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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06255106
Other study ID # DistalRadiuscast
Secondary ID
Status Completed
Phase
First received
Last updated
Start date February 1, 2022
Est. completion date July 15, 2023

Study information

Verified date February 2024
Source Istanbul University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 113
Est. completion date July 15, 2023
Est. primary completion date May 10, 2023
Accepts healthy volunteers No
Gender All
Age group 19 Years to 92 Years
Eligibility Inclusion Criteria: - Patients aged =18 years - Diagnosed with distal radius fracture - Treated with either cast or volar plate osteosynthesis were included in the study. Exclusion Criteria: - 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.

Study Design


Intervention

Other:
cast treatment
Surgical intervention vs cast treatment

Locations

Country Name City State
Turkey University Istanbul

Sponsors (1)

Lead Sponsor Collaborator
Istanbul University

Country where clinical trial is conducted

Turkey, 

References & Publications (5)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Radial height Radiologic outcome measurement 2 weeks
Primary Radial Inclination Radiologic outcome measurement 2 weeks
Primary Volar tilt Radiologic outcome measurement 2 weeks
Primary Sarmiento radiological score success of cast treatment 2 weeks
Secondary Axial Cast Index Cast index measure in axial plane CT 2 weeks
Secondary Three point index CT Three point index measure in CT 2 weeks
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