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Mid-term Outcome Following Revision Surgery of Clavicular Non- and Malunion

NCT02951468 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 14

Last updated 2016-11-04

No results posted yet for this study

Summary

Background Treatment of clavicular non- and malunion is still challenging. Current surgical procedures often result in partially frustrating functional outcome along with high-grade subjective impairment and increased rates of revision surgery. However, the combination of vital bone graft and a biomechanically sufficient fixation system seems to be a promising concept of treatment.

Methods In this retrospective study, 14 patients with a mean age of 44 years (26-67 years) suffering from non-union (n=11) and/or malunion (n=4) of the clavicle were enrolled. All patients were surgically treated using an anatomical precontoured locking compression plate (LCP) and autologous iliac crest bone graft. Functional outcome was assessed using the age- and sex-specific relative Constant Score.

Conditions

  • Fracture, Healed, Fibrous Union

Interventions

PROCEDURE

LCP plus iliac crest autograft

After exposure of the non- or malunion a complex multidimensional osteotomy of the clavicle with medial and lateral axial correction up to vital bone was performed \[14\]. Vital bone was verified by local blood extravasation resulting from drilling the previously osteotomized bone segments. The tricortical iliac crest bone graft was harvested according to the size assessed in the preoperative CT scan, consecutively adapted to the intraoperative measured size of the bony defect. After implantation of the bone graft the LCP was centered onto the clavicular shaft.

Sponsors & Collaborators

  • Technical University of Munich

    lead OTHER

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-01-31
Primary Completion
2014-12-31
Completion
2016-02-29

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02951468 on ClinicalTrials.gov