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NCT02686099: SL360
Sternal Closure With SternaLock 360: First in Man Study
NA trial testing SternaLock 360 in Sternal Fracture in 50 participants. Completed in 15 January 2018.
5 September 2017
Quick facts
| Lead sponsor | Zimmer Biomet |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | single |
| Primary purpose | treatment |
| Enrollment | 50 |
| Start date | 4 July 2015 |
| Primary completion | 5 September 2017 |
| Estimated completion | 15 January 2018 |
| Sites | 1 location across South Africa |
Drugs / interventions tested
- SternaLock 360
- Wire Cerclage
Conditions studied
- Sternal Fracture — all drugs for Sternal Fracture →
Sponsor
Zimmer Biomet — full company profile →
Who can join
30 and older, any sex, with Sternal Fracture. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The SternaLock 360 Sternal Closure Device combines the techniques of rigid fixation with a cerclage material into a single sternal closure system. The cerclage material serves to facilitate sternal approximation, and the plates and screws serve to provide rigid fixation and prevent sternal movement and separation. The combination of a cerclage material in combination with plate and screw fixation may also lead to increased stability compared to either method used as a standalone means of closure.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT02686099
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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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 NCT02686099 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Zimmer Biomet
- Last refreshed: 18 January 2018
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/NCT02686099.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing