NCT05722808

Brief Summary

Through this study we aim to investigate the rate of DRFs initially treated with successful closed reduction (to an acceptable position, then immobilized in a plaster cast), that re-displace and end up requiring surgery. This study will clarify the incidence of DRFs where surgical intervention could potentially be avoided if the initial closed reduction lasted until sufficient bone healing was attained. As DRFs are the most common fracture of the adult population treated in the Danish emergency departments, the aim of this study is to examine the amount of people with DRFs that could potentially avoid surgery and thereby lowering the cost to the health care system, as well as save the patient invasive surgery. Furthermore, we expect to classify which specific types of fractures according to Arbeitsgemeinschaft für Osteosynthesefragen/ Orthopaedic Trauma Association (AO/OTA) classification system have a high or low incidence of secondary surgery after primary closed reduction.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2018

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2018

Completed
5.1 years until next milestone

First Submitted

Initial submission to the registry

February 1, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

February 10, 2023

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

February 10, 2023

Status Verified

January 1, 2023

Enrollment Period

6 years

First QC Date

February 1, 2023

Last Update Submit

February 1, 2023

Conditions

Keywords

Distal radius fracture

Outcome Measures

Primary Outcomes (1)

  • Rate of surgical treatment

    Rate of surgical treatment of distal radial fractures treated at North Zealand Hospital

    Anticipated to be completed by 31/05-2023

Secondary Outcomes (4)

  • Rate of fracture displacement following primary conservative treatment compared with Dutch cohort

    Anticipated to be completed by 31/05-2023

  • sub analysis of risk of secondary displacement according to the "Arbeitsgemeinschaft für Osteosynthesefragen" (AO) classification system for DRFs

    Anticipated to be completed by 31/05-2023

  • Incidence of distal radial fractures with unaccetable displacement following following initial reduction

    Anticipated to be completed by 31/05-2023

  • Number of reductions performed per patient with distal radial fractures

    Anticipated to be completed by 31/05-2023

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult patients with displaced DRFs treated at North Zealand Hospital from 1.1.2018 to 31.12.2019.

You may not qualify if:

  • Concomitant fracture of the ulna (except ulnar styloid process' fractures)
  • Non-displaced DRFs
  • Multiple trauma patients
  • Ipsilateral upper extremity fractures, interfering with the treatment of the DRF

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

North Zealand Hospital

Hillerød, 3400, Denmark

Location

MeSH Terms

Conditions

Wrist Fractures

Condition Hierarchy (Ancestors)

Wrist InjuriesArm InjuriesWounds and InjuriesFractures, Bone

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 1, 2023

First Posted

February 10, 2023

Study Start

January 1, 2018

Primary Completion

December 31, 2023

Study Completion

December 31, 2023

Last Updated

February 10, 2023

Record last verified: 2023-01

Locations