Corrective Osteotomy of the Distal Radius Without Bone Grafting

• Sponsor: Cantonal Hospital of St. Gallen (Other)
• Overall Status: Completed
• CT.gov ID: NCT05690477
• Collaborator: (none)
• Enrollment: 15
• Location: 1
• Actual Duration (Months): 168
• Patients Per Site Per Month: 0.1

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Distal Radius Fracture	Procedure: Corrective osteotomy of the distal radius

Study Design

• Study Type: Observational
• Actual Enrollment: 15 participants
• Observational Model: Cohort
• Time Perspective: Retrospective
• Official Title: Corrective Osteotomy of the Distal Radius With Palmar Locking Plate Osteosynthesis Without Bone Grafting and Without Cortical Contact
• Actual Study Start Date: Jan 1, 2009
• Actual Primary Completion Date: Dec 31, 2022
• Actual Study Completion Date: Dec 31, 2022

Outcome Measures

Primary Outcome Measures

1. Secondary fracture dislocation [1 year]

2. complete bone healing [1 year]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hand, Plastic and Reconstructive Surgery	Saint Gallen		Switzerland	9007

Sponsors and Collaborators

• Cantonal Hospital of St. Gallen

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Vilijam Zdravkovic, Dr. med., Cantonal Hospital of St. Gallen
• ClinicalTrials.gov Identifier: NCT05690477
• Other Study ID Numbers: 27012022
• First Posted: Jan 19, 2023
• Last Update Posted: Jan 23, 2023
• Last Verified: Jan 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Radius Fractures

Study Results

No Results Posted as of Jan 23, 2023