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Frequency and Complications of Major Orthopedic Procedures in Medicare Beneficiaries

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02281747
Recruitment Status : Active, not recruiting
First Posted : November 4, 2014
Last Update Posted : August 15, 2022
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) )

Brief 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.

Condition or disease
Rheumatoid Arthritis Ankylosing Spondylitis

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.

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Study Type : Observational
Actual Enrollment : 521292 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Frequency and Complications of Major Orthopedic Procedures in Medicare Beneficiaries
Actual Study Start Date : October 24, 2014
Estimated Primary Completion Date : August 30, 2023
Estimated Study Completion Date : May 31, 2024


Group/Cohort
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.



Primary Outcome Measures :
  1. Complications [ Time Frame: 30 days ]
    Complications



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Medicare (1999 to 2015) and Medicaid (1999 to 2013) beneficiaries@@@@@@
Criteria
  • Subjects will be either Medicare or Medicaid beneficiaries with available claims from 1999 to 2014. For projects requiring detailed medication information, inclusion will be limited to those with Part D claims from 2006 to 2014. 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.


Information from the National Library of Medicine

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): NCT02281747


Locations
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United States, Maryland
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), 9
Bethesda, Maryland, United States, 20892
Sponsors and Collaborators
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Investigators
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Principal Investigator: Robert A Colbert, M.D. National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
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Responsible Party: National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
ClinicalTrials.gov Identifier: NCT02281747    
Other Study ID Numbers: 999915010
15-AR-N010
First Posted: November 4, 2014    Key Record Dates
Last Update Posted: August 15, 2022
Last Verified: June 14, 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: .undecided yet

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by National Institutes of Health Clinical Center (CC) ( National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) ):
Biologic Therapy
Rheumatoid Arthritis
Arthroplasty
Natural History
Additional relevant MeSH terms:
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Spondylitis
Arthritis
Arthritis, Rheumatoid
Spondylitis, Ankylosing
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Bone Diseases, Infectious
Infections
Bone Diseases
Spinal Diseases
Spondylarthritis
Spondylarthropathies
Ankylosis