Clinical trial NCT02566473: FORCE-TJR: Improving Orthopedic Outcomes Through a National TJR Registry
Official title: Improving Orthopedic Outcomes Through a National TJR Registry
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Osteoarthritis
Keywords: Patient reported outcomes
Osteoarthritis
Total joint replacement
Lead sponsor: University of Massachusetts, Worcester
Sponsor class: OTHER
Collaborators: name: Agency for Healthcare Research and Quality (AHRQ)
First posted: 2015-10-02
Enrollment: 30000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Men and women older than age 18, who schedule elective primary or revision arthroplasty (total joint replacement; hip resurfacing; uni-compartmental knee procedures

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.

Eligibility criteria: 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

Primary outcomes:
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
timeFrame: Up to 3 months prior to elective TJR surgery
measure: Unadjusted and risk-adjusted patient reported physical function composite score, measured by the Short Form 36 (SF 36) Physical Component sub-score
timeFrame: Up to 3 months prior to elective TJR surgery
measure: Change in unadjusted and risk-adjusted patient reported pain composite score, measured by the HOOS/KOOS pain score
timeFrame: 6 months post elective TJR
measure: Change in unadjusted and risk-adjusted patient reported physical function composite score, measured by the SF 36 Physical Component sub-score
timeFrame: 6 months post elective TJR
measure: Change in unadjusted and risk-adjusted patient reported pain composite score, measured by the HOOS/KOOS pain score
timeFrame: 12 months post elective TJR
measure: Change in unadjusted and risk-adjusted patient reported physical function composite score, measured by the SF 36 Physical Component sub-score
timeFrame: 12 months post elective TJR
measure: Change in unadjusted and risk-adjusted patient reported pain composite score, measured by the HOOS/KOOS pain score
timeFrame: 24 months post elective TJR
measure: Change in unadjusted and risk-adjusted patient reported physical function composite score, measured by the SF 36 Physical Component sub-score
timeFrame: 24 months post elective TJR
measure: Change in unadjusted and risk-adjusted patient reported pain composite score, measured by the HOOS/KOOS pain score
timeFrame: 36 months post elective TJR
measure: Change in unadjusted and risk-adjusted patient reported physical function composite score, measured by the SF 36 Physical Component sub-score
timeFrame: 36 months post elective TJR
measure: Change in unadjusted and risk-adjusted patient reported pain composite score, measured by the HOOS/KOOS pain score
timeFrame: 48 months post elective TJR
measure: Change in unadjusted and risk-adjusted patient reported physical function composite score, measured by the SF 36 Physical Component sub-score
timeFrame: 48 months post elective TJR
measure: Change in unadjusted and risk-adjusted patient reported pain composite score, measured by the HOOS/KOOS pain score
timeFrame: 60 months post elective TJR
measure: Change in unadjusted and risk-adjusted patient reported physical function composite score, measured by the SF 36 Physical Component sub-score
timeFrame: 60 months post elective TJR
measure: Change in unadjusted and risk-adjusted patient reported pain composite score, measured by the HOOS/KOOS pain score
timeFrame: 10 years post elective TJR
measure: Change in unadjusted and risk-adjusted patient reported physical function composite score, measured by the SF 36 Physical Component sub-score
timeFrame: 10 years post elective TJR
measure: Change in unadjusted and risk-adjusted patient reported pain composite score, measured by the HOOS/KOOS pain score
timeFrame: 15 years post elective TJR
measure: Change in unadjusted and risk-adjusted patient reported physical function composite score, measured by the SF 36 Physical Component sub-score
timeFrame: 15 years post elective TJR
measure: Change in unadjusted and risk-adjusted patient reported pain composite score, measured by the HOOS/KOOS pain score
timeFrame: 20 years post elective TJR
measure: Change in unadjusted and risk-adjusted patient reported physical function composite score, measured by the SF 36 Physical Component sub-score
timeFrame: 20 years post elective TJR
Secondary outcomes:
measure: Surveillance reports for adverse events, such as implant revision, hip dislocation, knee manipulation and other adverse events.
timeFrame: 6 months post elective TJR
Other outcomes:
Locations:
city: Worcester
country: United States
facility: University of Massachusetts Memorial Health Center; Arthritis and Total Joint Center
state: Massachusetts
Study officials:
affiliation: University of Massachusetts, Worcester
name: David Ayers, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
citation: 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.
citation: Ayers DC, Zheng H, Yang W, Yousef M. Gender Differences in Pain, Function, and Quality of Life Five Years Following Primary Total Knee Arthroplasty. J Arthroplasty. 2024 Aug;39(8S1):S100-S107. doi: 10.1016/j.arth.2024.04.031. Epub 2024 Apr 17.
citation: Zheng H, Ash AS, Yang W, Liu SH, Allison J, Ayers DC. Strengthening Quality Measurement to Predict Success for Total Knee Arthroplasty: Results from a Nationally Representative Total Knee Arthroplasty Cohort. J Bone Joint Surg Am. 2024 Apr 17;106(8):708-715. doi: 10.2106/JBJS.23.00602. Epub 2024 Jan 25.
citation: Yousef M, Zheng H, Yang W, Ayers DC. Predictive Factors of Pain and Functional Outcome 5 Years Following Total Hip Arthroplasty: A Prospective Function and Outcomes Research for Comparative Effectiveness in Total Joint Replacement Cohort Study. J Arthroplasty. 2024 Sep;39(9S1):S105-S111. doi: 10.1016/j.arth.2024.02.050. Epub 2024 Feb 25.