Single Versus Double Symphyseal Plating in Management of Vertically Unstable Open Book Pelvic Ring Injuries: A Randomized Controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Ain Shams University
- Enrollment
- 30
- Locations
- 2
- Primary Endpoint
- Rate of recurrent diastasis
Study Overview
Brief Summary
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
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Investigator, Outcomes Assessor)
Masking Description
Patients and physicians allocated to each intervention group were aware of the allocation; however, the data analysts and the outcome assessors were kept blinded to the allocation.
Eligibility Criteria
- Ages
- 16 Years to 60 Years (Child, Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Outcomes
Primary Outcomes
Rate of recurrent diastasis
Time Frame: throughout study completion, average one year postoperative
rate of symphyseal translation was measured \& compared between the two study groups
Rate of Excellent, Good, Fair or Poor clinical outcome
Time Frame: 1 year postoperative
clinical assessment by Majeed pelvic scoring system evaluated and calculated at each follow-up visit with the mean value presented
Rate of Excellent, Good, Fair or Poor radiological outcome
Time Frame: 1 year postoperative
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).
Secondary Outcomes
- Mean intraoperative blood loss(up to 5 days post-operative)
- Mean operative time(It was calculated intra-operative)
- postoperative complications' rate(1 year post-operative)
Investigators
Islam Moussa
lecturer of orthopedic surgery
Ain Shams University