The use of patient-specific implants: a promising strategy to reduce rigid external distractor-associated complications in syndromic craniosynostosis.

Authors

Jennifer Fuchs, Maximilian Appel, Sven Zittel, Cornelius Busch, Ahmed El Damaty, Reinald Kühle, Mats Scheurer, Jürgen Hoffmann, Michael Engel

Published in

Journal of cranio-maxillo-facial surgery : official publication of the European Association for Cranio-Maxillo-Facial Surgery. Volume 54. Issue 12. Pages 109924. Oct 25, 2026. Epub Oct 25, 2026.

Abstract

Midface distraction osteogenesis (DO) with rigid external distraction (RED) is an established technique for treating severe midfacial hypoplasia in patients with syndromic craniosynostosis. However, halo-type distractors are associated with substantial device-related complications, particularly at the cranial pin fixation and midfacial anchorage sites. Patient-specific implants (PSIs) for the retention of the halo frame and the maxillary anchorage may reduce fixation-related complications while maintaining reliable force transmission and distraction vectors.
This monocentric retrospective study included a cohort of consecutively treated patients with Apert, Crouzon, or Pfeiffer syndrome who underwent Le Fort III or Wassmund III midface advancement using DO with PSI bases for the RED fixation combined with either conventional or patient-specific maxillary anchorage between January 2022 and July 2024. Demographics, perioperative parameters, achievement of the planned distraction goal, and complications classified by Clavien-Dindo were analyzed, with particular focus on distractor- and fixation-related events.
Eight children (six boys, two girls; five Crouzon, two Pfeiffer, one Apert) were included. Mean age at surgery was 14.1 years (±0.4 years), and mean time to distractor removal was 3.3 months (±0.29 months). No intraoperative complications occurred. One patient developed a transient cerebrospinal fluid leak that resolved spontaneously (Clavien-Dindo grade I). Cranial RED fixation using PSIs was not associated with infections, loosening, migration, or transcranial penetration. One device-related complication occurred during retention (crossbar ball-joint screw loosening), managed by retightening (grade II). Three patients underwent conventional midfacial fixation using Leipzig retention plates, with one case of intraoral wound dehiscence requiring secondary suturing and antibiotics (grade II) and subjectively reduced oral hygiene/food intake. Five patients received PSI-based midfacial fixation with two transcutaneous wires; no fixation-related complications, dental injuries, or wound problems were observed. All patients achieved the planned advancement with correction of exorbitism and Angle Class III malocclusion. At mean follow-up of 25.7 months (±8.8 months), all patients had Whitaker Class I outcomes, with predominantly excellent aesthetic results.
PSI-based fixation of rigid external distractors (RED) to the cranium and midface appeared to be a feasible and safe approach in this preliminary cohort. While no fixation-related complications were observed, the retrospective design, small sample size, and absence of a comparative control group preclude conclusions regarding a reduction in complication rates. Larger comparative studies are required.

PMID:
42927707
Bibliographic data and abstract were imported from PubMed on 26 Oct 2026.

Read full publication at:
Please sign in to see all details.

Stats

1-terrible, 9-excellent. How would you rate this publication? Sign in in to submit your rating.

Post a comment

You need to be signed in to post comments. You can sign in here.

Comments

There are no comments yet.