FORCE-TJR: Improving Orthopedic Outcomes Through a National TJR Registry
NCT ID: NCT02566473
Last Updated: 2024-12-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
30000 participants
OBSERVATIONAL
2011-04-30
2031-04-30
Brief Summary
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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.
Detailed Description
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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.
Conditions
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Keywords
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Study Design
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COHORT
PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
* Must speak/read English or Spanish
Exclusion Criteria
* 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
18 Years
ALL
Yes
Sponsors
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Agency for Healthcare Research and Quality (AHRQ)
FED
University of Massachusetts, Worcester
OTHER
Responsible Party
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David Ayers
Principal Investigator
Principal Investigators
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David Ayers, MD
Role: PRINCIPAL_INVESTIGATOR
University of Massachusetts, Worcester
Locations
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University of Massachusetts Memorial Health Center; Arthritis and Total Joint Center
Worcester, Massachusetts, United States
Countries
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References
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Ayers DC, Yousef M, Zheng H, Yang W, Franklin PD. The Prevalence and Predictors of Patient Dissatisfaction 5-years Following Primary Total Knee Arthroplasty. J Arthroplasty. 2022 Jun;37(6S):S121-S128. doi: 10.1016/j.arth.2022.02.077. Epub 2022 Feb 26.
Ayers DC, Yousef M, Zheng H, Yang W, Franklin PD. Do Patient Outcomes Vary by Patient Age Following Primary Total Hip Arthroplasty? J Arthroplasty. 2022 Jul;37(7S):S510-S516. doi: 10.1016/j.arth.2022.03.032. Epub 2022 Mar 12.
Ayers DC, Zheng H, Yang W, Yousef M. How Back Pain Affects Patient Satisfaction After Primary Total Knee Arthroplasty. J Arthroplasty. 2023 Jun;38(6S):S103-S108. doi: 10.1016/j.arth.2023.03.072. Epub 2023 Mar 30.
Ayers DC, Yousef M, Yang W, Zheng H. Age-Related Differences in Pain, Function, and Quality of Life Following Primary Total Knee Arthroplasty: Results From a FORCE-TJR (Function and Outcomes Research for Comparative Effectiveness in Total Joint Replacement) Cohort. J Arthroplasty. 2023 Jul;38(7 Suppl 2):S169-S176. doi: 10.1016/j.arth.2023.04.005. Epub 2023 Apr 29.
Ayers DC, Zheng H, Yang W, Yousef M. Gender Differences in Pain, Function, and Quality of Life Five Years Following Primary Total Knee Arthroplasty. J Arthroplasty. 2024 Aug;39(8S1):S100-S107. doi: 10.1016/j.arth.2024.04.031. Epub 2024 Apr 17.
Zheng H, Ash AS, Yang W, Liu SH, Allison J, Ayers DC. Strengthening Quality Measurement to Predict Success for Total Knee Arthroplasty: Results from a Nationally Representative Total Knee Arthroplasty Cohort. J Bone Joint Surg Am. 2024 Apr 17;106(8):708-715. doi: 10.2106/JBJS.23.00602. Epub 2024 Jan 25.
Yousef M, Zheng H, Yang W, Ayers DC. Predictive Factors of Pain and Functional Outcome 5 Years Following Total Hip Arthroplasty: A Prospective Function and Outcomes Research for Comparative Effectiveness in Total Joint Replacement Cohort Study. J Arthroplasty. 2024 Sep;39(9S1):S105-S111. doi: 10.1016/j.arth.2024.02.050. Epub 2024 Feb 25.
Related Links
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The Prevalence and Predictors of Patient Dissatisfaction 5-years Following Primary Total Knee Arthroplasty
Do Patient Outcomes Vary by Patient Age Following Primary Total Hip Arthroplasty?
How Back Pain Affects Patient Satisfaction After Primary Total Knee Arthroplasty
Age-Related Differences in Pain, Function, and Quality of Life Following Primary Total Knee Arthroplasty: Results from a FORCE-TJR Cohort. Proceedings of the American Association of Hip and Knee Surgeons 2022
Gender Differences in Pain, Function, and Quality of Life Five Years Following Primary Total Knee Arthroplasty
Strengthening Quality Measurement to Predict Success for Total Knee Arthroplasty: Results from a Nationally Representative Total Knee Arthroplasty Cohort
Predictive Factors of Pain and Functional Outcome 5-year Following Total Hip Arthroplasty: A Prospective FORCE-TJR Cohort Study
Other Identifiers
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H00008642
Identifier Type: -
Identifier Source: org_study_id