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NCT04282408
Experimental Evaluation of Back Braces for the Treatment of Spinal Deformity Produced With 3D Printing Technology
NA trial testing Scoliosis back brace in Adolescent Idiopathic Scoliosis in 10 participants. Completed in 31 May 2021.
31 May 2021
Quick facts
| Lead sponsor | IRCCS Eugenio Medea |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | device feasibility |
| Enrollment | 10 |
| Start date | 9 July 2019 |
| Primary completion | 31 May 2021 |
| Estimated completion | 31 May 2021 |
| Sites | 1 location across Italy |
Drugs / interventions tested
- Scoliosis back brace
Conditions studied
- Adolescent Idiopathic Scoliosis — all drugs for Adolescent Idiopathic Scoliosis →
- Osteogenesis Imperfecta — all drugs for Osteogenesis Imperfecta →
Sponsor
IRCCS Eugenio Medea — full company profile →
Who can join
Adults 3 to 17, any sex, with Adolescent Idiopathic Scoliosis or Osteogenesis Imperfecta. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The proposed investigation is a pilot study that involves pediatric patients affected by spinal deformity (Adolescent Idiopathic Scoliosis and Osteogenesis Imperfecta). The main goal is to evaluate the acceptability, the safety and the overall satisfaction of the patients wearing the back braces produced with an innovative methodology using 3D printers, compared to the current braces manufactured with a production model based on thermoforming, that has well-established clinical efficacy.
Publications & conference data
2 peer-reviewed publications reference this trial (live from Europe PMC):
-
Additive Manufacturing of Spinal Braces: Evaluation of Production Process and Postural Stability in Patients with Scoliosis.
Storm FA, Redaelli DF, Biffi E, Reni G, et al · · 2022 · cited 5× · PMID 36143533 · DOI 10.3390/ma15186221 -
On mobility and gait in scoliosis patients: a comparison of conventional and 3D-printed braces during an instrumented timed-up and go test.
Costantini S, Redaelli DF, Fraschini P, Biffi E, et al · · 2025 · cited 2× · PMID 39871223 · DOI 10.1186/s12891-025-08311-w
Verify or expand the search:
- PubMed search for NCT04282408
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other IRCCS Eugenio Medea trials
Trials by the same sponsor.
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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 NCT04282408 (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 IRCCS Eugenio Medea
- Last refreshed: 31 March 2022
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/NCT04282408.
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