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NCT04141748
Comparative Effectiveness of Socket Casting Methods: Improving Form and Fit
NA trial testing Symphonie Aqua SystemTM in Lower Limb Amputation in 80 participants. Completed in 1 September 2023.
1 September 2023
Quick facts
| Lead sponsor | Northwestern University |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | crossover |
| Masking | double |
| Primary purpose | treatment |
| Enrollment | 80 |
| Start date | 1 September 2020 |
| Primary completion | 1 September 2023 |
| Estimated completion | 1 September 2023 |
| Sites | 3 locations across Italy, United States |
Drugs / interventions tested
- Symphonie Aqua SystemTM
- Hand Casting
Conditions studied
- Lower Limb Amputation — all drugs for Lower Limb Amputation →
Sponsor
Northwestern University
Who can join
18 and older, any sex, with Lower Limb Amputation. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The overall objective is to compare hand casting to standing hydrostatic pressure casting using a water cylinder in persons with lower limb amputation. Our overall hypothesis is that standing hydrostatic pressure casting with a water cylinder will lead to more consistent and efficient residual limb shape capture and improved initial socket fit and comfort compared to hand casting.
Publications & conference data
3 peer-reviewed publications reference this trial (live from Europe PMC):
-
Mechanical testing of transtibial prosthetic sockets: A discussion paper from the American Orthotic and Prosthetic Association Socket Guidance Workgroup.
Gariboldi F, Cutti AG, Fatone S, Nickel E, et al · · 2023 · cited 5× · PMID 36763513 · DOI 10.1097/pxr.0000000000000222 -
Accuracy, Repeatability, and Reproducibility of a Hand-Held Structured-Light 3D Scanner across Multi-Site Settings in Lower Limb Prosthetics.
Cutti AG, Santi MG, Hansen AH, Fatone S, et al · · 2024 · cited 1× · PMID 38610559 · DOI 10.3390/s24072350 -
Randomized crossover trial of hand and hydrostatic casting for custom lower limb prosthetic sockets: Assessing socket comfort and fabrication time.
Fatone S, Gravely A, Cutti AG, Hansen AH, et al · · 2025 · PMID 41270063 · DOI 10.1371/journal.pone.0337185
Verify or expand the search:
- PubMed search for NCT04141748
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Lower Limb Amputation
Currently open trials in the same condition.
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- NCT06556082 — Effect of PNF-Based Upper Extremity Strengthening With Core Stabilization on Fitness in Amputee Football Players · NA · active not recruiting
- NCT05830630 — Perineural Methylene Blue Infusion in Lower Limb Amputation Surgery · NA · recruiting
Other Northwestern University trials
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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 NCT04141748 (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 Northwestern University
- Last refreshed: 19 September 2024
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/NCT04141748.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing