Pelvic Fractures, Weight Bearing
Conditions
Keywords
Immediate weight bearimg, pelvic fracture rehabilitation, unstalbe pelvic fractures
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.
Interventions
OTHERImmediate Partial Weight Bearing
Immediate Partial Weight Bearing
Sponsors
Assiut University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Functional status | at 12 weeks and at 18 weeks | Functional status will be evaluated with the Majeed Pelvic Score |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| core and hip muscle strength | 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 |
| Pain level | 1st day, 6 weeks , 12 weeks, 18 weeks | Pain rating using numerical pain rating scale (NPRS) |
| Gait | At 18 weeks | Gait by (Functional Gait Assessment) |
| Radiological outcome | 1st day post-operative, 6 weeks, 12 weeks, 18 weeks | Radiological outcome, loss of reduction, by x-ray |
| Patient Quality of life | at 18 weeks | Patient Quality of life using short form (SF)12 |
Countries
Egypt
Contacts
CONTACTHager Emad Abdelzaher, Masters Candidate
CONTACTMariam I. Abdelazim, PHD
STUDY_DIRECTOROsama Ahmed Farouk, MD
Professor of Orthopedic and Trauma surgeries
STUDY_DIRECTORAlaaedien A. Kheiredien, PHD
Assistant Professor of Orthopedic Physiotherapy
Outcome results
None listed