026
- First submitted
- 17 Nov 2025
- Last updated
- 20 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immediate Versus Delayed Weight Bearing After Fixation of Pelvic Ring Injuries: Randomized Control Trial
- ClinicalTrials.gov ID
- NCT07538726
- Acronym / sponsor ID
- 04-2025-300685
- Conditions
- Pelvic Fractures, Weight Bearing
- Keywords
- Immediate weight bearimg, pelvic fracture rehabilitation, unstalbe pelvic fractures
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 31 Aug 2025 (actual)
- Primary completion
- May 2026 (estimated)
- Study completion
- Jun 2026 (estimated)
- First posted
- 20 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| weight bearing | Experimental | Other: Immediate Partial Weight Bearingimmediate partial weight bearing |
| non-weight bearing | No intervention | –Late weight bearing |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Immediate Partial Weight BearingImmediate Partial Weight Bearing | Other | weight bearing |
Primary outcome
Functional status
Time frame: at 12 weeks and at 18 weeks
Functional status will be evaluated with the Majeed Pelvic Score
5 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2026.
- Individual participant dataSharing planned: Yes
Related trials for Pelvic Fractures
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BDSF Vs DHS With Anterotational Screw in Vertical FNF
Evaluation of BDSF in FNF
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Pelvic and Acetabular Fracture: A Prospective Observational Study
Pelvic Fracture, Acetabular Fracture
Not yet recruiting
Trochanteric Bursa Repair and Lateral Hip Pain After Hemiarthroplasty for Femoral Neck Fracture
Femoral Neck Fracture
Active, not recruiting
Lumbar-Sacral Plexus Block vs Fascia Iliaca Block Plus Low-Dose Spinal Anesthesia for Femoral Neck Fracture Surgery
Femoral Neck Fractures, Nerve Block
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Osama Ahmed Farouk, MD study director
Professor of Orthopedic and Trauma surgeries
Alaaedien A. Kheiredien, PHD study director
Assistant Professor of Orthopedic Physiotherapy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Immediate Partial Weight Bearing in people with Pelvic Fractures and Weight Bearing, run by Assiut University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hager Emad Abdelzaher, Masters Candidate (00201555726135, Hager.Emad@med.aun.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Functional status (time frame: at 12 weeks and at 18 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2026.