Last reviewed · How we verify
NCT03598530: FROST
Fracture-Related Outcome Study for Operatively Treated Tibia Shaft Fractures
trial testing Surgery in Tibial Fracture in 1,000 participants. Participants enrolled and being followed up; not accepting new ones.
17 March 2025
Quick facts
| Lead sponsor | AO Clinical Investigation and Publishing Documentation |
|---|---|
| Status | Active, enrolled |
| Study type | OBSERVATIONAL |
| Enrollment | 1,000 |
| Start date | 4 April 2019 |
| Primary completion | 17 March 2025 |
| Estimated completion | 31 December 2025 |
| Sites | 15 locations across Hong Kong, South Africa, Belgium, United Kingdom, Germany, South Korea, Switzerland, Singapore |
Drugs / interventions tested
- Surgery
Conditions studied
- Tibial Fracture — all drugs for Tibial Fracture →
- Fracture of the Tibia Type AO/OTA 42 — all drugs for Fracture of the Tibia Type AO/OTA 42 →
Sponsor
AO Clinical Investigation and Publishing Documentation
Who can join
18 and older, any sex, with Tibial Fracture or Fracture of the Tibia Type AO/OTA 42. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Approximately 1000 patients presenting with tibial shaft fractures (AO type 42) will be enrolled prospectively in this registry. All patients are treated and followed at 6 weeks, 6 months and 1 year postoperative always following the local standard of care (routine) visit schedule up to 36 months if required. Data collection includes patient and fracture details, treatment details, functional, clinical and patient-reported outcomes and anticipated or procedure- and implant-related adverse events (i.e. complications) and their corresponding treatment
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Fracture-related outcome study for operatively treated tibia shaft fractures (F.R.O.S.T.): registry rationale and design.
Metsemakers WJ, Kortram K, Ferreira N, Morgenstern M, et al · · 2021 · cited 8× · PMID 33422025 · DOI 10.1186/s12891-020-03930-x
Verify or expand the search:
- PubMed search for NCT03598530
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Surgery
Trials testing the same drug.
- NCT07472478 — Phase II Neoadjuvant Study of Garsorasib Followed by Ivonescimab Plus Chemotherapy in Resectable Stage IIA-IIIB KRAS G12 · Phase 2 · not yet recruiting
- NCT07524452 — Becotatug Vedotin (MRG003) in Combination With PD-1 Inhibitor Versus PD-1 Inhibitor for the Treatment of EGFR-positive, · Phase 3 · recruiting
- NCT07053033 — Laser Interstitial Thermal Therapy (LITT) or Surgery and Adjuvant Reirradiation for Recurrent Brain Metastases (LaSAR Be · Phase 2 · recruiting
- NCT07352007 — Sintilimab Combined With Stereotactic Body Radiotherapy as Neoadjuvant Therapy for Resectable Hepatocellular · Phase 2 · not yet recruiting
- NCT07419932 — Response to Neoadjuvant Treatment in Locally Advanced Thyroid Cancer · recruiting
Other AO Clinical Investigation and Publishing Documentation trials
Trials by the same sponsor.
- NCT03380273 — AO Multicenter Intervention Trial for Prevention of Surgical Site Infection · NA · terminated
- NCT03849898 — Patients 60 Years and Older Suffering From Mandibular Fractures Registry · terminated
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 NCT03598530 (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 AO Clinical Investigation and Publishing Documentation
- Last refreshed: 22 August 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/NCT03598530.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing