Osteoarthritis, Knee — Orthosensor vs Conventional Total Knee Arthroplasty
Citation(s)
Camarata DA Soft tissue balance in total knee arthroplasty with a force sensor. Orthop Clin North Am. 2014 Apr;45(2):175-84. doi: 10.1016/j.ocl.2013.12.001. Epub 2014 Feb 1. Review.
Chow JC, Breslauer L The Use of Intraoperative Sensors Significantly Increases the Patient-Reported Rate of Improvement in Primary Total Knee Arthroplasty. Orthopedics. 2017 Jul 1;40(4):e648-e651. doi: 10.3928/01477447-20170503-01. Epub 2017 May 8.
Churchill JL, Khlopas A, Sultan AA, Harwin SF, Mont MA Gap-Balancing versus Measured Resection Technique in Total Knee Arthroplasty: A Comparison Study. J Knee Surg. 2018 Jan;31(1):13-16. doi: 10.1055/s-0037-1608820. Epub 2017 Nov 27.
Geller JA, Lakra A, Murtaugh T The Use of Electronic Sensor Device to Augment Ligament Balancing Leads to a Lower Rate of Arthrofibrosis After Total Knee Arthroplasty. J Arthroplasty. 2017 May;32(5):1502-1504. doi: 10.1016/j.arth.2016.12.019. Epub 2016 Dec 24.
Gustke KA, Golladay GJ, Roche MW, Elson LC, Anderson CR A new method for defining balance: promising short-term clinical outcomes of sensor-guided TKA. J Arthroplasty. 2014 May;29(5):955-60. doi: 10.1016/j.arth.2013.10.020. Epub 2013 Oct 24.
Jacobs CA, Christensen CP, Karthikeyan T Patient and intraoperative factors influencing satisfaction two to five years after primary total knee arthroplasty. J Arthroplasty. 2014 Aug;29(8):1576-9. doi: 10.1016/j.arth.2014.03.022. Epub 2014 Mar 28.
Krackow KA Instability in total knee arthroplasty: loose as a goose. J Arthroplasty. 2003 Apr;18(3 Suppl 1):45-7.
Kurtz S, Ong K, Lau E, Mowat F, Halpern M Projections of primary and revision hip and knee arthroplasty in the United States from 2005 to 2030. J Bone Joint Surg Am. 2007 Apr;89(4):780-5.
Meneghini RM, Ziemba-Davis MM, Lovro LR, Ireland PH, Damer BM Can Intraoperative Sensors Determine the "Target" Ligament Balance? Early Outcomes in Total Knee Arthroplasty. J Arthroplasty. 2016 Oct;31(10):2181-7. doi: 10.1016/j.arth.2016.03.046. Epub 2016 Apr 4.
Walker PS, Meere PA, Bell CP Effects of surgical variables in balancing of total knee replacements using an instrumented tibial trial. Knee. 2014 Jan;21(1):156-61. doi: 10.1016/j.knee.2013.09.002. Epub 2013 Sep 19.
Outcomes in Free-hand Versus Sensor-guided Balancing in Total Knee Arthroplasty: a Randomized Controlled Trial
Interventional studies are often prospective and are specifically tailored to evaluate direct impacts of treatment or preventive measures on disease.
Observational studies are often retrospective and are used to assess potential causation in exposure-outcome relationships and therefore influence preventive methods.
Expanded access is a means by which manufacturers make investigational new drugs available, under certain circumstances, to treat a patient(s) with a serious disease or condition who cannot participate in a controlled clinical trial.
Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.
Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.