Functional performance and safety of bone-anchored prostheses in persons with a transfemoral or transtibial amputation: a prospective one-year follow-up cohort study.

OBJECTIVES:: (1) To compare level of function, activity, health-related quality of life (HRQoL) and satisfaction in persons with a lower extremity amputation before surgery and 6- and 12-months after implantation of an osseointegration implant and (2) to report adverse events. DESIGN:: Prospective cohort study. SETTING:: University medical centre. SUBJECTS:: A total of 40 consecutive persons (median age: 56 years) who received a transfemoral (31) or transtibial (9) osseointegration implant, between April 2014 and March 2016. INTERVENTION:: Osseointegration implant surgery followed by a predefined rehabilitation programme. MAIN MEASURES:: Hip abductor strength, prosthetic use, back pain frequency, postoperative pain, mobility level (Timed-Up and Go (TUG) and wheelchair-boundedness), walking ability (6 minute walking test (6MWT) and walking distance in daily life), HRQoL, satisfaction regarding the prosthesis, and adverse events. RESULTS:: Strength, prosthetic use, walking distance, HRQoL, and satisfaction level increased significantly at 6- and 12-month follow-up compared to baseline ( P ⩽ 0.002). The TUG showed no change at 6-month follow-up ( P = 0.420) but improved significantly at 12-month follow-up compared to baseline ( P = 0.005). Wheelchair-boundedness decreased from 12/40 participants at baseline to 0 at follow-ups. The 6MWT ( P ⩾ 0.038) and back pain ( P ⩾ 0.437) did not change over time. Stump pain was present in 28/39 and 22/40 of the participants at 6-and 12-month follow-up, respectively. The major adverse events were managed successfully and included three dual-cone breakages and four bone fractures. An uneventful course was completed by 19/31 transfemoral and 4/9 transtibial bone-anchored prostheses users. CONCLUSION:: Bone-anchored prostheses lead to improved performance and appear to be safe, so they might be considered for persons with socket-related problems.

Long-term outcomes following lower extremity press-fit bone-anchored prosthesis surgery: a 5-year longitudinal study protocol.

BACKGROUND: Patients with lower extremity amputation frequently suffer from socket-related problems. This seriously limits prosthesis use, level of activity and health-related quality of life (HRQoL). An additional problem in patients with lower extremity amputation are asymmetries in gait kinematics possibly accounting for back pain. Bone-anchored prostheses (BAPs) are a possible solution for socket-related problems. Knowledge concerning the level of function, activity and HRQoL after surgery is limited. The aims of this ongoing study are to: a) describe changes in the level of function, activity, HRQoL and satisfaction over time compared to baseline before surgery; b) examine potential predictors for changes in kinematics, prosthetic use, walking ability, HRQoL, prosthesis comfort over time and level of stump pain at follow-up; c) examine potential mechanisms for change of back pain over time by identifying determinants, moderators and mediators. METHODS/DESIGN: A prospective 5-year longitudinal study with multiple follow-ups. All adults, between May 2014 and May 2018, with lower extremity amputation receiving a press-fit BAP are enrolled consecutively. Patients with socket-related problems and trauma, tumour resection or stable vascular disease as cause of primary amputation will be included. Exclusion criteria are severe cognitive or psychiatric disorders. Follow-ups are planned at six-months, one-, two- and five-years after BAP surgery. The main study outcomes follow, in part, the ICF classification: a) level of function defined as kinematics in coronal plane, hip abductor strength, prosthetic use, back pain and stump pain; b) level of activity defined as mobility level and walking ability; c) HRQoL; d) satisfaction defined as prosthesis comfort and global perceived effect. Changes over time for the continuous outcomes and the dichotomized outcome (back pain) will be analysed using generalised estimating equations (GEE). Multivariate GEE will be used to identify potential predictors for change of coronal plane kinematics, prosthetic use, walking ability, HRQoL, prosthesis comfort and for the level of post-operative stump pain. Finally, potential mechanisms for change in back pain frequency will be explored using coronal plane kinematics as a potential determinant, stump pain as moderator and hip abductor strength as mediator. DISCUSSION: This study may identify predictors for clinically relevant outcome measures. TRIAL REGISTRATION: NTR5776 . Registered 11 March 2016, retrospectively registered.

Walking ability and quality of life in subjects with transfemoral amputation: a comparison of osseointegration with socket prostheses.

OBJECTIVE: To investigate walking ability and quality of life of osseointegrated leg prostheses compared with socket prostheses. DESIGN: Prospective case-control study. SETTING: University medical center. PARTICIPANTS: Subjects (N=22) with transfemoral amputation (1 bilateral) referred to our center because of socket-related skin and residual limb problems resulting in limited prosthesis use. Their mean age was 46.5 years (range, 23-67y) and mean time since amputation was 16.4 years (range, 2-45y). Causes of amputation were trauma (n=20) and tumor (n=2). INTERVENTION: Implantation of an osseointegration prosthesis (OIP). MAIN OUTCOME MEASURES: Global score of the Questionnaire for Persons With a Transfemoral Amputation (Q-TFA), prosthesis use, 6-minute walk test (6MWT), Timed Up & Go (TUG) test, and oxygen consumption during treadmill walking. RESULTS: With the socket prosthesis, the mean ± SD Q-TFA global score, prosthesis use, 6MWT, TUG, and oxygen consumption were 39±4.7 points, 56±7.9h/wk, 321±28m, 15.1±2.1 seconds, and 1330±310mL/min, respectively, and significantly improved with OIP to 63±5.3 points, 101±2.4h/wk, 423±21m, 8.1±0.7 seconds, and 1093±361mL/min, respectively. CONCLUSIONS: Osseointegration is a suitable intervention for persons whose prosthesis use is reduced because of socket-related problems. Subjects with OIP significantly increased their walking ability and prosthesis-related quality of life.

A clinical prediction rule for ambulation outcomes after traumatic spinal cord injury: a longitudinal cohort study.

BACKGROUND: Traumatic spinal cord injury is a serious disorder in which early prediction of ambulation is important to counsel patients and to plan rehabilitation. We developed a reliable, validated prediction rule to assess a patient's chances of walking independently after such injury. METHODS: We undertook a longitudinal cohort study of adult patients with traumatic spinal cord injury, with early (within the first 15 days after injury) and late (1-year follow-up) clinical examinations, who were admitted to one of 19 European centres between July, 2001, and June, 2008. A clinical prediction rule based on age and neurological variables was derived from the international standards for neurological classification of spinal cord injury with a multivariate logistic regression model. Primary outcome measure 1 year after injury was independent indoor walking based on the Spinal Cord Independence Measure. Model performances were quantified with respect to discrimination (area under receiver-operating-characteristics curve [AUC]). Temporal validation was done in a second group of patients from July, 2008, to December, 2009. FINDINGS: Of 1442 patients with spinal cord injury, 492 had available outcome measures. A combination of age (<65 vs ≥65 years), motor scores of the quadriceps femoris (L3), gastrocsoleus (S1) muscles, and light touch sensation of dermatomes L3 and S1 showed excellent discrimination in distinguishing independent walkers from dependent walkers and non-walkers (AUC 0·956, 95% CI 0·936-0·976, p<0·0001). Temporal validation in 99 patients confirmed excellent discriminating ability of the prediction rule (AUC 0·967, 0·939-0·995, p<0·0001). INTERPRETATION: Our prediction rule, including age and four neurological tests, can give an early prognosis of an individual's ability to walk after traumatic spinal cord injury, which can be used to set rehabilitation goals and might improve the ability to stratify patients in interventional trials. FUNDING: Internationale Stiftung für Forschung in Paraplegie.

Magnetic-resonance-imaging-based three-dimensional muscle reconstruction of hip abductor muscle volume in a person with a transfemoral bone-anchored prosthesis: A feasibility study.

BACKGROUND: Persons with transfemoral amputation typically have severe muscle atrophy of the residual limb. The effect of bone-anchored prosthesis use on existing muscle atrophy is unknown. A potentially feasible method to evaluate this is magnetic resonance imaging (MRI)-based three-dimensional (3D) muscle reconstruction. We aimed to (1) examine the feasibility of MRI-based 3D muscle reconstruction technique in a person with a cobalt-chrome-molybdenum transfemoral bone-anchored prosthesis; and (2) describe the change of hip abductor muscle volume over time. METHODS: In this single case, 1-year follow-up study we reconstructed the 3D hip abductor muscle volumes semiautomatically from MRI scans at baseline, 6- and 12-month follow-up. The number of adverse events, difficulties in data analysis, time investment and participants' burden determined the level of feasibility. RESULTS: We included a man (70 years) with a transfemoral amputation who received a bone-anchored prosthesis after 52 years of socket prosthesis use. No adverse events occurred. The accuracy of the 3D reconstruction was potentially reduced by severe adipose tissue interposition. Data analysis was time-intensive (115 h). Participants' burden was limited to 3-h time investment. Compared to baseline, the total hip abductor volume of both the residual limb (6 month: 5.5%; 12 month: 7.4%) and sound limb (6 month: 7.8%; 12 month: 5.5%) increased. CONCLUSION: The presented technique appears feasible to follow muscle volume changes over time in a person with a cobalt-chrome-molybdenum transfemoral bone-anchored prosthesis in an experimental setting. Future research should focus on analysis of muscle tissue composition and the feasibility in bone-anchored prostheses of other alloys.

Comparison of bone-anchored prostheses and socket prostheses for patients with a lower extremity amputation: a systematic review.

PURPOSE: This study aimed to provide an overview of a) the used measurement instruments in studies evaluating effects on quality of life (QoL), function, activity and participation level in patients with a lower extremity amputation using bone-anchored prostheses compared to socket prostheses and b) the effects themselves. METHOD: A systematic literature search was conducted in MEDLINE, Cochrane, EMBASE, CINAHL and Web of Science. Included studies compared QoL, function, activity and/or participation level in patients with bone-anchored or socket prostheses. A best-evidence synthesis was performed. RESULTS: Out of 226 studies, five cohort and two cross-sectional studies were eligible for inclusion, all had methodological shortcomings. These studies used 10 different measurement instruments and two separate questions to assess outcome. Bone-anchored prostheses were associated with better condition-specific QoL and better outcomes on several of the physical QoL subscales, outcomes on the physical bodily pain subscale were inconclusive. Outcomes on function and activity level increased, no change was found at participation level. The level of evidence was limited. CONCLUSIONS: There is a need for a standard set of instruments. There was limited evidence that bone-anchored prostheses resulted in higher QoL, function and activity levels than socket prostheses, in patients with socket-related problems. Implications for Rehabilitation Use of bone-anchored prostheses in combination with intensive outpatient rehabilitation may improve QoL, function and activity level compared with socket prosthesis use in patients with a transfemoral amputation and socket-related problems. All clinicians and researchers involved with bone-anchored prostheses should use and publish data on QoL, function, activity and participation level. There needs to be an agreement on a standard set of instruments so that interventions for patients with a lower extremity amputation are assessed consistently.

Safety of "pain exposure" physical therapy in patients with complex regional pain syndrome type 1.

"Pain exposure" physical therapy (PEPT) is a new treatment for patients with complex regional pain syndrome type 1 (CRPS-1) that consists of a progressive-loading exercise program and management of pain-avoidance behavior without the use of specific CRPS-1 medication or analgesics. The aim of this study was to investigate primarily whether PEPT could be applied safely in patients with CRPS-1. Twenty patients with CRPS-1 were consecutively enrolled in the study after giving informed consent. The diagnosis of CRPS-1 was defined using the Bruehl and Harden/IASP diagnostic criteria. CRPS-1 was diagnosed between 3 and 18 months after the inciting event (trauma). According to a multiple single-case design (baseline [A1], treatment [B], follow-up [A2]), multiple baseline and follow-up measurements were performed to evaluate changes in CRPS signs and symptoms and to assess functional parameters. When comparing the baseline with the follow-up phase, patients improved significantly with respect to pain on the visual analogue scale (57%), pain intensity (48%), muscle strength (52%), arm/shoulder/hand disability (36%), 10-meter walking speed (29%), pain disability index (60%), kinesiophobia (18%), and the domains of perceived health change in the SF-36 survey (269%). Three patients initially showed increased vegetative signs but improved in all other CRPS parameters and showed good functional recovery at follow-up. We conclude that PEPT is a safe and effective treatment for patients with CRPS-1. A progressive-loading exercise program and management of pain-avoidance behavior without the use of specific medication ("pain exposure" physical therapy) is safe and effective for patients with complex regional pain syndrome.

Severe degeneration of peripheral motor axons after spinal cord injury: a European multicenter study in 345 patients.

OBJECTIVE: There are indications that perilesional and remote peripheral motor axons may degenerate after spinal cord injury (SCI). The authors investigated the magnitude and dependence on severity of SCI of this degeneration as well as whether motor axons so affected can recover. METHODS: The function of the peripheral motor axons was investigated by recording compound muscle action potentials (CMAPs) in 345 patients with cervical SCI. CMAP amplitude changes in the abductor digiti minimi (ADM) and abductor hallucis (AH) muscles were investigated in 3 groups with SCIs of differing severity: patients with permanent complete SCI (ASIA Impairment Scale [AIS] A-remain), patients with initially complete SCI converting to incomplete lesion (AIS A-convert), and patients with incomplete injury (Incomplete). RESULTS: Significant decreases in ADM and AH CMAP amplitudes were found in groups A-remain and A-convert. In group A-remain and group A-convert, the authors found a partial, although significant, recovery of ADM CMAP amplitude occurring between 5 and 12 months postinjury. In group A-remain, they found significant recovery of the AH CMAP amplitude. CONCLUSION: Following SCI, peripheral motor axons below the level of the lesion exhibit severe degeneration. There is partial, although significant, recovery of CMAP during the second half year following SCI. The observed motor axon dysfunction is likely a result of transsynaptic degeneration. The peripheral motor axon dysfunction observed after SCI is of sufficient magnitude that it may affect muscle power and thus contribute to impairment of recovery of functional activities in patients with SCI.

Study of the human pelvis using CAT-scan: gender differences and anatomy of the ramus ossis ischii.

OBJECTIVE: In a descriptive study we present the CAT-scan norm data of pelvic sizes in Caucasian men and women. The study was performed to investigate possible differences in pelvic sizes between men and women and the inter-individual range of pelvic sizes. The data may be useful as a guide in the development of orthoses and prostheses. METHODS: Pelvis CAT-scans of 40 subjects, 20 males (23-66 years) and 20 females (20-72 years) were investigated. The research was approved by the regional ethics committee. RESULTS: The angle of the ramus ossis ischii (ROI) with the line of progression in the transverse plane (angle a) was 38.6 degrees (SD 3.4) in females and 31.8 degrees (SD 4.4) in males. This difference was statistically significant (Student's t-test (p < 0.0001). The ROI angle in the coronal plane (angle b) was negative or zero both in males and females. The horizontal distance between the medial border of the ROI and the lateral border of the femur (RF distance) was slightly smaller in females (95 mm) compared to males (107 mm), but this difference was not statistically significant. The distance between the midfemoral line and the anterior surface of the leg was also slightly smaller in females (89 mm) than in males (106 mm) but the difference was not statistically significant. We found a linear relation between the total AP soft tissue distance and the soft tissue circumference of the proximal leg at the level of the ROI. CONCLUSION: There are significant gender differences in pelvic size and shape. The medial plane of the ROI is not in a slight angle of inclination towards the midline but appears to be zero. The medial contour of the ROI in the AP direction is slightly curved.