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

Long-term outcome following additional rhBMP-7 application in revision surgery of aseptic humeral, femoral, and tibial shaft nonunion - /

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
DRKS
Registry ID
DRKS00012652
Enrollment
133
Registered
2017-07-26
Start date
2016-09-05
Completion date
Unknown
Last updated
2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

M84.12 M84.15 M84.16

Interventions

Group 1: Twenty-two patients developed an aseptic humeral shaft nonunion. 13 out of those 22 patients were treated using rigid LC plating with autologous cancellous bone grafting and additional applic

Sponsors

BG Unfallklinik Murnau
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

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

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.

Design outcomes

Primary

MeasureTime frame
Point of time of radiological bony healing. Data was evaluated retrospectively according to available databased radiological and clinical findings.

Secondary

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

Countries

Germany

Contacts

Public ContactChristian von Rüden

BG Unfallklinik Murnau

christian.vonrueden@bgu-murnau.de08841-480

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Mar 9, 2026