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

Active, not recruiting

• Conditions: Osteoarthritis

• Registration Number: NCT02566473
• Lead Sponsor: University of Massachusetts, Worcester

Brief Summary

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

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.

Study Timeline

• Study Start: 2011-04
• Study First Submitted: 2015-08-03
• Study First Submitted QC: 2015-09-30
• Study First Posted: 2015-10-02
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-18
• Last Update Posted: 2024-12-20
• Primary Completion: 2031-04
• Study Completion: 2031-04

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 30000

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Unadjusted and risk-adjusted patient reported physical function composite score, measured by the Short Form 36 (SF 36) Physical Component sub-score	Up to 3 months prior to elective TJR surgery	Collection of patient reported physical function composite score from the SF 36 Physical Component sub-score measure
Change in unadjusted and risk-adjusted patient reported pain composite score, measured by the HOOS/KOOS pain score	20 years post elective TJR	Collection of patient reported pain composite score from the HOOS/KOOS measure
Change in unadjusted and risk-adjusted patient reported physical function composite score, measured by the SF 36 Physical Component sub-score	20 years post elective TJR	Collection of patient reported physical function composite score from the SF 36 Physical Component sub-score measure
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	Up to 3 months prior to elective TJR surgery	Collection of patient reported pain composite score from the HOOS/KOOS measure

Secondary Outcome Measures

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

Trial Locations

Locations (1)

University of Massachusetts Memorial Health Center; Arthritis and Total Joint Center; 🇺🇸 Worcester, Massachusetts, United States