NCT06255106

Brief Summary

Objectives: To compare the cast index and three-point index measurements obtained using computed tomography (CT) with those acquired using conventional methods for treating distal radius fractures Design: A retrospective cohort study Setting: Level 1 trauma center Patients: One hundred and thirteen (45 men and 68 women) patients with distal radius fractures Interventions: Patients with distal radius fractures were retrospectively analyzed and received either conservative cast treatment or surgical intervention through open reduction and internal fixation between 2016 and 2022. Main outcome measurements: The study evaluated the cast index and three-point index in the cast-treated group and their effectiveness using the Sarmiento index. Furthermore, radial height, volar tilt, and radial inclination were compared between the surgically treated and cast-treated groups.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
113

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2022

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

February 1, 2022

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 10, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 15, 2023

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

February 2, 2024

Completed
10 days until next milestone

First Posted

Study publicly available on registry

February 12, 2024

Completed
Last Updated

February 12, 2024

Status Verified

February 1, 2024

Enrollment Period

1.3 years

First QC Date

February 2, 2024

Last Update Submit

February 9, 2024

Conditions

Distal Radius Fractures

Keywords

distal radius fracturecast indexthree point indexcomputed tomography

Outcome Measures

Primary Outcomes (4)

  • Radial height

    Radiologic outcome measurement

    2 weeks

  • Radial İnclination

    Radiologic outcome measurement

    2 weeks

  • Volar tilt

    Radiologic outcome measurement

    2 weeks

  • Sarmiento radiological score

    success of cast treatment

    2 weeks

Secondary Outcomes (2)

  • Axial Cast İndex

    2 weeks

  • Three point index CT

    2 weeks

Study Arms (2)

Group 1

Group 1, consisting of individuals treated with a cast

Other: cast treatment

Group 2

Group 2, comprising those who underwent surgical intervention (Open reduction volar plate fixation.

Other: cast treatment

Interventions

cast treatmentOTHER

Surgical intervention vs cast treatment

Also known as: Open reduction volar plate fixation
Group 1Group 2

Eligibility Criteria

Age19 Years - 92 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

patients diagnosed with distal radius fractures.

You may qualify if:

  • Patients aged ≥18 years
  • Diagnosed with distal radius fracture
  • Treated with either cast or volar plate osteosynthesis were included in the study.

You may not qualify if:

  • Patients with multiple fractures in the same upper extremity
  • Those treated with dorsal plates or external fixators
  • Individuals with open fractures
  • Patients with known systemic or rheumatologic diseases
  • Those with cervical disk problems
  • Individuals lacking post-cast removal CT data
  • Patients with incomplete medical records were excluded.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University

Istanbul, 34093, Turkey (Türkiye)

Location

Related Publications (5)

  • Song J, Yu AX, Li ZH. Comparison of conservative and operative treatment for distal radius fracture: a meta-analysis of randomized controlled trials. Int J Clin Exp Med. 2015 Oct 15;8(10):17023-35. eCollection 2015.

    PMID: 26770293BACKGROUND

  • Kahraman HC, Sibar K, Alemdaroglu KB, Subasi IO, Gokgoz MB. Is three-point index reliable in the follow-up of the distal radius metaphys fractures in the pediatric age group? J Pediatr Orthop B. 2023 Jul 1;32(4):369-377. doi: 10.1097/BPB.0000000000001032. Epub 2022 Nov 14.

    PMID: 36377954BACKGROUND

  • Owen RA, Melton LJ 3rd, Johnson KA, Ilstrup DM, Riggs BL. Incidence of Colles' fracture in a North American community. Am J Public Health. 1982 Jun;72(6):605-7. doi: 10.2105/ajph.72.6.605.

    PMID: 7072880RESULT

  • Alemdaroglu KB, Iltar S, Aydogan NH, Say F, Kilinc CY, Tiftikci U. Three-point index in predicting redisplacement of extra-articular distal radial fractures in adults. Injury. 2010 Feb;41(2):197-203. doi: 10.1016/j.injury.2009.08.021. Epub 2009 Sep 26.

    PMID: 19782974RESULT

  • Hosseinzadeh P, Olson D, Eads R, Jaglowicz A, Goldfarb CA, Riley SA. Radiologic Evaluation of the Distal Radius Indices in Early And Late Childhood. Iowa Orthop J. 2018;38:137-140.

    PMID: 30104936RESULT

MeSH Terms

Conditions

Wrist Fractures

Condition Hierarchy (Ancestors)

Wrist InjuriesArm InjuriesWounds and InjuriesFractures, Bone

Study Officials

  • Yaşar Samet Gökçeoğlu, MD

    Istanbul University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

February 2, 2024

First Posted

February 12, 2024

Study Start

February 1, 2022

Primary Completion

May 10, 2023

Study Completion

July 15, 2023

Last Updated

February 12, 2024

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)