A randomized, placebo-controlled trial of long-acting dexamethasone viscous gel delivered by transforaminal injection for lumbosacral radicular pain.

TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT03372161.

Effect of transfemoral prosthetic socket interface design on gait, balance, mobility, and preference: A randomized clinical trial.

BACKGROUND: There are alternative transfemoral (TF) socket interface designs that have not been compared with the standard of care, ischial ramus containment (IRC). The interface directly affects performance. OBJECTIVES: To compare 3 TF interface designs, IRC, dynamic socket (DS), and subischial (Sub-I), regarding gait, balance, mobility, and preference. The authors hypothesized that these more active users may experience gait, mobility, and preference benefits from the less intrusive DS and Sub-I interface designs. STUDY DESIGN: Single-blind, repeated-measures, 3-period randomized controlled crossover clinical trial. METHODS: People with unilateral TF amputation with 1 year or longer prosthesis use experience, independent community ambulatory status, 18 to 60 years of age, of any race or ethnicity, with a body mass of 45 to 125 kg, and with a self-reported ability to walk for 20 minutes continuously were included in the study. Each participant was fit in all 3 interface designs. RESULTS: Thirteen participants completed the clinical trial. Velocity, cadence, mobility, and balance were not statistically different between the 3 socket conditions. The DS demonstrated significantly greater symmetry in swing, stance, single support percentage, and toe angle compared with IRC and Sub-I. Sixty days after study completion, 7 participants changed interfaces, trending away from IRC. CONCLUSIONS: Large differences were not observed. Small differences in spatiotemporal gait measures combined with patient preference may make a meaningful difference to individual patients and should be considered.

The effect of the transfemoral prosthetic socket interface designs on skeletal motion and socket comfort: A randomized clinical trial.

BACKGROUND: The most crucial aspect of a prosthesis is the socket, as it will directly determine gait stability and quality. The current standard of care ischial ramus containment socket is reported to increase coronal stability through gait; however, socket discomfort is the primary complaint among prosthetic users. OBJECTIVES: The purpose of this study is to compare ischial ramus containment to alternatives in the transfemoral amputee population. All subjects were fit with three different sockets: traditional ischial ramus containment, a dynamic socket, and a sub-ischial. In this study, authors hypothesized socket skeletal motion would be equivalent across interventions. STUDY DESIGN: Single-blind, repeated-measures, three-period randomized crossover clinical trial. METHODS: Outcome measures were socket comfort score and skeletal motion, viewed coronally with X-ray measuring the position of the skeleton in relationship to the socket in full weight-bearing and full un-loading. RESULTS: The mean age was 38.2 and mean Amputee Mobility Predictor score was 40. Mean vertical movement, horizontal movement, single limb prosthetic stance, mean femoral adduction in swing and stance, and median socket comfort score were not statistically different. CONCLUSION: The socket design did not significantly effect skeletal motion and socket comfort. All socket designs are suitable depending on the patient-centric preferences and prosthetist skill set. CLINICAL RELEVANCE: The comfort of the standard of care transfemoral amputation socket has been widely reported as problematic. A comparison of alternative designs in a controlled clinical trial environment will assist the clinician in understanding the impact of design regarding skeletal motion and comfort. Users could benefit from alternatives applied in clinical practice.

Clinically Relevant Outcome Measures Following Limb Osseointegration; Systematic Review of the Literature.

OBJECTIVES: The current standard of care for an amputee is a socket-based prostheses. An osseointegrated implant (OI) is an alternative for prosthetic attachment. Osseointegration addresses reported problems related to wearing a socket interface, such as skin issues, discomfort, diminished function, quality of life, prosthetic use, and abandonment. The purpose of this report is to systematically review current literature regarding OI to identify and categorize the reported clinically relevant outcome measures, rate the quality of available evidence, and synthesize the findings. DATA SOURCES: A multidisciplinary team used PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) methods. Search methodology was based on identifying clinically relevant articles. Three databases were searched: PubMed, CINAHL, and Web of Science. STUDY SELECTION: Clinical studies with aggregated data reporting at least 1 clinically relevant outcome measure were included. DATA EXTRACTION: The Grading of Recommendations Assessment, Development, and Evaluation (GRADE) criterion was used for critical appraisal and recommendations. CONCLUSIONS: This review identified 21 clinically relevant observational studies. Outcome measures were categorized into the following 9 categories: vibratory stimulation, complications, biomechanics, economics, patient-reported outcome measures, electromyography, x-ray, physical functional performance, and energy consumption. This systematic review consisted of Level III and IV observational studies. Homogeneous outcome measures with strong psychometric properties across prospective studies do not exist to date. Higher-level, prospective, randomized, long-term, clinically relevant trials are needed to prove efficacy of OI compared with socket prosthetic attachment. Osseointegration was at least equivalent to sockets in most studies. In some cases, it was superior. Osseointegration represents a promising alternative to socket prosthetic attachments for extremity amputees. LEVEL OF EVIDENCE: Therapeutic Level III. See Instructions for Authors for a complete description of levels of evidence.

The effectiveness of the bone bridge transtibial amputation technique: A systematic review of high-quality evidence.

BACKGROUND: This literature review was undertaken to determine if commonly held views about the benefits of a bone bridge technique are supported by the literature. METHODS: Four databases were searched for articles pertaining to surgical strategies specific to a bone bridge technique of the transtibial amputee. A total of 35 articles were identified as potential articles. Authors included methodology that was applied to separate topics. Following identification, articles were excluded if they were determined to be low quality evidence or not pertinent. RESULTS: Nine articles were identified to be pertinent to one of the topics: Perioperative Care, Acute Care, Subjective Analysis and Function. Two articles sorted into multiple topics. Two articles were sorted into the Perioperative Care topic, 4 articles sorted into the Acute Care topic, 2 articles into the Subjective Analysis topic and 5 articles into the Function topic. DISCUSSION: There are no high quality (level one or two) clinical trials reporting comparisons of the bone bridge technique to traditional methods. There is limited evidence supporting the clinical outcomes of the bone bridge technique. There is no agreement supporting or discouraging the perioperative and acute care aspects of the bone bridge technique. There is no evidence defining an interventional comparison of the bone bridge technique. CONCLUSION: Current level III evidence supports a bone bridge technique as an equivalent option to the non-bone bridge transtibial amputation technique. Formal level I and II clinical trials will need to be considered in the future to guide clinical practice. Clinical relevance Clinical Practice Guidelines are evidence based. This systematic literature review identifies the highest quality evidence to date which reports a consensus of outcomes agreeing bone bridge is as safe and effective as alternatives. The clinical relevance is understanding bone bridge could additionally provide a mechanistic advantage for the transtibial amputee.

RADIOGRAPHIC ASSESSMENT OF EXTREMITY OSSEOINTEGRATION FOR THE AMPUTEE.

Osseointegration (OI) is a bone-anchoring procedure that allows the direct skeletal attachment of a prosthesis through the use of an implant. Transcutaneous OI implants are similar to subcutaneous intramedullary joint implants with some exceptions. Particularly, OI implants are inserted at the distal aspect of the femur, while intramedullary implants are inserted at the proximal aspect of the femur. In this report, an additional adaptation of the radiographic zonal analysis used for intramedullary implants, known as Gruen zones, is introduced to include OI implants of extremity prosthetics. Radiographic zonal analyses and interpretations are proposed. Gruen zones are used for intramedullary implants, which are generally inserted from the proximal aspect of the bone. OI extremity implants are inserted from the distal end of the bone. Therefore, the zonal analysis is inverted. A radiographic zonal analysis has been introduced by the Osseointegration Group of Australia (OGA). This analysis is needed specifically for the clinical evaluation of extremity OI, as significant changes to the bone and OI implant have been reported and need to be clinically described. A classification technique is necessary for establishing treatment guidelines for the extremity osseointegrated implant. The OGA Zonal analysis addresses this need by adapting a common reference standard to osseointegration of the extremity amputee.

Impact of a supervised worksite exercise program on back and core muscular endurance in firefighters.

PURPOSE: Low back pain is a leading cause of disability in firefighters and is related to poor muscular endurance. This study examined the impact of supervised worksite exercise on back and core muscular endurance in firefighters. DESIGN: A cluster randomized controlled trial was used for this study. SETTING: The study occurred in fire stations of a municipal fire department (Tampa, Florida). SUBJECTS: Subjects were 96 full-duty career firefighters who were randomly assigned by fire station to exercise (n = 54) or control (n = 42) groups. INTERVENTION: Exercise group participants completed a supervised exercise targeting the back and core muscles while on duty, two times per week for 24 weeks, in addition to their usual fitness regimen. Control group participants continued their usual fitness regimen. MEASURES: Back and core muscular endurance was assessed with the Biering-Sorensen test and plank test, respectively. ANALYSIS: Changes in back and core muscular endurance from baseline to 24 weeks were compared between groups using analysis of covariance and linear mixed effects models. RESULTS: After 24 weeks, the exercise group had 12% greater (p = .021) back muscular endurance and 21% greater (p = .0006) core muscular endurance than did the control group. The exercise intervention did not disrupt operations or job performance. CONCLUSION: A supervised worksite exercise program was safe and effective in improving back and core muscular endurance in firefighters, which could protect against future low back pain.