ong-term outcome following additional rhBMP-7 application in revision surgery of aseptic humeral, femoral, and tibial shaft nonunio

• Conditions: M84.12; M84.15; M84.16

• Registration Number: DRKS00012652
• Lead Sponsor: BG Unfallklinik Murnau

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Completion: 2016-10-14
• Study Start: 2017-07-26
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 112

Inclusion Criteria

Patients were included who were treated with humeral, femoral, and tibial shaft fracture and had developed aseptic shaft nonunion.
Nonunion Treatment included stable internal Fixation in combination with autologous iliac crest bone graft or cancellous bone grafting, with or without additional application of recombinant human Bone Morphogenetic Protein rhBMP-7. No Intervention in the treatment algorithm was performed. All patients agreed and signed the off-label” treatment of rhBMP-7. Written informed consent for anonymous evaluation of patients' data was obtained from the patients before initial revision surgery in our institution.

Exclusion Criteria

Patients with congenital forms of nonunion or skeletal immaturity as well as patients with previous or consecutive positive bacterial cultures were excluded from the study to restrict the study group to aseptic nonunion.

Study & Design

• Study Type: observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Point of time of radiological bony healing. <br>Data was evaluated retrospectively according to available databased radiological and clinical findings.

Secondary Outcome Measures

Name	Time	Method
1. Differences in terms of nonunion healing.<br>2. Differences according to range of time between revision surgery and nonunion healing.<br>3. Differences in terms of complications (functional outcome).<br>Data was evaluated retrospectively according to available databased radiological and clinical findings.