FORCE-TJR: Improving Orthopedic Outcomes Through a National TJR Registry

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Improving Orthopedic Outcomes Through a National TJR Registry

Conditions
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Osteoarthritis

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in unadjusted and risk-adjusted patient reported physical function composite score, measured by the SF 36 Physical Component sub-score | Collection of patient reported physical function composite score from the SF 36 Physical Component sub-score measure | 15 years post elective TJR | 
| Change in unadjusted and risk-adjusted patient reported pain composite score, measured by the HOOS/KOOS pain score | Collection of patient reported pain composite score from the HOOS/KOOS measure | 20 years post elective TJR | 
| Change in unadjusted and risk-adjusted patient reported physical function composite score, measured by the SF 36 Physical Component sub-score | Collection of patient reported physical function composite score from the SF 36 Physical Component sub-score measure | 20 years post elective TJR | 
| Change in unadjusted and risk-adjusted patient reported pain composite score, measured by the HOOS/KOOS pain score | Collection of patient reported pain composite score from the HOOS/KOOS measure | 15 years post elective TJR | 
| Change in unadjusted and risk-adjusted patient reported physical function composite score, measured by the SF 36 Physical Component sub-score | Collection of patient reported physical function composite score from the SF 36 Physical Component sub-score measure | 10 years post elective TJR | 
| Unadjusted and risk-adjusted patient reported pain composite score, measured by the Hip disability and Osteoarthritis Outcome Score/Knee disability and Osteoarthritis Outcome Score (HOOS/KOOS) pain score | Collection of patient reported pain composite score from the HOOS/KOOS measure | Up to 3 months prior to elective TJR surgery | 
| Unadjusted and risk-adjusted patient reported physical function composite score, measured by the Short Form 36 (SF 36) Physical Component sub-score | Collection of patient reported physical function composite score from the SF 36 Physical Component sub-score measure | Up to 3 months prior to elective TJR surgery | 
| Change in unadjusted and risk-adjusted patient reported pain composite score, measured by the HOOS/KOOS pain score | Collection of patient reported pain composite score from the HOOS/KOOS measure | 6 months post elective TJR | 
| Change in unadjusted and risk-adjusted patient reported physical function composite score, measured by the SF 36 Physical Component sub-score | Collection of patient reported physical function composite score from the SF 36 Physical Component sub-score measure | 6 months post elective TJR | 
| Change in unadjusted and risk-adjusted patient reported pain composite score, measured by the HOOS/KOOS pain score | Collection of patient reported pain composite score from the HOOS/KOOS measure | 12 months post elective TJR | 
| Change in unadjusted and risk-adjusted patient reported physical function composite score, measured by the SF 36 Physical Component sub-score | Collection of patient reported physical function composite score from the SF 36 Physical Component sub-score measure | 12 months post elective TJR | 
| Change in unadjusted and risk-adjusted patient reported pain composite score, measured by the HOOS/KOOS pain score | Collection of patient reported pain composite score from the HOOS/KOOS measure | 24 months post elective TJR | 
| Change in unadjusted and risk-adjusted patient reported physical function composite score, measured by the SF 36 Physical Component sub-score | Collection of patient reported physical function composite score from the SF 36 Physical Component sub-score measure | 24 months post elective TJR | 
| Change in unadjusted and risk-adjusted patient reported pain composite score, measured by the HOOS/KOOS pain score | Collection of patient reported pain composite score from the HOOS/KOOS measure | 36 months post elective TJR | 
| Change in unadjusted and risk-adjusted patient reported physical function composite score, measured by the SF 36 Physical Component sub-score | Collection of patient reported physical function composite score from the SF 36 Physical Component sub-score measure | 36 months post elective TJR | 
| Change in unadjusted and risk-adjusted patient reported pain composite score, measured by the HOOS/KOOS pain score | Collection of patient reported pain composite score from the HOOS/KOOS measure | 48 months post elective TJR | 
| Change in unadjusted and risk-adjusted patient reported physical function composite score, measured by the SF 36 Physical Component sub-score | Collection of patient reported physical function composite score from the SF 36 Physical Component sub-score measure | 48 months post elective TJR | 
| Change in unadjusted and risk-adjusted patient reported pain composite score, measured by the HOOS/KOOS pain score | Collection of patient reported pain composite score from the HOOS/KOOS measure | 60 months post elective TJR | 
| Change in unadjusted and risk-adjusted patient reported physical function composite score, measured by the SF 36 Physical Component sub-score | Collection of patient reported physical function composite score from the SF 36 Physical Component sub-score measure | 60 months post elective TJR | 
| Change in unadjusted and risk-adjusted patient reported pain composite score, measured by the HOOS/KOOS pain score | Collection of patient reported pain composite score from the HOOS/KOOS measure | 10 years post elective TJR | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Surveillance reports for adverse events, such as implant revision, hip dislocation, knee manipulation and other adverse events. | Patients will complete questions regarding visits to the ER, hospital, day surgery and additional surgery | 6 months post elective TJR | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Patient reported outcomes, Osteoarthritis, Total joint replacement