BACKGROUND: Direct Socket for transfemoral (DS-TF) prosthetic user is a novel method of fabricating a laminated interface on to the residual limb but requires different training, production method and service model than what most prosthetists are familiar with. This method and model may improve patient satisfaction by enabling interface fabrication and delivery in one visit. OBJECTIVES: Document patient satisfaction regarding DS-TF interface versus the prosthetic users’ previous socket in terms of interface function and the clinic service model. METHODOLOGY: In this longitudinal study (from July 2018 to April 2020), the DS-TF was implemented in six prosthetic clinics across the United States. Certified prosthetists (CP) and assistants were trained using a standard protocol. 47 prosthetic users participated, both those in need of a new socket and those without need. Two modules from the Orthotics and Prosthetics Users’ Survey (OPUS), involving questions related to satisfaction with the Device and Services, was used to evaluate each DS-TF user outcome vs. baseline. The only part of the prosthesis that was replaced was the interface, except in 2 cases. FINDINGS: Each DS-TF interface was fabricated, fit and delivered in a single clinic visit. At 6-months follow-up, 38 users reported an average of 29.8% increase in satisfaction with their new interface compared with original, and a 14.8% increase in satisfaction with the services they received from the clinic in providing of the new prosthesis vs. their original prosthesis. The main outcome increases were between baseline (initial fitting) and 6-week follow-up and remained consistent after 6 months. This improvement was consistent irrespective if the user needed a new socket for clinical reasons or not. CONCLUSION: This study shows that after a standardized training and implementation, the DS-TF fabrication process including a new interface improves the user’s satisfaction with their prosthetic device and services. Layman's Abstract The connection between an amputee’s remaining limb and their prosthesis is called the interface and is the most critical part in a prosthetic system for the user satisfaction, comfort and mobility. Interfaces commonly consist of two parts; a flexible “liner” rolled onto the limb, which then goes into a hard socket custom-made by the prosthetist.  The assembled interface then provides a secure connection between the users remaining limb and the prosthesis. Historically the prosthetist’s fabrication and fitting procedure required many hours of time and multiple visits to the prosthetic clinic before the interface was delivered to the user. Direct Socket for above knee prosthetic users is a new method of fabricating laminated sockets directly on the residual limb that enables fabrication and delivery in a single visit. However, Direct Socket require different training and methods than what most prosthetists are familiar with. This new procedure was implemented in six different prosthetic clinics across the United States. Seven CP’s were trained, each in their clinic and the method was tested on 38 users for a period of 6 months. The users filled in questionnaires about their experience and satisfaction using their existing socket, as well as their satisfaction of using their new socket. Overall, the Direct Socket prosthetic users reported after the 6-months follow-up significantly greater (29.8%) satisfaction with their new socket compared to their previous socket. They also reported 14.8% increase in satisfaction with the services they obtained from the clinic when receiving the new socket, compared to their satisfaction with receiving their original socket. Article PDF Link: https://jps.library.utoronto.ca/index.php/cpoj/article/view/34672/26933 How To Cite: Marable W.R, Smith C, Sigurjónsson B.Þ, Atlason I.F, Johannesson G.A. Transfemoral socket fabrication method using direct casting: outcomes regarding patient satisfaction with device and services. Canadian Prosthetics & Orthotics Journal. 2020;Volume 3, Issue 2, No.6. https://doi.org/10.33137/cpoj.v3i2.34672 Corresponding Author: G. Anton Johannesson, PhDTeamOlmed, Kistagången 12, 164 40 Kista, Stockholm, Sweden.E-mail:  ajohannesson@teamolmed.seORCID: https://orcid.org/0000-0001-8729-458X

BACKGROUND: Amputation at the transfemoral (TF) level reduces the rate of successful prosthetic fitting, functional outcome, and quality of life (QoL) compared with transtibial amputation. The TF socket interface is considered the most critical part of the prosthesis, but socket discomfort is still the most common user complaint.  Direct Socket for transfemoral prosthesis users is a novel interface fabrication process where the socket is shaped and laminated directly on the residual limb and delivered in a single visit. OBJECTIVE(S): The aim of this study was to investigate if prosthetic users' quality of life (QoL), comfort, and mobility with a Direct Socket TF interface were comparable to their experience with their previous prostheses. METHODOLOGY: The pre/post design prospective cohort study included 47 subjects. From this cohort, 36 subjects completed the 6-months follow-up (mean age 58 years, 27 males). Outcomes at baseline included EQ-5D-5L®, PLUS-M™, CLASS, ABC, AMPPRO, and TUG. At 6-weeks and 6-months, subjects repeated all measures. Seven Certified Prosthetist (CP) investigators performed observations and data collection at six different sites (from July 2018 to April 2020).  FINDINGS: Results showed significant improvement in all outcome measures for the 36 subjects that completed both 6-weeks and 6-months follow-ups. CLASS sub-scales showed significantly improved stability, suspension, comfort, and socket appearance. Improvement in K-Level and less use of assistive devices were observed with the AMPPRO instrument, indicating improved user mobility and performance. QoL was also increased, as measured in Quality-Adjusted-Life-Years (QALY) from the EQ-5D-5L. CONCLUSION: Evidence from the findings demonstrate that the Direct Socket TF system and procedure can be a good alternative to the traditional method of prosthetic interface delivery. Layman's Abstract After lower limb amputation, the goal for most people is to regain mobility and independence and return to normal daily activities. Typically, people with transfemoral amputation are less likely to receive a prosthesis or fully use a prosthesis as compared to people with transtibial amputation. Moreover, their quality of life is also lower. The Direct Socket TF method is a new way of fabricating a prosthetic socket for users with above-knee amputation, enabling fabrication directly onto the residual limb and delivery of the socket in a single visit. In this study, we wanted to understand how the effect of Direct Socket TF on prosthetic 'user's quality of life, health, mobility level, and balance would compare to their previous prosthesis. This new Direct Socket TF procedure was implemented in six different prosthetic clinics across the United States and used by 36 prosthetic users for six months. Our first article on this study describes increased user satisfaction with their new interface and the single visit service model. This second article on the same clinical investigation documents the significant improvement in outcomes compared to their original interface in terms of quality of life, confidence, mobility, comfort, stability, and activity level. Article PDF Link: https://jps.library.utoronto.ca/index.php/cpoj/article/view/36065/27923 Direct Socket TF – Summary (YouTube): https://www.youtube.com/watch?v=-fvVFqjgxjo How To Cite: Walker J, Marable W.R, Smith C, Sigurjónsson B.Þ, Atlason I.F, Johannesson G.A. Clinical outcome of transfemoral direct socket interface (part 2). Canadian Prosthetics & Orthotics Journal. 2021;Volume 4, Issue 1, No.6. https://doi.org/10.33137/cpoj.v4i1.36065 Corresponding Author: Anton Johannesson, PhDTeamOlmed, Kistagången 12, 164 40 Kista, Stockholm, Sweden.E-mail:  ajohannesson@teamolmed.seORCID: https://orcid.org/0000-0001-8729-458X