Trial reportPloS one2025
Randomized crossover trial of hand and hydrostatic casting for custom lower limb prosthetic sockets: Assessing socket comfort and fabrication time.
Trial report in PloS one, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04141748 (Comparative Effectiveness of Socket Casting Methods), which is not on this map. Cited by 1 paper.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Comparative Effectiveness of Socket Casting Methods: Improving Form and Fit
Who cites it
1 citing paper in PubMed.
- Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
6 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
The aim of this study was to compare diagnostic sockets made by hand casting and standing hydrostatic pressure casting in persons with lower limb amputation. This multi-site, single-masked, randomized crossover trial (ClinicalTrials.gov NCT04141748) involved a prosthetist at each site taking one cast by hand (H) and another using hydrostatic casting (S). The process of casting, rectifying and modifying a diagnostic socket was timed in minutes. Socket comfort score (SCS) was assessed during static fitting of the diagnostic socket before (initial) and after (final) any modifications were made by the prosthetist. Difference scores for comfort and timing were calculated for each pair of casts within prosthetist. Bootstrapping methods were used to determine if the mean difference scores were significantly different from zero. Eighty participants with unilateral lower limb amputation were enrolled, with 75 completing the study. The initial SCS was significantly better in the transfemoral amputation group (TFA, n = 24) for the socket made from hand casting (H: 7.1 ± 1.9, S: 6.5 ± 2.2; p = 0.043). The final SCS was significantly better in the transtibial amputation group (TTA, n = 51) for the socket made from hydrostatic casting (H: 7.5 ± 2.0, S: 8.1 ± 1.3; p = 0.025). Total fabrication time for hydrostatic casting was significantly greater than hand casting (H: 42.1 ± 15.6, S: 48.0 ± 10.7; p = 0.001). It took significantly more time to cast (H: 10.6 ± 5.5, S: 23.7 ± 6.1; p < 0.0001) and significantly less time to rectify with hydrostatic casting (H: 23.4 ± 11.1, S: 16.6 ± 17.2; p < 0.0001). There was no difference between casting approaches for time to modify the diagnostic socket (H: 8.1 ± 7.5, S: 7.7 ± 6.6; p = 0.641). In individuals with both TTA and TFA results suggest that hydrostatic casting took more total time than hand casting to fabricate a diagnostic socket. While hand casting resulted in a significantly more comfortable socket initially for the TFA group, hydrostatic casting led to a more comfortable final socket for the TTA group.
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