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NCT05008029
Immobilization Without Reduction vs. Reduction Under General Anesthesia in Metaphyseal Fractures of the Distal Radius
NA trial testing In situ immobilization in Radius Fracture Distal in 59 participants. Terminated before completion.
15 April 2024
Quick facts
| Lead sponsor | Instituto de Ortopedia Infantil Roosevelt |
|---|---|
| Phase | NA |
| Status | Terminated |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | single |
| Primary purpose | treatment |
| Enrollment | 59 |
| Start date | 15 June 2021 |
| Primary completion | 15 April 2024 |
| Estimated completion | 15 July 2024 |
| Sites | 1 location across Colombia |
Drugs / interventions tested
- In situ immobilization
- Reduction under general anesthesia
Conditions studied
- Radius Fracture Distal — all drugs for Radius Fracture Distal →
Sponsor
Instituto de Ortopedia Infantil Roosevelt
Who can join
Adults 5 to 10, any sex, with Radius Fracture Distal. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Distal radius metaphyseal fractures are the most frequent in the pediatric population. The current treatment for angulated or shortened fractures is effective. Still, it exposes children to anesthetic risks supported by the pain generated by the reduction. Due to the excellent remodeling capacity of bone at an early age, it is questionable whether an anatomical reduction is necessary. The clinical experiment's objective is to compare the functional result of immobilization without reducing angulated or displaced metaphyseal fractures of the distal radius against fractures brought to reduction under general anesthesia. Means difference in function subdomain of the upper limb of the PROMIS® scale is the primary outcome. The secondary results are wrist mobility, radius alignment, wrist articular relationships, and surgical complications.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Casting Without Reduction Versus Closed Reduction With or Without Fixation in the Treatment of Distal Radius Fractures in Children: Protocol for a Randomized Noninferiority Trial.
Garcia-Rueda MF, Bohorquez-Penaranda AP, Gil-Laverde JFA, Aguilar-Sierra FJ, et al · · 2022 · cited 1× · PMID 35436224 · DOI 10.2196/34576
Verify or expand the search:
- PubMed search for NCT05008029
- Europe PMC full search
- ASCO Meeting Library
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05008029 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Instituto de Ortopedia Infantil Roosevelt
- Last refreshed: 3 October 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05008029.
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