Dexterity, activity performance, disability, quality of life, and independence in upper limb Veteran prosthesis users: a normative study.

PURPOSE: To present population data on standardized measures of dexterity, activity performance, disability, health-related quality of life (HRQoL) and community integration for persons with upper limb amputation (ULA), compare outcomes to normative values, and examine differences by prosthesis type and laterality (unilateral vs. bilateral amputation). MATERIALS AND METHODS: Multi-site, cross-sectional design, with in-person evaluations, functional performance, and self-report measures. Descriptive and comparative analyses were performed by amputation level and prosthesis type, data were compared for unilateral and bilateral amputation. RESULTS: One hundred and twenty-seven individuals participated; mean age 57 years, 59% percent body-powered prostheses users. All measures of dexterity differed (p < 0.05) by amputation level and by laterality. All measures of activity differed by amputation level with the best scores in transradial (TR) amputation groups. Comparisons of body-powered users with TR amputation found that dexterity was better for those with bilateral compared to unilateral amputation. CONCLUSIONS: Dexterity is markedly impaired in persons with ULA. Individuals with more proximal ULA levels are most impacted. HRQoL and community participation are less impacted and more equivalent to unimpaired persons. Further research is needed to examine differences by terminal device type and determine how best to match persons with ULA to the optimal prosthesis type and componentry, based on individual characteristics.Implications for RehabilitationThis study provides population-based, comparative data on dexterity, activity performance, disability, quality of life, and independence in upper limb prosthesis users.The study provides preliminary analyses comparing the effectiveness of body-powered devices, myoelectric devices with single degree of freedom and multi-degree of freedom terminal devices.The data presented in this study can be used to benchmark outcomes in patients who are upper limb prosthesis users.The data will also be useful to inform comparative evaluations of existing and emerging prosthetic technology.

Upper limb prosthesis users: A longitudinal cohort study.

BACKGROUND: No previous studies have followed prosthesis users with upper limb loss or limb deficiency using their own prostheses to assess change over time. OBJECTIVES: (1) To describe prostheses and terminal device types used at baseline and 1-year follow-up; (2) to examine changes in functional outcomes and device satisfaction over time; and (3) to examine whether changes in outcomes varied across level of amputation and type of prosthesis used. STUDY DESIGN: Multisite, observational time series design with in-person functional performance and self-report data collected at baseline and 1-year follow-up. METHODS: Baseline and follow-up outcome scores were compared using Wilcoxon signed-rank tests. Analyses were stratified by amputation level, time since amputation, prosthesis type, and change in device type. Published minimal detectable change (MDC) values were used to determine whether detectable change in outcome measures occurred. RESULTS: The longitudinal cohort consisted of 64 participants (mean age 64 years, 56% body-powered users). The only significant differences in outcome measures between baseline and follow-up (after adjustment for false discovery) were hours/day of prosthesis use, which increased from 6.0 (4.4) to 7.3 (5.3) hours (P = 0.0022). Differences in prosthesis use intensity remained significant in analyses stratified by amputation level, time since amputation, prosthesis type, and change in device type. Between 14 and 20% of the sample had change in one or more outcome measures that was greater than the known MDC. CONCLUSIONS: Most participants had stable outcomes over a year's time, whereas 14-20% experienced either improvement or decline in one or more tests indicating the importance of annual follow-up visits.

DuraSeal Exact Is a Safe Adjunctive Treatment for Durotomy in Spine: Postapproval Study.

STUDY DESIGN: A nonrandomized, two-armed prospective study. OBJECTIVE: Water-tight dural closure is paramount to the prevention of cerebrospinal fluid (CSF) leakage and associated complications. Synthetic polyethylene glycol (PEG) hydrogel has been used as an adjunct to sutured dural repair; however, its expansion postoperatively is a concern for neurological complications. A low-swell formulation of PEG sealant was introduced as DuraSeal Exact Spine Sealant System (DESS). A Post-Approval Study was performed primarily to evaluate the safety and efficacy of DESS for spinal dural repair compared to current alternatives, in a large patient population, reflecting a real-world practice. METHODS: A total of 36 sites in the United States enrolled 429 patients treated with DESS as an adjunct to dural repair in the spinal sealant group and 406 patients treated with all other modalities in the control arm, from October 2011 to June 2016. The primary endpoint was the incidence of CSF leak within 90 days of operation. The secondary endpoints evaluated were deep surgical site infection and neurological serious adverse events. RESULTS: The CSF leakage in the DESS group (6.6%) was not significantly different from the control group (6.5%) (p = .83), and there was no significant difference in the time to first leak. The two groups had no significant differences in deep surgical site infection (1.6% versus control 2.1%, p = .61) or proportion of subjects with neurological serious adverse events (2.9% versus control 1.6%, p = .516). CONCLUSIONS: DuraSeal Exact Spinal Sealant is safe when compared to current alternatives for spinal dural repair.

Clinical outcomes with selectively constrained SECURE-C cervical disc arthroplasty: two-year results from a prospective, randomized, controlled, multicenter investigational device exemption study.

STUDY DESIGN: Prospective, multicenter, randomized, and controlled Investigational Device Exemption clinical trial. OBJECTIVE: To compare the clinical safety and effectiveness of the selectively constrained SECURE-C (Globus Medical, Audubon, PA) Cervical Artificial Disc to anterior cervical discectomy and fusion (ACDF). SUMMARY OF BACKGROUND DATA: Cervical total disc replacement has been developed as an alternative to ACDF by allowing segmental motion. Current cervical total disc replacement designs incorporate constrained and unconstrained metal-on-metal or metal-on-polymer articulating designs with various means of fixation. METHODS: A total of 380 patients from 18 investigational sites were prospectively enrolled in the study. Patients were randomized, treated surgically, and evaluated postoperatively at 6 weeks, 3 months, 6 months, 12 months, and 24 months. Clinical outcomes include overall success, visual analogue scale pain (right arm, left arm, and neck), neck disability index, neurological status, Short Form 36 (SF-36) Health Status Survey questionnaires, range of motion, and adverse events. Bayesian statistical methods were used to analyze the outcomes. RESULTS: Overall success results demonstrated statistical superiority of the randomized SECURE-C group compared with the randomized ACDF group at 24 months, with a posterior probability of 100% using the protocol-specified criteria and 98.1% using Food and Drug Administration-defined criteria. At 24 months postoperatively, SECURE-C demonstrated clinically significant improvement in pain and function in terms of neck disability index, visual analogue scale, and 36-Item Short Form Health Survey. At 24 months, the percentage of patients experiencing secondary surgical interventions at the index level was statistically lower for the SECURE-C group (2.5%) than the ACDF group (9.7%). At 24 months, 84.6% of as-treated SECURE-C patients were range-of-motion successes. Satisfaction was high among SECURE-C patients. CONCLUSION: The selectively constrained SECURE-C Cervical Artificial Disc is as safe and effective as the standard of care, an anterior cervical discectomy and fusion. SECURE-C is statistically superior in terms of overall success, index-level subsequent surgical procedures, and patient satisfaction, making it an attractive surgical option for patients with symptomatic cervical disc disease. LEVEL OF EVIDENCE: 1.

Treatment of cervical stenotic myelopathy: a cost and outcome comparison of laminoplasty versus laminectomy and lateral mass fusion.

OBJECT: Cervical stenotic myelopathy due to spondylosis or ossification of the posterior longitudinal ligament is often treated with laminoplasty or cervical laminectomy (with fusion). The goal of this study was to compare outcomes, radiographic results, complications, and implant costs associated with these 2 treatments. METHODS: The authors analyzed the records of 56 patients (age range 42­81 years) who were surgically treated for cervical stenosis. Of this group, 30 underwent laminoplasty and 26 underwent laminectomy with fusion. Patients who had cervical kyphosis or spondylolisthesis were excluded. An average of 4 levels were instrumented in the laminoplasty group and 5 levels in the fusion group (p < 0.01). Forty-two percent of the fusions crossed the cervicothoracic junction, but no laminoplasty instrumentation crossed the cervicothoracic junction, and it only reached C-7 in one-third of the cases. Preoperative and postoperative Nurick grades and modified Japanese Orthopaedic Association (mJOA) scores were obtained. Outcomes were also assessed with neck pain visual analog scale (VAS) scores and the Odom outcome criteria. Postoperative length of stay, complications, and implant costs were calculated. RESULTS: The mean duration of follow-up, average patient age, and length of hospital stay were similar for both groups. The mean Nurick scores were also similar in the 2 groups and improved an average of 1.4 points in both (p < 0.01 for preoperative-postoperative comparison in each group). The mean mJOA scores improved 2.7 points in laminoplasty patients and 2.8 points in fusion patients (p < 0.01 for each group). The mean VAS scores for neck pain did not change significantly in the laminoplasty cohort (3.2 ± 2.8 [SD] preoperatively vs 3.4 ± 2.6 postoperatively, p = 0.50). In the fusion cohort, the mean VAS scores improved from 5.8 ± 3.2 to 3.0 ± 2.3 (p < 0.01). Excellent or good Odom outcomes were observed in 76.7% of the patients in the laminoplasty cohort and 80.8% of those in the fusion cohort (p = 0.71). In the fusion group, complications were twice as common and implant costs were nearly 3 times as high as in the laminoplasty group. When cases involving fusions crossing the cervicothoracic junction were excluded, analysis showed similar complication rates in the 2 groups. CONCLUSIONS: Patients treated with laminoplasty and patients treated with laminectomy and fusion had similar improvements in Nurick scores, mJOA scores, and Odom outcomes. Patients who underwent fusion typically had higher preoperative neck pain scores, but their neck pain improved significantly after surgery. There was no significant change in the neck pain scores of patients treated with laminoplasty. Our series suggests cervical fusion significantly reduces neck pain in patients with stenotic myelopathy, but that the cost of the implant and rate of reoperation are greater than in laminoplasty.

Biomechanical rigidity of an all-polyetheretherketone anterior thoracolumbar spinal reconstruction construct: an in vitro corpectomy model.

BACKGROUND CONTEXT: Polyetheretherketone (PEEK) is gaining favor as a spinal implant material for interbody and corpectomy cages as well as stabilizing rods. However, there has been little correlation to a relevant and reproducible clinical model. Biomechanical data on PEEK rod constructs have not been reported. PURPOSE: To quantify the stabilizing effects of PEEK versus titanium (Ti) instrumentation in a thoracolumbar corpectomy model. STUDY DESIGN: Corpectomy and randomized instrumentation with an all-Ti, all-PEEK, and hybrid cage/rod construct were performed on cadaveric spines to assess biomechanical differences. METHODS: Pure unconstrained bending moments were applied to the intact spine and subsequent test constructs in the three physiologic planes using a load control protocol. Motion tracking and analysis were carried out to quantify and compare the range of motion (ROM) between different test constructs in each plane. RESULTS: Flexion ROM did not show significant changes compared with intact, whereas the all-Ti and hybrid construct reduced ROM significantly in extension. Lateral bending was significantly reduced in all the treatment groups. Rotational stability of the construct was significantly compromised by an all-PEEK spinal construct. CONCLUSION: The rigidity of the corpectomy construct increased as the amount of Ti in the construct increased. A hybrid construct incorporating a PEEK corpectomy cage and Ti rods may provide adequate stability for an anterior thoracolumbar reconstruction in the sagittal and coronal planes. An all-PEEK construct may provide adequate stability in the coronal and sagittal planes but may compromise the stability significantly in axial rotation. Consideration should be given for supplemental posterior instrumentation if an all-PEEK construct is used in an anterior thoracolumbar spinal reconstruction procedure.

Reduction of hypoxia by perfluorocarbon emulsion in a traumatic spinal cord injury model.

OBJECT: Few therapies have consistently demonstrated effectiveness in preserving O2 delivery after spinal cord injury (SCI). Perfluorocarbons (PFCs) offer great promise to carry and deliver O2 more efficiently than conventional measures. The authors investigated the use of Clark-type microelectrodes to monitor spinal cord oxygenation directly (intraparenchymal [IP] recording) and indirectly (cerebrospinal fluid [CSF] recording) in the context of SCI, O2 therapy, and PFC treatment. METHODS: After placement of a subdural/CSF Licox probe in rats, incremental increases in the fraction of inspired O2 (FiO2) up to 100% were administered to establish a dose-response curve. The probe was then placed in the parenchyma of the same animals for a second dose-response curve. In a second study, rats with CSF or IP probes underwent SCI with the NYU Impactor and treatment with O2, followed by administration of PFC, or saline in the control group. RESULTS: All animals in the first experiment responded to the FiO2 dose increase, with changes in PO2 evident in both CSF and IP levels. The SCI in the second experiment caused a marked drop in PO2 from a mean of 21.4 to 10.4 mm Hg, with most animals dropping to less than half their preinjury value. All animals responded to 100% O2 treatment. Every animal that received PFCs showed significant improvement, with a mean increase in PO2 of 23.3 mm Hg. Only 1 saline-treated animal showed any benefit. Oxygen values in the PFC treatment group reached up to 6 times the normal level. CONCLUSIONS: Oxygen levels in SCI show a profound drop almost immediately postinjury. Administration of PFCs combined with 100% O2 therapy can reverse tissue hypoxia and holds promise for reducing ischemic injury.

Flexible rods and the case for dynamic stabilization.

The widespread use of instrumentation in the lumbar spine has led to high rates of fusion. This has been accompanied by a marked rise in adjacent-segment disease, which is considered to be an increasingly common and significant consequence of lumbar or lumbosacral fusion. Numerous biomechanical studies have demonstrated that segments fused with rigid metallic fixation lead to significant amounts of supraphysiological stress on adjacent discs and facets. The resultant disc degeneration and/or stenosis may require further surgical intervention and extension of the fusion to address symptomatic adjacent-segment disease. Recently, dynamic stabilization implants and disc arthroplasty have been introduced as an alternative to rigid fixation. The scope of spinal disease that can be treated with this novel technology, however, remains limited, and these treatments may not apply to patients who still require rigid stabilization and arthrodesis. In the spectrum between rigid metallic fixation and motion-preserving arthroplasty is a semirigid type of stabilization in which a construct is used that more closely mirrors the modulus of elasticity of natural bone. After either interbody or posterolateral arthrodesis is achieved, the fused segments will not generate the same adjacent-level forces believed to be the cause of adjacent-segment disease. Although this form of arthrodesis does not completely prevent adjacent-segment disease, the dynamic component of this stabilization technique may minimize its occurrence. The authors report their initial experience with the use of posterior dynamic stabilization in which polyetheretherketone rods were used for a posterior construct. The biomechanics of dynamic stabilization are discussed, clinical indications are reviewed, and case studies for its application are presented.