C3 Total Joint Patient Registry

DC2 Healthcare10,000 enrolled

Overview

This study will assess the efficacy of products, implants, and procedures for knee and hip replacement.

This registry will prospectively collect a core set of data on patients undergoing knee or hip replacement. This registry will include a variety of different products, implants, technologies and procedures. The registry will also collect any adverse events/complications that occur during or following these surgeries. This database can also be utilized in the future to answer research questions, by retrospectively going back through the data. This information also may go to insurance companies or hospitals for quality measurement and metrics reporting. The data will be utilized to develop strategic treatment pathways that will improve patient care. Ultimately, the goal of the registry is to enhance the understanding of treatment associated with knee and hip replacement and the resulting patient outcomes. The registry will also be used to provide quality measurement and metrics reporting.

Study Type

OBSERVATIONAL

Enrollment

10,000

Conditions

Knee Replacement Hip Replacement

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * At least 18 years of age * Undergoing knee or hip replacement * Subject is likely to follow standard of care post-operative follow up for at least 1 year Exclusion Criteria: * Inability to complete follow-up visits or required questionnaires * Inability to provide informed consent without a legally authorized representative

Locations (1)

DC2 Healthcare

Nashville, Tennessee, United States

RECRUITING

Outcomes

Primary Outcomes

Change in Hip disability and Osteoarthritis Outcome Score (HOOS) from baseline at 3 months

Assessment of hip symptoms and disability to be taken at baseline and 3 months after surgery

Time frame: baseline and 3 months

Change in Hip disability and Osteoarthritis Outcome Score (HOOS) from baseline at 6 months

Assessment of hip symptoms and disability to be taken at baseline and 6 months after surgery

Time frame: baseline and 6 months

Change in Hip disability and Osteoarthritis Outcome Score (HOOS) from baseline at 1 year

Assessment of hip symptoms and disability to be taken at baseline and 1 year after surgery

Time frame: baseline and 1 year

Change in Knee injury and Osteoarthritis Outcome Score (KOOS) from baseline at 3 months

Assessment of knee symptoms and disability to be taken at baseline and 3 months after surgery

Time frame: baseline and 3 months

Change in Knee injury and Osteoarthritis Outcome Score (KOOS) from baseline at 1 year

Assessment of knee symptoms and disability to be taken at baseline and 1 year after surgery

Time frame: baseline and 1 year

Change in Knee injury and Osteoarthritis Outcome Score (KOOS) from baseline at 6 months

Assessment of knee symptoms and disability to be taken at baseline and 6 months after surgery

Time frame: baseline and 6 months

Secondary Outcomes

Adverse Events at time of surgery

Time frame: Time of surgery

Central Contacts

Christina R Cook, PhD

CONTACT

615-712-9574 ccook@dc2healthcare.com

Risa Tyo, PharmD

CONTACT

615-712-9574 rtyo@dc2healthcare.com

Data from ClinicalTrials.gov

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