An observational study in Osteoarthritis, sponsored by University of Massachusetts, Worcester. Active, not recruiting at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-12-19.
Sponsored by University of Massachusetts, Worcester · Observational
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.
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.
4,398 studies on the registry are indexed under Osteoarthritis; 582 are open to participants now.
This study's planned enrollment of 30,000 is above the median of 100 across 791 observational studies indexed under Osteoarthritis.
Browse Osteoarthritis studies →University of Massachusetts, Worcester is the lead sponsor of 288 studies on the registry; 54 are open to participants now.
Of its 25 completed or terminated interventional studies of FDA-regulated products, 18 (72%) have results posted.
Counted across the registry records on this site, refreshed daily.
Men and women older than age 18, who schedule elective primary or revision arthroplasty (total joint replacement; hip resurfacing; uni-compartmental knee procedures
Exclusion Criteria:
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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 10 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
Time frame: 10 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 20 years post elective TJR
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
Time frame: 6 months post elective TJR
This study is active, not recruiting, as verified in Dec 2025. You cannot join it, but the record below documents what was studied.
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University of Massachusetts, Worcester