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

Osteoarthritis Clinical Trial

Official title: Improving Orthopedic Outcomes Through a National TJR Registry

Status Active, not recruiting

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Osteoarthritis

• NCT number: NCT02566473
• Study type: Observational [Patient Registry]
• Source: University of Massachusetts, Worcester
• Status: Active, not recruiting
• Start date: April 2011
• Completion date: April 2031