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NCT05690477 Clinical Trial

Corrective Osteotomy of the Distal Radius Without Bone Grafting

Distal Radius Fracture Clinical Trial

Official title:
Corrective Osteotomy of the Distal Radius With Palmar Locking Plate Osteosynthesis Without Bone Grafting and Without Cortical Contact

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05690477
Other study ID # 27012022
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 1, 2009
Est. completion date December 31, 2022

Study information
Verified date January 2023
Source Cantonal Hospital of St. Gallen
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The investigators retrospectively analyzed patients who underwent extraarticular corrective osteotomy of the distal radius via a palmar approach and without the use of a bone graft, even in the absence of cortical contact after corrective osteotomy. The goal of this retrospective observational study is to determine whether secondary dislocation or nonunion occurs after corrective osteotomy without bone grafting.

Recruitment information / eligibility
Status Completed
Enrollment 15
Est. completion date December 31, 2022
Est. primary completion date December 31, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - malunited distal radius fracture - extraarticular corrective osteotomy - palmar approach - no bone graft used - no cortical contact after dorsal open wedge osteotomy - signed informed consent Exclusion Criteria: - others reasons for malunion - intraarticular corrective osteotomy - use of a bone graft - cortical contact after open wedge osteotomy - lost to follow up

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• Corrective osteotomy of the distal radius
Corrective osteotomy of the distal radius with a palmar locking plate osteosynthesis without the use of a bone graft and without cortical contact.

Locations
Country Name City State
Switzerland Hand, Plastic and Reconstructive Surgery Saint Gallen

Sponsors (1)
Lead Sponsor Collaborator
Cantonal Hospital of St. Gallen

Country where clinical trial is conducted

Switzerland, 

Outcome
Type Measure Description Time frame Safety issue
Primary Secondary fracture dislocation 1 year
Primary complete bone healing 1 year
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