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NCT05175118 Clinical Trial

Minimally Invasive Fixation for Distal Radius Fractures

Distal Radius Fracture Clinical Trial

— DRF  

Official title:
Minimally Invasive Surgical Fixation for Unstable Fractures of the Distal End Radius in Adults

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT05175118
Other study ID # Minimally invasive fixation
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date December 20, 2024
Est. completion date October 2025

Study information
Verified date January 2023
Source Assiut University
Contact Ab Ma Ghozaly
Phone 01555167657
Email Abdalraoofmahmoud4@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Minimally invasive surgery avoids the tissue damage and impairment of physiological function caused by open surgery because of its precise location techniques and can effectively promote the early recovery of wrist function. Under conditions of no cutting of fracture fragments, no blood supply compromise in the fracture fragments

Description:

Distal radial fracture is common fracture and internal fixation needed in many cases so we use minimally invasive fixation in this study to minimize open surgery compilations

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 30
Est. completion date October 2025
Est. primary completion date September 2025
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: 1. patients with unstable distal radial fracture 2. skeletally mature Patients. 3. Acute fractures within one weeks of injury Exclusion Criteria: 1. contaminated open fractures. 2. fractures associated with vascular injury requiring repair, and suspected pathologic Fracture

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• Minimal invasive surgical fixation of distal radius Fractures
Fixation of distal radius Fractures by minimal invasive technique

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Assiut University

References & Publications (4)

Chmielnicki M, Prokop A. [New minimally invasive approach for palmar plating in distal radius fractures]. Z Orthop Unfall. 2015 Feb;153(1):25-8. doi: 10.1055/s-0034-1383103. Epub 2015 Feb 27. German. — View Citation

Igeta Y, Vernet P, Facca S, Naroura I, Hidalgo Diaz JJ, Diaz JJH, Liverneaux PA. The minimally invasive flexor carpi radialis approach: a new perspective for distal radius fractures. Eur J Orthop Surg Traumatol. 2018 Dec;28(8):1515-1522. doi: 10.1007/s00590-018-2124-z. Epub 2018 Jan 24. Erratum In: Eur J Orthop Surg Traumatol. 2018 Mar 3;:. Diaz JJH [corrected to Hidalgo Diaz JJ]. — View Citation

Liverneaux PA. The minimally invasive approach for distal radius fractures and malunions. J Hand Surg Eur Vol. 2018 Feb;43(2):121-130. doi: 10.1177/1753193417745259. Epub 2017 Dec 12. — View Citation

Slutsky DJ. Outcomes assessment in wrist surgery. J Wrist Surg. 2013 Feb;2(1):1-4. doi: 10.1055/s-0033-1333892. No abstract available. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Fracture healing Rate of fracture healing 6 minths
Primary Wrist function Percentage of restoration of wrist function One year
Secondary Fracture compilations Percentage of fracture healing compilations One year
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