Frequency and Complications of Major Orthopedic Procedures in Medicare Beneficiaries

NCT02281747 | Active Not Recruiting

• 2 other identifiers: 99991501015-AR-N010
• Study Type: observational
• Target: 521,292
• Locations: 1 country
• Sites: 1

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.

Conditions

Rheumatoid Arthritis; Ankylosing Spondylitis

Keywords

Biologic Therapy; Rheumatoid Arthritis; Arthroplasty; Natural History

Outcome Measures

Primary Outcomes (1)

• Complications

  Complications

  30 days

Study Arms (2)

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.

Eligibility Criteria

• Age: 20 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS): lead

Study Sites (1)

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), 9

Bethesda, Maryland, 20892, United States

Location

MeSH Terms

Conditions

Arthritis, Rheumatoid; Spondylitis, Ankylosing

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Axial Spondyloarthritis; Spondylarthropathies; Spondylarthritis; Spondylitis; Spinal Diseases; Bone Diseases; Ankylosis

Study Officials

• Robert A Colbert, M.D.

  National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 31, 2014
• First Posted: November 4, 2014
• Study Start: October 24, 2014
• Primary Completion (Estimated): May 30, 2029
• Study Completion (Estimated): May 31, 2029
• Last Updated: May 1, 2026

Record last verified: 2025-12-19

Locations

US (1)