The Prevalence of Vitamin D Deficiency in Patients Undergoing Total Knee Arthroplasty: A Propensity Score Matching Analysis.

PURPOSE: We investigated and compared the serum 25-OH vitamin D [25(OH)D] level and prevalence of vitamin D deficiency (VDD) between patients who underwent total knee arthroplasty (TKA) and healthy participants through a matched analysis. METHODS: The unmatched case group consisted of 824 patients who underwent TKA and the unmatched control group 2,794 healthy participants examined at our institution. The control group was matched on the various characteristics-sex, age, weight, body mass index (BMI), blood chemistry, and season of sampling-through propensity score matching (PSM). After PSM, 501 and 721 patients were matched in the case and control group, respectively. Levels of blood chemistry including 25(OH)D were examined and VDD was defined as < 20 ng/mL. RESULTS: The average serum 25(OH)D level was significantly lower in the OA group (15.3 ng/mL) than that in the control group (19.9 ng/mL, p < 0.001). When categorized using a 20 ng/mL cutoff, the VDD prevalence was 75.0% in the OA group and 59.4% in the control group. The prevalence of vitamin D insufficiency was 18.4% in the OA group and 24.5% in the control group. The prevalence of vitamin D sufficiency was 6.8% in the OA group and 15.9% in the control group (p < 0.001). CONCLUSIONS: The patients who underwent TKA had lower serum 25(OH)D level and higher VDD prevalence compared to the healthy participants who matched using PSM. There were no differences in VDD rates by sex or obesity and the VDD prevalence was more than 70% during all season. Therefore, in patients undergoing TKA, general attention to VDD is required regardless of sex, obesity, and season. Serum 25-OH vitamin D [25(OH)D] level and vitamin D deficiency (VDD) prevalence were compared between patients undergoing total knee arthroplasty and healthy individuals. The differences in serum 25(OH)D level and VDD prevalence were significant between the two groups after propensity score matching.

Preoperative vitamin D level does not affect the short-term functional outcome after total knee arthroplasty in elderly women.

BACKGROUND: We aimed to evaluate the effect of vitamin D levels on the functional outcome of elderly women who underwent total knee arthroplasty (TKA). METHODS: Seven hundred and four patients (1013 knees) who underwent primary TKA were included in our retrospective study. Preoperative vitamin D levels were measured and the relationship analyzed between these and age, weight, height, body mass index, and bone mineral density. Two hundred and twenty patients (220 knees) who received unilateral TKA and were followed up for more than 1 year after operation were divided into two groups: Group 1, serum 25-hydroxyvitamin D3 (25(OH)D3) level < 20 ng/ml; and Group 2, 25(OH)D3 level ≥ 20 ng/ml. Both groups were evaluated for the relationship between vitamin D levels and postoperative Visual Analogue Scale (VAS) score, Knee Society Knee Score (KSKS), Knee Society Function Score (KSFS), and Western Ontario and McMaster Universities Arthritis Index (WOMAC) score. RESULTS: The number of vitamin D-deficient patients (< 20 ng/ml of serum 25(OH)D3 level) was 556 (79.0%). In the correlation analysis, the vitamin D level was negatively correlated with weight only (p = 0.033). No significant differences were observed between the groups in terms of postoperative VAS score, KSKS, KSFS, and WOMAC score. CONCLUSIONS: Vitamin D deficiency was highly prevalent in patients who underwent TKA. Vitamin D levels negatively correlated with weight. Low vitamin D level was not a risk factor for unsatisfactory TKA outcome in elderly women.

Does posterior tibial slope affect the results of conservative treatment for anterior cruciate ligament tears?

OBJECTIVE: To evaluate the association between posterior tibial slope (PTS) and the short-term results of conservative treatment for the patients with anterior cruciate ligament (ACL) tears. METHODS: Thirty-seven patients (37 knees: male 33, female 4) who were managed with the same treatment protocols for ACL tears were included. All patients applied ACL brace and underwent standardized rehabilitation protocol. Group A consisted of 14 patients with successful results after conservative management and group B consisted of 23 patients who received operative treatments due to failed conservative management. For each group, a plain radiograph was used to measure the PTS. The demographic data of patients and differences of PTS between each group were analyzed. RESULTS: The mean age was 33.2 years in group A and 29.7 years in group B, respectively (p = 0.8). There was no significant difference between each group in terms of gender, body mass index, and injury mechanism. There was no significant difference between each group in the classification according to the isolated or combined injury (p = 0.83). The mean PTS was 8.3° in group A and 10.2° in group B. The mean PTS in group A was significantly lower than that in group B (p = 0.03). CONCLUSIONS: The patients with successful results after conservative management had a lower mean PTS than those with failed conservative treatment (8.3° vs. 10.2°, p = 0.03). The failure of conservative treatment after ACL tear was found to be associated with increased PTS.

Iatrogenic Medial Collateral Ligament Injury by Valgus Stress During Arthroscopic Surgery of the Knee.

PURPOSE: To evaluate the radiographic and clinical follow-up results of iatrogenic medial collateral ligament (MCL) injuries caused by valgus stress during arthroscopic surgery of the knee. METHODS: This study retrospectively evaluated 15 knees in 15 patients (8 female and 7 male patients), with a mean age of 58 years (range, 45-66 years), with iatrogenic MCL injuries caused by valgus stress during arthroscopic surgery of the knee. All patients were treated conservatively without an immobilizer or brace. The mean follow-up period was 24 months (range, 18-51 months). Evaluations included magnetic resonance imaging immediately postoperatively, as well as physical examinations and valgus stress radiographs (at 0° and 30° of knee flexion) 6 weeks after surgery and at final follow-up. RESULTS: Postoperative magnetic resonance imaging in all patients showed increased signal intensity, swelling, and partial loss of continuity at the meniscofemoral portion of the MCL. Physical examination showed mild tenderness in only 1 patient after 6 weeks and none at final follow-up. Valgus stress tests and valgus stress radiographs showed no significant differences between the injured and uninjured knees at 6 weeks postoperatively and at final follow-up (P > .05). CONCLUSIONS: Iatrogenic MCL injuries during arthroscopic knee surgery could be treated successfully without a splint or brace. LEVEL OF EVIDENCE: Level IV, prognostic case series.

A Multicenter, Double-Blind, Phase III Clinical Trial to Evaluate the Efficacy and Safety of a Cell and Gene Therapy in Knee Osteoarthritis Patients.

The aim of this study was to test the clinical efficacy of TissueGene-C (TG-C), a cell and gene therapeutic for osteoarthritis consisting of non-transformed and transduced chondrocytes (3:1) retrovirally transduced to overexpress transforming growth factor-ß1. A total of 163 Kellgren-Lawrence grade 3 patients with knee osteoarthritis were randomly assigned to receive intra-articular TG-C or placebo. Primary efficacy measures included criteria for subjective assessment by International Knee Documentation Committee (IKDC) and pain severity by Visual Analog Scale (VAS) for 52 weeks. Secondary efficacy measures included IKDC and VAS at 26 and 39 weeks; pain, stiffness, and physical function by the Western Ontario and McMaster Universities Arthritis Index (WOMAC); and pain, symptoms, daily activities, function in sports and recreation, and quality of life by the Knee Injury and Osteoarthritis Outcome Score (KOOS), X-ray, magnetic resonance imaging, and soluble urine and blood biomarkers. TG-C was associated with statistically significant improvement over placebo in the total IKDC score and individual categories, and in the VAS score at 26, 39, and 52 weeks. WOMAC and KOOS scores also improved with TG-C over placebo. Patients treated with TG-C showed trends directed toward thicker cartilage and slower growing rates of subchondral bone surface area in the medial tibia, lateral tibia, lateral patella, and lateral patella femoral regions, although these were not statistically significant (p > 0.05). Serum C-terminal telopeptide of type I collagen (CTX-I) and urine CTX-II levels were lower over 1 year in TG-C than placebo-treated patients, with CTX-I level reaching statistical significance. These tendencies supported TG-C as holding great potential as a disease-modifying osteoarthritis drug. The most frequent adverse events in the TG-C group were peripheral edema (9%), arthralgia (8%), joint swelling (6%), and injection site pain (5%). TG-C was associated with statistically significant improvements in function and pain in patients with knee osteoarthritis. The unexpected adverse events were not observed.

Synovial fluid levels of TWEAK and matrix metalloproteinase 1 in patients with osteoarthritis, and associations with disease severity.

PURPOSE: This study assessed the levels of soluble tumor necrosis factor-like weak inducer of apoptosis (TWEAK) and matrix metalloproteinase 1 (MMP-1) in the synovial fluid from osteoarthritic knees to determine their role as well as the relationship between these levels and the severity of osteoarthritis (OA). METHODS: Synovial fluid was obtained from 44 knees of 40 patients. The Kellgren-Lawrence (KL) grade was measured using radiograph. The concentration of TWEAK and MMP-1 in the synovial fluid was assessed by enzyme-linked immunosorbent assay. The underlying inflammatory factors (erythrocyte sedimentation rate and C-reactive protein) were also measured. We analyzed the correlation between the factors measured. In addition, the samples were subdivided into three groups according to OA severity using the KL grade, and the differences in TWEAK and MMP-1 levels between groups were analyzed. RESULTS: The TWEAK and MMP-1 levels in the synovial fluid showed a positive correlation with each other. The TWEAK and MMP-1 levels were compared between the three groups according to the KL grade, and the levels showed a significant difference. A post hoc test demonstrated that the group with advanced OA showed a lower concentration of both factors when compared to groups with early OA. CONCLUSION: The concentration of TWEAK and MMP-1 in the synovial fluid were relatively high in the early stage of OA, and the levels decreased as the OA progressed.

Does Posterior Tibial Slope Affect Graft Rupture Following Anterior Cruciate Ligament Reconstruction?

PURPOSE: The purpose of this study was to evaluate the association between posterior tibial slope (PTS) and anterior cruciate ligament (ACL) graft rupture in patients who have undergone ACL reconstruction by comparing results in patients who experienced graft rupture and a matched control group. METHODS: The study included 64 knees of 64 patients (58 men and 6 women), of mean age 31 years (range, 18-60 years) who underwent revision ACL reconstruction for ACL graft rupture, as well as a control group without ACL graft rupture matched for age, sex, body mass index (BMI), and left or right side. The mean time to failure in study group was 48.5 months, and after revision surgeries, the mean follow-up period was 37.7 months. The graft used for the primary surgery was autograft in 3 patients (4.7%) and allograft in 49 patients (76.6%). The type of graft could not be confirmed in the remaining 12 patients (18.7%). PTS was measured on plain radiographs and compared in the 2 groups. RESULTS: Mean PTS was significantly higher in patients with (13.2° ± 2.5°; range, 8.5°-18.2°) than without (10.9° ± 3.1°; range, 4.9°-13.6°) rerupture (P < .01). When mean PTS was compared in the 37 patients who underwent primary surgery by the same surgeon, it was significantly higher in patients with (13.5° ± 2.5°; range, 8.5°-18.2°) than without (11.1° ± 2.9°; range, 5.1°-13.6°) rerupture (P < .01). PTS in patients with rerupture was not significantly associated with age, gender, BMI, and right or left side. The odds ratio of ACL graft rupture in knees with PTS ≥12° was 4.52 (P < .001). CONCLUSIONS: This study showed that mean PTS was significantly greater in patients with than without noncontact ACL graft rerupture (13.2° vs 10.9°, P < .01). The failure of ACL reconstruction appears to be associated with increased PTS, with PTS ≥12° a risk factor for the failure of ACL reconstruction. LEVEL OF EVIDENCE: Level III, retrospective comparative study.

Enhanced Reality Showing Long-Lasting Analgesia after Total Knee Arthroplasty: Prospective, Randomized Clinical Trial.

To overcome the limitation of short-term efficacy of virtual reality (VR), an enhanced reality (ER) analgesia, (combination of the VR, real-time motion capture, mirror therapy [MT]) involving a high degree of patients' presence or embodiment was explored. Patients, who underwent unilateral total knee arthroplasty (TKA), received ER analgesia. The duration was 5 times a week, for 2 weeks for one group and 5 times a week, for 1 week in the other. Visual Analogue Scale (VAS) at rest and during movement, active knee range of motion (ROM) for flexion and extension were measured repeatedly. After screening 157 patients, 60 were included. Pre-interventional evaluation was performed at 6.7 days and ER was initiated at 12.4 days after surgery. Evaluation was performed at 5, 12, 33 days after the initiation of ER. Analgesia in the 2 week therapy group was effective until the third evaluation (p = 0.000), whereas in the other group, it was effective only until the second evaluation (p = 0.010). Improvement in ROM in the 2 week group was also maintained until the third evaluation (p = 0.037, p = 0.009). It could lay the foundations for the development of safe and long-lasting analgesic tools.

Comparison of Arthroscopically Guided Suprascapular Nerve Block and Blinded Axillary Nerve Block vs. Blinded Suprascapular Nerve Block in Arthroscopic Rotator Cuff Repair: A Randomized Controlled Trial.

BACKGROUND: The purpose of this study was to compare the results of arthroscopically guided suprascapular nerve block (SSNB) and blinded axillary nerve block with those of blinded SSNB in terms of postoperative pain and satisfaction within the first 48 hours after arthroscopic rotator cuff repair. METHODS: Forty patients who underwent arthroscopic rotator cuff repair for medium-sized full thickness rotator cuff tears were included in this study. Among them, 20 patients were randomly assigned to group 1 and preemptively underwent blinded SSNB and axillary nerve block of 10 mL 0.25% ropivacaine and received arthroscopically guided SSNB with 10 mL of 0.25% ropivacaine. The other 20 patients were assigned to group 2 and received blinded SSNB with 10 mL of 0.25% ropivacaine. Visual analog scale (VAS) score for pain and patient satisfaction score were assessed 4, 8, 12, 24, 36, and 48 hours postoperatively. RESULTS: The mean VAS score for pain was significantly lower 4, 8, 12, 24, 36, and 48 hours postoperatively in group 1 (group 1 vs. group 2; 5.2 vs. 7.4, 4.1 vs. 6.1, 3.0 vs. 5.1, 2.1 vs. 4.2, 0.9 vs. 3.9, and 1.3 vs. 3.3, respectively). The mean patient satisfaction score was significantly higher at postoperative 4, 8, 12, 24, 36, and 48 hours in group 1 (group 1 vs. group 2; 6.7 vs. 3.9, 7.4 vs. 5.1, 8.8 vs. 5.9, 9.2 vs. 6.7, 9.5 vs. 6.9, and 9.0 vs. 7.2, respectively). CONCLUSIONS: Arthroscopically guided SSNB and blinded axillary nerve block in arthroscopic rotator cuff repair for medium-sized rotator cuff tears provided more improvement in VAS for pain and greater patient satisfaction in the first 48 postoperative hours than blinded SSNB.

Bilateral Hypoplasia of the Medial and Lateral Menisci.

Hypoplasia of the meniscus is a very rare congenital abnormality, with only a few cases reported to date. A 9-year-old girl visited our hospital due to lateral knee pain following a hyperextension injury to the left knee. Magnetic resonance imaging showed hypoplasia of the medial and lateral menisci, as well as a posterior horn tear of the lateral meniscus, in both knee joints. To our knowledge, this is the first report of a patient with hypoplasia of the medial and lateral menisci in both knee joints.

Patterns and Influencing Factors of Medial Meniscus Tears in Varus Knee Osteoarthritis.

PURPOSE: To investigate the patterns of medial meniscus (MM) tears in patients with varus knee osteoarthritis who underwent total knee arthroplasty and analyze the factors that could affect MM tears. MATERIALS AND METHODS: The patients (365 knees, 268 patients) were classified into three groups; group I with MM posterior horn (PH) tear only; group II with MM root tear only; and group III with MMPH plus root tear. The following factors were evaluated: age, gender, body mass index, varus deviation of the mechanical axis, medial proximal tibial angle, posterior tibial slope (PTS), and anterior cruciate ligament (ACL) integrity (normal, degeneration, and tear or absence). RESULTS: MM tears were identified in all knees. The patterns of the combined MMPH tears in group III were less complex than those in group I. Varus deviation and PTS were significantly greater in group III than groups I and II. In group III, there were significantly more cases of ACL tear or absence than groups I and II. The others showed no differences among three groups. CONCLUSIONS: Severe varus knee osteoarthritis was always accompanied by MM tears. Risk factors for MMPH plus root tears were severe varus deformity, great PTS, and ACL tear or absence.

Gastrointestinal safety and efficacy of long-term GCSB-5 use in patients with osteoarthritis: A 24-week, multicenter study.

ETHNOPHARMACOLOGY RELEVANCE: A previous study indicated non-inferiority of GCSB-5 to celecoxib regarding efficacy and safety in treating OA; however, the gastrointestinal (GI) safety data was limited to 12 weeks. Accordingly, a longer term study with a larger number of patients was necessary to establish the GI safety of GCSB-5. AIM OF STUDY: The primary goal was to determine the safety and efficacy of 24-week use of GCSB-5. The secondary goal was to compare the GI safety data of GCSB-5 with that of the previously reported Celecoxib Long-term Arthritis Safety Study (CLASS). METHOD: This was a 24-week, multicenter, single-arm phase IV Study for the safety and efficacy of GCSB-5. A total of 761 patients were enrolled and 756 patients received at least one dose of GCSB-5. Among them, 629 patients (82.7%) completed the 24 week follow up. The primary goal was to determine the safety and efficacy of GCSB-5 for 24 weeks. The secondary goal was to compare the GI safety data of GCSB-5 with that of the previously reported Celecoxib Long-term Arthritis Safety Study (CLASS). RESULTS: The incidence of GI disorders of GCSB-5 was 23.7%. The annual rate of perforation, ulcer obstruction, or bleeding (PUB) incidence was 0.0%. The drop-out rate due to GI disorders following GCSB-5 use was 4.8%. Compared to celecoxib data from CLASS, the incidence of GI disorders (23.7% vs. 31.4%, p<0.001), annual rate of PUB and gastroduodenal ulcers (0.0% vs 2.2%, p=0.004), and drop-out rate due to GI disorders following GCSB-5 use were significantly low (4.8% vs 8.7%, p<0.001). Efficacy was proven by significant improvements in Western Ontario McMaster Questionnaire (WOMAC) scale, Korean Knee Score (KKS), 100-mm pain visual analogue scale (VAS), and physician's global assessments of patient's response to therapy (PGART). CONCLUSIONS: The safety and efficacy profile of GCSB-5 are comparable to celecoxib. These results indicate GCSB-5 is safe for a long-term treatment of knee OA patients. TRIAL REGISTRATION: ClinicalTrials.gov (NCT01604239).

The In vitro Effects of Nano-encapsulated Conjugated Linoleic Acid on Stability of Conjugated Linoleic Acid and Fermentation Profiles in the Rumen.

This study was aimed to evaluate the stability of conjugated linoleic acids (CLAs) by nano-encapsulation against in vitro ruminal biohydrogenation by microbial enzymatic conversion. CLAs (free fatty acid form of CLA [CLA-FFA], nano-encapsulated CLA-FFA, triglyceride form of CLA [CLA-TG], and nano-encapsulated CLA-TG) were used in the in vitro fermentation experiments. When Butyrivibrio fibrisolvens (B. fibrisolvens) was incubated with CLA-FFAs, the concentrations of cis-9, trans-11 CLA and vaccenic acid (VA) slightly was decreased and increased by nano-encapsulation, respectively. When B. fibrisolvens was incubated with CLA-TG, the concentrations of cis-9, trans-11 CLA and VA decreased, but these were increased when B. fibrisolvens was incubated with nano-encapsulated CLA-TG. The nano-encapsulation was more effective against the in vitro biohydrogenation activity of B.fibrisolvens incubated with CLA-FFA than with CLA-TG. In the in vitro ruminal incubation test, the total gas production and concentration of total volatile fatty acids incubated with nano-encapsulated CLA-FFA and CLA-TG were increased significantly after 24 h incubation (p<0.05). Nano-encapsulated CLA-FFA might, thus, improve the ruminal fermentation characteristics without adverse effects on the incubation process. In addition, nano-encapsulated CLA-FFA increased the population of Fibrobacter succinogenes and decreased the population of B. fibrisolvens population. These results indicate that nano-encapsulation could be applied to enhance CLA levels in ruminants by increasing the stability of CLA without causing adverse effects on ruminal fermentation.

Relationship between Mucoid Degeneration of the Anterior Cruciate Ligament and Posterior Tibial Slope in Patients with Total Knee Arthroplasty.

PURPOSE: The purpose was to analyze the relationship between posterior tibial slope (PTS) and mucoid degeneration of the anterior cruciate ligament (ACL) in patients with total knee arthroplasty. MATERIALS AND METHODS: Four hundred and twenty-four patients (24 males and 400 females; 636 knees) who received total knee arthroplasty for osteoarthritis were included. Their mean age was 68.9 years (range, 48 to 88 years). The patients were classified into three groups according to the status of ACL; normal ACL group (group I), mucoid degeneration of ACL group (group II) and ruptured or absent ACL group (group III). Plain lateral radiographs were used to measure the PTS and the values were compared among groups. RESULTS: There were no significant differences with regard to gender, age and left-to-right side ratio among groups (p>0.05). The mean PTS was 9.9° (range, 0.6° to 20.1°) in group I (161 knees), 10.8° (range, 0.2° to 21.8°) in group II (342 knees) and 12.3° (range, 2° to 22.2°) in group III (133 knees), which showed significant differences (p<0.001). CONCLUSIONS: The patients with mucoid degeneration of the ACL and those with ruptured or absent ACL had greater PTS than those with normal ACL. These findings suggest that an increased PTS may be one of the causative factors for mucoid degeneration of the ACL.

Preemptive Femoral Nerve Block Could Reduce the Rebound Pain After Periarticular Injection in Total Knee Arthroplasty.

BACKGROUND: We evaluated the effectiveness of postoperative pain management using intraoperative periarticular injection (PAI) and/or electromyography-guided preoperative femoral nerve block (FNB) in knees undergoing total knee arthroplasty (TKA). METHODS: This study included 90 patients (90 knees) who underwent primary TKA. Thirty patients received a single injection of electromyography-guided FNB, 30 received intraoperative PAI, and 30 received both. Pain at rest and while moving was evaluated by a visual analog scale (VAS) at 0, 4, 8, 24, and 48 hours. Postoperative range of motion, time to walking, amount of opioid consumption, and complications were analyzed. RESULTS: VAS immediately after surgery was significantly higher in the FNB group than in the PAI and combined groups, but did not differ significantly in the latter 2 groups. VAS after 4 and 8 hours showed similar results. VAS after 24 hours was significantly higher in the PAI than in the FNB and combined groups. After 48 hours, there were no differences among the 3 groups. Total opioid consumption was lower in the combined than in the FNB and PAI groups. Postoperative range of motion and time to walking were similar in the 3 groups. CONCLUSION: PAI was more effective than FNB during the early (0-8 hours) postoperative period after TKA. Patients treated with PAI, however, experienced rebound pain at 24 hours. The combination of PAI and FNB may provide greater postoperative pain management than either alone for the first 24 hours after TKA.

Comparison of Midterm Clinical and Radiographic Results Between Total Knee Arthroplasties Using Medial Pivot and Posterior-Stabilized Prosthesis-A Matched Pair Analysis.

BACKGROUND: Despite the theoretical advantage of a knee design that can more reliably replicate the medial pivot (MP) of the natural knee, only a few clinical studies have compared the clinical results between the MP prosthesis and another design of prosthesis. We compared the midterm results of total knee arthroplasty (TKA) using an MP prosthesis vs a posterior-stabilized prosthesis via a matched-pair analysis; we included results related to patellofemoral joint symptoms. METHODS: The midterm clinical and radiographic results of 125 consecutive patients (150 knees) who underwent a TKA with the ADVANCE MP prosthesis were compared with those of a control group who had undergone a primary TKA with a posterior-stabilized prosthesis. RESULTS: Values of the Knee Society's Knee Scoring System, Western Ontario and McMaster Universities Osteoarthritis Index, and Kujala and Feller scoring systems, as well as the range of motion after TKA, did not significantly differ between the 2 groups. No differences in femorotibial angle and component position, including the patella component, were observed between the 2 groups. No significant differences in the change of patella tilt angle and the postoperative patellar translation were observed between the 2 groups. CONCLUSION: Patients with the MP prosthesis experienced satisfactory pain relief and a functional recovery, providing results similar to those of the posterior-stabilized prosthesis, including the resolution of patellofemoral joint symptoms.

A randomized study to compare the efficacy and safety of extended-release and immediate-release tramadol HCl/acetaminophen in patients with acute pain following total knee replacement.

OBJECTIVE: To evaluate the relative efficacy and safety of extended-release tramadol HCl 75 mg/acetaminophen 650 mg (TA-ER) and immediate-release tramadol HCl 37.5 mg/acetaminophen 325 mg (TA-IR) for the treatment of moderate to severe acute pain following total knee replacement. METHODS: This phase III, double-blind, placebo-controlled, parallel-group study randomized 320 patients with moderate to severe pain (≥4 intensity on an 11 point numeric rating scale) following total knee replacement arthroplasty to receive oral TA-ER (every 12 hours) or TA-IR (every 6 hours) over a period of 48 hours. In the primary analysis, TA-ER was evaluated for efficacy non-inferior to that of TA-IR based on the sum of pain intensity difference (SPID) at 48 hours after the first dose of study drug (SPID48). Secondary endpoints included SPID at additional time points, total pain relief at all on-therapy time points (TOTPAR), sum of SPID and TOTPAR at all on-therapy time points (SPID + TOTPAR), use of rescue medication, subjective pain assessment (PGIC, Patient Global Impression of Change), and adverse events (AEs). RESULTS: Analysis of the primary efficacy endpoint (SPID48) could not establish the non-inferiority of TA-ER to TA-IR. However, a post hoc analysis with a re-defined non-inferiority margin did demonstrate the non-inferiority of TA-ER to TA-IR. No statistically significant difference in SPID at 6, 12, or 24 hours was observed between the TA-ER and TA-IR groups. Similarly, analysis of TOTPAR showed that there were no significant differences between groups at any on-therapy time point, and SPID + TOTPAR at 6 and 48 hours were similar among groups. There was no difference in the mean frequency or dosage of rescue medication required by both groups, and the majority of patients in both the TA-ER and TA-IR groups rated their pain improvement as 'much' or 'somewhat better'. The overall incidence of ≥1 AEs was similar among the TA-ER (88.8%) and TA-IR (89.5%) groups. The most commonly reported AEs by patients treated with TA-ER and TA-IR included nausea (49.7% vs 44.4%), vomiting (28.0% vs 24.2%), and decreased hemoglobin (23.6% vs 26.1%). This study is limited by the lack of placebo control, and the invalidity of the initial non-inferiority margin. CONCLUSION: This study demonstrated that the analgesic effect of TA-ER is non-inferior to TA-IR, and supports TA-ER as an effective and safe treatment for moderate to severe acute pain post total knee replacement. CLINICAL TRIAL REGISTRATION: Clinicaltrials.gov, NCT01814878.

Modified transtibial versus anteromedial portal technique in anatomic single-bundle anterior cruciate ligament reconstruction: comparison of femoral tunnel position and clinical results.

BACKGROUND: Although several studies have compared a conventional transtibial technique with an anteromedial (AM) portal technique for single-bundle (SB) anterior cruciate ligament (ACL) reconstruction, no study to date has investigated whether the modified transtibial technique results in the femoral tunnel being in a similar anatomic position and produces similar clinical outcomes with those of the AM portal technique. PURPOSE: To compare the clinical outcomes and femoral tunnel position of SB ACL reconstruction using a modified transtibial technique (creating a femoral tunnel with varus and internal rotation of the tibia as well as modification of the tibial tunnel orientation) with those of SB ACL reconstruction using an AM portal technique. STUDY DESIGN: Randomized controlled trial; Level of evidence, 1. METHODS: A total of 40 patients (40 knees) who underwent arthroscopic SB ACL reconstruction were included in this study. Patients were randomized using a computer-generated sequence into 2 groups: 20 patients by the modified transtibial technique (group 1) and 20 patients by the AM portal technique (group 2). Clinical evaluations included the 2000 International Knee Documentation Committee (IKDC) subjective knee score, Lysholm knee score, Tegner activity scale, Lachman test, pivot-shift test, 2000 IKDC knee examination, and KT-1000 arthrometer measurement. Three-dimensional computed tomography scans were analyzed according to the quadrant method, and the obliquity of the femoral tunnels in the coronal and sagittal planes and the size of the tunnel orifice were measured. RESULTS: All clinical parameters improved significantly after SB ACL reconstruction, with no between-group differences. The mean distance of the femoral tunnel center location from the posterior condylar surface (0.8% difference; P = .167) and from the Blumensaat line (2.1% difference; P = .067) was similar in groups 1 and 2. The mean coronal obliquity of the femoral tunnel was significantly lower in group 1 than in group 2 (42.5° ± 6.1° vs 49.3° ± 7.2°, respectively; P = .001), but the mean sagittal obliquity was similar between the 2 groups (41.9° ± 6.1° vs 43.3° ± 5.4°, respectively; P = .303). The mean area of the tunnel orifice was significantly greater in group 1 than in group 2 (11.6 ± 1.4 × 9.2 ± 1.6 mm vs 10.3 ± 1.1 × 9.1 ± 1.4 mm, respectively; P = .013). CONCLUSION: The modified transtibial technique for SB ACL reconstruction showed good clinical results and anatomic placement of the femoral tunnel, similar with those of the AM portal technique.

Total Knee Arthroplasty Using a Posterior Cruciate Ligament Sacrificing Medial Pivot Knee: Minimum 5-year Follow-up Results.

PURPOSE: To evaluate minimum 5-year follow-up clinical and radiological results of total knee arthroplasty (TKA) using a posterior cruciate ligament sacrificing (PS), non-substituting Advance Medial Pivot Knee. MATERIALS AND METHODS: One hundred and twenty knees in 80 patients who could be followed up for more than 5 years after TKA using the PS Advance Medial Pivot Knee were evaluated retrospectively. The evaluations included the preoperative and postoperative range of motion (ROM), tibiofemoral angle, Knee Society (KS) knee and function scores, and Western Ontario and McMaster Universities Arthritis Index (WOMAC) score. The Kaplan-Meier method was used for survival analysis. RESULTS: The ROM increased from a preoperative mean flexion contracture of 7.6° and further flexion of 115.1° to a postoperative mean flexion contracture of 1.5° and further flexion of 120.5°. The tibiofemoral angle was changed from 4.6° varus preoperatively to 5.8° valgus postoperatively. The KS knee and function scores as well as WOMAC score significantly improved after surgery (p<0.05). Complications developed in 4 cases (3.3%): 2 cases of periprosthetic patellar fracture (1.7%) and 2 cases of aseptic loosening (1.7%). The seven-year survival rate was 98.1% in the Kaplan-Meier survival analysis. CONCLUSIONS: The minimum 5-year follow-up results of TKA using the PS Medial Pivot Knee were satisfactory.

Prospective, double-blind, randomized controlled trial of electrophysiologically guided femoral nerve block in total knee arthroplasty.

BACKGROUND: The purpose of this study was to compare electrophysiologically guided and traditional nerve stimulator analgesia femoral nerve block after total knee arthroplasty. METHODS: Patients scheduled for unilateral total knee arthroplasty were randomized to electrophysiologically guided or traditional nerve stimulator analgesia by pre-emptive single injection femoral nerve block with corresponding assistance. We assessed pain scores using a visual analog scale (VAS, 0 = no pain, 100 = the worst pain) and the volumes of morphine consumed at 4, 24, 48, and 72 hours after total knee arthroplasty. RESULTS: Of the 60 patients enrolled, eight withdrew from the study. The remaining 52 patients were randomized to the electrophysiologically guided group (n = 27) or traditional nerve stimulator analgesia (n = 25) group. Four hours after total knee arthroplasty, VAS scores were significantly lower in the electrophysiologically guided group than in the traditional nerve stimulator group at rest (4.8 ± 1.4 versus 5.9 ± 0.8, P < 0.01) and while moving (6.2 ± 1.1 versus 6.9 ± 0.9, P < 0.01). The total volumes of morphine injected at 24, 48, and 72 hours were significantly decreased in the electrophysiologically guided group (P < 0.05 each). Variable × time interaction of VAS was significant in the electrophysiologically guided group (P < 0.05), with each VAS score at 24, 48, and 72 hours being significantly lower than the baseline score (P < 0.05). VAS scores at every time point were significantly lower in the electrophysiologically group guided than in the traditional nerve stimulator group (P < 0.05). CONCLUSION: Electrophysiologically guided single injection femoral nerve block may provide better postoperative analgesia and a greater reduction in the demand for pain killers than femoral nerve block using traditional nerve stimulator analgesia.