Successful methods to introduce new treatments in a developed country can vary depending on the national consensus. This may be the most important issue for many experts attempting to popularize a new therapeutic strategy. For example, in Japan, almost 60% of rheumatoid arthritis (RA) patients are treated by orthopedic surgeons. At the moment, it may be true that many practicing orthopedic surgeons are not familiar with new drugs such as infliximab. Consequently, we believe that a manual describing the safe use of infliximab to achieve improved RA therapy could be useful. This manual was originally planned by Dr. Inoue, who was chairman of the Meeting for Biologics Treatment by Orthopedics Experts. The manual was created by approximately 70 selected experts nationwide who are experienced users of infliximab in Japan. Each of the four meetings lasted at least 4 h, and a conclusion was made at the end of each meeting. All the conclusions were finally incorporated into the manual, so it should directly reflect the Japanese situation and provide useful information in the form of practical notes for new users of infliximab. The manual follows the guidelines given by the Japanese College of Rheumatology. The aim of this manual is to help generalize infliximab therapy in Japan, and we really hope that it will be well accepted by many orthopedic surgeons who are involved in RA clinics in their daily work.

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Objective: This study aimed to confirm the clinical efficacy, safety, and remission rate after 52 weeks of rheumatoid arthritis (RA) treated with etanercept (ETN).
Methods: A total of 78 RA patients were selected retrospectively and evaluated for safety. The clinical responses were evaluated in 64 patients at 24 weeks and 52 weeks of the ETN therapy using the European League Against Rheumatism (EULAR) response criteria. Clinical remission was defined as Disease Activity Score 28 using erythrocyte sedimentation rate (DAS28-ESR) <2.6.
Results: After treatment with ETN, the average DAS28-4ESR scores were 5.59, 4.65, 4.22, 3.91, and 3.64 at 0, 4, 12, 24, and 52 weeks, respectively. As for the EULAR response criteria, 18.8% and 62.6% obtained good and moderate responses at 24 weeks, respectively, and 32.4% and 48.6% obtained good and moderate responses at 52 weeks, respectively. Remission rates obtained in stage I+II/III+IV patients were 54.5% and 11.5%, respectively, and the remission rates in those with disease duration under 2 years and 2 years and greater were 50.0% and 22.9% at 52 weeks, respectively. Significant differences in clinical response were not seen between patients with or without concomitant methotrexate (MTX) as well as between elderly and young patients.
Conclusion: High remission rates were obtained in patients with disease duration of 2 years or less, who also had less joint destruction. Early and aggressive therapy aimed for tight control of the disease is desired.

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Objective: We investigated the clinical efficacy and safety of low-dose tacrolimus (less than 1 mg/day) in active rheumatoid arthritis (RA) patients who were followed up for more than 2 years.
Methods: The present study included 49 patients (26 were < 65 years old and 23 were ≧ 65 years old) with RA who had started tacrolimus therapy before April 2007. Adverse effects, persistence rate, and disease activity score 28/C reactive protein (DAS28-CRP) were compared between patients younger than 65 and older than 65.
Results: A total of 22 patients (7 younger than 65 and 15 older than 65) had several adverse effects, and 15 patients (6 younger than 65 and 9 older than 65) discontinued tacrolimus therapy. Older patients tended to have more adverse effects than younger patients did, and 10 older patients changed from tacrolimus to other drugs because of adverse effects. In the patients who continued to receive tacrolimus, DAS28-CRP improved from a baseline mean of 3.81±0.82 to 3.14±0.93 and 2.96±1.15 at 6 and 24 months after the start of therapy, respectively The efficacy of tacrolimus in patients older than 65 was as good as that in patients younger than 65.
Conclusion: When tacrolimus is administered to older patients or to those whose RA has complications, we must be particularly aware of the potential for adverse effects.

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Objective: The BICON-PLUS cup is an uncemented, threaded acetabular component. We evaluated the clinical results of the cup in revision surgery after failed bipolar hip arthroplasty.
Methods: In our institute, 71 hips underwent revision surgery for failed bipolar hip arthroplasty. A total of 30 hips in 25 patients were revised using the BICON-PLUS cup. Among them, we evaluated 24 hips in 21 patients with 2 or more years’ follow-up. All patients were women, and the average age at revision was 57 years. The average period of follow-up was 6 years. During the surgery, morselized allograft bone was filled and impacted into the bone defect, and then the cup was twisted into the bony acetabulum.
Results: The average hip score was 64 points before revision surgery and 84 points 2 years postoperatively. At the final follow-up, seven cups were unstable radiologically. Six hips required repeat revision among the unstable hips. Five hips were revised because of the varus migration of the cup and one hip because of recurrent dislocation. The score had improved to 84 points at 2 years after the repeat revision.
Conclusion: The varus and the repeat revision cases had a severe thinning in the anterior or posterior column, a huge bone defect, or an intraoperative fracture in the acetabulum. Most patients with failed bipolar hip arthroplasty had a severe bone defect in the acetabulum due to outer head migration and/or osteolysis. In addition, the quality of the acetabulum was poor. We suspected that the initial fixation was not adequate as the fins of the cup did not bite into the bony acetabulum. Moreover, the allograft bone could not provide adequate bearing against the load. In conclusion, the indication of the cup for use in failed bipolar hip arthroplasty should be limited to hips with minimum damage in the acetabulum.

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Objective: Not only the femoral rotational alignment but also the tibial rotational alignment of the total knee arthroplasty (TKA) is considered a significant factor in securing favorable knee joint function. However, for those patients with brittle bones, such as rheumatoid arthritis or elderly women, there are some cases in which we will give priority to bone coverage over rotational alignment. The purpose of this study was to examine the relationship between the tibial anteroposterior (AP) axis and the position of the tibial component that prioritizes bone coverage.
Methods: In total, 157 preoperative knees of 106 patients with varus osteoarthritis indicated for primary TKA were included in the study. Two knees in which it was not possible to identify the posterior cruciate ligament (PCL) insertion were excluded from the examination. Radiographic grading was performed by using the Kellgren-Lawrence (K-L) criteria (grade 3, n=59; grade 4, n=96). We used three-dimensional preoperative planning software (Athena, Soft Cube) to simulate the tibial component fixations in the assumed cases in which the bone coverage was maximized, and we compared them with Akagi’s tibial AP axis (a line connecting the center of the tibial PCL insertion and the medial border of the patella tendon). We defined the angle of rotating fixation as that between the component rotational axis, in cases in which the bone coverage was maximized, and the tibial AP axis.
Results: The simulated angle of rotating fixation between the component rotational axis and the tibial AP axis averaged 4.5°±4.2° (range, -5.1° to 16.2°). The average angle in K-L grade 4 was 4.9°±3.5°, significantly larger than the 3.5°±2.8° angle found in K-L grade 3 (p=0.04).
Conclusion: In most cases, the tibial components were fixed for external rotation relative to the tibial AP axis (138 knees, 89.0%). However, the variation among cases was not negligible, and the angle varied widely in the range -5.1° to 16.2°. Furthermore, we found a significant correlation between the angle of rotational fixation and the radiographic grade of osteoarthritis. In the present situation in which a consensus has not been established about the rotational position of the tibial component, we consider it is useful to use a mobile-type insert with a self-alignment mechanism.

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Objective: Proximal tibial bony defects are not uncommon in primary total knee arthroplasty (TKA). Management of bone defects encountered at the time of arthroplasty has remained controversial. There are many options for such defects, including autogenous bone grafting, cement and screw augmentation, and modular block augmentation. Some authors have reported good clinical results using metal wedge augmentation. The purpose of this study was to evaluate short-term clinical results of TKA using metal wedge augmentation for tibial bone stock deficiency.
Methods: Studies were carried out on ten knees in eight patients. There were seven knees with osteoarthritis, two knees with rheumatoid arthritis, and one knee with osteonecrosis of the medial part of the tibia. The mean age was 74.5 years, and the mean follow-up period was 29.5 months. We performed TKA with metal wedge augmentation and stem extension in all cases. The range of motion (ROM), Japanese Orthopaedic Association knee score (JOA score), type of bone defects, depth of bone defects, femorotibial angle (FTA), radiolucent line, and loosening were evaluated.
Results: The JOA score improved from a preoperative mean of 49 to 88 at the last evaluation. The ROM and the FTA also improved. The preoperative bone defect size was 22 mm, and the type was asymmetrical loss in all cases. A radiolucent line was found in two cases. There was no knee with loosening.
Conclusion: From this study, the short-term clinical results of primary TKA with metal wedge augmentation and stem extension for tibial bone defects were excellent. But in the X-ray evaluation, radiolucent lines beneath the metal wedge were present in two knees, so that long-term observation would be required for this procedure.

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Objective: We report our experience with the Vanguard^TM tprosthesis for total knee arthroplasty (TKA) in patients with osteoarthritis (OA) and rheumatoid arthritis (RA).
Methods: Our study involved 23 patients (33 joints) who had undergone TKA at least 6 months earlier. The underlying disease was OA in 15 patients (21 joints) and RA in 8 patients (12 joints) . The mean age was 73.9 years at the time of surgery, and the mean follow-up period was 11.1 months. A posterior cruciate ligament (PCL) -retaining (CR) implant was used in 21 joints and a PCL-substituting (PS) implant was employed in 12 joints. Cement was used for fixation in all joints. Patellar replacement was not performed in any of the joints.
Results: The mean operating time was 81.1±11.7 min. None of the patients showed any problems with respect to ROM, JOA score, and component angles on plain radiographs (α, β, and δ angles) at short-term assessment. In the present series, there were no differences in the operating time and range of motion (ROM) between the CR and PS implant. However, measurement of the γ angle on plain radiographs revealed various outcomes, with placement of the femoral component in a flexed position and notch formation being detected in some patients. We also detected an inappropriate component angle or implant size in some patients. Specifically, there was a gap between the anteromedial aspect of the femur and the implant despite correct component width and anterolateral positioning of the γ angle.
Conclusion: A favorable short-term outcome was observed in patients who underwent TKA using a Vanguard^TM prosthesis. The sizing and osteotomy of the femur should be performed carefully by a skilled surgeon. Development of a sizing apparatus that allows precise measurement appears to be necessary. Further improvement of the outcome achieved with the Vanguard^TM TKA can be expected as more skill in sizing and osteotomy of the femur is acquired.

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Objective: The PFC Sigma rotating-platform, high-flexion (RP-F) total knee prosthesis was designed to permit 155° of flexion without compromising wear or polyethylene contact stresses and without patellofemoral maltracking or instability. We report the short-term clinical results of the PFC Sigma RP-F total knee prosthesis.
Methods: Total knee arthroplasty (TKA) was performed on 46 knees using the PFC Sigma RP-F total knee prosthesis from March 2005 to June 2008. Forty-four knees had osteoarthritis (OA) and two knees had rheumatoid arthritis (RA). The mean age at the time of surgery was 75.2 years. We evaluated the femorotibial angle (FTA), the Japanese Orthopaedic Association knee score (JOA score), the range of motion (ROM), and complications and also carried out the Knee Society TKA roentgenographic evaluation.
Results: The average preoperative FTA was 188.6° and the postoperative FTA was 174.9°. The average preoperative extension was -11.2° and the preoperative flexion was 111.1°; the postoperative extension was -2.1° and the postoperative flexion was 121.1°. The preoperative JOA score was 54, and this improved to 85.6 postoperatively. In the postoperative Knee Society TKA roentgenographic evaluation, the mean α angle was 95.6°, the β angle was 89.5°, the γ angle was 1.8°, and the σ angle was 87.2°. One knee suffered a rotating platform dislocation.
Conclusion: From this study, the short-term clinical results of TKA using the PFC Sigma RP-F total knee prosthesis were satisfactory.

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Objective: We investigated patients with spontaneous osteonecrosis of the knee who were treated conservatively.
Methods: In total, 13 knees in 12 patients with osteonecrosis who underwent conservative treatment were evaluated. The average age at the initial diagnosis was 62.6 years (range, 40-74 years). The average follow-up period was 17.6 months. Regarding treatment, we carried out activities of daily living (ADL) restriction depending on pain. We investigated the onset pattern of pain, the period of pain reduction, and the presence of hydrarthrosis. We also classified the onset pattern of pain as either acute, chronic, or acute exacerbation. For radiological evaluations, the initial and final follow-up radiographs were reviewed to establish the necrotic area (mm²), the necrotic ratio [the ratio of the width of the lesion to the width of the medial femoral condyle (%)], the femorotibial angle (FTA) (°), and the stage of osteonecrosis.
Results: Regarding the onset pattern, seven knees were of the acute type, three knees of the chronic type, and three knees of the acute exacerbation type. It took an average of 3.6 months to experience a reduction in pain from the initial visit, and this was 9.4 and 6.2 months from the onset of knee pain for the acute and acute exacerbation types, respectively. Hydrarthrosis, present in six knees at the initial visit, had disappeared by the last visit. One knee was classified as stage 1, one as stage 2, four as stage 3, and seven as stage 4 at the initial visit. At the last visit, two knees were classified as stage 1, one as stage 3, and ten as stage 4. Radiologically, the necrotic area, necrotic ratio, and FTA showed changes from 257.8 to 267.3 mm², from 34.8% to 31.5%, and from 177.3° to 179.2°, respectively. These changes were not significant.
Conclusion: No index obtained from the radiographs demonstrated a significant difference between at the initial and the last visit. Our findings suggest that ADL restriction depending on pain applied for 4-6 months was effective regardless of the stage.

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Objective: We examined partial meniscectomy cases with a postoperative course of more than 10 years.
Method: Nine cases of partial meniscectomy were included in the study, four involving right knees and five involving left knees. The follow-up period was an average of 13 years and 1 month, and the average age of the patients was 39.8 years. The injuries were in the medial meniscus in four cases and in the lateral meniscus in five cases. We studied the area and the types of injury, as well as the resection area based on X-ray films and the clinical condition at the last follow-up.
Results and Conclusion: In previous reports, some improvements were described during the long-term course after the meniscectomy, but our results indicated that cases of medial meniscus injury and cases with a wide resection area yielded poor results.

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Objective: The first treatment selection for thumb carpometacarpal osteoarthritis is conservative treatment. If this approach is not sufficiently effective, we consider surgical treatment. In the present study, we reviewed the surgical results of ligament reconstruction interposition arthroplasty of the thumb.
Methods: We performed ligament reconstruction interposition arthroplasty using a half slip of the flexor carpi radialis tendon in 12 joints in nine patients. Three patients were men and six were women with a mean age of 62 years (from 56 to 66 years) and a mean follow-up period of 8 months (from 6 to 10 months). According to Eaton’s radiographic classification, six joints were stage II, five joints were stage III, and one joint was stage IV. We used Futami’s grading system for clinical evaluation. The items evaluated were degree of pain, difficulties in Activities of Daily Living (ADL), Range of Motion (ROM), pinch strength, grip strength, and radiographic changes.
Results: Complete pain relief was obtained in nine joints after surgery. ADL and ROM of the thumb showed good recovery. Mean pinch strength improved from 2.1 to 2.3 kg and mean grip strength improved from 18 to 22 kg. Seven of 12 joints were excellent and two were good. The space between the base of the first metacarpal and the distal tip of the scaphoid showed narrowing. Two joints (one case) were significantly painful on heavy activities.
Conclusion: Ligament reconstruction interposition arthroplasty using a half slip of the flexor carpi radialis tendon for thumb carpometacarpal osteoarthritis was an effective method if we appreciate the features that ADL and ROM show good recovery specifically.

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We herein report the case of a 65-year-old man who suffered from femoral nerve palsy which was caused by iliopectineal bursitis associated with rheumatoid arthritis. Neurological symptoms in the lower limb and coxalgia were identified during the initial visit, and the magnetic resonance imaging findings revealed both a lumbar lesion and a hip lesion (iliopectineal bursitis). The cyst was therefore punctured, and this relieved the femoral pain, and thereafter the femoral palsy also gradually disappeared after performing total hip arthroplasty. We identified the iliopectineal bursitis as the culprit lesion, even though iliopectineal bursitis was not confirmed at surgery. No recurrence of the bursitis has been observed in this patient after surgery.

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A 49-year-old man with equinus foot (left side) was diagnosed with malignant rheumatoid arthritis (MRA) . Uncontrollable disease activity led to plantar forefoot ulceration of the left fifth metatarsal bone with osteomyelitis. The activity of MRA was brought under control after steroid pulse therapy and etanercept administration. However, the patient suffered from bilateral hip joint pain because of severe joint damage and faced difficulty in standing and walking. In order to control the infection, below-knee amputation was performed. After the patient was fitted with a prosthesis, bilateral total hip arthroplasties were performed. The patient is now able to walk for short distances and is satisfied with the treatment. A below-knee amputation of the lower limb is effective in MRA patients with chronic osteomyelitis of the foot who require total arthroplasty of any joint of the lower extremity.

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A 55-year-old woman with rheumatoid arthritis (RA) presented with a lump of the right palm. The tumor was diagnosed as a synovial sarcoma by an incisional biopsy. After chemotherapy and radiotherapy, ray amputation of the index finger was performed and was followed by postoperative chemotherapy. At 47 months postoperatively, the patient had no evidence of tumor recurrence. When clinicians see a growing nodular lesion that does not respond to antirheumatic therapy in an RA patient, they should perform radiological and histological examinations to differentiate neoplasm from inflammatory lesion.

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