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

Osteoarthritis Clinical Trial

— FORCE-TJR  

Official title:

Improving Orthopedic Outcomes Through a National TJR Registry

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02566473
• Other study ID #: P50HS018910
• Secondary ID: P50HS018910
• Status: Active, not recruiting
• Start date: April 2011
• Est. completion date: April 2031

Study information

• Verified date: December 2023
• Source: University of Massachusetts, Worcester
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 30000
• Est. completion date: April 2031
• Est. primary completion date: April 2031
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Osteoarthritis

Locations

Country	Name	City	State
United States	University of Massachusetts Memorial Health Center; Arthritis and Total Joint Center	Worcester	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
University of Massachusetts, Worcester	Agency for Healthcare Research and Quality (AHRQ)

Country where clinical trial is conducted

United States, 

References & Publications (4)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Secondary	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

External Links

•   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
•   How Back Pain Affects Patient Satisfaction After Primary Total Knee Arthroplasty