Last reviewed · How we verify
NCT04250415: FACTS
Multi-Center Adolescent Clavicle Fracture Trial: Operative vs. Non-Operative Treatment
trial testing Surgery in Clavicle Fracture in 250 participants. Participants enrolled and being followed up; not accepting new ones.
1 June 2026
Quick facts
| Lead sponsor | Boston Children's Hospital |
|---|---|
| Status | Active, enrolled |
| Study type | OBSERVATIONAL |
| Enrollment | 250 |
| Start date | 11 March 2013 |
| Primary completion | 1 June 2026 |
| Estimated completion | 1 June 2027 |
| Sites | 8 locations across United States |
Drugs / interventions tested
- Surgery
Conditions studied
- Clavicle Fracture — all drugs for Clavicle Fracture →
Sponsor
Boston Children's Hospital
Who can join
Adults 10 to 18, any sex, with Clavicle Fracture. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Investigators from eight tertiary care, level 1 pediatric trauma centers have developed a protocol for the establishment of a formal, prospective multi-center adolescent clavicle registry, with designs for standardized radiographic assessment and the prospective collection of validated outcome measures and complications data, for all patients, ages 10-18, treated for clavicle shaft fractures, operatively and non-operatively. Eventually, the investigators would like to do comparative analysis for the operative and non-operative treatment arms, with additional sub-stratified analyses performed within these treatment arms by age and activity level. Among the primary goals of research projects stemming from the first arm of this registry, FACTS A, is to explore the hypothesis that non-operative treatment is associated with lower costs, greater safety, and equivalent or superior outcomes, compared with operative treatment, despite a national trend towards increasing surgical treatment. The second arm of the registry, FACTS B, will continue to investigate the same hypotheses, excluding cost outcomes, in patients only with completely displaced midshaft clavicle fractures.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Two-Year Functional Outcomes of Operative vs Nonoperative Treatment of Completely Displaced Midshaft Clavicle Fractures in Adolescents: Results From the Prospective Multicenter FACTS Study Group.
Heyworth BE, Pennock AT, Li Y, Liotta ES, et al · · 2022 · cited 23× · PMID 35984091 · DOI 10.1177/03635465221114420
Verify or expand the search:
- PubMed search for NCT04250415
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other recruiting trials for Clavicle Fracture
Currently open trials in the same condition.
- NCT07414654 — Descriptive Single-center Retrospective Study of a Series of Cases of Clavicle Pseudarthrosis: Epidemiology, Surgical Ma · active not recruiting
- NCT06981065 — The Scandinavian Displaced Lateral Clavicle Trial · NA · recruiting
- NCT05810129 — Crossed Education in Relation to Muscle Mass in Patients Operated of Clavicular Fracture · NA · recruiting
- NCT04161534 — KT Tape for Pediatric Clavicle Fractures · NA · active not recruiting
Other Boston Children's Hospital trials
Trials by the same sponsor.
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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 NCT04250415 (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 Boston Children's Hospital
- Last refreshed: 15 June 2025
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/NCT04250415.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing