CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 40 enrolled
Drug / intervention
Combined posterior and anterior ring fixation: Active comparator. Isolated posterior ring fixation: Experimental interventionprocedure
Likely dose
Not stated in record
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Search/NCT05042297
NCT05042297Phase 2Completed

Combined Posterior and Anterior Ring Fixation Versus Posterior Ring Fixation Alone in Management of Unstable Tile B2 and C1 Pelvic Ring Injuries: A Randomized Controlled Trial

Ain Shams University·interventional·Posted Sep 13, 2021·Updated Sep 13, 2021

In Brief

A Phase 2 clinical trial evaluating Combined posterior and anterior ring fixation: Active comparator. Isolated posterior ring fixation: Experimental intervention for Evaluation of PR Fixation in Tile B2 and C1 Injuries. Completed, enrolled 40 participants across 1 site.

Detailed Summary

The aim for surgical treatment of unstable Tile B2 \& C1 pelvic ring injuries is an anatomical reduction to allow early weight-bearing, pain relief and to prevent future pelvic asymmetry. So, we usually used combined posterior \& anterior ring fixation, relying on the fact that anterior pelvic ring adequate reduction and fixation better augment posterior ring fixation and enhance overall pelvic stability. However, anterior ring fixation requires a second incision with a longer operation time and more blood loss. The main disadvantage of the second incision is the higher risk of wound infection, either superficial or deep, which questions its necessity and raises concerns about the possibility of isolated posterior ring fixation in managing Tile B2 \& C1 pelvic ring injuries with good outcomes. The fundamental algorithm was the questionable need for additional anterior ring fixation in managing Tile B2 and C1 pelvic ring injuries combined with posterior ring fixation, whether the incidence of postoperative complications, radiological and clinical outcomes differed between these two groups. After reviewing the literature, we found a lack of knowledge in the prospective assessment of such outcomes between the two fixation groups. So, This RCT aims to reach a satisfactory result and prove or deny the questionable need for anterior ring fixation in managing Tile B2 and C1 pelvic ring injuries. Our hypothesis was that PR fixation is at least as good as APR fixation.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesEgypt
Collaborators--

Timeline

Phase 2CompletedFinished
20192020202120222023202420252026
First PostedSep 13, 2021
Enrollment StartMar 9, 2019
Primary CompletionJul 7, 2020
Study CompletionJul 15, 2021
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 4.8 years ago

Interventions

Combined posterior and anterior ring fixation: Active comparator. Isolated posterior ring fixation: Experimental interventionprocedure

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 in the combined APR fixation group was done via the classic Pfannenstiel approach or extension more lateral \& completing the anterior intrapelvic approach. Fixation was via pubic rami plating.