title: Understanding Orthopaedic Registry Studies: A Comparison with Clinical Studies.
abstract: Orthopaedic registries are valuable for monitoring patient outcomes in real-world settings. Registries are useful for identifying procedure incidence and device utilization, evaluating outcomes, determining patients at risk for complications and reoperations, identifying devices in recall situations, assessing comparative effectiveness of procedures and devices, and providing data for research studies. In the present report, we describe how orthopaedic registries can be used to conduct research and how they compare with randomized controlled trials (RCTs) in regard to methodology. Using an example, a comparison of the performance of mobile and fixed bearings in total knee arthroplasty, we evaluate the differences between, and the similarities of, RCTs and registry cohort studies with regard to how they are conducted and how their findings are reported. Orthopaedic registry studies differ from RCTs in many ways and offer certain advantages. The strengths and limitations of registry cohort studies and RCTs must be understood to properly evaluate the literature.
authors.affiliation: Surgical Outcomes and Analysis Department, Kaiser Permanente, San Diego, California E-mail address for M.C.S. Inacio: Maria.cs.inacio@kp.org.
authors.forename: Maria C S
authors.initials: MC
authors.lastname: Inacio
authors.affiliation: Surgical Outcomes and Analysis Department, Kaiser Permanente, San Diego, California E-mail address for M.C.S. Inacio: Maria.cs.inacio@kp.org liz.w.paxton@kp.org.
authors.forename: Elizabeth W
authors.initials: EW
authors.lastname: Paxton
authors.affiliation: Department of Orthopedic Surgery, Kaiser Permanente, Sacramento, California mark.dillon@kp.org.
authors.forename: Mark T
authors.initials: MT
authors.lastname: Dillon
mesh_terms: D019645:Arthroplasty, Replacement, Knee / Q000009:adverse effects / Q000379:methods*; D032882:Comprehension; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007720:Knee Prosthesis; D008297:Male; D009985:Orthopedics; D011183:Postoperative Complications / Q000503:physiopathology; D011475:Prosthesis Failure; D036301:Qualitative Research; D016032:Randomized Controlled Trials as Topic; D012042:Registries; D012086:Reoperation / Q000706:statistics & numerical data; D018570:Risk Assessment; D016896:Treatment Outcome