The Wrist-Free Study - Comparing Traditional Above Elbow Casts to Ones That Free the Wrist

NCT ID: NCT06496672

Last Updated: 2024-07-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

76 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-11-09

Study Completion Date

2024-08-31

Brief Summary

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This randomized controlled trial compares clinical outcomes, patient comfort and satisfaction of freeing the wrist in casts for supracondylar humerus fractures in children.

Detailed Description

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Conditions

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Supracondylar Humerus Fracture

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Traditional

Participants in this group receive the existing treatment, which is a cast that terminates at the palmar bar.

Group Type ACTIVE_COMPARATOR

Traditional long arm cast

Intervention Type PROCEDURE

Current standard of care where the cast extends up to the palmar bar

Modified

Participants in this group receive the experimental treatment, a cast that terminates at the wrist.

Group Type EXPERIMENTAL

Modified long arm cast

Intervention Type PROCEDURE

A shorter cast that frees the wrist

Interventions

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Modified long arm cast

A shorter cast that frees the wrist

Intervention Type PROCEDURE

Traditional long arm cast

Current standard of care where the cast extends up to the palmar bar

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Type I and Type IIa Supracondylar Humerus Fracture

Exclusion Criteria

* History of elbow injury
* Polytrauma
Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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KK Women's and Children's Hospital

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Kenneth PL Wong, FRCS

Role: PRINCIPAL_INVESTIGATOR

KK Women's and Children's Hospital

Locations

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KK Women's and Children's Hospital

Singapore, , Singapore

Site Status RECRUITING

Countries

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Singapore

Central Contacts

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Kenneth PL Wong, FRCS

Role: CONTACT

+6592355960

Facility Contacts

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Kenneth PL Wong, FRCS

Role: primary

+6592355960

References

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Khoshbin A, Leroux T, Wasserstein D, Wolfstadt J, Law PW, Mahomed N, Wright JG. The epidemiology of paediatric supracondylar fracture fixation: a population-based study. Injury. 2014 Apr;45(4):701-8. doi: 10.1016/j.injury.2013.10.004. Epub 2013 Oct 17.

Reference Type BACKGROUND
PMID: 24183392 (View on PubMed)

Micheloni GM, Novi M, Leigheb M, Giorgini A, Porcellini G, Tarallo L. Supracondylar fractures in children: management and treatment. Acta Biomed. 2021 Jul 26;92(S3):e2021015. doi: 10.23750/abm.v92iS3.11725.

Reference Type BACKGROUND
PMID: 34313666 (View on PubMed)

Boyd AS, Benjamin HJ, Asplund C. Splints and casts: indications and methods. Am Fam Physician. 2009 Sep 1;80(5):491-9.

Reference Type BACKGROUND
PMID: 19725490 (View on PubMed)

Shenoy PM, Islam A, Puri R. Current Management of Paediatric Supracondylar Fractures of the Humerus. Cureus. 2020 May 15;12(5):e8137. doi: 10.7759/cureus.8137.

Reference Type BACKGROUND
PMID: 32550057 (View on PubMed)

Vaquero-Picado A, Gonzalez-Moran G, Moraleda L. Management of supracondylar fractures of the humerus in children. EFORT Open Rev. 2018 Oct 1;3(10):526-540. doi: 10.1302/2058-5241.3.170049. eCollection 2018 Oct.

Reference Type BACKGROUND
PMID: 30662761 (View on PubMed)

Other Identifiers

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KKWCHWristFree

Identifier Type: -

Identifier Source: org_study_id

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