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 Table of Contents  
ORIGINAL ARTICLE
Year : 2017  |  Volume : 9  |  Issue : 2  |  Page : 93-98

Quick fabricated none modified prosthetic socket for transtibial (below knee) amputee: An alternative, cost-effective approach of prosthetic management


1 ESIC Medical College and ESIC Hospital Joka, Kolkata (WBUHS); National Institute for the Orthopaedically Handicapped, Kolkata, West Bengal, India
2 National Institute for the Orthopaedically Handicapped, Kolkata, West Bengal, India
3 ESIC Medical College and ESIC Hospital Joka, Kolkata (WBUHS), Kolkata, West Bengal, India

Date of Web Publication14-Dec-2017

Correspondence Address:
Dr. Sanjay Keshkar
Professor and HOD (Orthopaedics), ESIC Medical College and ESIC Hospital Joka, Kolkata - 700 104, West Bengal
India
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Source of Support: None, Conflict of Interest: None


DOI: 10.4103/0975-7341.220756

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  Abstract 


Background: The population of amputees in India is increasing day by day, but the existing technology does not permit to provide artificial limb to all in the right time and remote place. Although different types of fabrication procedures are available, still amputee spends significant time and effort to get prosthesis for regaining their lost walking proficiency. To overcome these problems, we have devised a new technique through which quick fabrication of desired prosthesis can be made with low cost, that too in remote areas and could be fabricated and delivered same day. Materials and Methods: The quick fabrication socket is a nonmodified prosthetic socket which can be made directly on the amputee stump using a composite material (fiberglass bandage) without taking a negative plaster cast. Quick fabrication socket, after fitted with modular TTP component has been evaluated by subjective (patient's satisfaction) and objective (kinematic gait analysis) method and also by economical and other factors. Results: We have taken 15 transtibial amputees to study the clinical effect of quick fabricated socket and compared with previous patellar tendon bearing socket. In subjective (patient's satisfaction) observation, the overall satisfaction level was found to be almost same in the majority of the subjects (12 subjects). In objective observation of kinematic gait analysis, all the gait parameters were found to be almost similar except the gait symmetry, which was found to be better in nonmodified socket. The quick fabricated nonmodified (QFNM) prosthesis was found to be prepared in less time, less delivery time (the same day) less costly and good cosmetic appearance. Conclusion: The QFNM socket prosthesis was found to be an alternative cost-effective method to provide prosthesis in less time, less tools, less manpower that too in a remote area without electricity. However its efficacy, durability and cosmetic aspects need further improvement.

Keywords: Gait and gait analysis, patellar tendon bearing socket, total surface bearing socket, transtibial amputee, transtibial prosthesis


How to cite this article:
Keshkar S, Kumar R, Lenka PK, Akhtar MN. Quick fabricated none modified prosthetic socket for transtibial (below knee) amputee: An alternative, cost-effective approach of prosthetic management. J Orthop Traumatol Rehabil 2017;9:93-8

How to cite this URL:
Keshkar S, Kumar R, Lenka PK, Akhtar MN. Quick fabricated none modified prosthetic socket for transtibial (below knee) amputee: An alternative, cost-effective approach of prosthetic management. J Orthop Traumatol Rehabil [serial online] 2017 [cited 2021 Mar 2];9:93-8. Available from: https://www.jotr.in/text.asp?2017/9/2/93/220756




  Introduction Top


There are more than 50 million physically handicapped people in India. A majority of them belong to poor strata of the society. Improvement in the quality of lives of these people is an important issue as it enables them to take part in the mainstream activities of the society and thus make them self-reliant. India is upcoming intelligent power in the world; still our technology is not sufficient to deal with the large demand of aids/appliances for persons with disability. From current statistical data source, the present percentage of locomotor disability is 49% of total disability and among it number of below knee amputees are also significant (National Sample Survey Organization report 2002). To bring these below-knee amputees in the mainstream activities of the society, provision of artificial limb (prosthesis) is a must. In prosthesis, the socket is the most vital and time taking part. Except socket, all the components are available in modular form. The present demand asks for good quality prosthesis in less time and cost. Looking this into consideration, we have taken a project to find out an alternative method of socket design keeping all the biomechanical principle in patella tendon bearing (PTB) socket-and that is the quick fabrication none modified (QFNM) socket. The beauty of this socket is uniform force distribution and total contact. In this study, we investigated functional outcome of QFNM socket given to transtibial amputees. We also compared the outcome of this newly designed prosthesis with traditional PTB prosthesis.


  Materials and Methods Top


This study was conducted in National Institute for the Orthopedically Handicapped (Kolkata) from 2004 to 2005. The subjects were of below knee (transtibial) amputees (12 males and 3 females); aged between 15 and 49 years and had already been using conventional PTB prosthesis. They were selected from outpatient department (OPD). Majority of them attended by their own for general check-up/repair/replacement of prosthesis however few of them were referred from some other hospital including ESI Hospitals of Kolkata. The inclusion criteria for transtibial amputees to be included in this study were:

  1. Adolocent or adult individuals (15-50 years).
  2. Had been using prosthesis for more than a year.
  3. Were active walkers with or without a walking aid.
  4. Had no present stump problems, and
  5. were able to bear distal end pressure.


The stump length was randomly taken according to availability and for testing the performance of the socket in long stump as well as short stump. Height and weight of the patients were also recorded to see variation in performance. After completion of general data and examination [Table 1], the QFNM prosthetic sockets were prepared using pressure pads [Figure 1]a, fiberglass bandage [Figure 1]b, and other materials for each patient. The materials and tools required for making this prosthesis is in [Table 2]. The steps of procedure for QFNM socket are in [Table 3].
Table 1: General demographic data of participants/subjects

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Figure 1a: Materials for quick fabricated nonmodified socket (pressure pads)

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Figure 1b: Materials for quick fabricated nonmodified socket (fiberglass bandage)

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Table 2: Materials and tools required for fabrication of QFNM prosthetic sockets

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Table 3: Procedure for fabrication of socket

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The prepared socket was attached to modular component of rest of prosthesis (shank and prosthetic sach foot) using adapter [Figure 1]c to make a definitive prosthesis [Figure 2]. Final covering and finishing was done on prosthesis to make it ready for use [Figure 3]. The whole procedure takes about 1.5 h so that the patient could get prosthesis on the same day. After preparation of prosthesis patients were allowed to use the new prosthesis [Figure 4] on the same day and immediate prosthetic evaluation was done by one subjective measure (i.e., patient's satisfaction) and one objective measures (i.e., gait analysis) in all patients. The comparison of subjective measure (i.e., patient's satisfaction) of this new prosthesis was done with previous conventional PTB prosthesis which they were using in all 15 patients based upon their experiences, and the satisfaction levels were noted as lower level, same level or higher levels compared to previous prostheses. Similarly, the comparison of objective measures (i.e., gait analysis) was also done not in all patients, but only five as because only those five subjects had previous prostheses in functional conditions. The method of subjective measure (i.e., patient's satisfaction) and objective measures (i.e., gait analysis) are in detail in the discussion section.
Figure 1c: Materials for quick fabricated nonmodified (adaptor)

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{Figure 3}
Figure 2: Fitting the Socket to adapter and then rest of prosthesis

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Figure 3: Quick fabricated none modified prosthesis

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Figure 4: Patient of transtibial amputees with quick fabricated none modified prosthesis

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Observation

Demographic data

In this study, 15 cases of transtibial (below knee) amputees were taken randomly from OPD. Majority of them were male (12 males and 3 females); aged between 15 and 49 years (mean age 28.33 years). Height (137 cm to 176.5 cm with mean height 158.2 cm) and weight (25.2 kg to 72 kg with a mean weight 53.8 kg) of the patients were also recorded. The stump length (shortest stump of 10 cm to longest stump of 16 cm with mean stump length 13.1 cm) was randomly taken according to availability. Of 15 amputees, majority (nine subjects) had traumatic cause of amputation followed by diabetic gangrene and osteomyelitis (two cases each) and postburn and tumor (one case each). All the 15 cases were already using conventional PTB prosthesis of which 13 had sach foot, and two had Jaipur foot. Of 15 cases five cases came for repair of prosthesis and 10 cases came for replacement of their broken prosthesis. Ten cases that came for the replacement were replaced by new prosthesis (QFNM prosthesis) and five cases that came for repair were not only repaired but also given new prosthesis (QFNM prosthesis) on the same day. Hence, of 15 subjects, all 15 had new prosthesis (QFNM prosthesis) and five had both [Table 1].

Prosthetic evaluation data

Subjective observation of patient's satisfaction on new prosthesis (QFNM prosthesis) based upon the part of Dutch version of prosthesis evaluation questionnaire (PEQ) was noted in all 15 subjects and compared it with their previous prosthesis (PTB prosthesis) in all 15 patients. In the majority of the subjects (12 subjects), the overall satisfaction level was found to be almost same however one subject had a higher level of satisfaction and two subjects had a lower level of satisfaction compared to the previous prosthesis [Table 4].
Table 4: Comparison of patient satisfaction

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The objective observation of kinematic gait analysis to verify the gait parameters (cadence, walking speed, stride length, and gait symmetry), was done for all patients with new prosthesis (QFNM prosthesis) however comparative gait analysis was done in five patients only using both prostheses (conventional PTB prosthesis with modified socket and QFNM socket). All the parameters were found to be almost similar [Table 5] except the gait symmetry, which was found to be better in nonmodified socket [Graph 1].
Table 5: Kinematic gait analysis data

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The economic issues (cost of prosthesis, time taken for preparation, and delivery time) and other issues (durability and cosmetic appearance) related to prosthesis were also noted and compared [Table 6]. On comparison, the QFNM prosthesis was found to be prepared in less time (1.5-2 h.), less delivery time (the same day) less costly (socket cost Rs. 500/- approximately) and good cosmetic appearance. The only negative factor with QFNM Prosthesis was its durability compared with conventional PTB Prosthesis (roughly 6 months).
Table 6: Comparison of economical and other Issues of both kinds of prostheses

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  Discussion Top


Comfortable socket fit is the essence of fitment of transtibial prosthesis. In earlier days, the sockets with thigh corsets were used, but the revolutionary introduction in the 1950s of the PTB prosthesis,[1] replaced it and was a major change in below-knee prosthetic design. Since then there has been tremendous changes in the materials used or in the manufacturing procedures despite that,[2] the PTB design is still the international standard in transtibial amputee socket design. The only problem with PTB socket is a soft tissue stretch leading to skin abrasions because of the stump's limited weight-bearing area and its piston motion in the socket.[3],[4],[5]

To overcome skin problem of PTB socket the most fundamental change [6] in socket design came and was the total surface bearing (TSB) socket.[7],[8] The silicone liners are being used in TSB sockets to transfer the force on the stump in an efficient manner. The stiffness of the stump-socket interface is being optimized by this, and the forces are distributed over the total surface of the stump during the stance phase. It also minimizes the movement of the stump relative to the socket because of the high friction coefficient between skin and liner [7] and hence works as a suction socket during swing phase. No doubt, the TSB design is having better socket fit and weight-bearing ability than PTB sockets, but it is very costly and it has been reported [9],[10] that use of silicone liners causes excessive perspiration, bacterial invasion of the hair follicles and knee skin irritation.

The present demand asks for good quality prosthesis in less time and less cost. The standard PTB socket prosthesis is not that costly but takes a long time for fabrication and at least 2-3 visits are required. On the other hand, TSB socket prosthesis is not taking that much time and can be fabricated with one visit only, but it is very costly. So both sockets are not fulfilling the present demand. Looking this into consideration, this project was undertaken to find out an alternative method of socket design so that the patient can get it in one visit on the same day with low cost and we call it “QFNM prosthetic socket for TTE”. This socket is prepared by keeping all the biomechanical principle in PTB socket — and the beauty of this socket is uniform force distribution and total contact.

The difference between conventional transtibial PTB prosthesis and the QFNM prosthesis is only one that is, prosthetic socket. Rest of the components (shank and prosthetic foot) of both the prostheses is same. Hence, the advantages and disadvantages of QFNM prosthesis over conventional PTB prosthesis depends upon the prosthetic socket, which can be discussed in terms of patient's satisfaction (comfort ability), gait analysis, the fabrication tools and process, and economical factors such as time taking, cost factor, etc.

Patient satisfaction

Patient's, subjective experiences were scored using parts of the Dutch version of the PEQ.[11] The various items were measured using a 100-mm visual analog scale and were grouped into scores on prosthetic function (asking specifically about issues such as transpiration, odor, stump swelling, and skin problems), mobility, satisfaction, and pain. In addition, we also noted the will of the patient regarding keeping and continue the new socket. In our study, in the majority of the subjects (12 subjects), the overall satisfaction level was found to be almost same; however, one subject had a higher level of satisfaction and two subjects had a lower level of satisfaction compared to the previous prosthesis. Almost all patients wanted this prosthesis to continue to use in future.

Gait analysis

The kinematic gait analysis was carried out on a 15-m straight track using a measurement setup reported previously.[12],[13],[14],[15] For each subject, six complete gait cycles were selected, 26 normalized to mean cycle length, and averaged. From the average gait cycle, we calculated cadence, walking speed, stride length, and gait symmetry. Gait symmetry was defined as the prosthetic stance-phase duration divided by the contralateral stance-phase duration. If this number was larger than one, the inverse (1/x) was calculated. Defined this way, a number between 0 and 1 is created, with 1 indicating perfect symmetry.

Gait analysis was done for all patients with new prosthesis (QFNM prosthesis) however comparative gait analysis was done in five patients only using both prostheses (conventional PTB prosthesis with modified socket and quick fabrication nonmodified socket). All the parameters were found to be almost similar [Table 5] except the gait symmetry, which was found to be better in nonmodified socket.

Material and tools required for fabrication of prosthetic socket

In conventional manufacturing process of exo/endo-skeletal prosthesis, the socket is essential and vital part of it. A good established workshop having endless number of tools and equipments are required for making such prosthesis. In contrast to the conventional prosthesis, the QFNM prosthesis can be prepared in a single stage on the same day by International Committee of the Red Cross (ICRC) technology using only few materials and tools [Table 2].

Procedure for fabrication of socket

In conventional PTB prosthesis, the prosthetic socket is prepared by taking negative cast on stump using plaster of paris then positive mold is prepared by prosthesis for open pleurostomy and finally the prosthetic socket is prepared by taking negative cast over the mold. The prepared socket is then modified for proper fitting on the stump and then the rest of components of prosthesis (shank and prosthetic foot) are attached by using an adapter to make a definitive prosthesis. The fabrication of prosthetic socket is three staged procedure. In contrast to the conventional prosthesis, the QFNM prosthesis can be prepared in a single stage. The procedure is designed in such a way so that the prosthesis can be fabricated in the camp-site itself. The steps of procedure for PTB socket are in [Table 3].

Economical and other factors

In conventional PTB prosthesis, the prosthetic socket takes a long time, more manpower, and high-cost, but of good cosmetic look and long durability. In contrast to the conventional prosthesis, the QFNM prosthesis takes very short fabrication time, less manpower and low cost, but of compromised cosmetic look and less durability. Comfort and gait parameters are almost similar in both kinds of prosthetic socket.

The time is a great factor for some of the poor participants comes to our institute for fitment of artificial limb as they depend on daily wages to look after their family. The nonmodified socket with ICRC technology was greatly accepted by the said group.

Looking to the advantages of QFNM prosthesis, the method is best suited in offsite camps and remote place for instant fit or quick fabrication. After fitting the quick fabricated socket with 23 subjects, the same technology was applied in Bihar Patna Camp at Gandhi Maidan 10th October 2004 to prove the importance of the method in the camp site. The technique was also utilized in victims of Kashmir earthquake 2005 where four transtibial amputees got benefitted.

The major constraints in experimental groups were cosmetic appearance. The finishing and smoothness in nonmodified socket is a major obstacle to psychology of the experimental group. Still work is going on to overcome this. Only five subjects had been fitted with both modified and nonmodified socket, still all to be tested with modified socket.


  Conclusion Top


The QFNM socket prosthesis (QFNM prosthesis) was found to be an alternative cost-effective method to provide prosthesis in less time, less tools, less manpower that too in a remote area without electricity. However its efficacy, durability, and cosmetic aspects need further improvement.

Declaration of patient consent

The authors certify that they have obtained all appropriate patient consent forms. In the form the patient(s) has/have given his/her/their consent for his/her/their images and other clinical information to be reported in the journal. The patients understand that their names and initials will not be published and due efforts will be made to conceal their identity, but anonymity cannot be guaranteed.

Financial support and sponsorship

Nil.

Conflicts of interest

There are no conflicts of interest.



 
  References Top

1.
Radcliffe CW, Foort J. The Patellar-Tendon-Bearing Below-Knee Prosthesis. Berkeley: University of California; 1961.  Back to cited text no. 1
    
2.
Trends Biomater Artif Organs 17.  Back to cited text no. 2
    
3.
Yiǧiter K, Sener G, Bayar K. Comparison of the effects of patellar tendon bearing and total surface bearing sockets on prosthetic fitting and rehabilitation. Prosthet Orthot Int 2002;26:206-12.  Back to cited text no. 3
    
4.
Lilja M, Johansson T, Oberg T. Movement of the tibial end in a PTB prosthesis socket: A sagittal X-ray study of the PTB prosthesis. Prosthet Orthot Int 1993;17:21-6.  Back to cited text no. 4
    
5.
Convery P, Buis AW. Conventional patellar-tendon-bearing (PTB) socket/stump interface dynamic pressure distributions recorded during the prosthetic stance phase of gait of a trans-tibial amputee. Prosthet Orthot Int 1998;22:193-8.  Back to cited text no. 5
    
6.
Sewell P, Noroozi S, Vinney J, Andrews S. Developments in the trans-tibial prosthetic socket fitting process: A review of past and present research. Prosthet Orthot Int 2000;24:97-107.  Back to cited text no. 6
    
7.
Kristinsson O. The ICEROSS concept: A discussion of a philosophy. Prosthet Orthot Int 1993;17:49-55.  Back to cited text no. 7
    
8.
Fillauer CE, Pritham CH, Fillauer KD. Evolution and development of the silicone suction socket (3S) for below-knee amputees. Prosthet Orthot Int 1989;1:92-103.  Back to cited text no. 8
    
9.
Cochrane H, Orsi K, Reilly P. Lower limb amputation. Part 3: Prosthetics – A 10 year literature review. Prosthet Orthot Int 2001;25:21-8.  Back to cited text no. 9
    
10.
Hachisuka K, Nakamura T, Ohmine S, Shitama H, Shinkoda K. Hygiene problems of residual limb and silicone liners in transtibial amputees wearing the total surface bearing socket. Arch Phys Med Rehabil 2001;82:1286-90.  Back to cited text no. 10
    
11.
Legro MW, Reiber GD, Smith DG, del Aguila M, Larsen J, Boone D. Prosthesis evaluation questionnaire for persons with lower limb amputations: Assessing prosthesis-related quality of life. Arch Phys Med Rehabil 1998;79:931-8.  Back to cited text no. 11
    
12.
Selles RW, Korteland S, Van Soest AJ, Bussmann JB, Stam HJ. Lower-leg inertial properties in transtibial amputees and control subjects and their influence on the swing phase during gait. Arch Phys Med Rehabil 2003;84:569-77.  Back to cited text no. 12
    
13.
Winter DA, Sienko SE. Biomechanics of below-knee amputee gait. J Biomech 1988;21:361-7.  Back to cited text no. 13
    
14.
Ganguli S. Observations on basic gait characteristics of Indian Industrial workers. Indian J Ind Med 1973;19:28-35.  Back to cited text no. 14
    
15.
Tibarewala DN, Ganguli S. Pattern recognition in tachographic gait records of normal and lower extremity handicapped human subjects. J Biomed Eng 1982;4:233-40.  Back to cited text no. 15
    


    Figures

  [Figure 1], [Figure 2], [Figure 3], [Figure 4], [Figure 5], [Figure 6]
 
 
    Tables

  [Table 1], [Table 2], [Table 3], [Table 4], [Table 5], [Table 6]



 

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