Chauhan SK, Clark GW, Lloyd S, Scott RG, Breidahl W, Sikorski JM Computer-assisted total knee replacement. A controlled cadaver study using a multi-parameter quantitative CT assessment of alignment (the Perth CT Protocol). J Bone Joint Surg Br. 2004 Aug;86(6):818-23. doi: 10.1302/0301-620x.86b6.15456.
Chauhan SK, Scott RG, Breidahl W, Beaver RJ Computer-assisted knee arthroplasty versus a conventional jig-based technique. A randomised, prospective trial. J Bone Joint Surg Br. 2004 Apr;86(3):372-7. doi: 10.1302/0301-620x.86b3.14643.
Hallan G, Aamodt A, Furnes O, Skredderstuen A, Haugan K, Havelin LI Palamed G compared with Palacos R with gentamicin in Charnley total hip replacement. A randomised, radiostereometric study of 60 HIPS. J Bone Joint Surg Br. 2006 Sep;88(9):1143-8. doi: 10.1302/0301-620X.88B9.18008.
Luring C, Bathis H, Tingart M, Perlick L, Grifka J Computer assistance in total knee replacement - a critical assessment of current health care technology. Comput Aided Surg. 2006 Mar;11(2):77-80. doi: 10.3109/10929080600578925.
Rand JA, Coventry MB Ten-year evaluation of geometric total knee arthroplasty. Clin Orthop Relat Res. 1988 Jul;(232):168-73.
Roos EM, Toksvig-Larsen S Knee injury and Osteoarthritis Outcome Score (KOOS) - validation and comparison to the WOMAC in total knee replacement. Health Qual Life Outcomes. 2003 May 25;1:17. doi: 10.1186/1477-7525-1-17.
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.
