Topical Erythropoietin Accelerates Wound Closure in Patients with Diabetic Foot Ulcers: A Prospective, Multicenter, Single-Blind, Randomized, Controlled Trial.

The diabetic foot ulcer (DFU) is a major disabling complication of diabetes mellitus. Growing evidence suggests that topical erythropoietin (EPO) can promote wound healing. The aim of this study is to clinically assess the efficacy of a proprietary topical EPO-containing hydrogel for treating DFUs. We conducted a randomized, controlled trial in 20 patients with DFUs. After a 14-day screening period, the DFUs of 20 eligible participants who fulfilled the inclusion criteria were randomly assigned (1:1) to either a 12-week of daily treatment with topical EPO and standard-of-care (SOC) or SOC treatment alone. The DFUs were assessed weekly until week 12. The primary outcome was 75% ulcer closure or higher. After 12 weeks of treatment, 75% ulcer closure was achieved in 6 of the 10 patients whose DFUs were treated with topical EPO and in one of the 8 patients whose DFUs were treated with SOC alone. The mean area of the DFUs that were treated with topical EPO and SOC was significantly smaller than those treated with SOC alone (1.2 ± 1.4 cm2 vs. 4.2 ± 3.4 cm2; p = 0.023). Re-epithelialization was faster in the topically EPO-treated DFUs than in the SOC-treated DFUs. There were no treatment-related adverse events. We conclude that topical EPO is a promising treatment for promoting the healing of DFUs. Clinical Trial Registration number: NCT02361931.

[RARE COMPARTMENT SYNDROME AFTER PHYSICAL ACTIVITY].

INTRODUCTION: A 16 years old girl presented with gradual foot pain after running 2 kilometers. Conservative treatment that consisted of rest and high dose of analgesia had no effect. An MRI scan revealed a partial tear of the abductor hallucis muscle with diffuse edema in the compartment. Under general anesthesia compartmental pressure was measured. The involved compartment's pressure was 130 mm/hg while the contralateral foot measured 10 mm/hg. Immediate fasciotomy was performed with instant pain relief. No analgesics were needed following surgery. Compartment syndrome usually develops following trauma. In unusual cases the syndrome can appear due to other causes, such as muscle tear and present with different clinical signs and rates of presentation. Exertional compartment syndrome presents in the pediatric population, but can rarely present in the foot. High clinical suspicion and awareness can help the diagnosis in challenging cases.

The Posterolateral Approach for Calcaneal Fractures.

BACKGROUND: Conventionally, the extended lateral approach (ELA) served as the standard extensile approach for intraarticular calcaneal fracture fixation. However, this approach has a high rate of wound complications. The purpose of this study was to describe an alternative approach, the posteriorlateral approach (PLA) and compare it to the ELA regarding soft tissue complications and functional outcome. MATERIALS AND METHODS: 32 patients operated through PLA and 66 patients treated through ELA were included in this retrospective study. Major and minor soft tissue complications up to 3 months postoperatively were recorded. Eighteen patients of the PLA group and 32 patients of the ELA group were available for 1-year functional outcome assessment with the American Foot and Ankle Score (AOFAS) score. RESULTS: The PLA group had no major complications requiring surgical intervention. Six patients (19%) had minor wound complications. The ELA group had 8 (12%) major complications and 9 (14%) minor complications. There were no significant differences in AOFAS scores at 1-year followup. PLA is a safe and efficient approach for open reduction and internal fixation of displaced intraarticular calcaneal fractures. CONCLUSION: In selected cases when fracture comminution and displacement may not be adequately treated through a less invasive approach, it is a good alternative with less concern about wound complications as in ELA.

The role of ferritin and adiponectin as predictors of cartilage damage assessed by arthroscopy in patients with symptomatic knee osteoarthritis.

The aim of the present study was to evaluate whether circulating serum ferritin and adiponectin (ADP) in the serum and synovial fluid correlate with cartilage damage severity assessed by arthroscopy in patients with knee osteoarthritis. The 40 subjects with symptomatic knee osteoarthritis were divided into four groups according to arthroscopy assessed cartilage damage, using Outerbridge (OB) grading. Group I included minor damage while Group IV included severe damage. Metabolic parameters, bone homeostasis, and insulin resistance markers were determined. Synovial fluid of the affected knee joint was obtained and assessed for synovial adiponectin levels. Parameters of bone homeostasis in the serum including levels of PTH, alkaline phosphatase, 25OH vitamin D, serum calcium and phosphorus were similar in the four groups. A significant difference in the level of serum ferritin was found: ferritin levels increased from Group 1 to Group 4 in a continuous fashion (p < 0.035). In General linear model (GLM) analysis significant by-group differences in circulating ferritin persisted even after adjustment (p = 0.030). Although all groups were similar in terms of serum ADP levels, between groups difference in synovial fluid ADP was found (p < 0.037). However, after controlling for the age, there was no between-group difference in terms of synovial ADP levels. Serum ferritin levels were associated with cartilage damage severity assessed by arthroscopy. This association was independent of age, sex, BMI, and CRP levels suggesting that ferritin may be actively involved in the progression of cartilage damage in patients with symptomatic knee OA.

Effects of long-term risedronate treatment on serum ferritin levels in postmenopausal women with osteoporosis: the impact of cardiovascular risk factor load.

OBJECTIVE: Although ferritin has been considered as a possible link between accelerated bone loss and atherosclerosis, the long-term impact of therapeutic agents widely used to treat osteoporosis, such as bisphosphonates, on ferritin levels has not been investigated. The present study investigated the effects of risedronate on serum ferritin levels in postmenopausal women with osteoporosis. METHODS: In an open-label, prospective, uncontrolled study, 68 postmenopausal women with osteoporosis were evaluated. Study participants received risedronate orally at a dose of 35 mg/week during a 6-month treatment period. Blood sampling for lipid profile, hemoglobin A1c, insulin, fibrinogen, C-reactive protein, osteoprotegerin, and ferritin was performed at baseline and after 6 months of treatment. Pulse-wave velocity and augmentation index at baseline were determined using SphygmoCor version 7.1 (AtCor Medical, Sydney, Australia). RESULTS: Mean (SD) serum ferritin decreased significantly from 62.1 (44.8) to 46.7 (29.4) µg/dL (P < 0.0001) during the treatment period. On multiple linear regression analysis, the significant predictors of Δferritin were pulse-wave velocity (P = 0.04; effect size, 0.188), C-reactive protein (P = 0.021; effect size, 0.043), insulin (P = 0.011; effect size, 0.100), and high-density lipoprotein cholesterol (P = 0.046; effect size, 0.132) at baseline. CONCLUSIONS: Risedronate treatment is associated with significantly decreased serum ferritin levels in postmenopausal women with osteoporosis and cardiovascular risk factors.

Clinical outcomes following ankle fracture: a cross-sectional observational study.

BACKGROUND: The purpose of the current study was to examine objective and subjective differences between three severity groups of ankle fractures patients compared to healthy controls. METHODS: This was a case-controlled study. 92 patients with an ankle fracture injury of which 41 patients were eligible to participate in the study. 72 healthy people served as controls. All patients underwent a computerized gait test, completed self-assessment questionnaires (The Foot and Ankle Outcome Score (FAOS) and the SF-36), evaluated with the American Foot and Ankle Score (AOFAS) form and completed the 6-min walk test. The control group performed a computerized gait test and completed the SF-36 health survey. RESULTS: All ankle fracture patients presented compromised gait patterns and limb symmetry compared to controls (p < 0.05). Ankle fracture patients also had lower SF-36 scores compared to controls (p < 0.05). Significant differences were found between the unimalleolar group compared to the bimalleolar and trimalleolar groups in most parameters, except for the FAOS scores. There were no significant differences between the bimalleolar fracture group and the trimalleolar fracture groups. CONCLUSIONS: Although all fracture severity classification groups presented a compromised gait pattern and worse clinical symptoms compared to controls, it seems that patients with a unimalleolar fracture is a different group compared to bimalleolar and trimalleolar fracture. Furthermore, it seems that bimalleolar fracture and trimalleolar fracture affect the gait pattern and clinical symptoms to an equal extent, at least in the short-term. TRIAL REGISTRATION: NCT01127776.

Primary closure of elective toe amputations in the diabetic foot--is it safe?

BACKGROUND: Toe amputation is the most common partial foot amputation. Controversy exists regarding whether to primarily close toe amputations or to leave them open for secondary healing. The purpose of this study was to evaluate the results of closed toe amputations in diabetic patients, with respect to wound healing, complications, and the need for further higher level amputation. METHODS: We retrospectively reviewed the results of 40 elective or semi-elective toe amputations with primary closure performed in 35 patients treated in a specialized diabetic foot unit. Patients with abscesses or necrotizing fasciitis were treated emergently and were excluded. Patients in whom clean margins could not be achieved due to extensive cellulitis or tenosynovitis and patients requiring vascular intervention were excluded as well. Outcome endpoints included wound healing at 3 weeks, delayed wound healing, or subsequent higher level amputation. RESULTS: Out of 40 amputations, 38 healed well. Thirty amputations healed by the time of stitch removal at 3 weeks and eight had delayed healing. In two patients the wounds did not heal and subsequent higher level amputation was eventually required. CONCLUSIONS: In carefully selected diabetic foot patients, primary closure of toe amputations is a safe surgical option. We do not recommend primary closure when infection control is not achieved or in patients requiring vascular reconstruction. Careful patient selection, skillful assessment of debridement margins and meticulous technique are required and may be offered by experienced designated surgeons in a specialized diabetic foot unit.

Primary Closure of Toe Amputations in the Diabetic Foot - Is it Safe?

Abstract BACKGROUND: METHODS: RESULTS: CONCLUSIONS:

Effect of Surgical Safety checklist implementation on the occurrence of postoperative complications in orthopedic patients.

BACKGROUND: Surgical adverse events are errors that emerge during perioperative patient care. The World Health Organization recently published "Guidelines for Safe Surgery." OBJECTIVES: To estimate the effect of implementation of a safety checklist in an orthopedic surgical department. METHODS: We conducted a single-center cross-sectional study to compare the incidence of complications prior to and following implementation of the Guidelines for Safe Surgery checklist. The medical records of all consecutive adult patients admitted to the orthopedics department at Wolfson Medical Center during the period 1 July 2008 to 1 January 2009 (control group) and from 1 January 2009 to 1 July 2009 (study group) were reviewed. The occurrences of all complications were compared between the two groups. RESULTS: The records of 760 patients (380 in each group) hospitalized during this 12 month period were analyzed. Postoperative fever occurred in 5.3% versus 10.6% of patients with and without the checklist respectively (P = 0.008). Significantly more patients received only postoperative prophylactic antibiotics rather than both pre-and postoperative antibiotic treatment prior to implementation of the checklist (3.2% versus 0%, P = 0.004). In addition, a statistically non-significant 34% decrease in the rate of surgical wound infection was also detected in the checklist group. In a logistic regression model of postoperative fever, the checklist emerged as a significant independent predictor of this outcome: odds ratio 0.53, 95% confidence interval 0.29-0.96, P = 0.037. CONCLUSION: A significant reduction in postoperative fever after the implementation of the surgical safety checklist occurred. It is possible that the improved usage of preoperative prophylactic antibiotics may explain the reduction in postoperative fever.

Precise technique for simple and accurate pip arthrodesis using a blunt KW technique.

Proximal interphalangeal joint (PIP) arthrodesis is a very common procedure in the practice of foot and ankle surgeons. The standard technique recommends using a Kirschner wire (KW) with double sharp ends. Using this technique there are some complication that can be eliminated by small modification. The technique of proximal interphalangeal joint arthrodesis using a simple blunt KW on one side with an accurate placement and avoidance of metatarsophalangeal joint (MTPJ) penetration without the need for fluoroscopy is described. This technique is simple, reproducible, very economical and avoiding most of the complications attributed to the KW.

[A multi-disciplinary approach to diabetic foot patients--an organizational model for the treatment of leg complications in diabetic patients].

Diabetes mellitus is the major cause of non-traumatic limb amputations in the Western world. In the diabetic foot patient, 85% have developed a leg ulcer prior to limb amputation. Due to the complicated nature of therapy in such patients, a multi-disciplinary approach is warranted. In this review, we describe an organizational model which provides an immediate solution to the factors involved in the evolution of a diabetic foot. At the end of 2002, The Wolfson Medical Center administration decided to centralize the diabetic foot patients into one unit situated in the Department of Medicine C. Ten beds were allocated for this purpose and situated at the far end of the department reducing the potential spread of infections to the rest of the ward. With the opening of the unit, a multi-disciplinary team was established that included internists, orthopedists, vascular surgeons, diabeticians, infectious disease specialists, and a specialized nursing staff that acquired their expertise while working with the medical staff and consultants including plastic surgeons and orthotists as required. With the initiation of the Diabetic Foot Unit, there was a reduction of 50% in major amputations in the unit when compared to the preceding years. During the years 2003-2004, the major amputation rate dropped to Less than 8%. Treatment of the diabetic foot patient is complex. In order to reduce the morbidity of limb amputation, a Diabetic Foot Unit is justified. In addition, specialized staff working in concert enable a synergistic effort that cannot be acquired individually. Most importantly, the amputation rate can be significantly reduced by utilizing the Diabetic Foot Unit model.

Efficacy of ozone-oxygen therapy for the treatment of diabetic foot ulcers.

BACKGROUND: Diabetic foot ulcers are associated with significant morbidity. Conventional treatment modalities are often of limited success in promoting complete wound closure. The aim of the present study was to examine the efficacy of noninvasive ozone-oxygen therapy in the treatment of diabetic foot ulcers. METHODS: Diabetes patients with a Wagner classification stage 2 or 3 ulcer or a stage 4 ulcer after debridement of at least 8 weeks in duration were included in this double-blind, randomized, placebo-controlled clinical trial. Patients received conventional treatment in combination with either ozone-oxygen treatment or sham treatments for 12 weeks, and after an additional 12 weeks, wound status was re-examined. RESULTS: In total, 61 patients (62% male, 62.6±9.8 years old) participated in the study; 32 were randomized to ozone treatment, and 29 to placebo. The proportion of subjects with full wound closure did not differ significantly by treatment assignment (41% vs. 33%, P=0.34). Among the 34 subjects who completed the study per protocol (PP) (16 in the ozone group, 18 in the placebo group), a significantly higher rate of complete wound closure was observed in the ozone group (81% vs. 44%, P=0.03). Among PP patients with wound size ≤5 cm(2), the rate of total wound closure was 100% versus 50% in the sham treatment group (P=0.006). A nonsignificant, 55.5% relative increase in healed wound area was detected in the ozone group versus the placebo group (4.2±4.9 cm(2) vs. 2.7±1.5 cm(2), P=0.23). CONCLUSIONS: Among PP patients, ozone treatment in addition to conventional treatment was superior to conventional treatment alone in promoting the complete healing of diabetic foot ulcers.

Achilles tendon rupture and our experience with the Achillon device.

BACKGROUND: Open repair of the Achilles tendon is still the gold standard for treating rupture. This technique has the disadvantages of a long and problematic operative scar and thickly scarred Achilles tendon. To improve the surgical outcome minimally invasive techniques have been developed. OBJECTIVES: To analyze our results of Achilles tendon repair using the Achillon device and compare them with published studies. METHODS: We performed surgical repair of the Achilles tendon in 28 patients during a 4 year period (2004-2008): 14 patients were treated with the Achillon device, 12 with the open suture technique and 2 with the percutaneous method. Fourteen patients were available for follow-up: 9 patients with the Achillon device, 3 patients with open suturing and 2 patients with the percutaneous technique. Follow-up ranged from 1 to 4 years. RESULTS: The average score of the AOFAS Ankle-Hindfoot Scale for the group treated with the Achillon device was 95.6 points (range 84-100) and for the group treated with the open method, 90 points (range 84-98). The length of the scar in patients operated with a minimally invasive technique was 3.81 cm (range 1-6 cm) as compared to 9.16 cm (range 8-10.5 cm) with the open suture. CONCLUSIONS: This is the first review on this procedure in Israel. Excellent functional results were achieved with this technique. Our outcomes were similar to those of two other studies.

The use of 99mTc-recombinant human annexin V imaging for differential diagnosis of aseptic loosening and low-grade infection in hip and knee prostheses.

UNLABELLED: The aim of this study was to assess the pattern of annexin V uptake in hip and knee prostheses suspected of being infected. METHODS: A total of 7 patients undergoing revision surgery for hip or knee prostheses were studied; 5 patients had total hip replacements, and 2 had total knee replacements. Infection was confirmed by pathology, culture results, laboratory evaluation, and clinical follow-up. All patients also underwent a bone scan before surgery. RESULTS: Annexin V scan findings were positive in 5 patients and negative in 2. Annexin V uptake was either focal (n = 4) or linear (n = 1). There were 4 true-positive, 2 true-negative, 1 false-positive, and no false-negative annexin V studies. Annexin V uptake was either more extensive or less extensive than, and usually was incongruent with, (99m)Tc-methylene diphosphonate uptake. CONCLUSION: Our findings suggest that annexin V imaging shows greater uptake with infection than with aseptic loosening and has a high negative predictive value for prosthetic infection.

Similar incidence of hypotension with combined spinal-epidural or epidural alone for knee arthroplasty.

BACKGROUND: We hypothesized that the incidence of hypotension during total knee replacement (TKR) surgery is lower in patients given combined spinal-epidural (CSE) anesthesia vs those receiving epidural anesthesia alone. METHODS: In a prospective study, 80 American Society of Anesthesiologists I-II patients (aged 40-80 yr), undergoing elective TKR surgery were randomly assigned to either CSE anesthesia (CSE, n = 40) or epidural anesthesia alone (Epidural, n = 40). Hemodynamic measurements included oscillometric mean arterial blood pressure (MAP), heart rate (HR), and cardiac index (CI) as determined by thoracic bioimpedance; systemic vascular resistance (SVR) was calculated. Our primary endpoint (outcome) was the number of hypotension episodes (defined as MAP < 70 mmHg). RESULTS: Using univariate analysis, we found no differences between the groups in regards to MAP, HR, CI, or SVR during the perioperative period. The incidence of hypotension was similar in both groups (two patients in each group), as was the incidence of bradycardia (12 patients in CSE, 7 in Epidural; P = 0.2). There were no differences between groups in other hemodynamic measurements including CI and calculated SVR. Analgesia supplementation with fentanyl was more frequently required in the Epidural group (20 vs 6 patients - P = 0.03). CONCLUSION: Combined spinal-epidural anesthesia and epidural anesthesia alone during TKR surgery are associated with the same incidence of hypotension with statistically and clinically similar hemodynamic responses.

Coccygectomy for intractable coccygodynia.

BACKGROUND: Coccygectomy is an uncommon procedure that many surgeons are reluctant to perform due to its proximity to the anus and the risk of rectal perforation and infection. OBJECTIVES: To evaluate the diagnostic accuracy and outcome of coccygectomy. METHODS: We retrospectively reviewed the operative results in nine patients (seven females and two males) who underwent coccygectomy for coccygodynia in the last 5 years following failure of conservative treatment. RESULTS: The outcome of the procedure was excellent in five patients, good in one patient and poor in two patients. CONCLUSIONS: It is mandatory to perform bone scanning in every patient with coccygodynia and before coccygectomy in order to rule out the presence of malignancy. Coccygectomy is recommended for patients with isolated coccygodynia.

Surgical treatment of posttraumatic radioulnar synostosis in children.

The authors describe two children who underwent surgical treatment of radioulnar synostosis. One case involved simple excision; the other, excision and interposition of Gore-Tex vascular graft material. In a review of the literature, no other report of the latter type of surgical treatment was found. A discussion of the literature concerning this rare complication in children and the current surgical treatment options are included.