Jon E. Block

Two-year fusion rate equivalency between Grafton DBM gel and autograft in posterolateral spine fusion: a prospective controlled trial employing a side-by-side comparison in the same patient.

Study Design. Multicenter, prospective equivalency trial with each patient serving as his/her own control. Objectives. To compare the effectiveness of a Grafton® DBM gel composite with iliac crest autograft in posterolateral spine fusion. Summary of Background Data. While autograft remains the preferred graft material to facilitate spine fusion, the supply is limited and harvesting produces undesirable clinical consequences. Methods. A total of 120 patients underwent posterolateral spine fusion with pedicle screw fixation and bone grafting. Iliac crest autograft was implanted on one side of the spine and a Grafton® DBM/autograft composite was implanted on the contralateral side in the same patient. An independent, blinded reviewer evaluated anteroposterior and lateral flexion-extension radiographs. The fusion mass lateral to the instrumentation on each side was judged fused or not, and the mineralization of the graft was rated absent, mild, moderate, or extensive. The degree of correspondence in outcomes between sides was estimated by computing the percentage agreement and kappa statistic. Results. Nearly 70% of patients (81 of 120) provided complete 24-month radiographic studies. The bone graft mass was fused in 42 cases (52%) on the Grafton® DBMside and in 44 cases (54%) on the autograft side. The overall percentage agreement for fusion status between sides was approximately 75% (61 of 81), indicating moderately strong statistical correspondence (kappa = 0.51, P < 0.0001). Bone mineralization ratings also were similar between treated sides. Perfect agreement was realized in almost 60% of patients (48 of 81) with moderate statistical correspondence (weighted kappa = 0.54, P < 0.0001). Conclusions. Grafton® DBM can extend a smaller quantity of autograft than is normally required to achieve a solid spinal arthrodesis. Consequently, a reduced amount of harvested autograft may be required, potentially diminishing the risk and severity of donor site complications.

US-Approved Intra-Articular Hyaluronic Acid Injections are Safe and Effective in Patients with Knee Osteoarthritis: Systematic Review and Meta-Analysis of Randomized, Saline-Controlled Trials

We conducted a systematic review and meta-analysis of randomized saline-controlled trials to determine the safety and efficacy of US-approved intra-articular hyaluronic acid (IAHA) injections for symptomatic knee osteoarthritis. A total of 29 studies representing 4,866 unique subjects (IAHA: 2,673, saline: 2,193) were included. IAHA injection resulted in very large treatment effects between 4 and 26 weeks for knee pain and function compared to pre-injection values, with standardized mean difference (SMD) values ranging from 1.07–1.37 (all P < 0.001). Compared to saline controls, SMDs with IAHA ranged from 0.38–0.43 for knee pain and 0.32–0.34 for knee function (all P < 0.001). There were no statistically significant differences between IAHA and saline controls for any safety outcome, including serious adverse events (SAEs) (P = 0.12), treatment-related SAEs (P = 1.0), study withdrawal (P = 1.0), and AE-related study withdrawal (P = 0.46). We conclude that intra-articular injection of US-approved HA products is safe and efficacious in patients with symptomatic knee osteoarthritis.

Clinical utility of ultrasound guidance for intra-articular knee injections: a review

Intra-articular corticosteroid and hyaluronic acid injections provide short-term symptom amelioration for arthritic conditions involving structural damage or degenerative changes in the knee. Conventional palpation-guided anatomical injections frequently result in inaccurate needle placement into extra-articular tissue and adjacent structures. The purpose of this review was to determine the effect of ultrasound guidance on the accuracy of needle placement, clinical outcomes, and cost-effectiveness in comparison with anatomical landmark-guided intra-articular large joint injections, with particular emphasis on the knee. A total of 13 relevant studies were identified; five studied the knee, seven studied the shoulder, one used both the knee and shoulder, and none studied the hip. Ultrasound was used in seven studies; the remaining studies utilized air arthrography, fluoroscopy, magnetic resonance arthrography, or magnetic resonance imaging. Across all studies (using all imaging modalities and all joints), needle placement accuracy ranged from 63% to 100% with ultrasound and from 39% to 100% with conventional anatomical guidance. Imaging guidance improved the accuracy of intra-articular injections of the knee (96.7% versus 81.0%, P < 0.001) and shoulder (97.3% versus 65.4%, P < 0.001). In particular, ultrasound guidance of knee injections resulted in better accuracy than anatomical guidance (95.8% versus 77.8%, P < 0.001), yielding an odds ratio of 6.4 (95% confidence interval 2.9–14). Ultrasound guidance notably improves injection accuracy in the target intra-articular joint space of large joints including the knee. The enhanced injection accuracy achieved with ultrasound needle guidance directly improves patient-reported clinical outcomes and cost-effectiveness.

Improved healing response in delayed unions of the tibia with low-intensity pulsed ultrasound: results of a randomized sham-controlled trial.

BackgroundWe compared the healing response of tibial delayed unions between subjects treated with low-intensity pulsed ultrasound (LIPUS) (n = 51) and subjects treated with a sham device (n = 50). Fracture age was ≥ 4 months in all cases. Study personnel and participants were blinded to random treatment assignment throughout the study.MethodsThis multi-center randomized sham-controlled trial was undertaken at six hospitals in Germany. Adult patients who had sustained a tibial shaft fracture that subsequently showed inadequate progress toward healing (i.e., delayed union) were enrolled and randomized to receive either LIPUS (Exogen 2000/2000+, Smith & Nephew GmbH, Schenefeld, Germany) or an identical nonoperative sham device. The daily treatment duration was 20 minutes, for a period of 16 weeks. Subjects randomly assigned to active treatment had the ultrasound pressure wave signal set at the following parameters: 1.5 MHz frequency, 1 kHz repetition rate, 200 μs pulse duration, 30 mW/cm2 spatial intensity. Progress toward healing was estimated from changes in bone mineral density (BMD) and gap area as determined from computed tomography scans. Intention-to-treat analysis was conducted using a multiple imputation methodology.ResultsBased on log-transformed data, mean improvement in BMD was 1.34 (90% confidence interval (CI) 1.14 to 1.57) times greater for LIPUS-treated subjects compared to sham (p = 0.002). A mean reduction in bone gap area also favored LIPUS treatment (p = 0.014).ConclusionsThese findings demonstrate significantly greater progress toward bone healing after LIPUS treatment compared to no LIPUS treatment in subjects with established delayed unions of the tibia.

Unload it: the key to the treatment of knee osteoarthritis

Osteoarthritis (OA) of the knee is a major public health problem whose prevalence is expected to grow dramatically commensurate with the aging of the population and increasing rates of obesity. Unfortunately, little progress has been made therapeutically to avert this epidemic. We hypothesize that the lack of effective interventions is due, in large part, to an overemphasis on pharmacotherapy and direct chondral repair. Instead, we propose that research and development efforts be aimed at addressing the aberrant biomechanics that are the primary driver in the progression of knee OA. In particular, technologies that “unload” the joint may reverse the structural damage, which is the cardinal feature of this disease. Re-establishing a favorable local mechanical environment may not only delay the requirement for an invasive joint reconstruction procedure but obviate the need entirely.

Clinical and economic consequences of the treatment gap in knee osteoarthritis management.

Osteoarthritis affects 27 million American adults of all ages and is a leading cause of disability in middle-aged and older adults. Initial management of knee osteoarthritis symptoms utilizes conservative care although long-term efficacy is poor. Arthroplasty and high tibial osteotomy may be considered for patients with severe pain or disability. We hypothesize that a distinct treatment gap exists for the patient with symptomatic knee osteoarthritis who is unresponsive to conservative care (including simple surgical treatments) yet refuses to undergo or is not an appropriate candidate for more invasive surgical procedures. This treatment gap represents a protracted period in which the patient experiences debilitating pain, reduced quality of life, and a significant financial burden. Approximately 3.6 million Americans linger in the knee osteoarthritis treatment gap and this number will grow to about 5 million people by 2025. The typical knee osteoarthritis treatment gap extends 20 years although the younger osteoarthritis patient is faced with the treatment gap throughout the majority of their adult life. There is great need for a safe, effective, and cost effective treatment option for patients with moderate to severe osteoarthritis that enjoys high patient acceptance.

Safety and effectiveness of bone allografts in anterior cervical discectomy and fusion surgery.

Study Design. Systematic review. Objective. The primary aim of this review was to evaluate clinical and radiographic outcomes in studies of anterior cervical discectomy and fusion (ACDF) using allograft versus ACDF with autograft, ACDF with cage devices, and cervical disc arthroplasty for the treatment of symptomatic cervical disc disease. Summary of Background Data. ACDF remains the standard of care for patients with cervical radiculopathy who are unresponsive to conservative medical care. However, no known study has compared patient outcomes after ACDF with allograft, ACDF with autograft, ACDF with cage, and disc arthroplasty. Methods. After applying strict inclusion criteria, 21 comparisons from 20 studies formed the basis for this review. Patient outcomes included neck and arm pain, neck disability index (NDI), physical component summary (PCS), and mental component summary (MCS) scores from the SF-36, radiographic fusion rate, and select adverse events (e.g., wound infection, dysphagia, and adjacent segment degeneration). Results. The four treatment groups included ACDF with allograft (allograft, n = 1341), ACDF with autograft (autograft, n = 568), ACDF with cage (cage, n = 87), and cervical disc arthroplasty (arthroplasty, n = 603). Neck pain was reduced similarly by 63% to 69% in all groups. Comparable improvements were realized in arm pain after ACDF with allograft (75%) or arthroplasty (73%) that were greater than other treatment groups (62–68%). There was notable improvement in neck disability (61–65%) with allograft and arthroplasty after treatment. PCS scores improved with allograft (42%) and arthroplasty (44%). MCS scores improved modestly (16–21%) with allograft and arthroplasty. Fusion rates were 91% for allograft and autograft and 97% for cage. Adverse events were uncommon in all groups. Conclusion. ACDF with allograft, ACDF with autograft, ACDF with cage, and cervical disc arthroplasty show similar improvements in pain, function, and quality of life with correspondingly low adverse event rates. All ACDF procedures result in high fusion rates.

clinical and economic Burden of Revision Knee Arthroplasty

Surgery is indicated for symptomatic knee osteoarthritis (OA) when conservative measures are unsuccessful. High tibial osteotomy (HTO), unicompartmental knee arthroplasty (UKA), and total knee arthroplasty (TKA) are surgical options intended to relieve knee OA pain and dysfunction. The choice of surgical intervention is dependent on several factors such as disease location, patient age, comorbidities, and activity levels. Regardless of surgical treatment, complications such as infection, loosening or lysis, periprosthetic fracture, and postoperative pain are known risks and are indications for revision surgery. The clinical and economic implications for revision surgery are underappreciated. Over 55,000 revision surgeries were performed in 2010 in the US, with 48% of these revisions in patients under 65 years. Total costs associated with each revision TKA surgery have been estimated to be in excess of

Safety and efficacy of US-approved viscosupplements for knee osteoarthritis: a systematic review and meta-analysis of randomized, saline-controlled trials

49,000. The current annual economic burden of revision knee OA surgery is

The KineSpring load absorber implant: rationale, design and biomechanical characterization.

2.7 billion for hospital charges alone. By 2030, assuming a 5-fold increase in the number of revision procedures, this economic burden will exceed