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NCT06093087
Randomized Controlled Trial of Internal Fixation Reconstruction With Stent Screw in the Treatment of Kummell's Disease
Phase 1, PHASE2 trial testing SAIF in BKP in 70 participants. Not yet recruiting.
1 January 2027
Quick facts
| Lead sponsor | Second Affiliated Hospital, School of Medicine, Zhejiang University |
|---|---|
| Phase | Phase 1, PHASE2 |
| Status | Not yet recruiting |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | treatment |
| Enrollment | 70 |
| Start date | 1 January 2024 |
| Primary completion | 1 January 2027 |
| Estimated completion | 1 September 2027 |
Drugs / interventions tested
- SAIF
- BKP
Conditions studied
- BKP — all drugs for BKP →
- Osteoporotic Vertebral Compression Fracture — all drugs for Osteoporotic Vertebral Compression Fracture →
- Kummell's Disease — all drugs for Kummell's Disease →
- Stent-screw-assisted Internal Fixation — all drugs for Stent-screw-assisted Internal Fixation →
Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University
Who can join
60 and older, any sex, with BKP or Osteoporotic Vertebral Compression Fracture. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This study is a multicenter, prospective, double-blind, randomized controlled trial using a parallel two-arm design to investigate whether the postoperative 6-month quality of life, vertebral stability, complication of patients with osteoporotic vertebral compression fractures (Kummell's disease) are better with the use of stent screw internal fixation and percutaneous bone cement reconstruction technique compared to patients undergoing traditional percutaneous balloon kyphoplasty (BKP) for vertebral augmentation
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT06093087
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other Second Affiliated Hospital, School of Medicine, Zhejiang University trials
Trials by the same sponsor.
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- NCT07505186 — Camrelizumab, Chemotherapy and Ivarmacitinib in Patients With Resectable Esophageal Squamous Cell Carcinoma · Phase 2 · not yet 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 NCT06093087 (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 Second Affiliated Hospital, School of Medicine, Zhejiang University
- Last refreshed: 23 October 2023
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/NCT06093087.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing