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Efficacy of Vitoss versus Vitoss BA in the treatment of Tibial- and Femoral Non-Union

Efficacy of Vitoss versus Vitoss BA in the treatment of Tibial- and Femoral Non-Union

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
DRKS
Registry ID
DRKS00013563
Enrollment
60
Registered
2018-03-07
Start date
2018-03-10
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

M84.1

Interventions

Group 1: Patients who suffer from defect (2-5cm3) nonunion of the tibia or femur receive standardized Masquelet technique treatment. After information and randomization all patients receive contrast-e
no additional radiographs will be taken. By using a questionnaire preoperatively, and postoperatively after 6 weeks, 3, 12 and 24 months, patients give information on pain (VAS - visual analog scale),

Sponsors

Klinik für Orthopädie und Unfallchirurgie, Universitätsklinikum Heidelberg,Abteilung für UnfallchirurgieProf. Dr. med. Gerhard Schmidmaier
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Patients of full age and patients who suffer from tibial or femoral non-unions with a bone defect of 2-5 cm3 and receive Masquelet treatment.

Exclusion criteria

Exclusion criteria: - Patients under 18 years of age - Patients who do not agree to participate in the study - Patients receiving an amputation because of persistent infection or extended soft tissue defects.

Design outcomes

Primary

MeasureTime frame
Union achieved one year after surgery by evaluation of x-rays in two planes (defined as cortical bridging of at least three out of four cortices).

Secondary

MeasureTime frame
quality of life (SF-12)/ non-union perfusion (CEUS/ DCE-MRI), pain (VAS), union achieved two years after surgery by evaluation of x-rays in two planes (defined as cortical bridging of at least three out of four cortices), revision surgery, postoperative infection, union achieved in CT scan one year after surgery

Countries

Germany

Contacts

Public ContactThomas Ferbert

Zentrum für Orthopädie und Unfallchirurgie, Universitätsklinik Heidelberg

thomas.ferbert@med.uni-heidelberg.de+4962215635554

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026