Total Contact Insole Research Articles

A 5-Year Follow-Up of Neuropathic Minimally Invasive Surgeries with Superconstructs for Mid-Foot Charcot Deformity

Category: Diabetes; Midfoot/Forefoot Introduction/Purpose: Charcot neuroarthropathy is associated with a progressive deformity that can result in wound breakdown, ulceration and ultimately amputation. Conservative management with total contact casting can allow ulcers to heal. However conservative treatment is dependent on continual podiatry and orthotic input. Surgical correction of the 'rocker bottom deformity has evolved. Minimally invasive surgical techniques utilising beams and bolts for a 'super-construct' to correct the Charcot deformity is possible through percutaneous incisions. We report the 5-year outcomes of a cohort of patients with diabetic neuroarthropathy treated with neuropathic minimally invasive surgeries including modifications of the surgical technique to reduce complications and improve outcomes. Methods: A cohort of 16 patients with diabetic neuroarthropathy was treated using neuropathic minimally invasive surgeries. Patients were recruited from the multidisciplinary diabetic foot clinic. Patients had been treated with total contact casting to heal ulcers and prevent future wound breakdown. Surgery was performed as a day case or overnight stay under general anaesthetic. Using fluoroscopy, closing wedge osteotomy was performed with minimally invasive 'Shannon' cutting and wedge burrs to create a triplane closing wedge osteotomy of the midfoot. Reduction of the forefoot to the midfoot was achieved using percutaneous beams and bolts. The void was filled with antibiotic bone graft substitute. Post-operatively patients were immobilised in total contact cast for eight to twelve weeks non-weight-bearing, followed by six weight-bearing in a moon-boot with total contact insole for six weeks. Results: The aim of surgical intervention is to create a stable plantigrade shoe able foot. Whilst osseous union is desirable, a stable fibrous union allows the patient to transition to footwear, with reduced risk of recurrence of deformity, wound breakdown or ulceration, Minimally invasive surgery with antibiotic bone graft substitutes reduces the risk of post-operative infection. The most common complication was the breakage of metalwork at the tip of the bolts. Infection was the second most common complication. Removal of metalwork, minimally invasive debridement and irrigation, allowed the infection to be irradicated. Lost of correction of deformity requiring revision surgery occurred in three patients with good outcomes. There was one amputation. Conclusion: Significant midfoot deformity correction can be performed using minimally invasive surgical techniques with beams and bolts to create a super-construct for stabilisation of midfoot Charcot deformity. The advantages of percutaneous incisions allow for earlier intervention before a major deformity has occurred. Neuropathic minimally invasive surgeries are optimal for patients who have no active ulceration and are systemically well but require prophylactic intervention to prevent further deformity and risk of amputation.

Comparison of Newly Designed Three Spike Insole and Total Contact Insole in Refractory Plantar Fasciitis: A Randomized, Double-Blinded, Non-Inferiority Study

Category:Ankle; HindfootIntroduction/Purpose:Plantar fasciitis is one of the common foot complaints that is chronic and can induce dysfunction. Total contact insole (TCI) is simple but effective in treating plantar fasciitis. Nevertheless of the effect, the cost and the long duration for production have been the major flaws. Therefore, we developed newly designed three-spike insole (TSI) that can be commercially productive and compared the clinical outcomes with TCI.Methods:Patients with plantar fasciitis refractory to conservative treatment for more than 6 weeks were candidates. We produced insoles with hardness of 58 +- 5 Shore-A. Twenty-eight patients were randomly allocated to use either TSI or TCI evenly (Figure 1). The following assessment tools were used: visual analog scale (VAS), American Orthopaedic Foot & Ankle Society score, Foot and Ankle Outcome Score, Karlsson-Peterson (KP) score, Short Form-36 for quality of life, and Foot Function Index. Non-inferiority was declared if VAS was within the statistical variability of minimal important difference. A blinded assessor evaluated the groups at baseline and after 6, 12, and 24 weeks.Results:The groups were homogenous for majority of variables at baseline. Overall patient-reported satisfaction showed improvement from mean 5.2 (range, 1 - 12) weeks of wearing and all clinical outcome scores showed significant improvements in both groups over time on the basis of Friedman test (p <.05). TSI showed non-inferiority to TCI at each time point. Post hoc analysis revealed that many scales showed significant superiority of TSI at 3 month (p <.0125) and KP score at 6 month (p <.001).Conclusion:We reaffirmed that semi-rigid insole is effective in refractory plantar fasciitis and showed TSI restores pedal function more rapidly than TCI. TSI can be not only effective in deriving better clinical outcomes but also be manufactured for popularization to lower the price and producing time of orthosis.

Superior pedal function recovery of newly designed three spike insole over total contact insole in refractory plantar fasciitis: A randomized, double-blinded, non-inferiority study.

Plantar fasciitis is one of the common foot complaints that is chronic and can induce dysfunction. Total contact insole (TCI) is simple but effective in treating plantar fasciitis. Despite its effect, the cost and long duration for production have been the major flaws. Therefore, we developed a newly designed three-spike insole (TSI) that can be commercially productive and compared its clinical outcomes to TCI. Patients with plantar fasciitis refractory to conservative treatment for more than 6 weeks were candidates. We produced insoles with hardness of 58 ± 5 Shore-A. Twenty-eight patients were randomized with equal allocation to either TSI or TCI. The following assessment tools were used: visual analog scale (VAS), American Orthopaedic Foot and Ankle score, Foot and Ankle Outcome Score, Karlsson-Peterson (KP) score, Short Form-36 for quality of life, and Foot Function Index. Non-inferiority was declared if VAS was within the statistical variability of minimal important difference. A blinded assessor evaluated the groups at baseline and after 6, 12, and 24 weeks. The groups were homogenous for majority of variables at baseline. Overall patient-reported satisfaction showed improvement from mean 5.2 (range, 1-12) weeks of wearing and all clinical outcome scores showed significant improvements in both groups over time on Friedman test (p ≤.032). TSI showed non-inferiority to TCI at each time point. Post hoc analysis revealed that many scales showed significant superiority of TSI at 3 month (p ≤.008) and KP score at 6 month (p < .001). We reaffirmed that semi-rigid insole is effective in refractory plantar fasciitis and showed TSI restores pedal function more rapidly than TCI. TSI can be not only effective in deriving better clinical outcomes but also be manufactured for popularization to lower the price and producing time of orthosis.

The Use of Total Contact Orthoses in Patients with Foot Problems in Foot Clinic, Siriraj Hospital

Objective: To study the use rate, outcome, and concomitant factors of the use of the total contact orthoses (TCO) in the Foot Clinic, Siriraj Hospital Materials and Methods: The present study was a cross-sectional descriptive study collecting data from patient medical records and questionnaires. Patients who had foot problems without impairment of foot sensation and received the TCO from the Foot Clinic between July 2015 and April 2016 were interviewed before and after using the latest TCO for one month. Results: One hundred seven participants were recruited. Most were female (84.1%) with a median age of 59.3 years. The majority had chronic plantar fasciitis (26.2%), posterior tibial tendon dysfunction (PTTD) (25.2%), hallux valgus (21.5%), or metatarsalgia (21.5%). The TCO user was defined as a participant who had to use the TCO for more than three days per week and for more or equal to 50% of daily walking and standing duration. The use rate was 67.3%. The TCO provides standing and walking stability (p=0.008). For patients with metatarsalgia, using the TCO could significantly reduce pain (p=0.002). Using univariate analysis, many factors were found to be associated with the use of the TCO including having level of convenience of putting on or taking off shoes with TCO at 9 or more (odds ratio 2.66, 95% CI 1.16 to 6.12), having difficulty to find proper shoes that fit with the TCO (odds ratio 0.36, 95% CI 0.15 to 0.89), receiving more than one pair of TCO (odds ratio 4.09, 95% CI 1.51 to 11.05), and having level of comfort satisfaction during the TCO use at 9 or more (odds ratio 3.61, 95% CI 1.55 to 8.40). The latter two factors were found to be associated with the use of the TCO from stepwise logistic regression analysis (adjusted odds ratio 3.39, 95% CI 1.18 to 9.71 and 3.02, 95% CI 1.07 to 8.47, respectively). Conclusion: The use of the TCO in the Foot Clinic, Siriraj Hospital was 67.3%. Using the TCO could promote walking stability. Factors affecting the use of the TCO included receiving more than the first pair of TCO and having comfort satisfaction level of 9 or more. Keywords: Use, Total contact orthoses, Total contact insole, Foot problems

Three-Spike Insole Can Substitute the Total Contact Insole (TCI) in Refractory Plantar Fasciitis: Randomized Control Trial

Category:HindfootIntroduction/Purpose:Plantar fasciitis is one of the common foot complaints that is chronic and can induce dysfunction. Approximately 80% of patients improve with conservative management such as stretching exercise, ice bag massage, and splint. Refractory plantar fasciitis, unresponsive to conservative care for more than 6months, can be treated with insole, extracorporeal shockwave therapy, injection, and surgery etc. Total contact insole (TCI) is effective in reducing pain with just putting it in the shoes but quite expensive and time consuming for the custom production. Therefore, we produced alternative three-spike insole that can press about half of patient’s plantar fascia using 3-dimensional (D) printing and compared the clinical outcomes with it and TCI.Methods:A pragmatic, participant-blinded randomized trial was carried out from February 2019 to January 2020. Inclusion criteria was refractory plantar fasciitis and the duration of follow-up for each patient was 6 months. Three-dimensional printing used thermoplastic polyurethane (TPU) for the material of insole and the hardness was 58 +- 5 Shore-A. Twenty-eight patients were randomly allocated to use a three-spike insole or a TCI (Figure 1). The following assessment tools were used; visual analog scale for pain, American Orthopaedic Foot & Ankle Society (AOFAS) score, Foot and Ankle Outcome Score (FAOS), Karlsson- Peterson (KP) score, Medical Outcomes Study Short Form-36 (SF-36) for quality of life, and Foot Function Index (FFI). The groups were evaluated by a blinded assessor at baseline and after 6, 12, and 24 weeks.Results:The groups were homogenous for the majority of variables at baseline. Overall patient reported satisfaction showed improvement from mean 5.2 (range, 1 - 12) weeks of wearing and patient’s wearing time in a day was mean 2.4 (range, 0.5 - 3.0) hours. All the subscales except for sports in FAOS and mental component summary in SF-36 showed significant improvement from 6 weeks in both groups. There was no significant difference in all parameters between both groups at 6 weeks but AOFAS score, some of FAOS subscales, KP score, SF-36, and FFI showed significantly better outcome in three-spike insole group at 12 weeks. Those significant differences in outcome parameters tended to diminish at 24 weeks.Conclusion:We reaffirmed that insole is effective in plantar fasciitis and showed the three-spike insole restores function rapidly comparing to TCI. Three-spike design that supports not the whole longitudinal arch but about half of it was efficient enough. We can manufacture the three-spike insole for the popularization that can lower the price and producing time.

Effects of vibro-medical insoles with and without vibrations on balance control in diabetic patients with mild-to-moderate peripheral neuropathy

The purpose of this study was to investigate the effects of a total-contact insole with and without subthreshold mechanical random noise on the balance control in diabetic patients with mild-to-moderate peripheral neuropathy. Twenty diabetic patients with mild-to-moderate neuropathy was recruited to this study. A total-contact insole was prototyped and vibratory motors were embedded into it. The parameters of the center of pressure (amplitude, velocity, and phase plane portrait) were analyzed after 30-minute walks with the shoe only, the shoe with vibro-medical insole with and without vibrations in eyes open and closed condition. The center of pressure amplitude, velocity, and phase plane portrait in the anterior-posterior and medio-lateral directions were significantly decreased using a vibro-medical insole without vibration in the eyes open condition (p < 0.05), as compared to the shoe, and with vibro- medical insole with vibration in both eyes open and closed conditions (p < 0.05) compared to the shoe. A significant drop was observed in the center of pressure amplitude, velocity and phase plane portrait parameters when the vibro-medical insole with vibration was used compared to vibro- medical insole without vibration in eyes closed condition (p < 0.05). The use of vibro-medical insoles was found to improve the patient’s balance control, as compared to the shoe. In the eyes closed condition, an improvement in the balance control was observed only with vibro-medical insole with vibration rather than vibro-medical insole without vibration or the shoe. Current finding suggest that a combination of the total-contact insole with vibration may improve the balance control remarkably in diabetic patients with mild-to-moderate neuropathy.

Total Contact Insole for Chronic Nonspecific Low Back Pain (LBP)

Total Contact Insole for Chronic Nonspecific Low Back Pain (LBP)

The effects of heel-elevated total contact insole on rearfoot pressure reduction in heel injury patients who had neurosensory impairment after receiving reconstructive flap operations

To evaluate the effects of a custom-molded heel-elevated total contact insole (TCI) on rearfoot pressure reduction and heel cushion for patients with heel-reconstruction. Eleven patients with unilateral heel-reconstruction were recruited in this study. Maximal force and plantar pressures (peak pressure and pressure-time integral) at three different areas (heel Midfoot and forefoot) were measured under 3 randomized conditions (shoe-only flat insole and heel- elevated TCI) after wearing a heel-elevated TCI for 3 months. Ulceration inspection and pain intensity were evaluated before and 3 months after wearing a heel-elevated TCI Results: Pain intensity was decreased and walking velocity was improved in all patients (p<0.01), and ulcerations were completely healed in all of the five patients who had heel ulcers 3 months after wearing heel-elevated TCIs. Compared to shoe-only condition, the heel-elevated TCI was effectively reduced maximal force and plantar pressures in heel area (p<0.01) while part of the body weight was shifted from heel to midfoot and forefoot. Plantar pressures in heel area were more effectively reduced in the heel-elevated TCI than in the flat insole (p<0.05). These findings suggested that heel-elevated TCI provided more effective heel pressure reduction and shock absorption, and resulted in improvement of clinical symptoms.

The effects of total contact insole with forefoot medial posting on rearfoot movement and foot pressure distributions in patients with flexible flatfoot

The purpose of this study is to evaluate the therapeutic effect of total contact insole with forefoot medial posting (TCIFMP) orthosis in patients with flexible flatfoot. The TCIFMP insole was custom- mode, made from semi-rigid plastazote and PPT. Using the gait analysis and the plantar-pressure measure systems, we investigate rearfoot motion and plantar pressure redistribution in these patients. The results of this study showed that the excessive valgus movement of the rearfoot can be reduced significantly by the TCIFMP insole in these patients. Besides, there were significant decreases in the peak pressure under the toe, lateral metatarsal, lateral foot and heel areas. Therefore, we suggested that the TCIFMP insole is an effective orthotic device for rearfoot motion control, plantar pressure reduction and re-distribution in patients with flexible flatfoot.

SAT0406 Effectiveness of Total Contact Insole on Plantar Fasciitis

BackgroundPlantar fasciitis (PF) in an inflammation of the fascia o on the bottom of the foot, characterized by stiffness in the medial arch and ankle, especially during one’s first steps,...

The role of a total contact insole in diminishing foot pressures following partial first ray amputation in diabetic patients

BackgroundIn diabetic subjects, reulcerations following first ray amputations are particularly frequent. Treatment usually includes an in-shoe intervention to reduce plantar pressure. ObjectiveTo investigate the effects of a total contact insole on the plantar pressure reduction in patients with partial first ray amputations. Material and methodsTwenty diabetic subjects (mean age 60 years, mean body mass index 27kg/m2) with partial first ray amputation of one foot. Plantar pressure data was recorded using Matscan system (Tekscan vers. 6.34, Boston, USA) while standing and taking a step for three conditions (shoe, shoe with total contact insole, and shoe with flat insole). Plantar pressures were determined at the five metatarsal areas, mid foot area and medial and lateral heel areas. ResultsPressures diminished significantly (P<0.05) in tested areas using the total contact insole while standing and walking. While using the flat insole, significant pressure changes were only seen while walking (P<0.05) (P<0.05). A highly significant change in pressures with the total contact insoles during walking in all areas except for the M1 area (P<0.001) as compared to that of flat insole. ConclusionThe conforming total contact insole showed significant reduction in plantar pressures in patients with first ray amputation.

A Comparison of Characteristics of Improved Total Contact Insoles

The purpose of this study is to investigate the effects of two kinds of total contact insoles (TCI). Traditional TCI reflects the shape of foot, while deformed total contact insole(DTCI) was established basing on the shape of footprints on clay prototypes. A female experimenter was asked to exert different loadings on clay prototypes to make footprints. Shapes of the footprints have been recorded by a reverse engineering method. Force distribution results in given preconditions were reflected and recorded for quantified comparison. shapes of two total contact insoles were rebuilt under different loadings. Having deformation of different magnitude over each area as a reference, effect and possibility of further improvement have been explored. Our findings showed that insoles based on larger deformation can be utilized to redistribute peak pressure effectively under normal loading. The results indicates that DTCI in this study can be used as a more important tool in adjusting functions or comfort ratings of shoes.

Transmetatarsal amputation prosthesis with carbon-fiber plate: enhanced gait function.

To determine whether the design of a transmetatarsal amputation prosthesis with a carbon-fiber plate would improve gait pattern in patients with transmetatarsal amputations. In the gait laboratory in a tertiary medical center, eight male patients with transmetatarsal amputations were recruited. Nine able-bodied male volunteers were recruited as the control group. A full-length standard shoe and a transmetatarsal amputation prosthesis with a carbon-fiber plate were the footwear used. Our transmetatarsal amputation prosthesis included a custom-molded insole, a mounted toe filler, and a thin, lightweight, carbon-fiber plate incorporated directly beneath the insole. After wearing the transmetatarsal amputation prosthesis with a carbon-fiber plate, the results of the kinetic and kinematic studies were summarized. The transmetatarsal amputation prosthesis with a carbon-fiber plate improved gait pattern significantly in patients with transmetatarsal amputations. Drastic shoe modifications are not necessary to have the prosthesis inserted. The carbon-fiber plate functions like the spring-steel shank within the sole of the shoe. The carbon-fiber plate, the toe filler, and the total-contact insole are all mounted as a whole to ensure better foot contact. Therefore, our transmetatarsal amputation prosthesis with a carbon-fiber plate can be a good alternative choice of footwear in patients with transmetatarsal amputations.

The effects of a new foot-toe orthosis in treating painful hallux valgus

Tang SF, Chen CP, Pan J-L, Chen J-L, Leong C-P, Chu N-K. The effects of a new foot-toe orthosis in treating painful hallux valgus. Arch Phys Med Rehabil 2002;83:1792-5. Objective: To assess the effects of a new foot-toe orthosis on painful hallux valgus. Design: Uncontrolled intervention study. Setting: An outpatient clinic in a tertiary medical center with an orthotic laboratory in Taiwan. Participants: Seventeen patients with painful hallux valgus. Intervention: Application of a new total contact insole with fixed toe separator. Main Outcome Measures: The hallux valgus angle, an 11-point numeric rating scale (NRS-11) for pain assessment, and walking ability scale. Results: The average hallux valgus angle reduction ± standard deviation was 6.5°±3.8° after insole application (P<.001). An improvement on the NRS-11 pain scale from 4.06±2.8 to 0.88±1.17 (P<.001) was noted after immediate insole application and was .42±.67 (P=.002) 3 months later for the 12 patients who completed the study. The walking ability scale improved at least 1 grade or more after the insole was worn for 3 months (P=.002). All patients tolerated the insole well without any clinical evidence of skin ulcers or blisters. Conclusion: Our new total contact insole with fixed toe separator reduced pain, and improved walking ability and the hallux valgus angle. It is an effective alternative treatment for patients with painful hallux valgus. © 2002 by the American Congress of Rehabilitation Medicine and the American Academy of Physical Medicine and Rehabilitation

A scientific approach to insole design for the diabetic foot

A total contact insole (TCI), scientifically designed for the individual diabetic foot, can be an effective long-term method of achieving these objectives: relieve areas of excessive plantar pressure; reduce shock and shear; accommodate and support deformities; and limit joint motion. A scientific approach to insole design should include: an understanding and evaluation of the biomechanics of the lower limb; identification of areas of excessive plantar pressure; determination of the desired function of the insole; and utilization of appropriate impression techniques and insole materials. A triple layer TCI, consisting of a moldable top layer, a shock absorbing middle layer, and a rigid bottom layer for control, can effectively achieve the desired treatment objectives.