Frequency and Complications of Major Orthopedic Procedures in Medicare Beneficiaries

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.

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.

Study Overview

• Status: Active, not recruiting
• Conditions: 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.

• Study Type: Observational
• Enrollment (Actual): 521292

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Bethesda, Maryland, United States, 20892
      • National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), 9

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Medicare (1999 to 2015) and Medicaid (1999 to 2015) beneficiaries

Description

• 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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

2

Cohorts and Interventions

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Complications	Complications	30 days

Collaborators and Investigators

• Sponsor: National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
• Investigators: Principal Investigator: Robert A Colbert, M.D., National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Study record dates

Study Major Dates

• Study Start (Actual): October 24, 2014
• Primary Completion (Estimated): May 30, 2024
• Study Completion (Estimated): May 31, 2029

Study Registration Dates

• First Submitted: October 31, 2014
• First Submitted That Met QC Criteria: October 31, 2014
• First Posted (Estimated): November 4, 2014

Study Record Updates

• Last Update Posted (Actual): March 8, 2024
• Last Update Submitted That Met QC Criteria: March 7, 2024
• Last Verified: March 5, 2024

More Information

Terms related to this study

• Keywords: Arthroplasty; Natural History; Rheumatoid Arthritis; Biologic Therapy
• Additional Relevant MeSH Terms: Infections; Immune System Diseases; Autoimmune Diseases; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Spinal Diseases; Bone Diseases; Spondylarthropathies; Spondylarthritis; Bone Diseases, Infectious; Ankylosis; Axial Spondyloarthritis; Arthritis; Arthritis, Rheumatoid; Spondylitis; Spondylitis, Ankylosing
• Other Study ID Numbers: 999915010; 15-AR-N010

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: .undecided yet

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No