Biological responses to individualized small titanium implants for the treatment of focal full-thickness knee cartilage defects in a sheep model.

BACKGROUND: The present study aimed to evaluate the functional, radiological and histological outcome of a customized focal implant for the treatment of focal full-thickness cartilage defects in sheep. METHODS: The study used magnetic resonance imaging data as the basis for construction of the titanium implant using a three-dimensional printing technique. This was then placed on the medial condyle of the knee joint in eight sheep and left in place in vivo over a period of six months. Following euthanasia, the local biological response was analyzed using micro-computed tomography, light microscopy and histological evaluation (International Cartilage Repair Society (ICRS) score). The variables were analyzed using a generalized linear mixed model. Odds ratios were given with 95% confidence intervals. RESULTS: The osseointegration rate was 62.1% (SD 3.9%). All implants were prone to the neighboring cartilage bed (4.4-1096.1 µm). Using the IRCS score, the elements 'surface', 'matrix', 'cell distribution' and 'cell population' all showed pathological changes on the operated side, although these did not correlate with implant elevation. On average, a difference of 0.7 mm (±2 mm) was found between the digitally planned implant and the real implant. CONCLUSIONS: As a result of imprecise segmentation and difficult preparation conditions at the prosthesis bed, as well as changes at the surface of the implant over the operational lifetime of the prosthesis, it must be stated that the approach implemented here of using a customized implant for the treatment of focal full-thickness cartilage defects at the knee did not meet our expectations.

Radial Extracorporeal Shock Wave Therapy Is Effective and Safe in Chronic Distal Biceps Tendinopathy.

OBJECTIVE: To assess the efficacy and safety of radial extracorporeal shock wave therapy (rESWT) for chronic distal biceps tendinopathy (cDBT). DESIGN: Case-control study (level of evidence, 3). SETTING: SUN Orthopaedics and Sports Medicine. PATIENTS: Patients with a diagnosis of cDBT were recruited between January 2010 and February 2015. INTERVENTIONS: Patients received a single session of rESWT (2000 shock waves with energy flux density of 0.18 mJ/mm) or other forms of nonoperative therapy. MAIN OUTCOME MEASURES: Patients completed the visual analog scale (VAS), the modified QuickDASH (MQD) score, and the Roles and Maudsley (RM) score over a 12-month period. RESULTS: Forty-eight patients completed the final review at 12 months and were included in the study. Subjects ranged in age from 30 to 64 years. Mean pretreatment VAS scores for the rESWT and control groups were 8.3 and 8.5, respectively. Three and 12 months after inclusion in the study, the mean VAS scores for the rESWT and control groups were 3.4 and 5.6 (P < 0.001) and 2.7 and 4.7 (P < 0.001), respectively. Twelve-month follow-up MQD-Sports and MQD-Work scores for the rESWT and control groups were 3.7 and 1.7 (P < 0.001) and 3.8 and 1.8 (P < 0.001), respectively. Differences in mean RM scores were statistically significant between groups at 3 months after the treatment. There were no significant complications. CONCLUSIONS: Overall, rESWT is an effective and safe treatment for cDBT. CLINICAL RELEVANCE: Radial ESWT as a novel, effective, and safe treatment for cDBT.

Efficacy and safety of extracorporeal shock wave therapy for orthopedic conditions: a systematic review on studies listed in the PEDro database.

BACKGROUND: Extracorporeal shock wave therapy (ESWT) is an effective and safe non-invasive treatment option for tendon and other pathologies of the musculoskeletal system. SOURCES OF DATA: This systematic review used data derived from the Physiotherapy Evidence Database (PEDro; www.pedro.org.au, 23 October 2015, date last accessed). AREAS OF AGREEMENT: ESWT is effective and safe. An optimum treatment protocol for ESWT appears to be three treatment sessions at 1-week intervals, with 2000 impulses per session and the highest energy flux density the patient can tolerate. AREAS OF CONTROVERSY: The distinction between radial ESWT as 'low-energy ESWT' and focused ESWT as 'high-energy ESWT' is not correct and should be abandoned. GROWING POINTS: There is no scientific evidence in favour of either radial ESWT or focused ESWT with respect to treatment outcome. AREAS TIMELY FOR DEVELOPING RESEARCH: Future randomized controlled trials should primarily address systematic tests of the aforementioned optimum treatment protocol and direct comparisons between radial and focused ESWT.

In-vivo analysis of epicutaneous pressure distribution beneath a femoral tourniquet--an observational study.

BACKGROUND: Compression of the tissue beneath tourniquets used in limb surgery is associated with varying degrees of soft tissue damage. The interaction between fluids and applied pressure seems to play an important role in the appearance of skin lesions. The extent of the transfer of force between the tourniquet and the skin, however, has yet to be studied. The aim of the present study was to quantify in-vivo the transfer of pressure between a tourniquet and the skin of the thigh. METHODS: Pressure under the tourniquet was measured using sensors in 25 consecutive patients over the course of elective surgical procedures. Linear mixed modeling was used to assess the homogeneity of the distribution of pressure around the circumference of the limb, variation in pressure values over time, and the influence of limb circumference and the Body-Mass-Index (BMI) on pressure transfer. RESULTS: Mean pressure on the skin was significantly lower than the inner pressure of the cuff (5.95%, 20.5 ± 9.36 mmHg, p < 0.01). There was a discrete, but significant (p < 0.001) increase in pressure within the first twenty minutes after inflation. Sensors located in the area of overlap of the cuff registered significantly higher pressure values (p < 0.01). BMI and leg circumference had no influence on the transfer of pressure to the surface of the skin (p = 0.88 and p = 0.51). CONCLUSIONS: Pressure transfer around the circumference of the limb was distributed inhomogeneously. The measurement series revealed a global pressure drop compared to the initial pressure of the cuff. No relationship could be demonstrated between the pressure transferred to the skin and the BMI or limb circumference.

Treatment of chronic plantar fasciopathy with extracorporeal shock waves (review).

There is an increasing interest by doctors and patients in extracorporeal shock wave therapy (ESWT) for chronic plantar fasciopathy (PF), particularly in second generation radial extracorporeal shock wave therapy (RSWT). The present review aims at serving this interest by providing a comprehensive overview on physical and medical definitions of shock waves and a detailed assessment of the quality and significance of the randomized clinical trials published on ESWT and RSWT as it is used to treat chronic PF. Both ESWT and RSWT are safe, effective, and technically easy treatments for chronic PF. The main advantages of RSWT over ESWT are the lack of need for any anesthesia during the treatment and the demonstrated long-term treatment success (demonstrated at both 6 and 12 months after the first treatment using RSWT, compared to follow-up intervals of no more than 12 weeks after the first treatment using ESWT). In recent years, a greater understanding of the clinical outcomes in ESWT and RSWT for chronic PF has arisen in relationship not only in the design of studies, but also in procedure, energy level, and shock wave propagation. Either procedure should be considered for patients 18 years of age or older with chronic PF prior to surgical intervention.

Cross-cultural adaptation and measurement properties of the italian version of the Patient-Rated Tennis Elbow Evaluation (PRTEE) questionnaire.

BACKGROUND: The Patient-Rated Tennis Elbow Evaluation (PRTEE) questionnaire is a tool designed for self-assessment of forearm pain and disability in patients with lateral elbow tendinopathy (LET). However, an Italian version of this questionnaire has not been available. OBJECTIVE: The aims of this study were: (1) to translate and cross-culturally adapt the PRTEE questionnaire into Italian and (2) to evaluate its measurement properties. DESIGN: This was a longitudinal, observational measurement study. METHODS: The PRTEE questionnaire was cross-culturally adapted to Italian according to established guidelines. Ninety-five individuals (41 women, 54 men) with unilateral, imaging-confirmed, chronic LET were selected consecutively to assess the measurement properties of the PRTEE questionnaire. Internal consistency, test-retest reliability, construct validity, and responsiveness were estimated. RESULTS: The Italian version of the PRTEE displayed a high degree of internal consistency, with a Cronbach alpha of .95. The test-retest reliability was high for both short-term and medium-term, with intraclass correlation coefficients (2,1) of .95 and .93, respectively. The PRTEE exhibited a strong correlation (r=.77-.91, P<.0001) with the Disabilities of the Arm, Shoulder and Hand (DASH) at the baseline and a moderate correlation (r=.58-.74, P<.0001) at discharge. The responsiveness was higher for the PRTEE than for the DASH. Limitations A methodological limitation of the study is that due to the small sample size, a factor analysis was not performed to assess convergent validity. CONCLUSIONS: The Italian version of the PRTEE questionnaire is internally consistent, demonstrates expected correlations with other measures, and is more responsive than the DASH in Italian patients with chronic LET.

Focused extracorporeal shock wave therapy in calcifying tendinitis of the shoulder: a meta-analysis.

BACKGROUND: The objective of this study is to assess the effectiveness of extracorporeal shock wave therapy in the management of calcifying tendinitis of the shoulder. Furthermore, a dose-response relationship was sought as a secondary confirmation of effectiveness. HYPOTHESIS: Focused extracorporeal shock wave therapy has a high, dose-responsive effectiveness in the management of calcifying tendinitis of the shoulder. STUDY DESIGN: Meta-analysis. METHODS: Studies were identified from online databases (MEDLINE, EMBASE, and Cochrane Controlled Trials Register), manual searches, and personal communication with experts in the field. After assessment of heterogeneity, a random effects model was generated. The primary end points were identified as pain and function by using the visual analog scale and the Constant-Murley Score, respectively. These end points were pooled and the weighted mean differences and 95% confidence intervals were estimated. Odds ratios of the secondary end point deposit resorption were pooled. RESULTS: In 14 studies, shock wave therapy led to a significantly higher reduction of pain (weighted mean difference, -2.8 points; 95% confidence interval, -4.2 to -1.5 points) and improvement of function (weighted mean difference, 19.8 points; 95% confidence interval, 13.4-26.3 points), compared to other treatments and placebo. High-energy treatment produced significantly better results than low-energy treatment for pain reduction (weighted mean difference, 1.7 points; 95% confidence interval, 0.7-2.6 points) and improvement of function (weighted mean difference, 10.7 points; 95% confidence interval, 7.2-14.1 points). These results are consistent with a dose-response relationship supporting the effectiveness of shock wave therapy. CONCLUSION: Shock wave therapy for calcifying tendinitis of the shoulder is effective in pain relief, function restoration, and deposit resorption; however, these conclusions are susceptible to bias arising from the limitations of the included studies.

Extracorporeal shock wave-mediated changes in proliferation, differentiation, and gene expression of human osteoblasts.

BACKGROUND: The goal of this study was to determine whether cell proliferation, differentiation, and gene expression of primary human osteoblasts (hOB) are influenced by shock wave application (SWA). METHODS: Osteoblast cultures were isolated from cancellous bone fragments and treated with 500 impulses of energy flux densities of 0.06 mJ/mm, 0.18 mJ/mm, 0.36 mJ/mm, and 0.50 mJ/mm. Twenty-four hours and 96 hours after SWA cell proliferation, alkaline phosphatase activity, and mineralization were analyzed. The global gene expression profiling was determined 96 hours after SWA employing Affymetrix HG-U133A microarrays. RESULTS: After 24 hours, hOB showed a dose-dependent increase in cell proliferation from 68.7% (at 0.06 mJ/mm, p = 0.002) up to 81.6% (at 0.5 mJ/mm, p = 0.001), which also persisted after 96 hours. Numbers of alkaline phosphatase-positive hOB increased after SWA treatment with peak levels of response between 0.18 mJ/mm and 0.5 mJ/mm after 24 hours. Mineralization was significantly higher in all groups compared with controls. Microarray analyses revealed SWA-induced differential expression of 94 genes involved in physiologic processes, cell homeostasis, and bone formation. Most intriguing was the up-regulation of multiple genes involved in skeletal development and osteoblast differentiation (e.g., PTHrP, prostaglandin E2-receptor EP3, BMP-2 inducible kinase, chordin, cartilage oligomeric matrix protein, matrillin). CONCLUSION: We showed that shock waves have direct dose-dependent stimulatory effects on proliferation and differentiation of osteoblasts from normal human cancellous bone. We demonstrated that several genes critical for osteoblast differentiation and function are regulated after SWA. Overall, data presented herein will aid further understanding of the osteogenic effect of shock waves and, in addition, will enhance current knowledge of the SWA-mediated gene expression.