How Comprehensive and Efficient Are Patient-Reported Outcome Measures for Individuals with Lower Extremity Amputation Undergoing Implantation of Osseointegrated Bone Anchored Limbs?

¼ Patient-reported outcome measures (PROMs) are essential for measuring quality and functional outcomes after implantation of osseointegrated bone anchored limbs for patients with lower extremity amputation.¼ Using a novel assessment criterion with 8 domains, this study assessed all commonly used PROMs for their efficiency and comprehensiveness.¼ Comprehensiveness was scored according to the presence or absence of PROM questions related to these 8 domains (maximum score = 60): mobility (15 items), prosthesis (14 items), pain (10 items), psychosocial status (10 items), independence/self-care (4 items), quality of life/satisfaction (4 items), osseoperception (1 item), general information (1 item), and vitality (1 item).¼ The efficiency scores were calculated by dividing the comprehensiveness score by the total number of questions answered by the patients with higher scores being deemed more efficient.¼ The most comprehensive PROMs were Orthotics and Prosthetics User's Survey-Lower Extremity Functional Status (OPUS-LEFS) (score = 36), Prosthesis Evaluation Questionnaire (PEQ) (score = 31), and Questionnaire for Persons with a Transfemoral Amputation (score = 27).¼ The most efficient PROMs were the OPUS-LEFS (score = 1.8) and European Quality of Life (score = 1.4).

Daily steps and stepping cadence increase one-year following prosthesis osseointegration in people with lower-limb amputation.

PURPOSE: People with lower-limb loss participate in less physical activity than able-bodied individuals, which increases the mortality risk and incidence of metabolic syndromes. This study evaluated the effect of lower-limb prosthesis osseointegration on physical activity, including daily steps and stepping cadence. METHODS: Free-living walking activity was assessed from 14 patients scheduled to undergo prosthesis osseointegration at two time points (within 2 weeks prior to osseointegration surgery and 12-months following). Daily step count, stepping time, number of walking bouts, average step cadence per bout, maximum step cadence per bout, and time spent in bands of step cadence were compared before and after osseointegration. RESULTS: Twelve months after prosthesis osseointegration, participants increased daily steps, daily stepping time, average step cadence, and maximum cadence per walking bout compared to pre-osseointegration. CONCLUSIONS: Participants engaged in more daily steps, higher stepping cadence, and longer bouts at higher cadence one year following osseointegration compared to when using a socket prosthesis. As a novel intervention that is becoming more common, it is important to understand walking activity outcomes as these are critical for long-term health.

People with lower-limb loss participate in less physical activity than able-bodied individuals, which increases the mortality risk and incidence of metabolic syndromes.Daily step count, walking bouts, and step cadence during free-living walking activity are promising measures to capture physical functional performance in patients with lower-limb amputation.This study shows that patients with osseointegrated prostheses increase their stepping activity, including daily steps, number of bouts, and stepping cadence compared to when using a socket prosthesis, which has positive implications on overall patient health.As a novel intervention that is becoming more common, it is important for clinicians, patients, and researchers to understand expectations for walking activity outcomes as a critical factor in long-term patient health after prosthesis osseointegration.

Changes in lower extremity joint moments one-year following osseointegration in individuals with Transfemoral lower-limb amputation: A case series.

BACKGROUND: Dissatisfaction with socket prostheses has led to the development of bone-anchored prostheses through osseointegration for people with transfemoral amputation, eliminating the need for a prosthetic socket. Gait deviations of transfemoral prosthesis users may be linked to increased risk of osteoarthritis, and it remains unknown if gait biomechanics change following osseointegration. The purpose of this case series was to evaluate the longitudinal changes in joint kinetics one year post-osseointegration in patients with transfemoral amputation during walking. METHODS: Knee, hip, and trunk internal moments were evaluated in the prosthetic and intact limbs during walking at a self-selected speed in four participants pre- and one-year post-osseointegration. Longitudinal changes were quantified using the percent change (%∆) in peak joint moments between the two time points and Cohen's d (d) effect size was used to determine the magnitude of effect on joint moments during walking one year following osseointegration. FINDINGS: Participants demonstrated increased peak knee extension moment (224 ± 308%∆, d = -1.31) in the prosthetic limb, while demonstrating reduced peak knee extension moment (-43 ± 34%∆, d = 1.82) in the intact limb post-osseointegration. Participants demonstrated bilateral reduction of peak hip extension moment (prosthetic: -22 ± 37%∆, d = 0.86; intact: -29 ± 10%∆, d = 1.27) and bilateral increase of peak hip abduction moment (prosthetic: 45 ± 40%∆, d = 1.20; intact: 23 ± 44%∆, d = 0.74) post-osseointegration. Participants demonstrated reduced peak trunk moments on both the prosthetic (extension: -31 ± 16%∆, d = 1.51; lateral flexion: -21 ± 20%∆, d = 0.63) and intact side (extension: -7 ± 22%∆, d = 0.38; lateral flexion: -22 ± 18%∆, d = 1.12) post-osseointegration. INTERPRETATION: This case series suggests improved gait symmetry in individuals with transfemoral amputation one year following osseointegration, justifying future investigation.

Improvements in disability and function in people with lower-limb amputation one year after prosthesis osseointegration.

BACKGROUND: People with lower-limb amputation (LLA) are routinely prescribed a socket prosthesis; however, many socket prosthesis users experience severe complications with the fit of their prosthesis including residual limb wounds and pain. Osseointegration is a procedure that creates a direct connection between the bone and prosthetic limb through a bone-anchored prosthesis, eliminating the need for a socket interface. It is offered as a secondary procedure to people with LLA who experience significant complications with socket prostheses. OBJECTIVES: To evaluate change in disability and function 1 year postosseointegration compared with preosseointegration in people with LLA. STUDY DESIGN: Single group, pretest, and post-test. METHODS: Twelve participants (9 transfemoral and 3 transtibial amputations, age: 44 ± 10 years, 7 female participants, 14 ± 12 years since amputation) with unilateral LLA underwent osseointegration with press-fit implants. Disability was measured with the World Health Organization Disability Assessment Schedule 2.0, and function was measured with both Prosthetic Limb Users Mobility Survey and the Activities-Specific Balance Confidence Scale. Questionnaires were administered preosseointegration and 1 year postosseointegration. Paired t tests assessed change in outcomes between time points. RESULTS: Postosseointegration, participants demonstrated reduced disability measured with World Health Organization Disability Assessment Schedule 2.0 (%Δ = -52.6, p = 0.01), improved mobility measured with Prosthetic Limb Users Mobility Survey (%Δ = 21.8, P < 0.01), and improved balance confidence measured with the Activities-Specific Balance Confidence Scale (%Δ = 28.4, P < 0.01). CONCLUSIONS: Participants report less disability and greater function in their prosthesis postosseointegration. Osseointegration is a novel procedure for people experiencing complications with their socket prosthesis, and this study is the first to show improvements in disability postosseointegration.

Osseointegrated prostheses improve balance and balance confidence in individuals with unilateral transfemoral limb loss.

BACKGROUND: More than half of patients with lower-limb amputation who use socket prostheses experience at least one fall annually. These falls are primarily attributed to reduced proprioception which negatively affects balance. A promising alternative to socket prostheses are osseointegrated prostheses that involve direct fixation of the prosthetic limb to the residual limb through a bone-anchored implant, yet its effect on balance remains unknown. RESEARCH QUESTION: Do osseointegrated prostheses change static and dynamic balance, as well as patient reported measures of balance confidence, compared to a socket prosthesis? METHODS: A sample of 10 patients with unilateral transfemoral amputation scheduled to undergo prosthesis osseointegration were enrolled (6 F/4 M, BMI: 26.7 ± 2.9 kg/m2, Age: 46.1 ± 6.3 years). Motion capture data during quiet standing (eyes opened and eyes closed) and overground walking at a self-selected speed, and the Activities-Specific Balance Confidence (ABC) scale, were collected before (with socket prosthesis) and 12-months following osseointegration. Postural sway via the center of pressure (COP), variability of spatiotemporal parameters, and ABC scores were compared using a repeated measures design before and after osseointegration. RESULTS: Following prosthesis osseointegration, COP path length and 95 % confidence ellipse area were reduced during quiet standing (d = 0.75, P = 0.09; d = 0.52, P = 0.29, respectively) and the variability of step width and length were reduced during overground walking (d = 0.50, P = 0.06; d = 0.72, P = 0.06, respectively). Furthermore, patients reported significantly improved ABC scores with an osseointegrated prosthesis compared to a socket prosthesis (d = -1.36, P = 0.01). SIGNIFICANCE: Improvements in postural sway, reductions in gait variability, and greater balance confidence indicate that osseointegrated prostheses improve balance for people with unilateral transfemoral amputation.

Relationships Among Perceived Functional Capacity, Self-Efficacy, and Disability After Dysvascular Amputation.

BACKGROUND: Prosthesis rehabilitation after dysvascular transtibial amputation (TTA) is focused on optimizing functional capacity with limited emphasis on promoting health self-efficacy. Self-efficacy interventions decrease disability for people living with chronic disease, but the influence of self-efficacy on disability is unknown for people with dysvascular TTA. OBJECTIVES: To identify if self-efficacy mediates the relationship between self-reported functional capacity and disability after dysvascular TTA. DESIGN: Cross-sectional, secondary data analysis. SETTING: Outpatient rehabilitation facilities. PARTICIPANTS: Thirty-eight men (63.6 ± 9.1 years old) with dysvascular TTA. METHODS: Participants had been living with an amputation for less than 6 months and using walking as their primary form of locomotion using a prosthesis. The independent variable, functional capacity, was measured using the Prosthesis Evaluation Questionnaire-Mobility Scale (PEQ-MS). The proposed mediator, self-efficacy, was measured with the Self-Efficacy of Managing Chronic Disease questionnaire (SEMCD). MAIN OUTCOME MEASURE: Disability was measured using the World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0) questionnaire. RESULTS: The relationship between self-reported functional capacity and disability is partially mediated by self-efficacy. Relationships between WHODAS 2.0 and PEQ-MS (r = -0.61), WHODAS 2.0 and SEMCD (r = -0.51), and PEQ-MS and SEMCD (r = 0.44) were significant (P < .01). Controlling for SEMCD (P = .04), the relationship between PEQ-MS and WHODAS 2.0 remained significant (P < .01). Statistically significant mediation was determined by a bootstrap method for the product of coefficients (95% confidence interval: -2.23, -7.39). CONCLUSIONS: This study provides initial evidence that the relationship between self-reported functional capacity and disability is partially mediated by self-efficacy after dysvascular TTA. The longitudinal effect of self-efficacy should be further examined to identify causal pathways of disability after dysvascular amputation. Furthermore, additional factors contributing to the relationship between self-reported functional capacity and disability need to be identified. LEVEL OF EVIDENCE: III.

Functional Outcomes After the Prosthetic Training Phase of Rehabilitation After Dysvascular Lower Extremity Amputation.

OBJECTIVE: To describe physical function outcomes and modes of physical therapy intervention for a cohort of patients with dysvascular lower extremity amputation (LEA) during the prosthetic training phase of rehabilitation. DESIGN: A retrospective cohort study. SETTING: Physical rehabilitation clinics at a Veterans Affairs medical center and a university hospital. PATIENTS: Forty-two patients (38 men, 4 women, age 60.2 ± 8.4 years) who completed outpatient physical therapy rehabilitation with prosthetic training after dysvascular LEA. METHODS: All patients underwent a prosthetic training phase of rehabilitation, with standardized outcome measures performed at initiation and discharge. MAIN OUTCOME MEASURES: Performance-based physical function measures included Two-Minute Walk (2 MW), Timed-Up and Go (TUG), and 5-meter gait speed. Self-report physical function measures included the Prosthesis Evaluation Questionnaire-Mobility Section (PEQ-MS) and the Patient-Specific Functional Scale. Rehabilitation dose was tracked as total number of clinic visits, rehabilitation duration, and specific intervention modes. RESULTS: There were significant improvements between initial and discharge values (mean ± SD) for the Two-Minute Walk (67.5 ± 29.9 m and 103.3 ± 45.8 m, respectively, P < .001), gait speed (0.58 ± 0.27 m/s and 0.88 ± 0.39 m/s, respectively, P < .001), TUG (34.8 ± 21.3 seconds and 18.6 ± 13.9 seconds, respectively, P < .001), PEQ-MS (2.2 ± 0.9 and 2.8 ± 0.8, respectively, P < .001), and Patient-Specific Functional Scale (3.2 ± 2.0 and 5.9 ± 2.3, respectively, P < .001). Performance-based (TUG) and self-report (PEQ-MS) changes in functional mobility from initial exam to discharge had low or no correlations with rehabilitation dose measures. The number of clinic visits was 12.7 ± 13.1 and rehabilitation duration was 13.7 ± 16.8 weeks. CONCLUSIONS: Significant improvements in performance-based and self-report measures of physical function occurred during the prosthetic training phase of physical rehabilitation after dysvascular major LEA. Despite improvements in function, gait speed, and TUG outcomes remained below clinically important thresholds, indicating patients were limited in community ambulation and at risk for falls. Lack of moderate or greater correlation between rehabilitation dose and outcome measures may indicate the need for more specific rehabilitation dose measures.