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NCT06367582
Spine Bone Cements Outcomes - Post Market Follow-up
trial testing Vertebroplasty (VP) in Vertebral Fracture in 500 participants. Currently enrolling.
4 September 2029
Quick facts
| Lead sponsor | Teknimed |
|---|---|
| Status | Recruiting now |
| Study type | OBSERVATIONAL |
| Enrollment | 500 |
| Start date | 4 September 2019 |
| Primary completion | 4 September 2029 |
| Estimated completion | 30 September 2039 |
| Sites | 12 locations across Portugal, France, Ukraine, Spain |
Drugs / interventions tested
- Vertebroplasty (VP)
- Kyphoplasty (KP)
- Pedicular Screw Augmentation (PSA)
Conditions studied
- Vertebral Fracture — all drugs for Vertebral Fracture →
- Compression Fracture — all drugs for Compression Fracture →
- Osteoporotic Fractures — all drugs for Osteoporotic Fractures →
Sponsor
Teknimed
Who can join
18 and older, any sex, with Vertebral Fracture or Compression Fracture. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
A Post-Market Clinical Follow-Up (PMCF) Study to collect clinical data on safety and performance of all TEKNIMED Spine range of products: SPINEFIX, HIGH V+, OPACITY+ and F20 bone cements and mixing and injection systems, and all their private labels. TEKNIMED bone cements are legacy products, some marketed for more than 10 years. Their performance and safety have already been demonstrated by Post-Market Surveillance and previous clinical studies. The current Post-Market Clinical Follow-Up study aims to confirm these claims by collecting data in a "real-life" setting. The study is a retrospective and prospective global, single arm, non-controlled, multicentric, prospective observational study. Patients will be followed as per local standard medical care of the sites.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT06367582
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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- NCT07100756 — Effectiveness of Implementation of Opportunistic AI-screening for Vertebral Fractures in Clinical Practice · active not recruiting
Other Teknimed trials
Trials by the same sponsor.
- NCT06374342 — Bone Substitutes Outcomes - Post Market Follow-up · recruiting
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 NCT06367582 (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 Teknimed
- Last refreshed: 9 September 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/NCT06367582.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing