Weight-bearing of Patients After Pelvic Ring Fracture

Recruiting

• Conditions: Weight-bearing of Patients After Pelvic Ring Fracture

• Registration Number: NCT06481865
• Lead Sponsor: University Hospital, Grenoble

Brief Summary

Pelvic ring fractures are fractures associated with high morbidity and mortality. When the fracture is displaced, surgical management to achieve reduction and fixation of the anterior and posterior annulus is the current reference. The optimal technique that gives the best results is controversial. Open reductions and internal fixations (ORIFs) are associated with more blood loss and a higher rate of infection, while closed reductions and percutaneous fixations (CRPF) are associated with more screw misplacements and thus vascular or nerve damage. The results appear to be similar in the literature between the two approaches

Surgery for pelvic ring fractures has become increasingly common over the past three decades Recovery is often delayed for weeks post-surgery, depending on the center. Modern management emphasizes early rehabilitation, including early mobility and weight-bearing, when possible. Increasing the number of screws, their diameter and length, and systematically fixing both anterior and posterior lesions add safety for early reloading

The aim of the study is The main objective of the study is to evaluate the clinical outcome associated with early weight-bearing in patients operated on for a pelvic ring fracture in a large cohort of patients at Grenoble University Hospital, compared to patients operated on for the same type of pelvic ring fracture with delayed weight-bearing.

The investigator hypothesize that early weight-bearing of pelvic ring fractures with biomechanically stable fixation does not result in significant differences in clinical outcomes at a minimum of one year compared to patients with delayed weight-bearing

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-06
• Study Start: 2024-06-01
• Study First Submitted: 2024-06-11
• Study First Submitted QC: 2024-06-28
• Last Update Submitted: 2024-06-28
• Study First Posted: 2024-07-01
• Last Update Posted: 2024-07-01
• Primary Completion: 2025-06-01
• Study Completion: 2025-06-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 250

Inclusion Criteria

• Adult patient at the time of injury
• Pelvic ring fracture
• Pre-operative X-rays
• Pre-operative CT scan
• Post-operative X-rays
• Postoperative CT scan
• Willingness and ability to participate in the study.

Exclusion Criteria

• Ipsi-lateral fracture of the femoral and/or associated acetabulum (Floating Hip C or B)
• Pregnant and breastfeeding women
• People under guardianship, protected adults

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Evaluate the clinical outcome associated with early weight-bearing in patients operated on for a pelvic ring fracture compared to patients operated on for the same type of pelvic ring fracture with delayed weight-bearing	1 year	Clinical outcomes according to functional assessment ( Majeed score)

Secondary Outcome Measures

Name	Time	Method
Define the prognostic factors associated with poor clinical outcomes and Pseudoarthrosis or vicious callus.	1 year	Prognostic factors from operative data (Ilio-inguinale,Ilio-stoppa,stoppa,stoppa + external window,kocher-Langenbeck, anterior + posterior, operating time (min), blood loss (ml),intraoperative re-transfusion (ml))
Compare clinical outcomes and radiological results with the literature	1 year	Clinical outcomes according to radiological results
Evaluation of the outcomes and complications of immediate weight-bearing in elderly patients.	1 year	Intraoperative and postoperative complications (including complications of immediate weight-bearing)

Trial Locations

Locations (1)

Grenoble Alpes university Hospital,La tronche; 🇫🇷 Grenoble, France