The American journal of orthopedics
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Multicenter Study Clinical Trial
Clinical outcomes of lumbar degenerative disc disease treated with posterior lumbar interbody fusion allograft spacer: a prospective, multicenter trial with 2-year follow-up.
The clinical benefits and complications of posterior lumbar interbody fusion (PLIF) have been studied over the past 60 years. In recent years, spine surgeons have had the option of treating low back pain caused by degenerative disc disease using PLIF with machined allograft spacers and posterior pedicle fixation. The purpose of this clinical series was to assess the clinical benefits of using a machined PLIF allograft spacer and posterior pedicle fixation to treat degenerative disc disease, both in terms of fusion rates and patient outcomes, and to compare these results with those in previous studies using autograft and metal interbody fusion devices. ⋯ The graft-related complication rate among all patients who underwent PLIF was 1.61%. When performed with machined allograft spacers and posterior pedicle fixation, PLIF is a safe and effective surgical treatment for low back pain caused by degenerative disc disease. The patients in this clinical series had outcomes equal or superior to the outcomes in previous series.
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Randomized Controlled Trial Multicenter Study
Tramadol/acetaminophen tablets in the treatment of postsurgical orthopedic pain.
Tramadol/acetaminophen (APAP) combination tablets were shown effective and safe for postsurgical orthopedic pain in a 6-day, multicenter, randomized, double-blind, active- and placebo-controlled study. Of 305 intent-to-treat (ITT) postsurgical patients, 153 patients undergoing arthroscopy who had at least moderate pain were randomized to receive either tramadol 37.5 mg/APAP 325 mg (mean, 4.3 tablets), or codeine 30 mg/APAP 300 mg (mean, 4.6 tablets), or placebo. Tramadol/APAP was superior to placebo for the following outcome variables: total pain relief (TOTPAR, P = .013), sum of pain intensity differences (SPID, P = .049), sum of total pain relief and sum of pain intensity differences (SPRID, P = .018), and average daily pain relief (P = .031). Similar incidence of adverse events for tramadol/APAP and codeine/APAP was found, except for constipation (0% vs 10.9%) and vomiting (8.2% vs 16.4%).
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Randomized Controlled Trial Multicenter Study Comparative Study Clinical Trial
Intravenous parecoxib sodium foracute pain after orthopedic knee surgery.
Our objective in a randomized, multicenter, double-blind, parallel-group, placebo- and active-controlled study was to evaluate and compare the analgesic effectiveness of single intravenous (IV) doses of parecoxib sodium 20 and 40 mg, morphine 4 mg, and ketorolac 30 mg in the postsurgical orthopedic pain model. After undergoing unilateral total knee replacement surgery, 208 healthy adult patients were randomized to receive placebo or a study drug within 6 hours of discontinuation of patient-controlled analgesia on postoperative day 1. ⋯ Parecoxib sodium was safe and well tolerated. In conclusion, IV parecoxib sodium 40 mg is as effective as ketorolac 30 mg and is more effective than morphine 4 mg and therefore has potential widespread utility in acute postoperative pain management.
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Multicenter Study Comparative Study Clinical Trial
Spinal anesthesia versus general anesthesia for hip fracture repair: a longitudinal observation of 741 elderly patients during 2-year follow-up.
The Baltimore Hip Studies, a multicenter, noninterventional, observational trial, provided an opportunity to investigate the effects of anesthetic technique on the long-term outcome of elderly patients after hip fracture repair. Detailed interviews assessing functional status and pain were conducted during the hospital stay. Out-of-hospital evaluations were repeated after the procedure at 2, 6, 12, 18, and 24 months with a portable gait and balance laboratory. ⋯ Of 741 enrolled patients who completed the study, 430 and 311 patients received spinal anesthesia or general anesthesia, respectively. Subgroup analysis of three spinal anesthetics, tetracaine, lidocaine, and epinephrine, was also done. In the present large observational study, general anesthesia was at least as efficacious as spinal anesthesia, and possibly better, in affording good long-term outcome.