OsteoarthritisFORCE-TJRNCT02566473
FORCE-TJR: Improving Orthopedic Outcomes Through a National TJR Registry
An observational study of Osteoarthritis, run by University of Massachusetts, Worcester at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Osteoarthritis
- How many people
- 30,000 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2011to Apr 2031
- How long will I take part?
- 20 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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
Who may be able to join
- Must be scheduled elective primary or revision arthroplasty
- Must speak/read English or Spanish
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Massachusetts Memorial Health Center; Arthritis and Total Joint Center
Worcester, Massachusetts, 01655
About this study
Official title: Improving Orthopedic Outcomes Through a National TJR Registry
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.
Read the 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.
- Conditions
- Osteoarthritis
- Keywords
- Patient reported outcomes, Osteoarthritis, Total joint replacement
- Medical subject headings
- Osteoarthritis
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 20 years post elective TJR
Secondary outcomes (1)
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
Measured: 6 months post elective TJR
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2015 (estimated)
- Study startApr 2011
- Primary completionApr 2031 (estimated)
- Study completionApr 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for OsteoarthritisStudies of the same condition, open and under way.
- More trials run by University of Massachusetts, WorcesterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30,000 participants (estimated)
- Target duration
- 20 Years
Sponsor and investigators
- Lead sponsor
- University of Massachusetts, Worcester
- Sponsor type
- University, hospital or other
- Collaborators
- Agency for Healthcare Research and Quality (AHRQ)
- Responsible party
- Principal investigator, David Ayers, University of Massachusetts, Worcester
- Investigators
- David Ayers, MD, Principal investigator, University of Massachusetts, Worcester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02566473
- Sponsor's protocol ID
- H00008642
- Other IDs
- P50HS018910
- Acronym
- FORCE-TJR
- Status last verified
- Dec 2025
- First submitted
- 3 Aug 2015
- Last updated
- 19 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 35227816Ayers 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.
PubMed 35292339Ayers 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.
PubMed 37001625Ayers 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.
PubMed 37121490Ayers 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(8 Suppl 1):S100-S107. doi: 10.1016/j.arth.2024.04.031. Epub 2024 Apr 17.
PubMed 38640963Zheng 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.
PubMed 38271493Yousef 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(9 Suppl 1):S105-S111. doi: 10.1016/j.arth.2024.02.050. Epub 2024 Feb 25.
PubMed 38412901Ayers DC, Zheng H, Yang W, Yousef M. The Chitranjan S. Ranawat Award: Factors That Predict Outcome Five Years Following Total Knee Arthroplasty. J Arthroplasty. 2025 Jul;40(S7):S12-S19. doi: 10.1016/j.arth.2025.03.006. Epub 2025 Mar 9.
PubMed 40068725
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Orthopedic Outcomes Through a National TJR Registry
- ClinicalTrials.gov ID
- NCT02566473
- Acronym / sponsor ID
- FORCE-TJR / H00008642
- Conditions
- Osteoarthritis
- Keywords
- Patient reported outcomes, Osteoarthritis, Total joint replacement
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 30,000 participants (estimated)
- Lead sponsor
- University of Massachusetts, WorcesterUniversity, hospital or other
- Collaborators
- Agency for Healthcare Research and Quality (AHRQ)
- Study start
- Apr 2011
- Primary completion
- Apr 2031 (estimated)
- Study completion
- Apr 2031 (estimated)
- First posted
- 2 Oct 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 20 Years
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (2 listed)
- Must be scheduled elective primary or revision arthroplasty
- Must speak/read English or Spanish
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Time frame: Up to 3 months prior to elective TJR surgery
Collection of patient reported pain composite score from the HOOS/KOOS measure
Unadjusted and risk-adjusted patient reported physical function composite score, measured by the Short Form 36 (SF 36) Physical Component sub-score
Time frame: 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
Time frame: 6 months 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
Time frame: 6 months post elective TJR
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
Time frame: 12 months 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
Time frame: 12 months post elective TJR
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
Time frame: 24 months 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
Time frame: 24 months post elective TJR
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
Time frame: 36 months 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
Time frame: 36 months post elective TJR
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
Time frame: 48 months 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
Time frame: 48 months post elective TJR
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
Time frame: 60 months 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
Time frame: 60 months post elective TJR
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
Time frame: 10 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
Time frame: 10 years post elective TJR
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
Time frame: 15 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
Time frame: 15 years post elective TJR
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
Time frame: 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
Time frame: 20 years post elective TJR
Collection of patient reported physical function composite score from the SF 36 Physical Component sub-score measure
1 secondary outcome
Surveillance reports for adverse events, such as implant revision, hip dislocation, knee manipulation and other adverse events.
Time frame: 6 months post elective TJR
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2025.
- Background: PubMed 35227816Ayers 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.
- Background: PubMed 35292339Ayers 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.
- Background: PubMed 37001625Ayers 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.
- Background: PubMed 37121490Ayers 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.
- Background: PubMed 38640963Ayers 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(8 Suppl 1):S100-S107. doi: 10.1016/j.arth.2024.04.031. Epub 2024 Apr 17.
- Background: PubMed 38271493Zheng 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.
- Background: PubMed 38412901Yousef 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(9 Suppl 1):S105-S111. doi: 10.1016/j.arth.2024.02.050. Epub 2024 Feb 25.
- Background: PubMed 40068725Ayers DC, Zheng H, Yang W, Yousef M. The Chitranjan S. Ranawat Award: Factors That Predict Outcome Five Years Following Total Knee Arthroplasty. J Arthroplasty. 2025 Jul;40(S7):S12-S19. doi: 10.1016/j.arth.2025.03.006. Epub 2025 Mar 9.
- The Prevalence and Predictors of Patient Dissatisfaction 5-years Following Primary Total Knee ArthroplastyLink provided by the sponsor.
- Do Patient Outcomes Vary by Patient Age Following Primary Total Hip Arthroplasty?Link provided by the sponsor.
- How Back Pain Affects Patient Satisfaction After Primary Total Knee ArthroplastyLink provided by the sponsor.
- 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 2022Link provided by the sponsor.
- Gender Differences in Pain, Function, and Quality of Life Five Years Following Primary Total Knee ArthroplastyLink provided by the sponsor.
- Strengthening Quality Measurement to Predict Success for Total Knee Arthroplasty: Results from a Nationally Representative Total Knee Arthroplasty CohortLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Ayers, MD principal investigator
University of Massachusetts, Worcester
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Osteoarthritis, run by University of Massachusetts, Worcester at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 19 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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 (time frame: Up to 3 months prior to elective TJR surgery). The study lists 20 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02566473, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Dec 2025.