Comparison of Ischial Containment and Subischial Sockets Effect on Gait Biomechanics in People With Transfemoral Amputation: A Randomized Crossover Trial.

OBJECTIVE: To compare gait biomechanics of the Northwestern University Flexible Sub-Ischial Vacuum (NU-FlexSIV) Socket to the ischial containment (IC) socket. DESIGN: Randomized crossover trial with 2, 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: Gait analyses were conducted at 1, 4, and 7 weeks post socket delivery. Differences between sockets in selected gait variables related to hip motion and coronal plane socket stability were assessed. RESULTS: For participants with data for both sockets at week 7 (n=19), there were no significant differences in any gait variables between sockets at self-selected normal walking speed. However, when all participants and all study time points were assessed (n=25), there was a significant main effect of socket (P=.013), with prosthetic side sagittal plane hip range of motion being significantly greater for the NU-FlexSIV Socket at self-selected normal walking speed. There were no other significant effects. CONCLUSIONS: The results suggest that, compared to the IC socket, the NU-FlexSIV Socket did not alter gait biomechanics related to hip motion and coronal plane socket stability in people with unilateral transfemoral amputation.

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.

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.

Quantification of Shear Stresses Within a Transtibial Prosthetic Socket.

BACKGROUND: There is a paucity of objectively recorded data delineating the pattern of weightbearing distribution within the prosthetic socket of patients with transtibial amputation. Our current knowledge is based primarily on information obtained from finite element analysis computer models. METHODS: Four high-functioning transtibial amputees were fit with similar custom prosthetic sockets. Three load cells were incorporated into each socket at high stress contact areas predicted by computer modeling. Dynamic recording of prosthetic socket loading was accomplished during rising from a sitting position, stepping from a 2-leg stance to a 1-leg stance, and during the initiation of walking. By comparing the loads measured at each of the 3 critical locations, anterior/posterior shear, superior/inferior shear, and end weightbearing were recorded. RESULTS: The same load pattern in all 4 subjects was found during each of the 3 functional activities. The load transmission at the distal end of the amputation residual limbs was negligible. Consistent forces were observed in both the anterior/posterior and superior/inferior planes. Correlation coefficients were used to compare the loads measured in each of the 4 subjects, which ranged from a low of .82 to a high of .98, where a value approaching 1.0 implies a linear relationship amongst subjects. CONCLUSION: This experimental model appears to have accurately recorded loading within a transtibial prosthetic socket consistent with previously reported finite element analysis computer models. CLINICAL RELEVANCE: This clinical model will allow objective measurement of weightbearing within the prosthetic socket of transtibial amputees and allow objective comparison of weightbearing distribution within the prosthetic sockets of patients who have undergone creation of different versions of a transtibial amputation residual limb and prosthetic socket designs.

A feasibility trial of a prefabricated immediate postoperative prosthetic limb system.

In this feasibility trial, 32 consecutive patients undergoing transtibial or knee disarticulation amputation had application of a prefabricated immediate postoperative prosthesis in the operating room following lower extremity amputation. Partial weightbearing was initiated on the first postoperative day. Twenty-nine underwent primary amputation as a consequence of nonsalvageable gangrene or diabetic foot infection. Others were performed at the time of wound closure following traumatic amputation for a crushed extremity and one was performed for an infected nonunion of the tibia and fibula. Seventeen of the 29 patients with diabetes were insulin dependent. Nine patients required renal dialysis and were diagnosed with concurrent malnutrition. Twenty were male and 12 were female, with an average age of 61.6 (range, 42-90) years. The average time to custom prosthetic limb fitting was 8.1 (range, 4-16) weeks. This preliminary experience with a commercially available pneumatic immediate postoperative prosthetic limb system supports its role in the early rehabilitation of lower extremity amputees.