NCT05175118

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

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2024

Shorter than P25 for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 1, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 3, 2022

Completed
3 years until next milestone

Study Start

First participant enrolled

December 20, 2024

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2025

Completed
Last Updated

August 5, 2024

Status Verified

August 1, 2024

Enrollment Period

9 months

First QC Date

December 1, 2021

Last Update Submit

August 2, 2024

Conditions

Outcome Measures

Primary Outcomes (2)

  • Fracture healing

    Rate of fracture healing

    6 minths

  • Wrist function

    Percentage of restoration of wrist function

    One year

Secondary Outcomes (1)

  • Fracture compilations

    One year

Study Arms (1)

Minimally invasive fixation

OTHER

Minimally Invasive Surgical Fixation for Unstable Fractures of the distal end Radius in Adults

Device: Minimal invasive surgical fixation of distal radius Fractures

Interventions

Fixation of distal radius Fractures by minimal invasive technique

Minimally invasive fixation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • patients with unstable distal radial fracture
  • skeletally mature Patients.
  • Acute fractures within one weeks of injury

You may not qualify if:

  • contaminated open fractures.
  • fractures associated with vascular injury requiring repair, and suspected pathologic Fracture

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (4)

  • 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.

    PMID: 29231799BACKGROUND
  • 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.

    PMID: 25723576BACKGROUND
  • 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.

    PMID: 29368237BACKGROUND
  • 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.

    PMID: 24436782BACKGROUND

MeSH Terms

Conditions

Wrist Fractures

Condition Hierarchy (Ancestors)

Wrist InjuriesArm InjuriesWounds and InjuriesFractures, Bone

Study Officials

  • Ab Ma Ghozaly

    Assiut University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Minimally Invasive Surgical Fixation for Unstable Fractures of the distal end Radius in Adults

Study Record Dates

First Submitted

December 1, 2021

First Posted

January 3, 2022

Study Start

December 20, 2024

Primary Completion

September 1, 2025

Study Completion

October 1, 2025

Last Updated

August 5, 2024

Record last verified: 2024-08

Data Sharing

IPD Sharing
Will not share

Study analytic results