Rheumatoid ArthritisNCT02281747
Frequency and Complications of Major Orthopedic Procedures in Medicare Beneficiaries
An observational study of Rheumatoid Arthritis and Ankylosing Spondylitis, run by National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 100 years
- Conditions the study is for
- Rheumatoid Arthritis, Ankylosing Spondylitis
- How many people
- 521,292 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Oct 2014to 31 May 2029
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Medicare (1999 to 2015) and Medicaid (1999 to 2015) beneficiaries
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), 9
Bethesda, Maryland, 20892
About this study
Official title: Frequency and Complications of Major Orthopedic Procedures in Medicare Beneficiaries and Other Databases
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.
Read more
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.
Read the detailed description
Major orthopedic procedures, including total joint replacement and spine surgeries, are among the most common procedures in the population. Learning about how often these surgeries are performed can give indications of whether the treatment of arthritis and other musculoskeletal conditions has been improving over time. Learning about the complications associated with these surgeries can give indications about ways to alter the care of patients before and after surgeries that may decrease the risk of complications and improve patient outcomes. We will analyze Medicare and Medicaid data from 1999 to 2015 to examine a series of questions, including whether the use of joint replacement surgery has changed over time among patients with rheumatoid arthritis and ankylosing spondylitis, to see if rheumatoid arthritis medications are associated with some types of surgical complications, to see if anticoagulation medication after joint replacement is associated with the risk of complications, to see if regional differences in surgery rates can be explained by differences in patient characteristics, and to determine the surgical treatment for hip fractures that is associated with the fewest long-term complications. From the Framingham Heart Study Cohort, we will study the changes in the incidence of hip fractures and the risk factors for osteoporosis over time.
- Conditions
- Rheumatoid Arthritis, Ankylosing Spondylitis
- Keywords
- Biologic Therapy, Rheumatoid Arthritis, Arthroplasty, Natural History
- Medical subject headings
- Arthritis, Rheumatoid, Spondylitis, Ankylosing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| affected with arthritis | arthritis may be either rheumatoid, osteoarthritis, or ankylosing spondylitis | |
| unaffected with arthritis | in some analyses, the comparison is by arthritis status. in other analyses, it is within arthritis status by clinically relevant subgroups. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complications
Complications
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2014 (estimated)
- Study start24 Oct 2014
- Primary completion30 May 2029 (estimated)
- Study completion31 May 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 521,292 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Robert A Colbert, M.D., Principal investigator, National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02281747
- Sponsor's protocol ID
- 999915010
- Other IDs
- 15-AR-N010
- Status last verified
- 19 Dec 2025
- First submitted
- 31 Oct 2014
- Last updated
- 8 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: undecided yet