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NCT03532945
A Follow-up Study to Evaluate the Efficacy and Safety of Novomax in Posterior Lumbar Interbody Fusion
NA trial testing Bioactive Glass-Ceramic Spacer in Degenerative Lumbar Spinal Stenosis in 62 participants. Completed in 7 April 2016.
13 September 2013
Quick facts
| Lead sponsor | BioAlpha Inc. |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 62 |
| Start date | 28 October 2010 |
| Primary completion | 13 September 2013 |
| Estimated completion | 7 April 2016 |
Drugs / interventions tested
- Bioactive Glass-Ceramic Spacer
- Titanium cage
Conditions studied
- Degenerative Lumbar Spinal Stenosis — all drugs for Degenerative Lumbar Spinal Stenosis →
Sponsor
BioAlpha Inc.
Who can join
Adults 30 to 80, any sex, with Degenerative Lumbar Spinal Stenosis. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This is a long-term follow-up study for more than 3 years to evaluate the efficacy and safety of bioactive glass-ceramic intervertebral spacer (Novomax) in posterior lumbar interbody fusion.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
A Long-Term Follow-up, Multicenter, Comparative Study of the Radiologic, and Clinical Results Between a CaO-SiO2-P2O5-B2O3 Bioactive Glass Ceramics (BGS-7) Intervertebral Spacer and Titanium Cage in 1-Level Posterior Lumbar Interbody Fusion.
Lee JH, Kim SK, Kang SS, Han SJ, et al · · 2020 · cited 12× · PMID 32080009 · DOI 10.1097/bsd.0000000000000950
Verify or expand the search:
- PubMed search for NCT03532945
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Degenerative Lumbar Spinal Stenosis
Currently open trials in the same condition.
- NCT06320899 — Mid- or High-flex Rods Versus Low-flex Rods of SpineShape System IV for Treatment of Degenerative Lumbar Spine Diseases · NA · recruiting
- NCT05273346 — TCM Conservative Treatment for the Degenerative Lumbar Spinal Stenosis · NA · active not recruiting
- NCT04469387 — Preventive Effect of Limited Decompression on Adjacent Segment Following Posterior Lumbar Interbody Fusion · NA · recruiting
- NCT04407338 — Efficacy and Tolerance Study of B-DYN Versus Conventional Fusion in the Treatment of Lumbar Stenosis on the Degree of Po · NA · recruiting
- NCT04467944 — Effect of Pre-existing Adjacent Segment Degeneration on Long-term Effectiveness After Lumbar Fusion Surgery · recruiting
Other BioAlpha Inc. trials
Trials by the same sponsor.
- NCT02425514 — Evaluation of Bone Union Following Anterior Cervical Fusion Using a NovoMax™ · NA · completed
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 NCT03532945 (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 BioAlpha Inc.
- Last refreshed: 22 May 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/NCT03532945.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing