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NCT Number: NCT06687109

A Prospective Total Joint Surgery Registry to Monitor Short- and Long-Term Clinical Outcomes

The investigators propose a prospective longitudinal registry study to collect and compare preoperative and postoperative information from patients who undergo total joint arthroplasty (TJA). Outcomes will be assessed with common, routinely available patient-reported outcomes measures (PROM's) such as the HOOS Jr., Oxford score, Knee Society Score, Harris Hip Score, and other patient satisfaction and function assessments in use in Orthopedics.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Spokane Joint Replacement Center

Spokane, Washington, 99218, United States

Location status: Recruiting

Location contact

Annalise R McInelly, MPH

CONTACT

[email protected]

509-466-6393 ext. 51

About this study

The investigators propose a prospective longitudinal registry study to collect and compare preoperative and postoperative information from patients who undergo total joint arthroplasty (TJA). Outcomes will be assessed with common, routinely available patient-reported outcomes measures (PROM's) such as the HOOS Jr., Oxford score, Knee Society Score, Harris Hip Score, and other patient satisfaction and function assessments in use in Orthopedics. Investigators will also record both demographic and clinical data about the subject's history of joint pain, past treatment, medical co-morbidities, and surgical procedure.

Additionally, gait analysis and standardized physical capacity testing will be included as an option. All patients undergoing hip or knee replacement with the primary investigator will be included for data collection. All procedures and treatment will follow the standard of care, and all prosthetic implants with be FDA-approved. Data will be used to evaluate the effect on both short and long-term comfort and function of patients diagnosed with hip or knee pain who undergo joint replacement. The main purpose of the study is to provide quality improvement data on the patients in the Principal Investigator's (PI's) practice currently undergoing joint surgery. This project creates a data repository to store participants' data for this and possible future research.

Who can participate

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

Inclusion criteria

  • Patients who are scheduled to undergo TJA by the Principal Investigator

Exclusion criteria

  • Age < 18
  • Unable to speak and read English
  • Prisoners or any other patients who, in the opinion of the investigator, are unlikely to return for follow-ups or unreliable in completing the assessments

Treatment and study plan

Total knee arthroplasty

Procedure

Total Knee Arthroplasty

Total Hip Arthroplasty

Procedure

Total Hip Arthroplasty

Primary outcomes

  1. Knee Society Score

    Time frame: Pre-op, 6 weeks, 6 months, 1 year, 2 years, and 5 years

    The Knee Society Score (KSS) provides a 0 to 100 score measuring function, pain, and range of motion in the knee before and after surgery. A score of 0 indicates the worst outcome, while a score of 100 indicates the best outcome.

  2. Forgotten Joint Score

    Time frame: Pre-op, 6 weeks, 6 months, 1 year, 2 years, and 5 years

    The Forgotten Joint Score assesses how aware the patient is of their joint in everyday life. A score of 0 is the worst (always aware) while a score of 100 is the best (the patient is so comfortable, they forget that the joint was replaced).

  3. Joint Awareness Survey

    Time frame: Pre-op, 6 weeks, 6 months, 1 year, 2 years, and 5 years

    The Joint Awareness Survey is an abbreviated version of the Forgotten Joint Score. It also has 0 as the worst outcome and 100 as the best. We are including it to determine if it can reliably be used in place of the Forgotten Joint Score, which is longer and more burdensome for patients to fill out.

  4. Pain Satisfaction Expectations

    Time frame: Pre-op, 6 weeks, 6 months, 1 year, 2 years, and 5 years

    This survey assesses patients' satisfaction with their joint, their pain level, their overall function, and their need for pain medication. 0 is the worst score while 100 is the best.

  5. PROMIS Global Health

    Time frame: Pre-op, 6 weeks, 6 months, 1 year, 2 years, and 5 years

    This survey assesses the general health and quality of life of the patient. It is also a 0-100 point scale with 100 being best, 0 being worst, and 50 being average. Every 10 points represents one standard deviation from the mean.

  6. Koos Jr. Knee Survey

    Time frame: Pre-op, 6 weeks, 6 months, 1 year, 2 years, and 5 years

    This survey assesses stiffness, pain, and function of the knee. 0 is the worst score and 100 is the best.

  7. Harris Hip

    Time frame: Pre-op, 6 weeks, 6 months, 1 year, 2 years, and 5 years

    This survey assesses pain, deformity, and range of motion of the hip. A score of 0 indicates the worst outcome and 100 indicates the best.

  8. Hoos Jr.

    Time frame: Pre-op, 6 weeks, 6 months, 1 year, 2 years, and 5 years

    This survey assesses pain and function of the hip in daily life. A score of 0 indicates the worst outcome, while a score of 100 indicates the best.

Study contacts

Contact information is provided by the study sponsor or research team.

Annalise R McInelly, MPH

CONTACT

[email protected]

509-466-6393 ext. 51

David F Scott, MD

CONTACT

[email protected]

509-466-6393 ext. 15

Sponsors and collaborators

Lead sponsor

Spokane Joint Replacement Center

Other

Registry information

Important dates

Study start
2020
Primary completion
2030
Study completion
2030
First posted
Nov 13, 2024
Registry last updated
Apr 29, 2026

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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