Introduction

Osteochondral defects (OCDs) of the talus are treated initially by arthroscopic bone marrow stimulation. For both large and secondary defects, current alternative treatment methods have disadvantages such as donor site morbidity or two-stage surgery. Demineralized bone matrix (DBM) was published for the treatment of OCDs of rabbit knees. Autologous platelet-rich plasma (PRP) may improve the treatment effect of DBM. We previously developed a goat model to investigate new treatment methods for OCDs of the talus. The aim of the current study was to test whether DBM leads to more bone regeneration than control OCDs, and whether PRP improves the effectiveness of DBM.

There is no optimal treatment for osteochondral defects of the talus after failed primary surgical treatment. To treat these patients, a 15-mm diameter metal implant was developed for the medial talar dome. The present study was undertaken to evaluate the clinical effectiveness of the metal implantation technique for osteochondral lesions of the medial talar dome.

This is a prospective case series. The inclusion criteria were the combination of a large OCD (ϕ >12 mm) of the medial talar dome, persistent complaints >1 year after treatment, and clinically relevant pain levels. The exclusion criteria were: age <18 years, OCD size >20 mm, ankle osteoarthritis grade 2 or 3, concomitant ankle pathology, and diabetes. The primary outcome measure was the Numeric Rating Scale pain (NRS) rest, walking, running, and stair climbing. Secondary outcome measures were: Foot Ankle Outcome Score (FAOS), American Orthopaedic Foot and Ankle Society (AOFAS) Ankle-Hindfoot score, and clinical and radiographic complications. The Wilcoxon signed ranks test was used to calculate p-values.

Between October 2007 and March 2009 10 patients were included. The median follow-up was 2 years (range, 2–3 years). On preoperative CT scanning, the median lesion size was 15 (range, 12–20) × 11 (range, 8–14) mm. The NRS rest improved from a median of 3 (0–7) preoperatively to 0.5 (0–2) at final follow-up (p = 0.017), NRS walking from 6.5 (4–8) to 1 (0–4) (p = 0.005), NRS running from 9 (6–10) to 3 (0–10) (p = 0.024), and NRS stair climbing from 6 (4–8) to 1 (0–7) (p = 0.012). The FAOS improved significantly on four of five subscales. The AOFAS improved from a median of 70 (47–75) before surgery to 89 (69–100) at final follow-up (p = 0.008). There were three temporary complications: hyposensibility about the scar in two and a superficial wound infection in one. There were no radiographic complications.

PURPOSE

Osteochondral talar defects (OCDs) are sometimes located so far posteriorly that they may not be accessible by anterior arthroscopy, even with the ankle joint in full plantar flexion, because the talar dome is covered by the tibial plafond. It was hypothesized that computed tomography (CT) of the ankle in full plantar flexion could be useful for preoperative planning. The dual purpose of this study was, firstly, to test whether CT of the ankle joint in full plantar flexion is a reliable tool for the preoperative planning of anterior ankle arthroscopy for OCDs, and, secondly, to determine the area of the talar dome that can be reached by anterior ankle arthroscopy.

Objectives

Osteochondral ankle defects (OCDs) mainly occur in a young, active population. In 63% of cases the defect is located on the medial talar dome. Arthroscopic debridement and microfracture is considered the primary treatment for defects up to 15 mm. To treat patients with a secondary OCD of the medial talar dome, a 15-mm diameter metal implant (HemiCAP ®) was developed. The set of 15 offset sizes was designed to correspond with the anatomy of various talar dome curvatures. Recently, two independent biomechanical cadaver studies were published, providing rationale for clinical use. The present study was undertaken to evaluate the clinical effectiveness and safety of the metal implantation technique for osteochondral lesions of the medial talar dome in a prospective study.

Background: A recent study found that after median term follow-up disability correlated with pain rather than the limited residual impairments in motion and strength. We studied impairment and disability an average of twenty-one years after injury in a cohort of Dutch patient, with the hypothesis that both impairment and disability would be lower in patients that were skeletally immature at the time of injury.

Methods: Seventy-one patients were evaluated an average of 21 years after injury. The majority of the 35 skeletally immature patients were treated conservatively with closed reduction and cast immobilization and the majority of the 36 skeletally mature patients were treated with plate and screw fixation. Objective evaluation included radiographs and measurements of range of motion and grip strength. Questionnaires were used to measure arm-specific disability (Disabilities of the Arm, Shoulder and Hand: DASH), misinterpretation or over interpretation of pain (Pain Catastrophizing Scale-PCS-), and depression (CES-D). Multivariable analysis of variance and multiple linear regression were used to compare patients that were skeletally mature and immature at the time of injury and to identify predictors of arm-specific disability (SPSS 17.0, SPSS inc., Chicago).

Results: There were 44 men and 27 women with a an average age of forty-one at time of follow-up (range, 20 to 81). Fractures were classified as AO/OTA-type A3 in 46 patients (simple), B3 in 18 (including wedge fragment) and C fractures in 7 patients (comminuted). The average DASH score was 8 points (0 to 54) and 73% reported no pain. Both rotation and wrist flexion/extension were 91% of the uninjured side; grip strength was 94%. There were small, but significant differences in rotation (151 versus 169 degrees, p=0.004) and wrist flexion/extension (123 versus 142 degrees, p=0.002), but not disability between skeletally mature and immature patients. The best predictors of DASH score were nerve damage, pain and grip strength, explaining 56% of the variation in DASH scores. Disability did not correlate with depression or misconceptions about pain.

Conclusions: Twenty-one years after initial fracture, both skeletally immature and mature patients have limited impairment (averaging over 90% motion and grip strength) and disability after non operative and operative treatment respectively. Patients that were skeletally immature at the time of injury had better motion, but comparable disability. Disability correlated with pain rather than motion, but did not correlate with psychosocial measures.

Purpose: To evaluate the safety and efficacy of hylan G-F 20 viscosupplementation in patients with symptomatic osteoarthritis (OA) of the ankle.

Methods: Prospective, multi-center, open study in patients with primary or secondary grade II talocrural OA confirmed by X-ray. At baseline, patients had to score between 50–90 mm on the Patient-completed Ankle OA Pain VAS (0–100 mm). Patients received one intra-articular injection of 2 ml of hylan G-F 20 and were given an option of a second and final 2 ml injection if their pain remained between 50-90 mm on the VAS after 1, 2 or 3 months. Intraarticular injections were placed in the anteromedial portal of the ankle joint as described for ankle arthroscopy. Patients were followed for 6 months after the final injection. As rescue medication, patients could only take paracetamol up to 4 g per day, except on the day of or the day before a study visit.

All treatment emergent adverse events (AEs) were recorded. The primary efficacy endpoint was change from baseline (at final injection) in the Ankle OA Pain VAS at 3 months after the final injection. Secondary endpoints were Ankle OA Pain VAS scores at all other time-points, total Ankle OA Scale, Patient and Physician Global OA Assessment (VAS), and health-related quality of life (SF-36).

Results: Fifty-five patients (33 M; 22 F) were enrolled and received a first injection of hylan G-F 20. Twenty-four patients (44%) received a second injection. The mean age was 41 years (range 19–70). Overall, treatment with hylan G-F 20 was well tolerated. Seventeen patients (31%) had a treatment related AE of the target ankle. All were of mild or moderate intensity, the majority consisting of arthralgia and injection site pain. There was a statistically significant decrease in Ankle OA Pain VAS score from 68.0 mm at Baseline to 33.8 mm at Month 3 (p< 0.001, paired t-test), which was maintained at 6 months follow-up. The decrease was statistically significant at all time points. Patients who received only 1 injection demonstrated a greater decrease at 3 months (−42.5 mm) than patients with 2 injections (−23.5 mm). The secondary efficacy endpoints showed similar results. Of the total study population, 29 patients (53%) were responders (i.e. at least a 50% decrease in ankle OA pain) after 3 months. 64% of patients receiving 1 injection were responders after 3 months. The SF-36 questionnaire showed statistically significant improvements for both the physical and mental component scores at 3 and 6 months follow-up.

Conclusions: Treatment of OA of the ankle with intraarticular hylan G-F 20 injections is well tolerated. Treatment with hylan G-F 20 significantly decreases pain which is maintained for up to 6 months.

BACKGROUND: Oral DVT prophylaxis not requiring monitoring is an advantage in orthopaedic patients. Dabigatran etexilate is an oral direct thrombin inhibitor undergoing evaluation for the prevention of venous thromboembolic events (VTE) following orthopaedic surgery.

METHODS: In a phase III, multicenter, non-inferiority, double-blind study, patients undergoing total knee replacement were randomized to 3 treatments. The patients received 8±2 days of oral dabigatran etexilate, 150 or 220 mg once daily starting with a half dose (i.e.75 or 110 mg) 1–4 hours after surgery, or subcutaneous enoxaparin 40 mg once daily starting 12 hours prior to surgery. The primary efficacy outcome was the composite of total VTE and all causes of mortality during the treatment period. All efficacy and safety outcome events were adjudicated by blinded independent committees.

RESULTS: Efficacy could be evaluated for 1541 (75%) treated and operated patients. Total VTE and death occurred in 40.5%, 36.4% and 37.7% of patients assigned to dabigatran etexilate 150 or 220mg once daily or enoxaparin, respectively. Proximal DVT and/ or PE occurred in 3.8%, 2.6% and 3.5% of patients receiving dabigatran 150 or 220mg or enoxaparin, respectively. Three deaths occurred during the treatment period, one in each of the treatment groups. Safety was evaluated for all 2076 patients receiving study treatment. The rate of major bleeding was 1.3%, 1.5% and 1.3% of patients receiving dabigatran 150 or 220mg or enoxaparin. Elevated LFTs (ALT > 3xULN) occurred in 3.7%, 2.8% and 4.0% of the patients treated with 150 and 220 mg dabigatran or enoxaparin during the study. A temporary rise in LFTs was observed during the follow-up period in 0.5% of the patients who had received dabigatran and in 0.4% of the patients who had received enoxaparin.

CONCLUSIONS: Non-inferiority for the primary efficacy endpoint was met for both doses of dabigatran etexilate compared to enoxaparin. There was no difference in bleeding rates between the treatment groups. Oral administration of dabigatran etexilate once daily, given early in the postoperative period, was effective and safe for the prevention of total VTE in patients undergoing total knee replacement surgery.