Expired Study
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Worcester, Massachusetts 01655


Purpose:

Aim 1. Establish a national registry of diverse patients of orthopedic surgeons representing all regions of the country and varied hospital and surgeon practice settings (e.g., urban/rural, low and high volume) to ensure that registry analyses and research reflect typical clinical practice thereby providing optimal guidance for patients, clinicians, and national healthcare policymakers. Collect pre-operative and post-operative patient reported outcomes (PROs) for pain and function. Aim 2: Develop new and transformative comparative effectiveness tools useful to both clinical practice and healthcare policy. Aim 3. Broadly disseminate surveillance reports for adverse events, such as implant revision, hip dislocation, knee manipulation, and identify important variation to inform quality improvement priorities.


Study summary:

Patients scheduling elective total joint replacement surgery are eligible to participate. The Aims of the registry are as follows: Aim 1. Establish a national registry of diverse patients of orthopedic surgeons representing all regions of the country and varied hospital and surgeon practice settings (e.g., urban/rural, low and high volume) to ensure that registry analyses and research reflect typical clinical practice thereby providing optimal guidance for patients, clinicians, and national healthcare policymakers. Collect pre-operative and post-operative patient reported outcomes (PROs) for pain and function. Pre-surgery data. Patients will complete a set of computer-based clinical and behavioral health questions prior to surgery. A paper option is available as well. Data collected include demographics, medical and musculoskeletal comorbidities, pain and function measures. 6 month survey. Patients will receive an invitation to complete the 6 month survey either on the computer at home or on paper. This survey includes the symptom assessment and a screening survey for complications. 12 month and subsequent annual surveys. The 6 month survey will be repeated at 12 months and annually thereafter. In addition, the patient's contact information will be updated. Oxford Knee Scale, EQ-5D Survey and Satisfaction Questions may be added to a subset of questionnaires. Using the data collected to date from more than 25,000 patients, the investigators have identified national norms for pre-op and post-op pain and function as well as a Risk-adjustment model for outcomes. Aim 2: Develop new and transformative comparative effectiveness tools useful to both clinical practice and healthcare policy. Aim 3. Broadly disseminate surveillance reports for adverse events, such as implant revision, hip dislocation, knee manipulation, and identify important variation to inform quality improvement priorities.


Criteria:

Inclusion Criteria: - Must be scheduled elective primary or revision arthroplasty - Must speak/read English or Spanish Exclusion Criteria: - Arthroplasty is scheduled due to fracture or malignancy - Inability to provide informed consent due to dementia or cognitive impairment - Terminal illness with life expectancy of less than 1 year - Emergently scheduled surgery. - Individuals who are under 18 years of age - Pregnant women - Prisoners


NCT ID:

NCT02566473


Primary Contact:

Principal Investigator
Patricia D Franklin, MD MBA MPH
University of Massachusetts, Worcester


Backup Contact:

N/A


Location Contact:

Worcester, Massachusetts 01655
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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