ORIGINAL RESEARCH| Volume 102, ISSUE 11, P2063-2073.e2, November 2021

Download started.


Comparison of Ischial Containment and Subischial Sockets on Comfort, Function, Quality of Life, and Satisfaction With Device in Persons With Unilateral Transfemoral Amputation: A Randomized Crossover Trial



      To compare comfort and functional performance of the Northwestern University Flexible Subischial Vacuum (NU-FlexSIV) Socket with the ischial containment (IC) socket in persons with unilateral transfemoral amputation.


      Randomized crossover trial with two 7-week periods.


      Private prosthetic clinics and university research laboratory.


      A total of 30 enrolled (N=30); 25 participants completed the study with full (n=18) or partial data (n=7).


      Two custom-fabricated sockets (IC and NU-FlexSIV), worn full-time for 7 weeks, with testing at 1, 4, and 7 weeks after socket delivery.

      Main Outcome Measures

      The primary outcome was change in Socket Comfort Score (SCS) at 7 weeks. Secondary outcomes at 7 weeks included the Orthotic and Prosthetic Users’ Survey (OPUS) to assess lower extremity functional status, health-related quality of life, and satisfaction with device, as well as the 5-Times Rapid Sit-to-Stand Test, Four Square Step Test, and T-Test of Agility to assess functional performance.


      At 7 weeks, the mean SCS for IC (7.0±1.7) and NU-FlexSIV (8.4±1.1) Sockets were significantly different (P<.001; 95% confidence interval, 0.8-2.3). Results from a linear mixed-effects model, accounting for data from all time points, indicated that the SCS was 1.7 (SE=0.45) points higher for the NU-FlexSIV Socket (P<.001). For the secondary outcomes, only OPUS satisfaction with device was significantly better in the NU-FlexSIV Socket after accounting for all data points.


      The results suggest that after 7 weeks’ accommodation, the NU-FlexSIV Socket was more comfortable and led to greater satisfaction with device than the IC socket in persons with unilateral transfemoral amputation and K3/K4 mobility. Other patient-reported outcomes and function were no different between sockets.


      List of abbreviations:

      4SST (Four Square Step Test), IC (ischial containment), MDC (minimal detectable change), NU-FlexSIV (Northwestern University Flexible Subischial Vacuum Socket), OPUS (Orthotics and Prosthetics Users’ Survey), QOL (quality of life), STST (Sit-to-Stand Test), SCS (Socket Comfort Score), TFA (transfemoral amputation), VASS (vacuum-assisted suction suspension)
      To read this article in full you will need to make a payment

      Purchase one-time access:

      Academic & Personal: 24 hour online accessCorporate R&D Professionals: 24 hour online access
      One-time access price info
      • For academic or personal research use, select 'Academic and Personal'
      • For corporate R&D use, select 'Corporate R&D Professionals'


      Subscribe to Archives of Physical Medicine and Rehabilitation
      Already a print subscriber? Claim online access
      Already an online subscriber? Sign in
      Institutional Access: Sign in to ScienceDirect


        • Muller M
        Transfemoral amputation: prosthetic management.
        in: Krajbich JI Atlas of amputations and limb deficiencies: surgical, prosthetic and rehabiltiaton principles. 4th ed. American Academy of Orthopaedic Surgeons, Rosemont2016: 537-554
        • Whiteside S
        • Allen M
        • Bick J
        • et al.
        Practice analysis of certified practitioners in the disciplines of orthotics and prosthetics.
        American Board for Certification in Orthotics and Prosthetics, Inc, Alexandria2015
        • Klotz R
        • Colobert B
        • Botino M
        • Permentiers I
        Influence of different types of sockets on the range of motion of the hip joint by the transfemoral amputee.
        Ann Phys Med Rehabil. 2011; 54: 399-410
        • Rabuffetti M
        • Recalcati M
        • Ferrarin M
        Trans-femoral amputee gait: socket-pelvis constraints and compensation strategies.
        Prosthet Orthot Int. 2005; 29: 183-192
        • Tranberg R
        • Zügner R
        • Kärrholm J
        Improvements in hip- and pelvic motion for patients with osseointegrated trans-femoral prostheses.
        Gait Posture. 2011; 33: 165-168
        • Dillingham T
        • Pezzin L
        • MacKenzie E
        Limb amputations and limb deficiencies: epidemiology and recent trends in the United States.
        South Med J. 2001; 95: 875-883
        • Pezzin LE
        • Dillingham TR
        • MacKenzie EJ
        • Ephraim P
        • Rossbach P
        Use and satisfaction with prosthetic limb devices and related services.
        Arch Phys Med Rehabil. 2004; 85: 723-729
        • Legro MW
        • Reiber G
        • del Aguila M
        • et al.
        Issues of importance reported by persons with lower limb amputations and prostheses.
        J Rehabil Res Dev. 1999; 36: 155-163
        • Fatone S
        • Caldwell R
        Northwestern University Flexible Subischial Vacuum Socket for persons with transfemoral amputation: part 1 description of technique.
        Prosthet Orthot Int. 2017; 41: 237-245
        • Fatone S
        • Dillon M
        • Stine R
        • Tillges R
        Coronal plane socket stability during gait in persons with unilateral transfemoral amputation: pilot study.
        J Rehabil Res Dev. 2014; 51: 1217-1228
        • Fatone S
        • Johnson W
        • Tran L
        • Tucker K
        • Mowrer C
        • Caldwell R
        Quantification of rectifications for Northwestern University Flexible Sub-Ischial Vacuum (NU-FlexSIV) Socket.
        Prosthet Orthot Int. 2017; 41: 251-257
        • Fatone S
        • Caldwell R
        Northwestern University Flexible Subischial Vacuum Socket for persons with transfemoral amputation: part 2 description and preliminary evaluation.
        Prosthet Orthot Int. 2017; 41: 246-250
        • Fatone S
        • Yohay J
        • Caldwell R
        Change in residual limb size over time in the NU-FlexSIV Socket: a case study.
        Prosthet Orthot Int. 2018; 42: 620-625
        • Brown S
        • Russell Esposito E
        • Ikeda A
        • Wilken J
        • Fatone S
        Evaluation of NU-FlexSIV Socket performance for military service members with transfemoral amputation.
        US Army Med Dep J. 2018; 2-18: 38-47
        • Wurdeman S
        • Stevens P
        • Campbell J
        Mobility Analysis of AmpuTees (MAAT I): quality of life and satisfaction are strongly related to mobility for patients with a lower limb prosthesis.
        Prosthet Orthot Int. 2018; 42: 498-503
        • Whitney SL
        • Wrisley DM
        • Marchetti GF
        • Gee MA
        • Redfern MS
        • Furman JM
        Clinical measurement of sit-to-stand performance in people with balance disorders: validity of data for the Five-Times-Sit-to-Stand Test.
        Phys Ther. 2005; 85: 1034-1045
        • Lusardi M
        • Pellecchia G
        • Schulman M
        Functional performance in community living older adults.
        J Geriat Phys Ther. 2003; 26: 14-22
        • Dite W
        • Temple VA
        A clinical test of stepping and change of direction to identify multiple falling older adults.
        Arch Phys Med Rehabil. 2002; 83: 1566-1571
        • Raya MA
        • Gailey RS
        • Gaunaurd IA
        • et al.
        Comparison of three agility tests with male servicemembers: Edgren Side Step Test, T-Test, and Illinois Agility Test.
        J Rehabil Res Dev. 2013; 50: 951-960
        • Gailey RS
        • Gaunaurd IA
        • Raya MA
        • et al.
        Development and reliability testing of the Comprehensive High-Level Activity Mobility Predictor (CHAMP) in male servicemembers with traumatic lower-limb loss.
        J Rehabil Res Dev. 2013; 50: 905-918
        • Gailey RS
        • Scoville C
        • Gaunaurd IA
        • et al.
        Construct validity of Comprehensive High-Level Activity Mobility Predictor (CHAMP) for male servicemembers with traumatic lower-limb loss.
        J Rehabil Res Dev. 2013; 50: 919-930
        • Hanspal RS
        • Fisher K
        • Nieveen R
        Prosthetic socket fit comfort score.
        Disabil Rehabil. 2003; 25: 1278-1280
        • Gailey RS
        • Roach KE
        • Applegate EB
        • et al.
        The Amputee Mobility Predictor: an instrument to assess determinants of the lower-limb amputee's ability to ambulate.
        Arch Phys Med Rehabil. 2002; 83: 613-627
        • Heinemann AW
        • Bode R
        • O'Reilly C
        Development and measurement properties of the Orthotics and Prosthetics Users’ Survey (OPUS): a comprehensive set of clinical outcome instruments.
        Prosthet Orthot Int. 2003; 27: 191-206
        • Sanders JE
        • Youngblood RT
        • Hafner BJ
        • et al.
        Effects of socket size on metrics of socket fit in trans-tibial prosthesis users.
        Med Eng Phys. 2017; 44: 32-43
        • Hafner BJ
        • Morgan SJ
        • Askew RL
        • Salem R
        Psychometric evaluation of self-report outcome measures for prosthetic applications.
        J Rehabil Res Dev. 2016; 53: 797-812
        • Heinemann A
        Scoring guide for the Orthotics and Prosthetics Users Survey.
        Shirley Ryan AbilityLab, Chicago2014: 7
        • Resnik L
        • Borgia M
        Reliability of outcome measures for people with lower-limb amputations: distinguishing true change from statistical error.
        Phys Ther. 2011; 91: 555-565
        • Faul F
        • Erdfelder E
        • Buchner A
        • Lang AG
        Statistical power analyses using G*Power 3.1: tests for correlation and regression analyses.
        Behav Res Methods. 2009; 41: 1149-1160
        • Faul F
        • Erdfelder E
        • Lang AG
        • Buchner A
        G*Power 3: a flexible statistical power analysis program for the social, behavioral, and biomedical sciences.
        Behav Res Methods. 2007; 39: 175-191
        • Ziegler-Graham K
        • MacKenzie E
        • Ephraim P
        • Travison T
        • Brookmeyer R
        Estimating the prevalence of limb loss in the United States: 2005 to 2050.
        Arch Phys Med Rehabil. 2008; 89: 422-429
        • Mazzone B
        • Yoder A
        • Zalewski B
        • Wyatt M
        • Sheu R
        Comprehensive treatment strategy for chronic low back pain in a patient with bilateral transfemoral amputations integrating changes in prosthetic socket design.
        J Prosthet Orthot. 2017; 29: 190-197
        • Kahle J
        • Miro R
        • Ho L
        • et al.
        The effect of the transfemoral prosthetic socket interface designs on skeletal motion and socket comfort: a randomized clinical trial.
        Prosthet Orthot Int. 2020; 44: 145-154
        • Kahle JT
        • Highsmith MJ
        Transfemoral interfaces with vacuum assisted suspension comparison of gait, balance, and subjective analysis: ischial containment versus brimless.
        Gait Posture. 2014; 40: 315-320
        • Kahle JT
        • Highsmith MJ
        Transfemoral sockets with vacuum-assisted suspension comparison of hip kinematics, socket position, contact pressure, and preference: ischial containment versus brimless.
        J Rehabil Res Dev. 2013; 50: 1241-1252
        • Kahle J
        • Klenow T
        • Sampson W
        • Highsmith M
        The effect of transfemoral interface design on gait speed and risk of falls.
        Technol Innov. 2016; 18: 167-173
        • Kahle J
        • Klenow T
        • Highsmith M
        Comparative effectiveness of an adjustable transfemoral prosthetic interface accommodatin volume fluctutation: case study.
        Technol Innov. 2016; 18: 175-183
        • Traballesi M
        • Delussu AS
        • Averna T
        • Pellegrini R
        • Paradisi F
        • Brunelli S
        Energy cost of walking in transfemoral amputees: comparison between Marlo Anatomical Socket and ischial containment socket.
        Gait Posture. 2011; 34: 270-274
        • Hachisuka K
        • Umezu Y
        • Ogata H
        • Ohmine S
        • Shinkoda K
        • Arizono H
        Subjective evaluations and objective measurements of the ischial-ramal containment prosthesis.
        J UOEH. 1999; 21: 107-118
        • Lee VS
        • Solomonidis SE
        • Spence WD
        Stump-socket interface pressure as an aid to socket design in prostheses for trans-femoral amputees–a preliminary study.
        Proc Inst Mech Eng H. 1997; 211: 167-180
        • Gailey RS
        • Lawrence D
        • Burditt C
        • Spyropoulos P
        • Newell C
        • Nash MS
        The CAT-CAM socket and quadrilateral socket - a comparison of energy-cost during ambulation.
        Prosthet Orthot Int. 1993; 17: 95-100
        • Krouskop T
        • Brown JE
        • Goode B
        • Winningham D
        Interface pressures in above-knee sockets.
        Arch Phys Med Rehabil. 1987; 68: 713-714
        • Trieb K
        • Lang T
        • Stulnig T
        • Kickinger W
        Silicone soft socket system: its effect on the rehabilitation of geriatric patients with transfemoral amputations.
        Arch Phys Med Rehabil. 1999; 80: 522-525

      CHORUS Manuscript

      View Open Manuscript