Frequency and Complications of Major Orthopedic Procedures in Medicare Beneficiaries (NCT02281747) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Frequency and Complications of Major Orthopedic Procedures in Medicare Beneficiaries
United States521,292 participantsStarted 2014-10-24
Plain-language summary
Background:
\- Orthopedic procedures are common in the United States. These include joint replacement and spine surgeries. Researchers want to study data about these procedures over time. They want to see if treatment has gotten better. They also want to find ways to change the care that people get before and after they have these procedures. These changes may lower the risk of problems people can have during and after treatment. They may also improve people s results.
Objectives:
\- To study a series of questions about surgery, medicine, treatments, and outcomes for orthopedic procedures.
Eligibility:
\- Data from the U.S. Centers for Medicare and Medicaid Services from 1999 to 2015.
Design:
* Researchers will look at data for people ages 20-100.
* No new participants will be used in this study.
* The study will last 6 years.
Who can participate
Age range
20 Years – 100 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
* Subjects will be either Medicare or Medicaid beneficiaries with available claims from 1999 to 2015. For projects requiring detailed medication information, inclusion will be limited to those with Part D claims from 2006 to 2015. Eligibility for each project will be based on claims for the appropriate disease (e.g. RA) or procedure (e.g. hip arthroplasty).
Medicare beneficiaries will be excluded (or censored) if they do not have both Part A and Part B coverage, or enrolled in Medicare Advantage plans (Part C), as detailed claims for these beneficiaries are not available. We will also exclude dual-eligible (Medicare and Medicaid recipients) as these subjects have distinct clinical conditions (e.g. blindness) that distinguishes them from most Medicare beneficiaries. There will be no exclusions based on gender, race, ethnicity, or cognitive impairment.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This study is looking at complications after major orthopedic procedures in Medicare patients with rheumatoid arthritis or ankylosing spondylitis — what kinds of complications are they tracking, and how might knowing that information affect the decisions we make about my treatment?
2Since this is an observational study using Medicare data rather than a trial testing a new treatment, could the findings from this research actually change the recommendations my doctor makes about whether I should have an orthopedic procedure?
3The study is no longer recruiting, which means results may be available soon — has any data come out of this research yet that my doctor thinks is relevant to my specific situation with rheumatoid arthritis or ankylosing spondylitis?
4Given that this study focuses on Medicare beneficiaries specifically, does the complication data being gathered here apply to my age group and insurance situation, and is that something we should factor into our conversations about surgery?
5Before considering any major orthopedic procedure, are there non-surgical treatment paths we should try first, and does research like this study give my doctor any insight into when surgery tends to carry more or less risk for someone with my condition?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Complications
Timeframe: 30 days
Trial details
NCT IDNCT02281747
SponsorNational Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)