A Randomized, Multicenter, Phase III Trial to Evaluate the Efficacy and Safety of Polmacoxib Compared with Celecoxib and Placebo for Patients with Osteoarthritis

BACKGROUND: The aim of this study was to evaluate the safety and analgesic efficacy of polmacoxib 2 mg versus placebo in a superiority comparison or versus celecoxib 200 mg in a noninferiority comparison in patients with osteoarthritis (OA). METHODS: This study was a 6-week, phase III, randomized, double-blind, and parallel-group trial followed by an 18-week, single arm, open-label extension. Of the 441 patients with knee or hip OA screened, 362 were randomized; 324 completed 6 weeks of treatment and 220 completed the extension. Patients were randomized to receive oral polmacoxib 2 mg (n = 146), celecoxib 200 mg (n = 145), or placebo (n = 71) once daily for 6 weeks. During the extension, all participants received open-label polmacoxib 2 mg. The primary endpoint was the change in Western Ontario and McMaster Universities (WOMAC)-pain subscale score from baseline to week 6. Secondary endpoints included WOMAC-OA Index, OA subscales (pain, stiffness, and physical function) and Physician's and Subject's Global Assessments at weeks 3 and 6. Other outcome measures included adverse events (AEs), laboratory tests, vital signs, electrocardiograms, and physical examinations. RESULTS: After 6 weeks, the polmacoxib-placebo treatment difference was −2.5 (95% confidence interval [CI], −4.4 to −0.6; p = 0.011) and the polmacoxib-celecoxib treatment difference was 0.6 (CI, −0.9 to 2.2; p = 0.425). According to Physician's Global Assessments, more subjects were “much improved” at week 3 with polmacoxib than with celecoxib or placebo. Gastrointestinal and general disorder AEs occurred with a greater frequency with polmacoxib or celecoxib than with placebo. CONCLUSIONS: Polmacoxib 2 mg was relatively well tolerated and demonstrated efficacy superior to placebo and noninferior to celecoxib after 6 weeks of treatment in patients with OA. The results obtained during the 18-week trial extension with polmacoxib 2 mg were consistent with those observed during the 6-week treatment period, indicating that polmacoxib can be considered safe for long-term use based on this relatively small scale of study in a Korean population. More importantly, the results of this study showed that polmacoxib has the potential to be used as a pain relief drug with reduced gastrointestinal side effects compared to traditional nonsteroidal anti-inflammatory drugs for OA.

Results of Microfracture in the Osteoarthritic Knee with Focal Full-Thickness Articular Cartilage Defects and Concomitant Medial Meniscal Tears

PURPOSE: To evaluate the efficacy of arthroscopic microfracture in patients with focal full-thickness cartilage defects in the osteoarthritic knee. MATERIALS AND METHODS: Seventy-six patients were enrolled in this study. They were divided into group I (n=38) who underwent microfracture plus meniscectomy and group II (n=38) who underwent only meniscectomy. Clinical and radiological evaluations were performed. RESULTS: At the time of the three-year follow-up, a total of five failures (6.6%) were reported: four patients in group I and one in group II. The two groups showed no significant difference in the Lysholm score, the Tegner activity score and the visual analog pain scale score at three years after surgery. However, at the time of the three-month follow-up, group II showed significantly more improvement in the Tegner activity and the visual analog pain score compared with group I. CONCLUSIONS: In the osteoarthritic knee, additional microfracture did not confer any additional benefit to meniscectomy.

Characteristics of Radial Tears in the Posterior Horn of the Medial Meniscus Compared to Horizontal Tears

BACKGROUND: The clinical and radiologic features of radial tears of the medial meniscus posterior horn were compared with those of horizontal tears. METHODS: From January 2007 to December 2008, 387 consecutive cases of medial meniscal tears were treated arthroscopically. Among these, 91 were radial tears in the medial meniscus posterior horn, and 95 were horizontal tears in the posterior segment of the medial meniscus. The patients' data (age, gender, duration of symptom, body mass index, and injury history), radiographic findings (Kellgren and Lawrence score, posterior tibial slope, and femorotibial angle), and chondral lesions were recorded. RESULTS: The patient factors of age, gender, and body mass index were related to radial tears of the medial meniscus posterior horn. Radial tears were significantly correlated with Kellgren and Lawrence score, varus alignment, posterior tibial slope, and severity of the chondral lesion. CONCLUSIONS: Radial tears of the medial meniscus posterior horn are a unique clinical entity that are associated with older age, females and obesity, and are strongly associated with an increased incidence and severity of cartilage degeneration compared to horizontal tears.

Medial Meniscal Tears in Anterior Cruciate Ligament-Deficient Knees: Effects of Posterior Tibial Slope on Medial Meniscal Tear

PURPOSE: To evaluate the incidence of meniscal tears in patients with chronic anterior cruciate ligament (ACL)-deficient knees, and to determine the influence of posterior tibial slope (PTS) on medial meniscal tears in ACL-deficient knees. MATERIALS AND METHODS: We reviewed 174 patients (174 knees) with a mean age of 30.7 years who underwent ACL reconstruction for chronic ACL tears. We divided the patients into two groups: low group (135 knees with a PTS or =13degrees). RESULTS: The incidence of medial meniscus tears was 44% (77/174), and that of lateral meniscus tears was 35% (61/174). The mean PTS in patients with medial meniscal tears was 11.4degrees+/-3.0degrees, whereas that in patients without medial meniscal tears was 9.8degrees+/-2.4degrees. The incidence of meniscal tears was 57.8% (78/135) in the low group and 89.7% (35/39) in the high group (p or =13degrees is a risk factor for secondary medial meniscal tears in ACL-deficient knees. So, we suggest that PTS is one of the considerations for determining early ACL reconstruction to prevent secondary meniscal tears.

Ligament Reconstruction in Congenital Absence of the Anterior Cruciate Ligament: A Case Report

Congenital absence of the cruciate ligament is an extremely rare condition that was first reported in Giorgi's radiographic study in 1956. The authors report on a case of anterior cruciate ligament reconstruction performed on a 21-year-old female patient with congenital anterior cruciate ligament absence. We also discuss radiographic evidence that could provide clues to the congenital absence and possible difficulties that may be encountered during surgery with a review of the relevant literature.

Treatment of Multiple Ligaments Injuries

Multiple ligament injury, which means disruption of at least 3 of the 4 major ligaments, generally occurs due to high energy trauma. Knee dislocation usually leads to the multiple ligament injury, and the terms 'knee dislocation' and 'multiple ligament injury' are used interchangeably. In some cases, a dislocated knee may have been spontaneously reduced immediately after the trauma. This is the reason why we should consider the possibility of knee dislocation and carry out a thorough vascular and neurologic evaluation when a patient with multiple ligament injury presents to an emergency department. Multiple ligament injury, when not properly treated, may lead to instability of the knee joint, resulting in posttraumatic arthritis. Though treatment and rehabilitation of multiple ligament injury is difficult, we should pursue full recovery of the knee joint through precise examination and proper treatment. There is controversy about conservative vs. surgical treatment, early vs. delayed surgeory, and repair vs. reconstruction, but surgical treatment and early reconstruction are now preferred.

Results of Screw Fixation for Displaced Femoral Neck Fracture / 대한정형외과학회잡지

PURPOSE: This study retrospectively reviewed the results of a closed reduction and internal fixation with cannulated screws for a displaced femoral neck fracture. MATERIALS AND METHODS: Among 631 patients between January 1991 and December 2000, 27 patients classified as Garden stage III or IV were treated with a closed reduction and internal fixation with cannulated screws. The mean follow-up duration was 4.5 years. The mean age of the patients was 56.5 years. RESULTS: Union and the restoration of function was observed in 15 cases (55.6%), and failure occurred in 12 cases (44.4%). The cause of failure was early stage reduction loss due to a failure to obtain anatomical reduction on the surgical field in 4 cases, reduction loss and displacement during the follow up period after an appropriate reduction at surgery in 4 cases and avascular necrosis in 4 cases. Seven cases were converted to a total hip arthroplasty, 4 cases were converted to bipolar hemiarthroplasty and 1 case is currently being followed up. CONCLUSION: A closed reduction and internal fixation for displaced femoral neck fracture showed a high failure rate. Therefore, an accurate anatomical reduction, firm internal fixation and efforts to prevent further unnecessary vascular injury will be needed to reduce the high failure rate and complications.

Carpal Tunnel Syndrome Caused by Space Occupying Lesions / 대한정형외과학회잡지

PURPOSE: To evaluate the diagnosis and treatment of the carpal tunnel syndrome (CTS) due to space occupying lesion (SOL)s. MATERIALS AND METHODS: 14 patients (15 cases) that underwent surgery from 1992 to 2002 for CTS due to SOL were studied. The average age was 51 years. There were 6 men and 8 women. Mean follow up period was 16 months. In patients with swelling or tenderness on the area of wrist flexion creases, MRI and/or CT scan were additionally taken as well as the carpal tunnel view. We performed conventional open transverse carpal ligament release and removal of SOL. RESULTS: The types of lesion were, in three cases tuberculosis tenosynovitis, nonspecific tenosynovitis in three cases, gout in one case, mass in four cases, and abnormal palmaris longus hypertrophy in one case. Bony lesions were, in one case Kienbock's disease (stage III), neglected volar dislocation of lunate in two cases. Following surgery, all cases showed alleviation of symptoms. CONCLUSION: In cases with swelling or tenderness on the area of wrist flexion creases, it is important to obtain a carpal tunnel view, and if necessary, MRI and/or CT should be supplemented in order to rule out SOLs.

Analysis of the Factors Influencing on the Postoperative Results of Radial Head Fractures Combined with Elbow Dislocation / 대한정형외과학회잡지

PURPOSE: Radial head fractures are the most common elbow fractures in adults, and are often accompanied with elbow dislocation resulting in various complications. This study examined the outcome of surgical treatment of a radial head fracture and its prognostic factors. MATERIALS AND METHODS: From January 1997 to February 2004, a retrospective analysis was performed on 25 radial head fracture patients with an elbow dislocation, also including elbow fracture, whose follow-up data could be obtained for more than 12 months. The surgical results were evaluated according to the prognostic factors and the Mayo Elbow Performance Index, which assessed the elbow joint function and pain. RESULTS: According to the Mayo Elbow Performance Index, the results were excellent in 11 cases, good in 5 cases, fair in 5 cases, and poor in 4 cases. Cases with post-surgical elbow joint instability showed statistically meaningful poor outcomes. However, there were good in the groups without an accompanied fracture, with no open fracture, type II and III Mason classification, and fixation period 4 weeks or less. Correlation analysis revealed a younger age and shorter immobilization period to have better results, and the immobilization period showed the strongest correlations with the Mayo Elbow Performance index. CONCLUSION: In conclusion, younger age, less severe injury in the initial event and a shorter immobilization period are good prognostic factors in radial head fractures combined elbow dislocations.

Delayed Onset Neurological Deterioration due to a Spinal Epidural Hematoma after a Spine Fracture

There are no reports of a 7-day delay in the onset of neurological deterioration because of a spinal epidural hematoma (SEH) after a spinal fracture. A hematoma was detected from the T12 to L2 area in a 36-year-old male patient with a T12 burst fracture. On the same day, the patient underwent in situ posterior pedicle instrumentation on T10-L3 with no additional laminectomy. On the seventh postoperative day, the patient suddenly developed weakness and sensory changes in both extremities, together with a sharp pain. A MRI showed that the hematoma had definitely increased in size. A partial laminectomy was performed 12 hours after the onset of symptoms. Two days after surgery, recovery of neurological function was noted. This case shows that spinal surgeons need to be aware of the possible occurrence of a delayed aggravated SEH and neurological deterioration after a spinal fracture.

Results of Treatment for Acute Deep Infected Total Knee Arthroplasty / 대한정형외과학회잡지

PURPOSE: To evaluate the results of open or arthroscopic debridememt with a retention of the components for acute deep infected total knee arthroplasty. MATERIALS AND METHODS: From January 1991 to December 2005, among 1282 patients, 1457 TKAs, 8 cases of acute deep infected total knee arthroplasty was retrospectively reviewd. A radiologic and clinical assessment were performed to analyze the treatment results. The mean age was 63.9 (57-77) years. One patient was male, and 7 were female. RESULTS: The acute infection rate was 0.55% and the mean follow-up period was 41 months ( range, 30 months to 62 months). Using the Segawa classification, 3 cases were Type 2, and five cases were Type 3. Six cases were treated with arthroscopic debridement and antibiotic therapy. Two cases were treated with open debridement and antibiotic therapy. Intravenous antibiotic therapy was administered over a 3 week period. There were 2 cases of recurred infection. In synovial fluid culture, 4 cases were positive to S. aureus, 2 cases were positive to S. epidermidis and no bacteria was found in 2 cases. At the last follow-up, the mean Knee Society Score was 86.4 points. There were no chronic infection, loosening or osteolytic changes in the implants. CONCLUSION: If an early diagnosis is made, open or arthroscopic debridememt with a retention of the components is a useful method for acute deep infected total knee arthroplasty.

Comparison of the Pollard Method and the MRI Dimensions for Meniscal Sizing in Koreans / 대한정형외과학회잡지

PURPOSE: The purpose of this study was to investigate the accuracy of the Pollard method for meniscal sizing of the meniscal allograft by comparison with the MRI dimensions. MATERIALS AND METHODS: The width and length of 50 medial and lateral menisci were measured and compared using the Pollard method and MRI. The meniscal thickness was measured using MRI and we evaluated the individual differences. RESULTS: The measurements of the width of the medial meniscus and the length of the lateral meniscus using the Pollard method and MRI were similar (p=0.459, p=0.108, respectively). However, the measurements of the length of the medial meniscus and the width of the lateral meniscus using MRI were significantly higher that those measured using the Pollard method (p=0.000 and p=0.001, respectively). The medial and lateral meniscal thicknesses were 6.26+/-0.86 mm and 6.47+/-0.84 mm, respectively, and there was no significant individual difference. CONCLUSION: The measurements of the length of the medial meniscus and the width of the lateral meniscus, using the Pollard method and on MRI had significant differences. The Pollard method must be modified for meniscal sizing.

Treatment of the Snapping Discoid Lateral Meniscus without Tear in Pediatrics: Contouring Surgery and Posterolateral Repair

PURPOSE: To evaluate the results of arthroscopic contouring surgery and posterolateral meniscal repair for pediatrics with snapping discoid lateral meniscus without tear. MATERIALS AND METHODS: Nine children below 10 years, with snapping discoid lateral meniscus without tear were evaluated in this study. 3 cases had a morphologic deformity of lateral meniscus in MRI and arthroscopic findings, but there was no meniscal tear. Only contouring surgery was performed in 6 cases, and in 3 cases, because of the instability of meniscus over 5mm in traction due to the relaxation of the menisco-capsular junction after contouring surgery, posterolateral repair was performed. The average duration of follow up was 39 months(range, 25 to 72 months). RESULTS: Additional posterolateral repair was done due to remaining snapping, in three cases of six contouring surgery cases. In all cases, snapping was disappeared. The average Lysholm score was improved from 71 in preoperative status to 97 in postoperative status(p=0.008) CONCLUSION: In case of the increased instability of the posterolateral corner of lateral meniscus after contouring surgery in the treatment of snapping discoid lateral meniscus, posterolateral repair is effective to improve the snapping symptom from meniscal subluxation.

Arthroscopic Inside-out Meniscal Repair Leaving Posterior Horn Tear

PURPOSE: To evaluate the clinical results of arthroscopic inside-out repair leaving posterior horn tear. MATERIALS AND METHODS: Among the patients taken arthroscopic meniscal repair due to meniscus longitudinal tear from Jan. 1999 to Dec. 2004, total 32 patients were evaluated, and followed at minimum of two years(mean 32 months). Meniscal repair was done as maximum 3mm interval. The length of unrepaired posterior horn was mean 7.5mm. RESULTS: Preoperative Lysholm score was mean 62.5 and postoperative improved to 91.0. Twenty eight cases(87.5%) showed excellent or good results by Tapper and Hoover criteria. In 4 cases, symptoms recurred at 4 to 12 months after repair and 2 cases were combined with ACL deficiency. Second look arthroscopy was performed in 10 cases, 4 cases for recurred symptom and 6 cases for determining whether healing of untreated posterior horn occurred or not. We observed complete healing of 4 cases and incomplete healing of 2 cases on the acquisition of stability. CONCLUSION: It was suggested that meniscal repair leaving posterior horn tear may be healed if both stabilities of the torn area and the knee joint were maintained.

A Study of Electrodiagnostic Changes after Decompression of Chronic Cauda equina compression in dogs / 대한정형외과학회잡지

The purposes of this study were to detect the indices of evaluating for degree of compression and to detect the indices of recovery after decompression in different time intervals in the animal model of 50 percent compression of the cauda equina, through the examination of neurologic status and electrodiagnosis. Twenty-one male dogs, weighing between nine and eleven kilogram, were used. Three experimental groups were studied. One group (5 dogs) served as controls. In the other groups, the cauda equina was constricted by 50 percent to produce chronic compression, and decompression was done after 2 weeks compression in one group and 4 weeks compression in another group. The dogs in which the cauda equina had been decompressed at 2 weeks, showed the recovery of sensory evoked potentials at 2 weeks after decompression and bulbocavernosus reflexes at 4 weeks. The dogs in which the cauda equina had been decompressed at 4 weeks, showed the recovery of sensory evoked potentials and bulbocavernosus reflexes at 4 weeks after decompression. In both groups of the cauda equina compression, motor evoked potentials were partially recovered by 6 weeks after decompression. The initial neurological deficits in both groups were improved by 6 weeks. The cauda equina revealed that the epidural scar tissue in compressed site was more severe in 4 weeks compression group. But the substance of the cauda equina did not have any pathological changes in gross examination. Microscopically, neural tissue was showed the normal appearance without pathological changes in all groups. In conclusions, the early decompression of cauda equina revealed that the onset of recovery was more faster and the amplitude of recovery was larger comparing with delayed decompression in electrodiagnostic test. Also, the surgical decompression itself was helpful to improve the electrodiagnostic changes around 4 weeks after decompression. Sensory evoked potential was improved at the first and motor evoked potentials was recovered after disappearance of the claudication.

Prevention of heterotopic bone formation after total hip arthroplasty using 600 rad in single dose in high risk patient

Nineteen patients received single-dose exposure to 600 rad delivered within 48 hours of total hip arthroplasty (THA) with shielding of the prosthesis region for the prevention of heterotopic ossification. The patients were considered at high risk for developing heterotopic ossification (HO) because of hypertropic osteoarthritis, post-traumatic osteoarthritis or the presence of previously-formed ectopic bone. The average follow-up period was 42 months (range, 37 months-48 months). At a follow-up study, all hips except one were classified as Brooker class 0. The single exception was classified as class I. All patients were asymptomatic at the last follow-up study and no component demonstrated subsidence or radiolucent line indicative of loosening. The authors concluded that 600 rad, single-fraction radiation therapy is cost effective, convenient and safe for the prevention of heterotopic ossification after total hip arthroplasty.

Mechanical and Physical Properties of Regenerate Bone of Distraction Osteogenesis / 대한정형외과학회잡지

Distraction osteogenesis techniques have provided more than a clinical treatment of limb length discrepancies and bone deformities. The nature of this mechanical environment and the characteristics of the regenerate bone are not typical of that found elsewhere in the skeleton. The purposes of this study were to investigate the physical and mechanical properties of regenerate bone in different consolidation period (sacrificing at the period of 8, 12, 18, 20, 24, 26 weeks post surgery) and to find out the relationship between both properties. Two ring Ilizarov fixators were applied to the right tibia in 7 large, skeletally mature dogs. A subperiosteal osteotomy of tibia was performed. Postoperatively, after 7 days of latency period, distraction was begun. Distraction of 1mm daily, 3 times per day was continued until radiographic evidence of a 2.5 cm distraction. Sacrifice was at 8, 12, 18, 20, 22, 24, 26 weeks post surgery. Allof the specimens were obtained from regenerate bone and were cutted in the rectangular shape of approximately 8x4x4 mm. Specimens were tested in axial compression and displayed an average modulus of elasticity of 215(sd=184)Mpa, an average yield stress of 3.58(sd=2.54)MPa, an average apparent bone density of 0.399(sd=0.107)g/cc, and an average ash weight density of 0.164(sd=0.084)g/cc. A linear regression of yield stress on modulus of elasticity was significant(p < 0.001) with R-square=0.28, and a slope of 0.007. The radiographic bone densitometry was performed before sacrifice. The results of densitometry of regenerate bone was osteoporotic comparing with those of the opposite tibia which did not be operated in all of the animals. The linear regressions of mechanical properties on physical properties were significant, only 12-34% of the variance in mechanical properties could be explained by the physical properties. In conclusion, based on the observation of the low ash fraction, it would be expected that the relationship between physical properties and mechanical properties may not be strong. This study suggested that the regenerate bone was a composite of bone and non-mineralized tissue until 26 weeks of post surgery. For the more accurate information of material property, testing of real regenerate bone without non-mineralized bone may be necessary.

Lengthening of Short Tubular Bone by Gradual Distraction / 대한정형외과학회잡지

Thirteen cases of lengthening of short tubular bone by gradual axial distraction using an unilateral external fixator(Orthofix M-100, Orthofix CP0089) are reported. This study aims to prove effective- ness of gradual distraction for lengthening of short tubular bone and usefulness of the newly designed external fixator. Nine patients had brachymetatarsia and four brachymetacarpia. The etiology was consisted of post-traumatic physeal injury in two and congenital in eleven cases. The average amount of lengthening was 14.5mm(37.0%) in metacarpal bone, and 17.3mm(37.5%) in metatarsal. Complications were angular deformity in 3, pin loosening in 2 cases, and premature consolidation, nonunion and pin site infection in one case, respectively. Cosmetical and functional satisfactory results were obtained in all cases. We believe that callotasis is effective for short tubular bone lengthening. Also we confirmed the newly designed external fixa- tor(Orthofix CP0089) useful.

Effects of Saponin on Osteoporosis Induced by Ovriectomy in Rats / 대한정형외과학회잡지

Osteoporosis is defined as a pathologic condition that there occurs no change in the chemical composition of the bone, while bone resorption is abnormally increased, compared with osteogenesis, leading to a decrease in bone amount. Though many varieties of therapy have been tried, no definitely effective method has been found. Ginseng saponin is an importanat component of Korean ginseng and many studies have been performed for investigating its effectiveness. But there has been no report on saponin effects to osteoporosis. The purpose of this studies is to find out the effect of saponin in osteoporosis induced by ovariectomy in rats. For the study, 30 rats underwent sham operation(group I) and 90 rats were ovariectomized. In group ll (30 rats), only ovariectomy was performed. In group III (30 rats), 50mg/kg/day ginseng saponin was administered per oral route and group IV (30 rats) was administrated 150mg/kg/day saponin. All the rats were sacrificed at the 16th week. The sections of the femoral shaft were stained using Villanueva bone stain and the sections of the tibia were stained with hematoxylin-eosin. The femoral shaft and metaphyseal region were applied to compression device for measurements of bone consistency. The effect of saponin increased weight of the femur. The cross sectional area and cortical area of the femoral shaft were significantly higher in 50mg saponin group(group III) than osteoporosis group. But there was no significant difference in the size and number of osteoclast and the percentage of trabecular bone between saponin group(group III ,IV)and osteoporosis group. In the biomechanical test, the consistency of cortical bone was significantly increased in 50mg saponin group than osteoporosis group. In conclusion, saponin had an effect on experimental osteoporosis induced by ovariectomy in rats. As though its precise mechanism was unknown, we considered that its action mechanism was due to osteoblastic activity resulting in a correction of bone mass deficit in osteoporotic rats.

Prevention of Heterotopic Bone Formation after Total Hip Arthroplasty in High Risk Patient with Radiation Therapy / 대한정형외과학회잡지

Heterotopic ossification(HO) is a frequent complication of total hip arthroplasty(THA), If it is sevre enough, it can convert a successful result of the operation into a poor one. Among several strategies that researches in recent years have tested, radiation therapy have been accepted to have efficacy for prevention of heterotopic ossification by many authors. While postoperative irradiation has been shown to lower the incidence of HO effectively in high risk patients following THA, patients in multiple dose protocols continue to develop some heterotopic ossifiction despite therapy and have some problems. Ninteen patients received single dose exposure to 600 rad delivered within 48 hours of THA with shielding of prosthesis region. The patients were considered high risk group for developing HO because of hypertropic osteoarthritis, post-traumatic osteoarthritis or the presence of previous formed ectopic bone. The average follow up period was 10.2 months(range 6 months