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

Arch Phys Med Rehabil. 2021 Nov;102(11):2063-2073.e2. doi: 10.1016/j.apmr.2021.05.016. Epub 2021 Jun 29.

Abstract

Objective: 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.

Design: Randomized crossover trial with two 7-week periods.

Setting: Private prosthetic clinics and university research laboratory.

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

Interventions: 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.

Results: 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.

Conclusions: 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.

Trial registration: ClinicalTrials.gov NCT02678247.

Keywords: Artificial; Artificial limbs; Leg; Leg prosthesis; Rehabilitation; Rehabilitation outcome.

Publication types

  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, N.I.H., Extramural
  • Research Support, U.S. Gov't, Non-P.H.S.

MeSH terms

  • Adult
  • Amputation, Surgical / methods
  • Artificial Limbs*
  • Cross-Over Studies
  • Female
  • Humans
  • Ischium / anatomy & histology*
  • Leg*
  • Male
  • Middle Aged
  • Patient Satisfaction
  • Prosthesis Design*
  • Quality of Life
  • Recovery of Function
  • Single-Blind Method
  • Weight-Bearing

Associated data

  • ClinicalTrials.gov/NCT02678247