7 research outputs found

    Comparison of the iAssist Handheld Guidance System to Conventional Instruments for Mechanical Axis Restoration in Total Knee Arthroplasty.

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    BACKGROUND: Recent advances in total knee arthroplasty (TKA) include an intelligent instrument system designed to provide intraoperative guidance to reduce mechanical alignment errors. Internal position-sensing technology is integrated into microelectronic pods that attach to cutting blocks. The purpose of this prospective, randomized study was to determine whether this iAssist system enables the surgeon to make more accurate bone resections and better restore the mechanical axis compared to conventional instruments in TKA. METHODS: We randomized patients undergoing TKA into 2 groups. Group I (n = 25) underwent TKA assisted by the iAssist guidance system, group II (n = 25) underwent TKA using conventional instruments. Preoperative and postoperative mechanical axes were measured from full-length lower extremity radiographs to evaluate alignment. Additional surgical parameters were also assessed, including tourniquet time and blood loss. RESULTS: Patient demographics and preoperative mechanical axis alignments were similar between the groups. Postoperatively, 4.0% of patients had greater than 3° of tibial or femoral component mal-alignment in the guidance-assisted cohort, compared with 36.0% in the conventional group (P \u3c .05). Additionally, group I showed significant improvement in variance seen in both the femoral mechanical axis (1.65° ± 0.17° vs 2.23° ± 0.33°, P \u3c .005) and tibial mechanical axis (1.28° ± 0.13° vs 1.71° ± 0.24°, P \u3c .005) compared to group II. There were no significant differences in tourniquet time (P = .86) or blood loss (P = .39) between groups. CONCLUSION: Use of the iAssist system in TKA results in an improved postoperative mechanical axis and decreased alignment variability compared to conventional instruments, without significantly increasing operative time

    Intraoperative Comparison of Measured Resection and Gap Balancing Using a Force Sensor: A Prospective, Randomized Controlled Trial.

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    BACKGROUND: For establishing femoral component position, gap-balancing (GB) and measured resection (MR) techniques were compared using a force sensor. METHODS: Ninety-one patients were randomized to undergo primary total knee arthroplasty using either MR (n = 43) or GB (n = 48) technique using a single total knee arthroplasty design. GB was performed with an instrumented tensioner. Force sensor data were obtained before the final implantation. RESULTS: GB resulted in greater range of femoral component rotation vs MR (1.5° ± 2.9° vs 3.1° ± 0.5°, P \u3c .05) and posterior condylar cut thickness medially (10.2 ± 2.0 mm vs 9.0 ± 1.3 mm) and laterally (8.5 ± 1.9 mm vs 6.4 ± 1.0 mm). Force sensor data showed a decreased intercompartmental force difference at full flexion in GB (.8 ± 2.3 vs 2.0 ± 3.3u, 1u ≈ 15 N, P \u3c .05). CONCLUSION: GB resulted in a greater range of femoral component rotation and thicker posterior condylar cuts resulting in an increased flexion space relative to MR. Intercompartmental force difference trended toward a more uniform distribution between full extension and full flexion in the GB vs MR group

    Percutaneous auricular nerve stimulation (neuromodulation) for the treatment of pain: A proof-of-concept case report using total joint arthroplasty as a surrogate for battlefield trauma

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    BackgroundThere are few effective pain treatments following trauma on the battlefield other than opioids, which are limited by respiratory depression. Ultrasound-guided percutaneous peripheral nerve stimulation ("neuromodulation") has been proposed as an analgesic, but requires physician-level skills, advanced equipment, and an hour to administer. In contrast, percutaneous auricular neuromodulation may be placed by a medic in the field under nonsterile conditions in a few minutes, theoretically provides analgesia for any anatomic location, has no side effects, and no significant risks. It therefore offers the potential to be applied quickly on the battlefield without any of the limitations of opioids. We propose total joint replacement as a surrogate for battlefield trauma and here present a case report to demonstrate proof of concept.MethodsFollowing open total knee or hip arthroplasty under spinal anesthesia, two patients had an auricular neuromodulation device applied within the recovery room. Patients were discharged with the unit and contacted daily for 7 days.ResultsThe devices were each applied in under 3 minutes without difficulty, were well tolerated during use, and removed without complication at home on Day 5. During use, neither patient experienced pain while lying, sitting, or ambulating. Neither required analgesics other than scheduled celecoxib; and a single tablet (50 mg) of tramadol for one patient on postoperative Days 3 and 4 for pain while lowering herself to a seated position. On Days 6 and 7, both patients experienced an increase in pain, one of whom required around-the-clock tramadol.ConclusionAmbulatory postoperative percutaneous auricular neuromodulation is feasible. In these two cases, it appears to have markedly reduced pain scores and opioid requirements free of systemic side effects during the week following major orthopedic surgery. Considering the potential of this modality to treat trauma on the battlefield without systemic side effects, additional investigation appears warranted.Level of evidenceTherapeutic/care management; Level V

    A Randomized Controlled Pilot Study Using Ultrasound-Guided Percutaneous Cryoneurolysis of the Infrapatellar Branch of the Saphenous Nerve for Analgesia Following Total Knee Arthroplasty

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    IntroductionTotal knee arthroplasty (TKA) is frequently associated with severe, prolonged postsurgical pain, and therefore local anesthetic-based peripheral nerve blocks are commonly used for postoperative analgesia. Cryoneurolysis involves the use of freezing temperatures to provide a reversible sensory (and motor) block with a duration measured in weeks and months, more commensurate with the typical period of post-TKA pain. We therefore conducted a randomized controlled pilot study to evaluate the use of this modality for the treatment of pain following TKA to (1) determine the feasibility of and optimize the study protocol for a subsequent definitive clinical trial; and (2) estimate analgesia and opioid reduction within the first 3 postoperative weeks.MethodsA convenience sample of 16 patients undergoing primary TKA with a single-injection and/or continuous adductor canal nerve block were randomized to receive either active cryoneurolysis or a sham procedure targeting the infrapatellar branch of the saphenous nerve, in a participant-masked fashion. This was a pilot study with a relatively small number of participants, and therefore resulting data were not analyzed statistically.ResultsCompared with participants receiving sham, the active treatment group reported slightly lower average and worst pain scores as well as opioid consumption and sleep disturbances due to pain at a majority of postoperative time points between postoperative days (POD) 4-21.ConclusionsPreoperative ultrasound-guided cryoneurolysis of the infrapatellar branch of the saphenous nerve is feasible and may provide analgesic benefits for multiple weeks following TKA. A definitive randomized controlled trial appears warranted

    An international randomised placebo-controlled trial of a four-component combination pill ("Polypill") in people with raised cardiovascular risk

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    Background: There has been widespread interest in the potential of combination cardiovascular medications containing aspirin and agents to lower blood pressure and cholesterol ('polypills') to reduce cardiovascular disease. However, no reliable placebo-controlled data are available on both efficacy and tolerability. Methods: We conducted a randomised, double-blind placebo-controlled trial of a polypill (containing aspirin 75 mg, lisinopril 10 mg, hydrochlorothiazide 12.5 mg and simvastatin 20 mg) in 378 individuals without an indication for any component of the polypill, but who had an estimated 5-year cardiovascular disease risk over 7.5%. The primary outcomes were systolic blood pressure (SBP), LDL-cholesterol and tolerability (proportion discontinued randomised therapy) at 12 weeks follow-up. Findings: At baseline, mean BP was 134/81 mmHg and mean LDL-cholesterol was 3.7 mmol/L. Over 12 weeks, polypill treatment reduced SBP by 9.9 (95% CI: 7.7 to 12.1) mmHg and LDL-cholesterol by 0.8 (95% CI 0.6 to 0.9) mmol/L. The discontinuation rates in the polypill group compared to placebo were 23% vs 18% (RR 1.33, 95% CI 0.89 to 2.00, p = 0.2). There was an excess of side effects known to the component medicines (58% vs 42%, p = 0.001), which was mostly apparent within a few weeks, and usually did not warrant cessation of trial treatment. Conclusions: This polypill achieved sizeable reductions in SBP and LDL-cholesterol but caused side effects in about 1 in 6 people. The halving in predicted cardiovascular risk is moderately lower than previous estimates and the side effect rate is moderately higher. Nonetheless, substantial net benefits would be expected among patients at high risk. Trial Registration: Australian New Zealand Clinical Trials Registry ACTRN12607000099426
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