The Biosculptor's CNC milling machine, the Biomill, offered four different surfaces machined on positive models. This study aims to adopt the surface topography method in characterizing the four different surface roughness of polyethylene Pe-Lite liner as a product of the Biomill. Three surface parameters chosen were the arithmetic average (Ra), root mean square roughness (Rq), and ten-point height (Rz). The surface parameters were used to define the four different surfaces (STANDARD, FINE, COARSE, and FAST) and then compared with the same liner material from a conventionally fabricated socket. The Ra values of the conventional liner, 8.43 μm, were determined to be in-between the Ra values of STANDARD and FAST surfaces which were 8.33 μm and 8.58 μm respectively. STANDARD surface required 43.2 min to be carved while FAST surface took almost only a third of the time compared to STANDARD surface (conventional socket takes 2–3 days). The results of this study would be one of the guidelines to the prosthetists using the Biosculptor in socket fabrication to produce sockets according to the suitable surface to cater to different requirements and levels of activity of each amputee.

The development of the CAD/CAM (Computer-aided design and computer-aided manufacturing) system has globally changed the fabrication and delivery of prosthetics and orthotics. Furthermore, since the introduction of CAD/CAM in the 1980s, many successful CAD/CAM system are available in the market today. However, less than 20% of amputees have access to digital fabrication technology and large portion of the amputees are from the developing countries. This review designed to examine selected studies from 1980 to 2019 on CAD/CAM systems in the production of transtibial prosthetic sockets. A review was conducted based on articles gathered from Web of Science, Pubmed and Science Direct. From the findings, 92 articles found related to CAD/CAM-derived transtibial prosthetic socket (TPS). After a further screening of the articles, 20 studies were chosen and only one study was done in a developing country. The results showed an increase interest in CAD/CAM application in Transtibial prosthetic socket (TPS) production for both developed and developing countries, yet the technology has not fully utilised in the developing countries. Factors such as resources, accessibility, knowledge-gap and lack of experienced prosthetists remain the major causes of the lack of CAD/CAM system studies. Large-scale trials are required to employ digital fabrication in the developing regions, consequently advancing the production of high-quality CAD-CAM-derived TPS where most prosthetic and orthotics are needed.

Purpose: This study aimed to examine the accuracy and validity of the Biosculptor’s Bioscanner shape capturing system as a portable measuring device by analysing the changes in transtibial residual limb circumference parameters while walking. Assessment on an amputee could also allow for the clinical usability of the digital scanner to be studied. Methods: To verify the accuracy of the system, the Bioscanner method was compared to the widely used standard anthropometric manual measurement technique (i.e., tape measure). One transtibial prosthetic user was recruited to conduct a walking activity at a normal walking pace for 5 to 15 minutes. Circumferential profiles of the participant were obtained digitally and manually during 2–5 minutes of resting walking intervals. The mean differences between the two methods were compared and percentage differences were calculated. The means were used to calculate the standard error measurement (SEM) and the 95% confidence intervals. Study of the limit of agreement between the two method was also used to validate the accuracy of Bioscanner. Results: The findings showed that both measurements gave a general comparable linear pattern. The averaged results from both methods resulted in only small distinctive differences especially at circumference near the mid-patella tendon. Similarly, the pressure-sensitive areas of the limb resulted in only an average of 2.28% differences between the two measurement techniques. The system showed high reliability and SEM with < 1 of 95% CI values and repeatability study gave ICC > 0.9. Conclusions: Bioscanner appeared to be comparable with the standard manual method. The Biosculptor system provides the portability, fast, reliable, and high accuracy measurements of the transtibial residual limb circumference, thus, it can be considered as a valuable tool for daily measurement of amputee’s residual limb and pre-prosthetic training.

This study aims to evaluate the validity and reliability of the Biosculptor’s Bioscanner system in capturing transtibial residual limb volume fluctuations in active and nonactive amputees during walking activity. Residual limb volume was obtained by measuring the limb circumference after amputees walked for 5 to 25 minutes for five consecutive days. The comparison of mean circumference between Bioscanner and manual measurements (i.e., tape measure) showed that the Bioscanner gave a higher estimation of circumference for the different amputees. Short-term changes in girth and volume due to an activity such as walking do not fluctuate uniformly. The results reflected as such as nonconsistence circumference change identified at different locations of the circumference profiles. Both amputees experienced a significant increase in circumference at the distal end of the limbs after 5 minutes of walking (7.35% change in nonactive and 8.83% in active amputees), and the measurement decreased as amputees walked longer. At 4-8 cm below the mid-patella tendon (pressure tolerant areas), both amputees experienced minor changes in the size of their circumference. The residual limb volume calculation resulted in the percentage difference between the two methods ranging from 2.4% to 9.3%. Pearson coefficient correlation obtained showed a high correlation between the two techniques, ranging from 0.97 to 1. The analysis of the limit of agreements showed that the majority of measurements were closed to the mean, suggesting that Bioscanner and manual techniques may be interchangeable and agree with one another. This study has implied that Bioscanner is comparable to the standard measurement method and may serve as an alternative tool in managing daily residual limb volume change.