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NCT Number: NCT02566473

FORCE-TJR: 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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Osteoarthritis Arthritis Joint Diseases Musculoskeletal Diseases Rheumatic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Massachusetts Memorial Health Center; Arthritis and Total Joint Center

Worcester, Massachusetts, 01655, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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

  10. 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

  11. 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

  12. 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

  13. 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

  14. 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

  15. 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

  16. 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

  17. 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

  18. 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

  19. 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

  20. 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

Secondary outcomes

  1. Surveillance reports for adverse events, such as implant revision, hip dislocation, knee manipulation and other adverse events.

    Time frame: 6 months post elective TJR

    Patients will complete questions regarding visits to the ER, hospital, day surgery and additional surgery

Sponsors and collaborators

Lead sponsor

University of Massachusetts, Worcester

Other

Collaborators

  • Agency for Healthcare Research and Quality (AHRQ)

Registry information

Official study title

Improving Orthopedic Outcomes Through a National TJR Registry

Acronym: FORCE-TJR

Important dates

Study start
2011
Primary completion
2031
Study completion
2031
First posted
Oct 2, 2015
Registry last updated
Dec 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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