Results of a Phase II Study to Determine the Efficacy and Safety of Genetically Engineered Allogeneic Human Chondrocytes Expressing TGF-ß1.

Genetically engineered chondrocytes virally transduced with a transforming growth factor (TGF)-ß1 (TG-C [TissueGene-C]) expression vector have been shown to have potential benefits in the nonoperative management of knee osteoarthritis. Previous literature has reported on safe dosages of TG-C. Therefore, the purpose of this study was to evaluate the Phase II results and a 24-month efficacy of this injectable mixture compared with placebo in patients with Kellgren-Lawrence (K-L) grade III knee osteoarthritis. Specifically, we assessed (1) functional outcomes, (2) pain scores, (3) adverse events (AEs), and (4) magnetic resonance imaging (MRIs) findings. We performed a multicenter, double-blinded, placebo-controlled, and randomized study of adults who had K-L grade III knee osteoarthritis. A total of 102 patients were 2:1 randomized to TG-C at a dose of 3.0 × 107 cells, or placebo injections between May 1, 2011 and October 31, 2012. Outcomes analyzed were knee joint function, pain, quality of life, adverse events, and MRI findings using the whole-organ magnetic resonance imaging score (WORMS) system. There were significant improvements in the International Knee Documentation Committee (IKDC) and visual analogue scale (VAS) scores in the TG-C cohort, when compared with the placebo cohort at weeks 12, 52, 72, and 104 (p < 0.05). No severe AEs were observed. Common AEs were arthralgia, joint inflammation, and joint effusion which were similar between both cohorts. Whole-knee MRIs at 12 months showed less progression of cartilage damage, infrapatellar fat pad-synovitis, and effusion-synovitis in the TG-C cohort. Patients who received TG-C had significant improvements in IKDC and VAS scores. These patients also reported less severe and frequent pain. Additionally, fewer patients treated with TG-C showed progression of cartilage damage, as well as less progression of infrapatellar fat pad synovitis and effusion-synovitis. Furthermore, treatment with TG-C was generally well tolerated with minor AEs. Therefore, based on these results, TG-C appears to be a safe and effective modality for the management of K-L grade III osteoarthritis.

Smoking Is a Risk Factor for Wound Complications after Direct Anterior Hip Arthroplasty with Mesh Tape Closure.

OBJECTIVE: To determine what factors increase the risk of early wound complications in patients undergoing direct anterior total hip arthroplasty whose wounds were closed with 2-octyl cyanoacrylate with mesh. METHODS: This study was a retrospective review of 75 consecutive patients who underwent direct anterior total hip arthroplasty closed with 2-octyl cyanoacrylate with mesh. MAIN RESULTS: Of 29 patients who were smokers, five patients (17.2%) developed a wound complication, whereas out of 46 nonsmokers, only one patient (2.2%) developed a wound complication (P = .029). CONCLUSIONS: The authors recommend a closure technique that sufficiently protects the wound during healing, as well as preoperative patient optimization and smoking cessation.

Patient perceptions of antibiotic prophylaxis for dental procedures after total joint arthroplasty.

OBJECTIVE: Investigating patients' perceptions regarding need for antibiotic prophylaxis during dental procedures after undergoing joint arthroplasty. METHODS: Questionnaire was administered to patients presenting at: 1)an orthopaedic office; 2)a dental office; regarding perceptions of antibiotic prophylaxis. RESULTS: 36 orthopaedic patients responded "Yes" to always taking prophylaxis; 36 patients responded "No" (36/72, 50.0% compliance). Five dental patients responded "Yes" to always taking prophylaxis; 19 patients responded "No" (5/24, 20.8% compliance) (p = 0.017). 67/135 orthopaedic patients (49.6%) endorsed some form of dental prophylaxis, versus 34/58 dental patients (58.6%) (p = 0.27). CONCLUSION: Patient perceptions of the need for dental prophylaxis vary within orthopaedic and dental practices.

Radiographic Calibration With a Prosthetic Femoral Head Allows Accurate Preoperative Templating for Total Hip Arthroplasty.

Templating for total hip arthroplasty requires proper radiographic calibration. One option for radiograph calibration is using a cobalt-chrome femoral head ball. The authors reviewed radiographs and clinical data for patients undergoing primary total hip arthroplasty. Radiographs were calibrated using a 28-mm cobalt-chrome femoral head ball. Agreements between templated and actual implant size were calculated. The templated acetabulum matched within one size of the actual acetabulum in 76.7% to 80.0% of cases. The templated femur matched within one size of the actual femur in 83.3% to 93.3% of cases. This technique is an attractive option when a standardized calibration marker is unavailable. [Orthopedics. 2019; 42(3):e346-e349.].

Perioperative factors associated with increased length of stay after revision of metal-on-metal total hip arthroplasty.

OBJECTIVE: To investigate patient factors influencing length-of-stay (LOS) after revision metal-on-metal (MoM) total hip arthroplasty (THA). METHODS: We reviewed 23 hips undergoing revision of a MoM THA with minimum 2-year follow-up. A multiple linear regression was calculated to predict LOS using multiple variables. RESULTS: Average length of stay (LOS) was 2.1 days. Multiple linear regression analysis identified a significant correlation between presence of an abductor injury (beta = 0.8886; p < 0.0001), patient age (beta = -0.4452, p = 0.0083), and pre-revision head size (beta = 0.4082; p = 0.0172) with LOS (R2 = 0.6351, p = 0.0002). CONCLUSION: Patients with abductor injury, larger femoral heads, and younger age are at risk for longer LOS.

Increased Incidence of Bleeding and Wound Complications With Factor-Xa Inhibitors After Total Joint Arthroplasty.

BACKGROUND: Factor-Xa inhibitors have been introduced for prevention of venous thromboembolism (VTE) after joint arthroplasty. However, these agents could also be associated with bleeding or wound complications after surgery. METHODS: We retrospectively reviewed a consecutive series of 59 patients (31 knees, 28 hips) undergoing joint arthroplasty at a high-volume joint arthroplasty referral center, both before and after implementation of a new VTE risk-stratification tool at our institution. Patients with a history of VTE, bilateral procedures, or medical conditions already requiring VTE chemoprophylaxis were excluded. We reviewed the medical records to determine (1) type of VTE prophylaxis used, (2) incidence of bleeding/wound complications in the postoperative period, (3) incidence of VTE in the postoperative period, and (4) change in serum hemoglobin. RESULTS: Twenty-seven patients (46%) were given aspirin for VTE prophylaxis, while 32 patients (54%) received a factor-Xa inhibitor. There were no new VTE complications in either group. And 6 of 32 patients (18.7%) in the Xa inhibitor group had a postoperative bleeding/wound complication (4 delayed healing/blistering, 1 hematoma/excessive ecchymosis, and 1 readmission for cellulitis). There were no (0%) bleeding/wound complications in the aspirin group (P = .03). The change in hemoglobin level was -2.76 g/dL in patients receiving aspirin vs -2.84 g/dL in patients receiving a Xa inhibitor (P = .73). CONCLUSION: In our study of total joint patients, factor-Xa inhibitors were associated with a higher incidence of bleeding/wound complications. The choice of VTE prophylaxis should be based on the perceived risks of bleeding and wound complications compared to the risks of VTE in each patient.