Frequency and Complications of Major Orthopedic Procedures in Medicare Beneficiaries

Active, not recruiting

• Conditions: Rheumatoid Arthritis; Ankylosing Spondylitis

• Registration Number: NCT02281747
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2014-10-24
• Study First Submitted: 2014-10-31
• Study First Submitted QC: 2014-10-31
• Study First Posted: 2014-11-04
• Status Verified: 2024-12-27
• Last Update Submitted: 2025-04-18
• Last Update Posted: 2025-04-20
• Primary Completion: 2025-05-30
• Study Completion: 2029-05-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 521292

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Complications	30 days	Complications

Trial Locations

Locations (1)

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), 9; 🇺🇸 Bethesda, Maryland, United States