Clinical trial NCT02188199: C3 Total Joint Patient Registry
Official title: Clinical Care Continuum (C3) Total Joint Patient Registry
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Knee Replacement
Hip Replacement
Keywords: Hip
Knee
Hip replacement
Knee replacement
Total Joint
Lead sponsor: DC2 Healthcare
Sponsor class: INDUSTRY
Collaborators: name: Clinical Care Continuum (C3) Foundation
name: National Research Independent Operations Management
First posted: 2014-07-11
Enrollment: 10000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population will come from cohorts of patients undergoing either knee or hip replacement in accordance with a nationwide multicenter observational study design. Eligibility criteria require only that patients are undergoing knee or hip replacement, are able to sign informed consent and are 18 years of age or older. Approximately 10,000 patients will be enrolled

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

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in Hip disability and Osteoarthritis Outcome Score (HOOS) from baseline at 3 months
timeFrame: baseline and 3 months
measure: Change in Hip disability and Osteoarthritis Outcome Score (HOOS) from baseline at 6 months
timeFrame: baseline and 6 months
measure: Change in Hip disability and Osteoarthritis Outcome Score (HOOS) from baseline at 1 year
timeFrame: baseline and 1 year
measure: Change in Knee injury and Osteoarthritis Outcome Score (KOOS) from baseline at 3 months
timeFrame: baseline and 3 months
measure: Change in Knee injury and Osteoarthritis Outcome Score (KOOS) from baseline at 1 year
timeFrame: baseline and 1 year
measure: Change in Knee injury and Osteoarthritis Outcome Score (KOOS) from baseline at 6 months
timeFrame: baseline and 6 months
Secondary outcomes:
measure: Adverse Events at time of surgery
timeFrame: Time of surgery
measure: Adverse Events at 6 weeks after surgery
timeFrame: 6 weeks after surgery
measure: Adverse Events at 3 months after surgery
timeFrame: 3 months after surgery
measure: Adverse Events at 6 months after surgery
timeFrame: 6 months after surgery
measure: Adverse Events at 1 year after surgery
timeFrame: 1 year after surgery
Other outcomes:
Locations:
city: Nashville
country: United States
facility: DC2 Healthcare
state: Tennessee
Study officials:
References: