DRF: Minimally Invasive Fixation for Distal Radius Fractures

• Sponsor: Assiut University (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05175118
• Collaborator: (none)
• Enrollment: 30
• Arm: 1
• Anticipated Duration (Months): 9.4

Study Details

Study Description

Brief 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

Condition or Disease	Intervention/Treatment	Phase
Distal Radius Fracture	Device: Minimal invasive surgical fixation of distal radius Fractures	N/A

Detailed 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

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 30 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Minimally Invasive Surgical Fixation for Unstable Fractures of the Distal End Radius in Adults
• Anticipated Study Start Date: Dec 20, 2022
• Anticipated Primary Completion Date: Sep 1, 2023
• Anticipated Study Completion Date: Oct 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Other: Minimally invasive fixation Minimally Invasive Surgical Fixation for Unstable Fractures of the distal end Radius in Adults	Device: Minimal invasive surgical fixation of distal radius Fractures; Fixation of distal radius Fractures by minimal invasive technique

Outcome Measures

Primary Outcome Measures

1. Fracture healing [6 minths]

   Rate of fracture healing

2. Wrist function [One year]

   Percentage of restoration of wrist function

Secondary Outcome Measures

1. Fracture compilations [One year]

   Percentage of fracture healing compilations

Eligibility Criteria

Criteria

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

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Assiut University

Investigators

• Principal Investigator: Ab Ma Ghozaly, Assiut University

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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.
• 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].
• 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. Review.
• Slutsky DJ. Outcomes assessment in wrist surgery. J Wrist Surg. 2013 Feb;2(1):1-4. doi: 10.1055/s-0033-1333892.

• Responsible Party: Abdalraouf M Ghozaly, Minimally Invasive Surgical Fixation for Unstable Fractures of the distal end Radius in Adults, Assiut University
• ClinicalTrials.gov Identifier: NCT05175118
• Other Study ID Numbers: Minimally invasive fixation
• First Posted: Jan 3, 2022
• Last Update Posted: Jul 20, 2022
• Last Verified: Jul 1, 2022

• 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: Fractures, Bone; Radius Fractures

Study Results

No Results Posted as of Jul 20, 2022