Knee Arthroplasty Registry
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|ClinicalTrials.gov Identifier: NCT01132365|
Recruitment Status : Unknown
Verified July 2016 by R. David Heekin, MD, Heekin Orthopedic Research Institute.
Recruitment status was: Enrolling by invitation
First Posted : May 28, 2010
Last Update Posted : July 26, 2016
Describe the clinical and demographic characteristics of patients who undergo knee arthroplasty and document post operative outcomes.
Examine the relationship between processes of care, hospital and surgeon associated outcomes.
Provide expanded data to characterize existing and evolving practice patterns, delivery of care, and resource utilization in the management of knee arthroplasty patients.
Analyze and design ancillary studies to address unanswered questions.
Disseminate findings through publication in peer-reviewed scientific journals.
|Condition or disease||Intervention/treatment|
|Osteoarthritis, Knee||Device: any knee joint arthroplasty device|
Population: All male and non-pregnant females undergoing knee arthroplasty.
Study Design: Prospective, consecutive series on an unlimited number of patients.
Patient Demographics- age, weight, height, gender, affected side, co-morbidities, current medications, and contact information Knee Society Score SF-12 Evaluation of radiographs- AP, ML, and merchant view Preop lab results
Surgical approach ASA level Size of implants, catalog and lot numbers Time of surgery Estimated blood loss (ml) Length of incision (cm) Intraoperative ROM Any peculiar findings (i.e. heterotopic bone, large osteophytes, etc.) Preop lab results
Postoperative Data Sf-12 Modified Knee Society Score Quad strength testing Evaluation of radiographs, AP, ML, and merchant view
|Study Type :||Observational|
|Estimated Enrollment :||7793 participants|
|Official Title:||Knee Arthroplasty Registry a. Function and Survival Stratified by BMI b. Return of Quadriceps Strength After Primary TKA|
|Study Start Date :||April 2005|
|Estimated Primary Completion Date :||December 2018|
|Estimated Study Completion Date :||December 2018|
Device: any knee joint arthroplasty device
Cohort consist of all consented patients receiving knee arthroplasty
- Knee Society Score [ Time Frame: 2 weeks, 6 weeks, 3 months, 6 months, 1, 2, 5, 10 years ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01132365
|United States, Florida|
|Heekin Orthopedic Specialists|
|Jacksonville, Florida, United States, 32204|
|Principal Investigator:||Richard D Heekin, MD||Heekin Orthopedic Specialists|