The purpose of this paper was to review the literature through a structured literature review and provide a grade of recommendation for patient safety, gait energy efficiency, and cost effectiveness of the C-Leg microprocessor-controlled prosthetic knee for transfemoral amputees. Medline (Ovid) and CINAHL (EBSCO) data bases were searched to identify potentially pertinent studies within the 1995-2009 time range. Studies were screened and sorted. Pertinent studies were rated for methodologic quality and for risk of bias. Following assessment of methodologic quality and bias risk, the level of evidence and a grade of recommendation was determined for each of three categories: Safety, energy efficiency, and cost effectiveness. A total of 18 articles were determined to be pertinent: seven for safety, eight for energy efficiency, and three for cost effectiveness. Methodologic quality was low with a moderate risk of bias in the safety and energy effectiveness categories. Studies in cost effectiveness received high scores for methodologic quality. Though methodologic quality varied across the selected topics, there was sufficient evidence to suggest increased efficacy of the C-Leg in the areas of safety, energy efficiency and cost when compared with other prosthetic knees for transfemoral amputees.
Age alone should not determine prosthetic rehabilitation. Comorbidities and general health are important determinants. The more proximal the amputation, the more energy is demanded from the cardiovascular and pulmonary systems for prosthetic gait. Changes in surgical technique and revascularization procedures have allowed preservation of the knee, which decreases energy demands and allows more older patients a chance to undergo rehabilitation for ambulation. Although the ratio of below knee (transtibial) amputations to above knee (transfemoral) amputations has increased, overall postsurgical mortality (10-30%), long term survival (40-50%@2 years, 30-40%@5 years), and risk of loss of the contralateral leg (15-20%@2 years) has not changed significantly since the 1960s. Despite the lack of improvement in survival as a result of the systemic vascular disease, the older patient can benefit from rehabilitation efforts with goals of prosthetic ambulation or simply cosmesis. The shortened longevity emphasizes the need for timely rehabilitation to enhance the quality of the remaining years. The geriatrician can add to the presurgical care and preprosthetic phase of rehabilitation by attention to the problems common to the older patient, i.e., multiple comorbidities, polypharmacy, immobility, and depression. Postoperatively, early mobilization is crucial to avoid the deleterious effects of immobility in the older person. Further investigations into the psychosocial issues and cost benefits of limb loss and prosthetic rehabilitation are needed. In addition, comparison of the various rehabilitation protocols and the impact of cardiac resting before rehabilitation are needed.
We have developed a reliable radiographic scoring instrument for assessing radiographic OA of the LS spine. It appears that painless LS disc OA is one factor that influences spinal motion.
Group physical therapy was not more effective than individual physical therapy for primary and secondary study outcomes. Either group physical therapy or individual physical therapy may be a reasonable delivery model for health care systems to consider.
Background
Physical therapy (PT) and other exercise-based interventions are core components of care for knee osteoarthritis (OA), but both are underutilized, and some patients have limited access to PT services. This clinical trial is examining a STepped Exercise Program for patients with Knee OsteoArthritis (STEP-KOA). This model of care can help to tailor exercise-based interventions to patient needs and also conserve higher resource services (such as PT) for patients who do not make clinically relevant improvements after receiving less costly interventions.
Methods / Design
Step-KOA is a randomized trial of 345 patients with symptomatic knee OA from two Department of Veterans Affairs sites. Participants are randomized to STEP-KOA and Arthritis Education (AE) Control groups with a 2:1 ratio, respectively. STEP-KOA begins with 3 months of access to an internet-based exercise program (Step 1). Participants not meeting response criteria for clinically meaningful improvement in pain and function after Step 1 progress to Step 2, which involves bi-weekly physical activity coaching calls for 3 months. Participants not meeting response criteria after Step 2 progress to in-person PT visits (Step 3). Outcomes will be assessed at baseline, 3, 6 and 9 months (primary outcome time point). The primary outcome is the Western Ontario and McMasters Universities Osteoarthritis Index (WOMAC), and secondary outcomes are objective measures of physical function. Linear mixed models will compare outcomes between the STEP-KOA and AE control groups at follow-up. We will also evaluate patient characteristics associated with treatment response and conduct a cost-effectiveness analysis of STEP-KOA.
Discussion
STEP-KOA is a novel, efficient and patient-centered approach to delivering exercise-based interventions to patients with knee OA, one of the most prevalent and disabling health conditions. This trial will provide information on the effectiveness of STEP-KOA as a novel potential model of care for treatment of OA.
Trial Registration
Clinicaltrials.gov,
NCT02653768
(STepped Exercise Program for Knee OsteoArthritis (STEP-KOA)), Registered January 12, 2016.
Electronic supplementary material
The online version of this article (10.1186/s12891-019-2627-8) contains supplementary material, which is available to authorized users.
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