Single vs Double Symphyseal Plating in Management of Vertically Unstable Open Book Pelvic Ring Injuries:

Single Versus Double Symphyseal Plating in Management of Vertically Unstable Open Book Pelvic Ring Injuries: A Randomized Controlled Trial

compare functional, radiological outcomes, implant failure and the incidence of recurrent diastasis of single superior symphyseal plate versus double plating in management of vertically unstable open book injuries

Study Overview

• Status: Active, not recruiting
• Conditions: Evaluation of Single Symphyseal Plating in APC III Injuries
• Intervention / Treatment: Procedure: single symphyseal plating in management of vertically unsable open book pelvic ring injuries

Detailed Description

The real algorithm was the necessity for double superior & anterior plating versus single superior symphyseal plate in management of APC III pelvic ring injuries, whether the incidence of intraoperative and short-term postoperative complications, recurrent diastasis, radiological and functional outcomes differed between these two methods. Our hypothesis was that the use of an additional anterior symphyseal plating could provide a more rigid fixation, with less complications of recurrent diastasis or implant failure. Also it will be applied through the same incision without increasing the patient overall morbidity.

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Abassia
    • Cairo, Abassia, Egypt, 1234
      • Islam Sayed Moussa

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Anterior ring symphyses diastasis
• Tile C pelvic ring injuries
• Age between 16-60 years' old

Exclusion Criteria:

• Tile B pelvic ring injuries
• Isolated bony fractures of the anterior pelvic ring
• Open fractures
• Age less than 14 years and older than 60 years
• Associated internal organ injuries that require definitive intervention

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: single superior symphyseal plate; 15 cases undergoing single superior symphyseal plate, reduction of the posterior ring was either closed reduction in SI joint dislocations & fracture-dislocations and sacral fractures or open reduction in iliac wing fractures through the lateral window of the ilioinguinal approach.Anterior pelvic ring reduction and fixation was done via the classic Pfannenstiel approach	Procedure: single symphyseal plating in management of vertically unsable open book pelvic ring injuries; open book pelvic ring injuries can be managed via the two techniques.; Other Names: double symphyseal plating in management of vertically unsable open book pelvic ring injuries
Active Comparator: double superior & anterior symphyseal plates; 15 cases undergoing double superior & anterior symphyseal plates, 15 cases undergoing double superior & anterior symphyseal plates, reduction of the posterior ring was either closed reduction in SI joint dislocations & fracture-dislocations and sacral fractures or open reduction in iliac wing fractures through the lateral window of the ilioinguinal approach.Anterior pelvic ring reduction and fixation was done via the classic Pfannenstiel approach	Procedure: single symphyseal plating in management of vertically unsable open book pelvic ring injuries; open book pelvic ring injuries can be managed via the two techniques.; Other Names: double symphyseal plating in management of vertically unsable open book pelvic ring injuries

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of Excellent, Good, Fair or Poor clinical outcome	clinical assessment by Majeed pelvic scoring system evaluated and calculated at each follow-up visit with the mean value presented	1 year postoperative
Rate of Excellent, Good, Fair or Poor radiological outcome	Radiological assessment using Matta & Tornetta radiological principles via plain x-ray pelvis showing both hips: anteroposterior, inlet and outlet views & CT pelvis if available; we evaluated five criteria on X-ray films postoperatively: residual posterior displacement, vertical displacement, pubic symphyseal translation, sagittal rotation, and gapping of the sacroiliac joint; according to the grading of Matta and Tornetta, we classified the results into Excellent (less than or equal 4 mm), Good (4-10 mm), Fair (10-20 mm), and Poor (more than 20 mm).	1 year postoperative
Rate of recurrent diastasis	rate of symphyseal translation was measured & compared between the two study groups	throughout study completion, average one year postoperative

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean intraoperative blood loss	The mean blood loss was calculated in milliliters and compared between the two study groups, it was measured intraoperative and postoperative from suction drains	up to 5 days post-operative
Mean operative time	The mean operation time was calculated in minutes and compared between the two study groups	It was calculated intra-operative
postoperative complications' rate	We focused the evaluation of Postoperative complications on the local complications related to fixation principles and technique: LLD, implant failure, wound infection, residual malunion or non-union of the anterior ring, and loss of reduction (2ry SI dislocation or any rotational or vertical re-displacement)	1 year post-operative

Collaborators and Investigators

• Sponsor: Ain Shams University
• Investigators: Study Chair: Islam S Moussa, MD, no funding recieved

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2023
• Primary Completion (Actual): April 15, 2024
• Study Completion (Estimated): July 15, 2024

Study Registration Dates

• First Submitted: May 26, 2024
• First Submitted That Met QC Criteria: May 30, 2024
• First Posted (Actual): June 3, 2024

Study Record Updates

• Last Update Posted (Actual): June 3, 2024
• Last Update Submitted That Met QC Criteria: May 30, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: functional outcome; APC III pelvic ring injuries; single symphyseal plating; double symphyseal plating; Majeed pelvic score
• Additional Relevant MeSH Terms: Wounds and Injuries
• Other Study ID Numbers: FMASU R65/2023

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: share the plan
• IPD Sharing Time Frame: 1 year
• IPD Sharing Access Criteria: full access
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No