Leslie Delgado

During amputation, a peripheral artery bypass surgery was performed to restore blood flow via a plastic tube. Excessive pressure on the lateral aspect of his residual limb – where the plastic tube is located – has caused discomfort over time. 

His prosthetist has tried several different suspension styles over the years (anatomical suspension, suction, pin lock). Another solution involved making a channel in the socket to help relieve the plastic artery, however this would cause the socket to be looser due to the length of the plastic artery. 

Up to now, Leslie has been most comfortable using a 6ply sock fit. When the prosthetist made a socket with a 0-3 ply fit, there was too much compression of the plastic artery throughout the day as his limb volume changed. If the offloaded channel was too big to account for this volume change, then the socket would significantly rotate. Leslie did not want to use suspension sleeves to help with this rotation, as the bunching behind the knee limited his range of motion.

Patricia Figueroa

Pat has had anterior distal femur pain present since amputation which was present both when she was and wasn’t wearing her prosthetic. She also had a stent placement two weeks prior to INSIGHT System testing as she had been experiencing collapsing arteries. 

Previously, as an attempt at resolving her prosthesis-related pain, reliefs have been built into the socket during modifications. Additional holes in the rigid frame were cut and reliefs made into the inner flexible tube.

Prior to using INSIGHT System, the prosthetist would have to guess on location and estimate how much relief they were putting in. Pat would then have to leave to trial the new socket and see if any irritations arose, then return to the clinic at a later date to highlight any concerns. 

Timothy Times

Timothy’s amputation was due to dysvascular complications. His weight category has historically limited his prosthetic foot selection. Over the years, he has had to use feet that are very stiff to ensure they would not break on him. This caused more difficulty with rollover and made him feel like he had to “walk harder” with his prosthesis.

The end of Timothy’s tibia is very broad and does not have tapering, typical of an ideal amputation. He has two very sharp corners present at the medial and lateral distal end of the tibia. These areas experience constant breakdown in sockets that prior prosthetists have made for him. He frequently has skin breakdown and liner breakdown due to these areas rubbing. He then would put in gel pads over the areas to help cover up the broken down liner.

Luke West

Luke has done very well with his prosthesis overall over 25 years and has always been very active despite having a very short and very bony residual limb. 

Outside of work Luke is very active, he plays soccer, jogs and goes to a gym on a regular basis. He also has a dog that he takes for several walks each day. He lives independently and ambulates without any assistive devices. He wears his prosthesis from the time he gets up in the morning until the time he is ready for bed.

Fortunately he has very good circulation in his residual limb and when he does develop a sore on his limb he heals very quickly.  He also has a high pain tolerance but as his limb as matured he has less tissue/muscle to support and protect his residual limb in the socket. As a result his socket fits have had to be more precise as the bony structures in his residual limb become more prominent. 

Portugal 

Centro de Medicina de Reabilitação de Alcoitão

The main purpose of the first study was to evaluate the INSIGHT System (a combined socket interior 3D scanner, patient wearable, and tablet app) and its performance on residual limb-socket fittings – in particular to test how the efficiency of the fitting process could be improved, and how comfortable and usable the final prosthesis was for the patient. 

To reach this objective it was important to garner quantitative feedback from the clinicians prescribing and fitting the prosthesis, technicians designing and building the prosthesis, and lower limb patients wearing and using the prosthesis within clinic and while performing their activities of daily living (post-fitting).

The majority of patients achieved a satisfactory socket in just 1 visit with a quarter of patients requiring 2 visits. The technician’s evaluation time using INSIGHT was on average half that of using traditional evaluation methods. The utility and acceptability of the INSIGHT System was positively evaluated by both patients and technicians, as assessed by opinion questionnaires. 

USA

De La Torre O&P, Pittsburgh, PA 
Prosthetics & Orthotic Associates, Middletown, NY.

The main purpose of this study is to deeper evaluate the INSIGHT System (a combined socket interior 3D scanner, patient wearable, and iPad app) and its performance on residual limb-socket fittings. This study is based on a previously successful independent study, led by Principal Investigator Natália Ramos M.D. at the Centro de Medicina de Reabilitação de Alcoitão in Portugal. 

This study is currently running at De La Torre O&P, Pittsburgh, PA, and Prosthetics & Orthotic Associates, Middletown, NY. It will expand on the previous study’s objectives: testing the efficiency of the fitting process; how comfortable and usable the final prosthesis; and financial analysis into the commercial benefit of the INSIGHT system for OAP clinics. The study will use clinically recognised benchmark tests to gather quantitative feedback from the clinicians, technicians and patients.

THIS STUDY IS ONGOING