Anterior Cruciate Ligament Injuries — How to Best Treat Anterior Cruciate Ligament Injuries
Citation(s)
Eitzen I, Holm I, Risberg MA Preoperative quadriceps strength is a significant predictor of knee function two years after anterior cruciate ligament reconstruction. Br J Sports Med. 2009 May;43(5):371-6. doi: 10.1136/bjsm.2008.057059. Epub 2009 Feb 17.
Ekas GR, Engebretsen L [The cruciate ligament register--due for a change?]. Tidsskr Nor Laegeforen. 2016 Feb 23;136(4):298. doi: 10.4045/tidsskr.15.1291. eCollection 2016 Feb 23. No abstract available. Norwegian.
Engebretsen L, Forssblad M, Lind M Why registries analysing cruciate ligament surgery are important. Br J Sports Med. 2015 May;49(10):636-8. doi: 10.1136/bjsports-2014-094484. Epub 2015 Feb 2. No abstract available.
FAITH Investigators Fixation using alternative implants for the treatment of hip fractures (FAITH): design and rationale for a multi-centre randomized trial comparing sliding hip screws and cancellous screws on revision surgery rates and quality of life in the treatment of femoral neck fractures. BMC Musculoskelet Disord. 2014 Jun 26;15:219. doi: 10.1186/1471-2474-15-219.
Frobell RB, Lohmander LS, Roos EM The challenge of recruiting patients with anterior cruciate ligament injury of the knee into a randomized clinical trial comparing surgical and non-surgical treatment. Contemp Clin Trials. 2007 May;28(3):295-302. doi: 10.1016/j.cct.2006.10.002. Epub 2006 Oct 6.
Krumholz HM Registries and selection bias: the need for accountability. Circ Cardiovasc Qual Outcomes. 2009 Nov;2(6):517-8. doi: 10.1161/CIRCOUTCOMES.109.916601. No abstract available.
Lauer MS, D'Agostino RB Sr The randomized registry trial--the next disruptive technology in clinical research? N Engl J Med. 2013 Oct 24;369(17):1579-81. doi: 10.1056/NEJMp1310102. Epub 2013 Aug 31. No abstract available.
Mathes T, Buehn S, Prengel P, Pieper D Registry-based randomized controlled trials merged the strength of randomized controlled trails and observational studies and give rise to more pragmatic trials. J Clin Epidemiol. 2018 Jan;93:120-127. doi: 10.1016/j.jclinepi.2017.09.017. Epub 2017 Sep 22.
Pandis N Randomization. Part 2: Minimization. Am J Orthod Dentofacial Orthop. 2011 Dec;140(6):902-4. doi: 10.1016/j.ajodo.2011.08.016. No abstract available.
Roos EM, Lohmander LS The Knee injury and Osteoarthritis Outcome Score (KOOS): from joint injury to osteoarthritis. Health Qual Life Outcomes. 2003 Nov 3;1:64. doi: 10.1186/1477-7525-1-64.
Seil R, Mouton C, Theisen D How to get a better picture of the ACL injury problem? A call to systematically include conservatively managed patients in ACL registries. Br J Sports Med. 2016 Jul;50(13):771-2. doi: 10.1136/bjsports-2015-095027. Epub 2015 Sep 23. No abstract available.
Sims AL, Parsons N, Achten J, Griffin XL, Costa ML, Reed MR; CORNET trainee collaborative A randomized controlled trial comparing the Thompson hemiarthroplasty with the Exeter polished tapered stem and Unitrax modular head in the treatment of displaced intracapsular fractures of the hip: the WHiTE 3: HEMI Trial. Bone Joint J. 2018 Mar 1;100-B(3):352-360. doi: 10.1302/0301-620X.100B3.BJJ-2017-0872.R2.
Spindler KP, Wright RW Clinical practice. Anterior cruciate ligament tear. N Engl J Med. 2008 Nov 13;359(20):2135-42. doi: 10.1056/NEJMcp0804745. No abstract available.
Yndigegn T, Hofmann R, Jernberg T, Gale CP Registry-based randomised clinical trial: efficient evaluation of generic pharmacotherapies in the contemporary era. Heart. 2018 Oct;104(19):1562-1567. doi: 10.1136/heartjnl-2017-312322. Epub 2018 Apr 17.
Ytterstad K, Granan LP, Engebretsen L [The Norwegian Cruciate Ligament Registry has a high degree of completeness]. Tidsskr Nor Laegeforen. 2011 Feb 4;131(3):248-50. doi: 10.4045/tidsskr.10.0536. Norwegian.
Improving the Treatment of Anterior Cruciate Ligament Tears in Norway With Register-RCTs - Who Should Have Surgery
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.
