Prospective randomized study on immobilization of upper extremity fractures using wood and plastic casts in children and adolescents under 16 years of age

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

DRKS

Registry ID

DRKS00017440

Enrollment

150

Registered

2019-06-13

Start date

2018-03-01

Completion date

Unknown

Last updated

2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

S50-S59 S40-S49

Interventions

Group 1: Woodcast® arm Group 2: Dynacast® arm

Eligibility

Sex/Gender

All

Age

0 Years to 16 Years

Inclusion criteria

Inclusion criteria: Children areeligible when they are under 16 years of age and presented with an acute, symptomatic, low-risk fractures of the upper extremity within 48 hours after injury. The fractures included non-displaced forearm fractures (distal radial epiphysiolysis, medtaphysical and diaphysical fractures), supracondylar fractures of the humerus (type I and type IIa fractures), epiconylar and condylar humeral fractures with immobilization time of at least two weeks.

Exclusion criteria

Exclusion criteria: Adults or children (age> 16 years) with the following injuries or conditions should be excluded from the study: Fractures requiring reduction and / or surgical treatment Acute elbow dislocations Pregnancy

Design outcomes

Primary

Measure	Time frame
Stress stability of the cast material. Stress stability is defined as absence of any deformations or fractures within the cast during study period (within 21 or 28 days after the cast application). Non-used casts materials shoul be additionally biomechanically and chemically tested at the HTWK.	—

Secondary

Measure	Time frame
Subjective evaluation of the patient / medical staff for the survery of patient acceptance and ease of use for the medical staff determined by specific questionnaires. Operationalization of the secondary endpoint: Clinical applicability • Application time (mean and standard deviation) • Investigation after the learning curve with n = 20 patients per cast material • Application comfort (patient and staff) and complications • Dwell period, comfort and complications • Comfort by cast removal and complications • Chemical test • Complications The time of the secondary endpoint measurement is the entire study period (21 or 28 days after the cast application).	—

Measure

Time frame

Subjective evaluation of the patient / medical staff for the survery of patient acceptance and ease of use for the medical staff determined by specific questionnaires. Operationalization of the secondary endpoint: Clinical applicability • Application time (mean and standard deviation) • Investigation after the learning curve with n = 20 patients per cast material • Application comfort (patient and staff) and complications • Dwell period, comfort and complications • Comfort by cast removal and complications • Chemical test • Complications The time of the secondary endpoint measurement is the entire study period (21 or 28 days after the cast application).

—

Countries

Germany

Contacts

Public ContactRoland Böhm

Klinik und Poliklinik für Kinderchirurgie Universitätsklinikum Leipzig AöR

roland.boehm@uniklinik-leipzig.de0341 - 97 26400

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026