1. Amputee’s Satisfaction with Two Different Transfemoral Suspension Systems and the Experienced Problems Hossein Gholizadeh 1,2, Noor Azuan Abu Osman 1, Arezoo Eshraghi 1,2, Mojtaba Kamyab 2, Hassan Saeedi 2, Sadeeq Ali 1, Morteza Mohammadi 2 1 Department of Biomedical Engineering, Faculty of Engineering, University of Malaya, Malaysia 2 Department of Orthotics and Prosthetics, Faculty of Rehabilitation Sciences, Tehran University of Medical Sciences, Tehran, Iran

2.  Appropriate prosthetic suspension system can enhance patient’s satisfaction, and facilitate the rehabilitation process. Clinicians rely on their experience and the technical information provided by manufacturer to choose appropriate liners for their patients.

3. The main intention of this study was to compare the Iceross Seal-In ® liner with traditional suction socket with regards to patients’ satisfaction, and to investigate any problems they experienced through the use of a Prosthesis Evaluation Questionnaire (PEQ).

4. In order to measure user’s satisfaction with the two suspension systems and to identify any problems associated with prosthetic use, a questionnaire survey was conducted with 30 transfemoral amputees (traumatic) in Janbazan Medical and Engineering Research Center (JMERC), Tehran, Iran.

5. All the amputees involved in the study had used a suction socket (SS) suspension system with their prosthesis for a period of ten years or more (mean, 23.7, SD, 5.3). Prior to socket replacement, the subjects were asked to complete a PEQ questionnaire that measured their satisfaction levels with their current prosthesis. Following this, their existing suspension system was replaced with a new suspension system, which is known as the Seal-In ® liner socket suspension.

7. In order to study the effect of different suspension systems on, satisfaction of amputees who wore lower-limb prosthetic devices, a number of elements of PEQ were utilized. The questionnaires employed within this study were based on the Persian version of this questionnaire

8. A descriptive analysis was performed on the demographic information of the amputees. To analyze the satisfaction and perceived problems related to the use of the Seal-In suspension and suction socket suspension systems, a Multivariate Analysis of Variance (MANOVA) test was utilized to compute the mean differences between the questionnaire scores. All data analysis was implemented using SPSS 16.0.

9. The level of patient’s satisfaction between the Seal-In ® liner suspension system and the suction suspension (SS) system differed significantly (p<0.05), except for satisfaction while walking and when navigating stairs

10. A significant difference in the mean scores pertaining to problems/complaints was noticed among the two suspension systems. For the Seal-In ® liner suspension, the overall mean problems/complaints on a 0-100 point numerical rating scale was 95.15 (SD=7.302) and for the suction suspension it was 78.10 (SD=14.92) (Table 4).

11. Descriptive Statistics Suspension system MeanStd. DeviationN fitting satisfactionSeal-In ® 92.339.16630 SU85.839.83330 Total89.089.97860 donning and doffing satisfactionSeal-In ® 83.339.49930 SU54.8317.64030 Total69.0820.09560 sitting satisfactionSeal-In ® 79.4316.56730 SU69.2312.59630 Total74.3315.47160 walking satisfactionSeal-In ® 73.7713.47230 SU68.8313.41930 Total71.3013.56160 uneven walking satisfationSeal-In ® 67.7012.68230 SU61.7010.18230 Total64.7011.79760 stair satisfactionSeal-In ® 69.7312.02330 SU64.5711.79330 Total67.1512.09160 suspension satisfactionSeal-In ® 91.338.50330 SU68.8313.37030 Total80.0815.87860 cosmetic satisfactionSeal-In ® 73.0015.17730 SU64.6713.25730 Total68.8314.74060 overal satisfactionSeal-In ® 74.1710.99230 SU64.0010.93930 Total69.0812.02060

12.  An amputee’s rehabilitation is a challenging procedure that requires expertise, especially in the selection of prosthetic components based on the real needs of the amputee. Prosthetic satisfaction is a multi-factorial issue. Some of these factors are level of amputation, prosthetic alignment, prosthetic components, prosthetists’ skills, stump condition, amputee’s level of activity and socket fit

13.  Few studies have compared the outcome of different suspension systems on transfemoral amputee satisfaction, and even fewer have studied patient’s satisfaction with regard to other prosthetic components, such as the knee joint [28]. It was, therefore, challenging to compare the results of this study with those that had been conducted by other researches.

14.  As anticipated, the results of the study revealed a significant difference between the problems and complaints identified by patients who utilized the two different suspension systems as the amputees experienced fewer problems with the Seal-In liner. Furthermore, the Seal-In liner promoted increased comfort and satisfaction for the participants who were identified with higher activity levels (K3). Effortless donning and doffing does appear to have a positive effect on a patient’s experience of a prosthetic device

15.  One limitation of this study was the small sample size which is of particular importance for satisfaction studies. In addition to this, further research is needed to compare more suspension alternatives in order to provide a better guideline for suspension system selection. Future research should also investigate and compare the proprioception effects of various suspension systems.

16.  Overall this study revealed that the transfemoral subjects were more satisfied with the new the Seal-In® liner suspension system than they were with the traditional suction socket method due to the firm attachment that was created between the stump/liner and socket. Moreover, manufacturers and health care providers should constantly gain the feedback of prosthetic users and apply it to improve their products and services.

17.  The authors would like to special thank to  Mr. Shahram Gharib panah,  Mr. Mohamad Maghami,  Mr. Behrad Kyvan  Mr. Aghil Asadi  Mr. Reza Kabiri  And all our collogues in Janbazan Medical and Engineering Research Center (JMERC) for their help and encouragement.

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19.  Thank you