Lumbopelvic movement coordination during walking improves with transfemoral bone anchored limbs: Implications for low back pain.

BACKGROUND: Low back pain (LBP) is more prevalent in patients with transfemoral amputation using socket prostheses than able-bodied individuals, in part due to altered spinal loading caused by aberrant lumbopelvic movement patterns. Early evidence surrounding bone-anchored limb functional outcomes is promising, yet it remains unknown if this novel prosthesis influences LBP or movement patterns known to increase its risk. RESEARCH QUESTION: How are self-reported measures of LBP and lumbopelvic movement coordination patterns altered when using a unilateral transfemoral bone-anchored limb compared to a socket prosthesis? METHODS: Fourteen patients with unilateral transfemoral amputation scheduled to undergo intramedullary hardware implantation for bone-anchored limbs due to failed socket use were enrolled in this longitudinal observational cohort study (7 F/7 M, Age: 50.2±12.0 years). The modified Oswestry Disability Index (mODI) (self-reported questionnaire) and whole-body motion capture during overground walking were collected before (with socket prosthesis) and 12-months following bone-anchored limb implantation. Lumbopelvic total range of motion (ROM) and continuous relative phase (CRP) segment angles were calculated during 10 bilateral gait cycles. mODI, total ROM, CRP and CRP variabilities were compared between time points. RESULTS: mODI scores were significantly reduced 12-months after intramedullary hardware implantation for the bone-anchored limb (P = 0.013). Sagittal plane trunk and pelvis total ROM during gait were reduced after implantation (P = 0.001 and P < 0.001, respectively). CRP values were increased (more anti-phase) in the sagittal plane during single limb stance and reduced (more in-phase) in the transverse plane during pre-swing of the amputated limb gait cycle (P << 0.001 and P = 0.029, respectively). No differences in CRP values were found in the frontal plane. SIGNIFICANCE: Decreases in mODI scores and lumbopelvic ROM, paired with the changes in lumbopelvic coordination, indicate that bone-anchored limbs may reduce LBP symptoms and reduce compensatory movement patterns for people with unilateral transfemoral amputation.

Have Surgery and Implant Modifications Been Associated With Reduction in Soft Tissue Complications in Transfemoral Bone-anchored Prostheses?

BACKGROUND: The most frequently occurring adverse events in individuals with a transfemoral amputation treated with a bone-anchored prosthesis are soft tissue infections and stoma-related complications. These soft tissue complications are believed to be influenced by surgical technique and implant design, but little is known about the effect of changes to treatment on these events. QUESTIONS/PURPOSES: (1) What is the result of surgical technique and implant modifications on the incidence of soft tissue infections and stoma-related complications in transfemoral bone-anchored prosthesis users, depending on whether they had a conventional stoma and a cobalt-chrome-molybdenum (CoCrMo) osseointegration implant (treatment period 2009 to 2013) or a shallower stoma and titanium osseointegration implant (2015 to 2018)? (2) What is the incidence of serious complications, such as bone or implant infection, aseptic loosening, intramedullary stem breakage, and periprosthetic fracture? METHODS: Between 2009 and 2013, we performed osseointegration implant surgery using a conventional surgical technique and a CoCrMo implant in 42 individuals who had a lower extremity amputation experiencing socket-related problems that resulted in limited prosthesis use. We considered all individuals treated with two-stage surgery with a standard press-fit transfemoral osseointegration implant as potentially eligible for inclusion. Based on this, 100% (42) were eligible, and 5% (two of 42) were excluded because they did not provide informed consent, leaving 95% (40 of 42) for analysis. Between 2015 and 2018, we treated 79 individuals with similar indications with osseointegration implant surgery, now also treating individuals with dysvascular amputations. We used an adapted surgical technique resulting in a shallower stoma combined with a titanium implant. Using the same eligibility criteria as for the first group, 51% (40 of 79) were eligible; 49% (39 of 79) were excluded because they were treated with transtibial amputation, a patient-specific implant, or single-stage surgery and 1% (one of 79) were lost before the 2-year follow-up interval, leaving 49% (39 of 79) for analysis. The period of 2013 to 2015 was a transitional period and was excluded from analysis in this study to keep groups reasonably comparable and to compare a historical approach with the present approach. Hence, we presented a comparative study of two study groups (defined by surgical technique and implant design) with standardized 2-year follow-up. The risk factors for adverse events were similar between groups, although individuals treated with the shallow stoma surgical technique and titanium implant potentially possessed an increased risk because of the inclusion of individuals with dysvascular amputation and the discontinuation of prolonged postoperative antibiotic prophylaxis. Outcomes studied were soft tissue infections and stoma-related complications (hypergranulation or keloid formation as well as stoma redundant tissue) and bone or implant infection, aseptic loosening, implant stem breakage, periprosthetic fracture, and death. RESULTS: Patients treated with the shallow stoma surgical technique and titanium implant experienced fewer soft tissue infections (13 versus 76 events, absolute risk 0.17 [95% CI 0.09 to 0.30] versus 0.93 [95% CI 0.60 to 1.45]; p < 0.01), which were treated with less invasive measures, and fewer stoma redundant tissue events (0 versus five events, absolute risk 0 versus 0.06 [95% CI 0.03 to 0.14]) than patients treated with the conventional stoma surgical technique and CoCrMo implant. This was contrasted by an increased incidence of surgical site infections occurring between surgical stages 1 and 2, when no stoma was yet created, after the implementation of treatment changes (conventional surgery and CoCrMo implant versus shallow stoma surgery and titanium implant: one versus 11 events, absolute risk 0.01 [95% CI 0.00 to 0.08] versus 0.14 [95% CI 0.08 to 0.25]; p = 0.02). Patients treated with the shallow stoma surgical technique and titanium implant did not experience serious complications, although bone infections occurred (six events in 8% [three of 40] of patients) in the conventional surgery and CoCrMo implant group, all of which were successfully treated with implant retention. CONCLUSION: Adaptations to surgical technique and newer implant designs, as well as learning curve and experience, have resulted in a reduced incidence and severity of soft tissue infections and stoma redundant tissue, contrasted by an increase in surgical site infections before stoma creation. Serious complications such as deep implant infection were infrequent in this 2-year follow-up period. We believe the benefits of these treatment modifications outweigh the disadvantages and currently advise surgeons to create a shallower stoma with a stable soft tissue envelope, combined with a titanium implant. LEVEL OF EVIDENCE: Level III, therapeutic study.

Testing and evaluation of lower limb prosthesis prototypes in people with a transfemoral amputation: a scoping review on research protocols.

BACKGROUND: When developing new lower limb prostheses, prototypes are tested to obtain insights into the performance. However, large variations between research protocols may complicate establishing the potential added value of newly developed prototypes over other prostheses. OBJECTIVE: This review aims at identifying participant characteristics, research protocols, reference values, aims, and corresponding outcome measures used during prosthesis prototype testing on people with a transfemoral amputation. METHODS: A systematic search was done on PubMed and Scopus from 2000 to December 2020. Articles were included if testing was done on adults with transfemoral or knee disarticulation amputation; testing involved walking with a non-commercially available prototype leg prosthesis consisting of at least a knee component; and included evaluations of the participants' functioning with the prosthesis prototype. RESULTS: From the initial search of 2027 articles, 48 articles were included in this review. 20 studies were single-subject studies and 4 studies included a cohort of 10 or more persons with a transfemoral amputation. Only 5 articles reported all the pre-defined participant characteristics that were deemed relevant. The familiarization time with the prosthesis prototype prior to testing ranged from 5 to 10 min to 3 months; in 25% of the articles did not mention the extent of the familiarization period. Mobility was most often mentioned as the development or testing aim. A total of 270 outcome measures were identified, kinetic/kinematic gait parameters were most often reported. The majority of outcome measures corresponded to the mobility aim. For 48% of the stated development aims and 4% of the testing aims, no corresponding outcome measure could be assigned. Results indicated large inconsistencies in research protocols and outcome measures used to validate pre-determined aims. CONCLUSIONS: The large variation in prosthesis prototype testing and reporting calls for the development of a core set of reported participant characteristics, testing protocols, and specific and well-founded outcome measures, tailored to the various aims and development phases. The use of such a core set can give greater insights into progress of developments and determine which developments have additional benefits over the state-of-the-art. This review may contribute as initial input towards the development of such a core set.

Effect of elective neck dissection versus sentinel lymph node biopsy on shoulder morbidity and health-related quality of life in patients with oral cavity cancer: A longitudinal comparative cohort study.

OBJECTIVE: To research the difference in shoulder morbidity and health-related quality of life between patients with cT1-2N0 oral cavity squamous cell carcinoma that undergo either elective neck dissection (END) or a sentinel lymph node biopsy (SLNB) based approach of the neck. MATERIALS AND METHODS: A longitudinal study with measurements before surgery, 6 weeks, 6 months, and 12 months after surgery. Shoulder morbidity were determined with measurements of active range of motion of the shoulder and patient-reported outcomes for shoulder morbidity (SDQ, SPADI) and health-related quality of life (HR-QoL) (EQ5D, EORTC-QLQ-HN35). Linear mixed model analyses were used to analyze differences over time between patients that had END, SLNB or SLNB followed by complementing neck dissection. RESULTS: We included 69 patients. Thirty-three patients were treated with END. Twenty-seven patients had SLNB without complementing neck dissection (SLNB), and nine were diagnosed lymph node positive followed by completion neck dissection (SLNB + ND). Ipsilateral shoulder abduction (P = .031) and forward flexion (P = .039) were significantly better for the SLNB group at 6 weeks post-intervention compared to the END and SLNB + ND group. No significant differences for shoulder morbidity, or health-related quality of life were found at 6 weeks, 6 months, and 12 months between the three groups. CONCLUSION: With oncologic equivalence for the END and SLNB as strategies for the cN0 neck already demonstrated, and the SLNB being more cost-effective, our demonstrated benefit in short-term shoulder function strengthens the choice for the SLNB as a preferred treatment strategy.

Identifying unmet needs and limitations in physical health in survivors of Head and Neck Cancer.

OBJECTIVE: To gain insight into the level of unmet needs and limitations in physical health experienced by survivors of head and neck cancer, and to evaluate whether unmet needs in physical health and limitations in physical performance are associated. MATERIALS AND METHODS: In this cross-sectional study, unmet needs were measured with Supportive Care Needs Surveys (SCNS-SF34, SCNS-HNC). Limitations in physical health were measured for maximal mouth opening, neck and shoulder function, hand grip strength and lower body strength, level of mobility and walking ability. RESULTS: The SCNSs showed that 48% had a cancer generic unmet need and 46% had at least one HNC-specific unmet need. In total, 76% of sHNC had a cancer generic limitation in physical health and that 58% had an HNC-specific limitation in the mobility of neck and shoulders or maximum mouth opening. The domain of physical and daily living needs showed a weak association with lateral flexion of the neck to the left (R = -0.319; p = 0.024). CONCLUSION: Survivors of HNC might benefit from the use of both SCNSs and physical performance measurements during usual care follow-up for early and optimal identification of unmet needs and limitations in physical health.

Reproducibility of measurements on physical performance in head and neck cancer survivors; measurements on maximum mouth opening, shoulder and neck function, upper and lower body strength, level of physical mobility, and walking ability.

BACKGROUND: Survivors of Head and Neck Cancer experience specific problems in functional performance. The aim of this study was to obtain the test-retest reliability of measurements on Maximal Mouth Opening (MMO), shoulder and neck function, lower and upper body strength, level of mobility and walking ability. MATERIALS AND METHODS: Test-retest study design. Measurements on MMO (intra- and extra orally), Active range of motion of shoulders and neck, 30 Seconds Chair Stand Test, Grip Strength, Timed Up and Go test, and Six Minute Walk test. RESULTS: In total 50 participants were included. The mean age was 68.6. ± 9.9 years and median time since end of treatment was 3.0 years (Q1-Q3: 1.0-5.25 years). We found good to excellent test-retest reliability on the core set of measurements (Intraclass Correlation Coefficient (ICC) 0.77 to 0.98). Measurement of MMO with cardboard card, forward flexion shoulder and Six Minute Walk test had a relatively small measurement error (Smallest Detectable Change (SDC) % 5.4% - 15.1%). Measurement of MMO with a caliper, shoulder abduction, shoulder external rotation, later flexion and rotation of the neck, grip strength, 30 Seconds Chair Stand Test, and Timed up and Go test had a relatively large measurement error (SDC% 19.8% - 44.7%). CONCLUSION: This core set of measurements on physical performance is found reliable and therefore able to differentiate in physical performance. The reported measurement errors should be taken into consideration when interpreting the results of repeated measurements. IMPLICATIONS FOR CANCER SURVIVORS: A core set of physical measurements can be used to measure physical performance in survivors of Head and Neck Cancer.

Reproducibility and discriminant validity of two clinically feasible measurement methods to obtain coronal plane gait kinematics in participants with a lower extremity amputation.

INTRODUCTION: Measuring coronal plane gait kinematics of the pelvis and trunk during rehabilitation of participants with a lower extremity amputation is important to detect asymmetries in gait which are hypothesised as associated with secondary complaints. The aim of this study was to test the reproducibility and discriminant validity of a three-dimensional (3-D; inertial measurement units) and a two-dimensional (2-D; video-based) system. METHODS: We tested the test-retest and inter-rater reproducibility of both systems and the 2-D system, respectively, in participants with a lower extremity amputation (group 1) and healthy subjects (group 2). The discriminant validity was determined with a within-group comparison for the 3-D system and with a between-group comparison for both systems. RESULTS: Both system showed to be test-retest reliable, both in group 1 (2-D system: ICC3.1agreement 0.52-0.83; 3-D system: ICC3.1agreement 0.81-0.95) and in group 2 (3-D system: ICC3.1agreement 0.33-0.92; 2-D system: ICC3.1agreement 0.54-0.95). The 2-D system was also inter-rater reliable (group 1: ICC2.1agreement 0.80-0.92; group 2: ICC2.1agreement 0.39-0.90). The within-group comparison of the 3-D system revealed a statistically significant asymmetry of 0.4°-0.5° in group 1 and no statistically significant asymmetry in group 2. The between-group comparison revealed that the maximum amplitude towards the residual limb (MARL) in the low back (3-D system) and the (residual) limb-trunk angle (2-D system) were significantly larger with a mean difference of 1.2° and 6.4°, respectively, than the maximum amplitude of healthy subjects. However, these average differences were smaller than the smallest detectable change (SDC) of group 1 for both the MARL (SDCagreement: 1.5°) and the residual limb-trunk angle (SDCagreement: 6.7°-7.6°). CONCLUSION: The 3-D and 2-D systems tested in this study were not sensitive enough to detect real differences within and between participants with a lower extremity amputation and healthy subjects although promising reproducibility parameters for some of the outcome measures.

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.

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.

Complications of bone-anchored prostheses for individuals with an extremity amputation: A systematic review.

BACKGROUND: This study aimed to provide an overview of device-related complications occurring in individuals with an upper or lower extremity amputation treated with a screw, press-fit or other type of bone-anchored implant as well as interventions related to these complications. METHOD: A systematic literature search was conducted in the MEDLINE, Cochrane, EMBASE, CINAHL and Web of Science databases. The included studies reported on device-related complications and interventions occurring in individuals with bone-anchored prostheses. The outcomes evaluated were death, infection, bone/device breakage, implant loosening, soft tissue complications, systemic events, antibiotic and surgical treatment. Subgroup analyses were performed for the following groups: a) implant type (screw, press-fit and other types of implants) and b) level of amputation (transfemoral, transtibial and upper extremity amputation). RESULTS: Of 309 studies, 12 cohort studies were eligible for inclusion, all of which had methodological shortcomings and 12 studies were excluded due to complete overlap of patient data. Implant infection were rare in certain transfemoral implants (screw: 2-11%, press-fit: 0-3%, Compress: 0%) but common in transtibial implants (29%). The same was observed for implant loosening, in transfemoral (screw: 6%, press-fit: 0-3%, Compress: 0%), transtibial implants (29%) as well as for upper extremity implants (13-23%). Intramedullary device breakage were rare in transfemoral implants (screw: 0%, press-fit: 1%, Compress: unknown) but frequent in individuals with transradial implants (27%) and absent in transtibial implants. Soft tissue infections and complications were common and underreported in most articles. CONCLUSIONS: Major complications (e.g. implant infection, implant loosening and intramedullary device breakage) are rare in transfemoral bone-anchored prosthesis and seem to occur less frequently in individuals with press-fit implants. Minor complications, such as soft tissue infections and complications, are common but are substantially influenced by the learning curve, implant design and surgical technique. Data for patients treated with a transtibial, upper extremity or Compress implant are underreported, precluding definitive conclusions. There is a need for either an international database to report on or a standard core set of complications as well as the need to follow classification systems that result in unequivocal data.

[Osseointegration click-on prosthesis following leg amputation]. / Osseo-integratieklikprothese bij beenamputatie.

Since its introduction in 2009, more than 150 people in the Netherlands have received an osseointegration prosthesis following leg amputation. Serious complications such as septic or aseptic loosening and breakage of the implant are rare. In this article we highlight the results so far, the indications and contra-indications, our first experiences with patients who have undergone amputation due to vascular disease, and the future of osseointegration treatment in the Netherlands.

Gait symmetry and hip strength in women with developmental dysplasia following hip arthroplasty compared to healthy subjects: A cross-sectional study.

INTRODUCTION: Untreated unilateral developmental dysplasia of the hip (DDH) results in asymmetry of gait and hip strength and may lead to early osteoarthritis, which is commonly treated with a total hip arthroplasty (THA). There is limited knowledge about the obtained symmetry of gait and hip strength after the THA. The objectives of this cross-sectional study were to: a) identify asymmetries between the operated and non-operated side in kinematics, kinetics and hip strength, b) analyze if increased walking speed changed the level of asymmetry in patients c) compare these results with those of healthy subjects. METHODS: Women (18-70 year) with unilateral DDH who had undergone unilateral THA were eligible for inclusion. Vicon gait analysis system was used to collect frontal and sagittal plane kinematic and kinetic parameters of the hip joint, pelvis and trunk during walking at comfortable walking speed and increased walking speed. Furthermore, hip abductor and extensor muscle strength was measured. RESULTS: Six patients and eight healthy subjects were included. In the patients, modest asymmetries in lower limb kinematics and kinetics were present during gait, but trunk lateral flexion asymmetry was evident. Patients' trunk lateral flexion also differed compared to healthy subjects. Walking speed did not significantly influence the level of asymmetry. The hip abduction strength asymmetry of 23% was not statistically significant, but the muscle strength of both sides were significantly weaker than those of healthy subjects. CONCLUSIONS: In patients with a DDH treated with an IBG THA modest asymmetries in gait kinematics and kinetics were present, with the exception of a substantial asymmetry of the trunk lateral flexion. Increased walking speed did not result in increased asymmetries in gait kinematics and kinetics. Hip muscle strength was symmetrical in patients, but significantly weaker than in healthy subjects. Trunk kinematics should be included as an outcome measure to assess the biomechanical benefits of the THA surgery after DDH.

Clinimetric properties of hip abduction strength measurements obtained using a handheld dynamometer in individuals with a lower extremity amputation.

INTRODUCTION: Suitable handheld dynamometer (HHD)-techniques to test hip abduction strength in individuals with a lower extremity amputation, irrespective of their amputation level are absent. The aim of this study was to optimise a HHD-technique and to test its reproducibility and validity. METHODS: This study involved three phases, in which two techniques were evaluated. Both HHD-techniques used a lever-arm of 22 centimetre. HHD-technique 1 used a break-technique. After obtaining within-session test-retest reproducibility (phase 1) we optimised the HHD-technique by adding a fixation-belt and using a make-technique (HHD-technique 2). We tested the within-session test-retest and inter-rater reproducibility (phase 2) and the validity (phase 3) of HHD-technique 2 using an isokinetic dynamometer. New cohorts of participants were recruited for each phase. RESULTS: Phase 1: we tested HHD-technique 1 in 26 participants with a lower extremity amputation. It was test-retest reproducible (ICC3.1agreement: 0.80-0.92, standard error of measurement (SEM): 3.1-4.4 Nm and smallest detectable change (SDC): 8.6-12.3 Nm). There were questions regarding the validity of the measurement, because the mean muscle torque of the residual limb and sound limb were similar, which is uncommon. Phase 2: reproducibility of HHD-technique 2 was tested in 44 participants with a lower extremity amputation. It was test-retest reproducible (ICC3.1agreement: 0.96-0.97, SEM: 3.9-4.7 Nm and SDC: 10.9-12.9 Nm) but not inter-rater reproducible despite having good reliability (ICC3.1agreement: 0.92, SEM: 6.9-7.6 Nm and SDC: 19.2-21.2 Nm). Systematic bias and bias related to the magnitude of the muscle torque was suspected. Phase 3: the concurrent validity was established in 30 healthy participants (r = 0.84). Systematic bias in measurement error was present, including a consistent overestimation of the muscle torque of 28% using the HHD. CONCLUSION: HHD-technique 2 is a test-retest reproducible and valid measuring technique The technique may be further optimised by the use of an external device to stabilise the HHD.

Gait rehabilitation for a patient with an osseointegrated prosthesis following transfemoral amputation.

BACKGROUND: In patients with a transfemoral amputation socket-related problems are associated with reduced prosthetic use, activity, and quality of life. Furthermore, gait asymmetries are present that may explain secondary complaints. Bone-anchored prostheses (BAPs) may help these patients. Two types of BAP are available, screw and press-fit implants. Rehabilitation following surgery for a press-fit BAP is poorly described. PURPOSE: To describe a rehabilitation program designed to minimize compensation strategies and increase activity using a case-report of an active, 70-year-old man with a traumatic transfemoral amputation who had used a socket prosthesis for 52 years and received a press-fit BAP [Endo-Exo Femoral Prosthesis - EEFP]. INTERVENTION: A 13-week physiotherapy program. OUTCOMES: Outcomes were assessed before surgery, at the end of rehabilitation, and six-month and one-year follow-ups. After rehabilitation gait had improved, the patient had more arm movement, more pelvic shift, less hip rotation during swing phase on the prosthetic side, and absence of vaulting on the sound side. Isometric hip abductor strength was 15% higher on the sound side and 16% higher on the prosthetic side, and walking distance increased from 200 m to 1500 m. At the six-month follow-up, the patient had lower back complications and reduced hip abductor strength and walking distance. At one-year follow-up, walking distance had recovered to 1000 m and gait pattern had improved again, with yielding and absence of terminal impact on the prosthetic side. CONCLUSION: The described rehabilitation program may be an effective method of improving gait in patients with an EEFP even after long-term socket usage.

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.

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.