Satoru Fujita

Deep venous thrombosis after posterior spinal surgery.

Study Design. A prospective clinical study using venography to evaluate deep venous thrombosis after posterior spinal surgery. Objectives. To demonstrate the prevalence of deep venous thrombosis after posterior spinal surgery with no prophylaxis. Summary of Background Data. There have been few studies about the occurrence of deep venous thrombosis after spinal surgery in which venography was used for screening. Methods. Of the enrolled 134 patients undergoing posterior spinal surgery, 110 (82.1%) were examined with complete surveillance for deep venous thrombosis by venography. There were 64 males and 46 females. The average age at operation was 59.0 years (range, 14–86 years). The levels of the operation were cervical in 54, thoracic in 7, and lumbar in 49. All procedures were performed with patients under general anesthesia. Neither mechanical methods nor anticoagulation medications were used for prophylaxis against thromboembolism. Bilateral ascending venography was performed within 14 days after surgery. Results. There were no patients with clinical signs of deep venous thrombosis and pulmonary embolism. However, 17 patients (15.5%) showed venographic evidence of deep venous thrombosis, of whom 16 had distal thrombi, and only one had a proximal thrombus. Deep venous thrombosis was venographically evident in 3 (5.6%) of 54 patients who underwent cervical procedures, and it was evident in 13 (26.5%) of 49 patients who underwent lumbar procedures. This difference was statistical significant (&khgr;2 test, P = 0.003). Statistical comparison between patients who did and did not have deep venous thrombosis showed that age was statistically significant (Mann–Whitney test;P < 0.05). Conclusions. The prevalence of deep venous thrombosis after posterior spinal surgery is higher than generally recognized. Therefore, further study is necessary to clarify the appropriate method for screening and the effect of prophylaxis against thromboembolism after spinal surgery.

Safety and Efficacy of Edoxaban, an Oral Factor Xa Inhibitor, Versus Enoxaparin for Thromboprophylaxis After Total Knee Arthroplasty: The STARS E-3 Trial

INTRODUCTION This phase 3 trial compared the safety and efficacy of edoxaban, an oral direct factor Xa inhibitor, with enoxaparin sodium (enoxaparin) for thromboprophylaxis after total knee arthroplasty (TKA) in patients in Japan and Taiwan. MATERIALS AND METHODS In this randomized, double-blind, double-dummy study, patients received oral edoxaban 30 mg once daily beginning 6 to 24 hours postsurgery or enoxaparin 2000 IU (equivalent to 20 mg) subcutaneously twice daily beginning 24 to 36 hours postsurgery for 11 to 14 days. The primary efficacy endpoint was the composite of symptomatic pulmonary embolism and symptomatic and asymptomatic deep vein thrombosis. Safety endpoints included the incidence of major bleeding, clinically relevant non-major (CRNM) bleeding, major bleeding or CRNM bleeding, all bleeding events, adverse events, and adverse drug reactions. RESULTS Of 716 patients enrolled, 360 and 356 were randomized to receive edoxaban or enoxaparin, respectively. The primary efficacy outcome occurred in 22/299 (7.4%) and 41/295 (13.9%) patients in the edoxaban and enoxaparin groups, respectively (relative risk reduction=46.8%), indicating non-inferiority (P <0.001) and superiority (P=0.010) of edoxaban versus enoxaparin. In the edoxaban and enoxaparin groups, major bleeding occurred in 4/354 (1.1%) versus 1/349 (0.3%) patients (P=0.373); major or CRNM bleeding occurred in 22/354 (6.2%) versus 13/349 (3.7%) patients (P=0.129), respectively. CONCLUSIONS Edoxaban 30 mg once daily was more effective for thromboprophylaxis than subcutaneous enoxaparin 2000 IU twice daily following TKA and demonstrated a similar incidence of bleeding events.

Safety and efficacy of edoxaban in patients undergoing hip fracture surgery

INTRODUCTION Edoxaban is an oral, direct, once-daily factor Xa inhibitor. This study evaluated the safety and efficacy of edoxaban compared to subcutaneous enoxaparin in Japanese patients undergoing hip fracture surgery. MATERIALS AND METHODS In this multicenter, randomized, open-label, active-comparator, phase 3 trial, 92 patients were randomized 2:1 to receive edoxaban 30mg once daily (n=62) or enoxaparin sodium (enoxaparin) 2000IU (equivalent to 20mg) twice daily (n=30) for 11 to 14days. The primary endpoints were the incidence of major or clinically relevant non-major (CRNM) bleeding and incidence of any bleeding events (major, CRNM, or minor bleeding). Secondary efficacy endpoints included the incidence of thromboembolic events, venous thromboembolism-related deaths, and all-cause deaths. Additional adverse events were recorded throughout the study. RESULTS In the edoxaban and enoxaparin treatment groups, the incidence of major or CRNM bleeding was 3.4% and 6.9%, respectively, while any bleeding event occurred in 25.4% and 17.2% of patients, respectively. The incidence of thromboembolic events was 6.5% in the edoxaban group and 3.7% in the enoxaparin group. All events were asymptomatic deep vein thrombosis. The incidence of adverse events was 72.9% and 82.8% in the edoxaban and enoxaparin groups, respectively. CONCLUSIONS Compared to subcutaneous enoxaparin 2000IU twice daily, oral edoxaban 30mg once daily demonstrated similar safety and efficacy in the prevention of thromboembolic events in Japanese patients undergoing hip fracture surgery. CLINICAL TRIALS REGISTRATION NUMBER NCT01181141.

Prevention of postoperative venous thromboembolism in Japanese patients undergoing total hip or knee arthroplasty: two randomized, double-blind, placebo-controlled studies with three dosage regimens of enoxaparin

BackgroundEnoxaparin is a low-molecular-weight heparin indicated in Europe and North America for the prevention of venous thromboembolism (VTE) in patients undergoing major orthopedic surgery. Registration trials of enoxaparin have been conducted primarily in Caucasian populations, and the efficacy and safety of enoxaparin in Japanese patients have not been demonstrated. We evaluated three dosage regimens of postoperative enoxaparin in Japanese patients undergoing elective total hip or knee arthroplasty.MethodsTwo multicenter, randomized, double-blind studies enrolled 436 and 396 Japanese adults undergoing total hip or knee arthroplasty, respectively. The dosage regimens of enoxaparin were 20 mg once daily (qd), 40 mg qd, 20 mg twice daily (bid), or placebo for 14 consecutive days. The primary efficacy endpoint was the incidence of VTE in the modified intention-to-treat (mITT) population up to 15 days after surgery. VTE was defined as a composite of deep vein thrombosis (determined by venography) and symptomatic pulmonary embolism (confirmed by appropriate objective methods). Patients were also followed up at 90 days for VTE events. The primary safety outcome was the incidence of any bleeding during treatment and the follow-up period.ResultsIn the mITT populations, the incidence of VTE was 41.9% and 60.8% in the placebo groups after hip or knee arthroplasty, respectively, 25.9% and 44.9% in the enoxaparin 20 mg qd groups, 33.8% and 35.1% in the enoxaparin 40 mg qd groups, and 20.0% and 29.8% in the enoxaparin 20 mg bid groups. Only enoxaparin 20 mg bid significantly lowered the risk of VTE relative to placebo (by 52.2% and 51.0% after hip and knee arthroplasty, respectively). At the 90-day follow-up, no further cases of VTE were reported. In both the hip and knee studies, the four treatment groups did not differ significantly regarding the incidence of patients with any bleeding.ConclusionsOur findings support the use of enoxaparin (20 mg bid daily, commencing 24–36 h postoperatively) in Japanese patients undergoing total hip or knee arthroplasty.

Complications following metatarsal lengthening by callus distraction for brachymetatarsia

We performed six metatarsal lengthenings in four patients for brachymetatarsia of the fourth toe by callus distraction from 1991 to 1995. Healing was achieved in all cases. The average amount of lengthening was 30% (range, 15-41%) of the original length. The average healing index was 82 days/cm (range, 66-113 days/cm). After the operation, range of movement of the metatarsophalangeal joint decreased in all cases (120 degrees before and 57 degrees after surgery). In two cases in which the lengthening exceeded 40% of the original length, stiffness of the joint (20 degrees and 0 degrees each) and joint deformity occurred. These two cases also had angulation of the metatarsal. Corrective osteotomy and release surgery was performed in one case. Angulation of the metatarsal was corrected, but the range of movement of the joint did not much recover after surgery. Another case was left untreated because the patient had no complaints. In metatarsal lengthening by callus distraction, the amount of lengthening should not exceed 40% of the original length.

Modified Sauvé-Kapandji Procedure for Disorders of the Distal Radioulnar Joint in Patients with Rheumatoid Arthritis

BACKGROUND The Sauvé-Kapandji procedure has become popular for the treatment of disorders of the distal radioulnar joint in patients with rheumatoid arthritis, but this procedure is impossible to perform in patients with poor bone quality in the distal part of the ulna. We have modified the procedure for patients with poor bone quality in the distal part of the ulna. The modified procedure involves resecting the distal part of the ulna, making a drill-hole in the ulnar cortex of the distal part of the radius, rotating the resected portion of the ulna 90 degrees , inserting it into the distal part of the radius, and fixing it at that site with use of an AO cancellous-bone screw. In the present report, we describe the new operative technique and report the results after a minimum duration of follow-up of three years. METHODS This operation was performed in fifty-six patients (sixty-six wrists) with rheumatoid arthritis. The mean age at the time of the operation was 59.3 years. The mean duration of follow-up was forty-eight months. Patients were evaluated in terms of wrist pain, grip strength, and range of motion. Radiographic evaluation included calculation of the carpal translation index to assess the extent of ulnar translation of the carpus. RESULTS Osseous union was achieved in all cases. Wrist pain resolved or decreased in all patients. The mean total range of forearm rotation increased from 144 degrees preoperatively to 167 degrees at the time of the most recent follow-up (p < 0.01). The mean carpal translation index did not change after the operation. CONCLUSIONS The modified Sauvé-Kapandji procedure results in rigid fixation of the grafted bone. The technique provides sufficient osseous support of the carpus even in patients with rheumatoid arthritis and poor bone quality in the distal part of the ulna.

Accuracy of Atlantoaxial Transarticular Screw Insertion

Study Design. The accuracy and safety of atlantoaxial transarticular screw insertion were evaluated in clinical cases. Objectives. To evaluate the accuracy and safety of atlantoaxial transarticular screw insertion under lateral fluoroscopic monitoring without opening the joint. Summary of Background Data. Atlantoaxial transarticular screw fixation has been reported to be biomechanically superior to posterior atlantoaxial wiring techniques. Several clinical series have been reported in the literature. In some reports, the risk of screw insertion in this technique has been pointed out. Materials and Methods. Fifty-six consecutive patients with atlantoaxial instability were treated by transarticular screw fixation. One hundred twelve screw insertions in these 56 patients were assessed by surgical record and computed tomographic examination. One screw could not be inserted because of the difficulty of adequate placement during operation; 111 screws were therefore inserted. Adequate position was defined as when the screw perforated the lateral atlantoaxial joint. Results. In this series, neither vertebral artery injury nor spinal cord injury was experienced clinically. One guide wire was broken during drilling with a cannulated drill. Computed tomographic examination demonstrated that 106 screws perforated the atlantoaxial joint. Therefore, 95.5% of screws were adequately positioned. There were two screws positioned lateral to the joint, two medially, and one anteroinferiorly to the joint. Conclusions. Atlantoaxial transarticular screw insertion using image intensifier without opening the lateral joint was performed safely, but not accurately, in all cases.

Modified Sauve-Kapandji procedure for disorders of the distal radioulnar joint in patients with rheumatoid arthritis. Surgical technique.

BACKGROUND The Sauvé-Kapandji procedure has become popular for the treatment of disorders of the distal radioulnar joint in patients with rheumatoid arthritis, but this procedure is impossible to perform in patients with poor bone quality in the distal part of the ulna. We have modified the procedure for patients with poor bone quality in the distal part of the ulna. The modified procedure involves resecting the distal part of the ulna, making a drill-hole in the ulnar cortex of the distal part of the radius, rotating the resected portion of the ulna 90 degrees, inserting it into the distal part of the radius, and fixing it at that site with use of an AO cancellous-bone screw. In the present report, we describe the new operative technique and report the results after a minimum duration of follow-up of three years. METHODS This operation was performed in fifty-six patients (sixty-six wrists) with rheumatoid arthritis. The mean age at the time of the operation was 59.3 years. The mean duration of follow-up was forty-eight months. Patients were evaluated in terms of wrist pain, grip strength, and range of motion. Radiographic evaluation included calculation of the carpal translation index to assess the extent of ulnar translation of the carpus. RESULTS Osseous union was achieved in all cases. Wrist pain resolved or decreased in all patients. The mean total range of forearm rotation increased from 144 degrees preoperatively to 167 degrees at the time of the most recent follow-up (p < 0.01). The mean carpal translation index did not change after the operation. CONCLUSIONS The modified Sauvé-Kapandji procedure results in rigid fixation of the grafted bone. The technique provides sufficient osseous support of the carpus even in patients with rheumatoid arthritis and poor bone quality in the distal part of the ulna.

Clinical application of computed radiography in orthopedic surgery

Since 1988, Fuji Computed Radiography (FCR) system (Fuji Medical Systems, Tokyo, Japan) has been used at Osaka Prefectural Hospital (Osaka, Japan) for all kinds of images. In this paper, we discuss the advantages and disadvantages of computed radiography (CR) images from the standpoint of an orthopedic surgeon. Contours, which can not be seen on conventional radiographs, are clearly visualized on the CR image. Adequate information for diagnosis can be obtained with a great reduction in x-ray exposure during the screening of scoliosis or congenital dislocation of hip joint. However, because the scale is reduced by one half in antero-posterior views of the bilateral hip joint, CR images are unsuitable for postoperative measurement of total hip arthroplasty (THA). Furthermore, caution is required because the clear zone after THA is emphasized on edge-enhanced CR image.

Modified Sauvé-Kapandji procedure for rheumatoid wrists: A long-term study with a minimum follow-up of 5 years

Abstract Objectives. We performed a modified Sauvé-Kapandji procedure for treating disorders of distal radioulnar joint in patients with rheumatoid arthritis (RA). This procedure involves resecting the distal part of the ulna, rotating the resected portion by 90° and fixating it with the distal part of the radius for shelf plasty. The purpose of this study was to examine the clinical and radiographic outcomes of this procedure with more than 5 years’ follow-up. Methods. We studied 32 wrists of 27 RA patients with the mean follow-up of 93.1 months after operation. Pain, grip strength and range of motion of the wrist were examined clinically, while two indices for evaluation of ulnar and palmar translation of the carpus, carpal translation index and palmar carpal subluxation ratio were calculated on radiographs. Results. The wrist pain reduced in all cases. Range of motion increased significantly regarding pronation and supination but decreased significantly regarding flexion. Change in grip power was not significant. No significant differences were recognized between radiographic indices, suggesting carpal alignment was maintained well throughout the follow-up period. Conclusions. We think this procedure could be applied for distal radioulnar joint disorders in RA patients with promising clinical as well as radiographic outcomes over a long period.