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

NCT06687109 | Recruiting

• 1 other identifier: SJRC-REG
• Study Type: observational
• Target: 10,000
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Osteoarthritis

Outcome Measures

Primary Outcomes (8)

• Knee Society Score

  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.

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

• Forgotten Joint Score

  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).

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

• Joint Awareness Survey

  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.

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

• Pain Satisfaction Expectations

  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.

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

• PROMIS Global Health

  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.

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

• Koos Jr. Knee Survey

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

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

• Harris Hip

  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.

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

• Hoos Jr.

  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.

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

Study Arms (2)

Registry Knee

Subjects receiving total knee arthroplasty.

Procedure: Total Knee Arthroplasty

Registry Hip

Subjects receiving total hip arthroplasty.

Procedure: Total Hip Arthroplasty

Interventions

Total Knee Arthroplasty PROCEDURE

Total Knee Arthroplasty

Registry Knee

Total Hip Arthroplasty PROCEDURE

Total Hip Arthroplasty

Registry Hip

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

For this study, we will recruit patients who are scheduled to undergo TJA by the Principal Investigator. We will include all patients aged 18 and older. The patients must be able to speak and read English. We will not enroll prisoners or any other patients who, in the opinion of the investigator, are unlikely to return for follow-ups, or would be unable to complete the PROM's. All other patients who meet eligibility criteria will be enrolled. Involvement in this study will not preclude enrollment in other studies, as the nature is non-interventional (i.e., observational).

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Spokane Joint Replacement Center: lead

Study Sites (1)

Spokane Joint Replacement Center

Spokane, Washington, 99218, United States

RECRUITING

MeSH Terms

Conditions

Osteoarthritis

Interventions

Arthroplasty, Replacement, Knee; Arthroplasty, Replacement, Hip

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Arthroplasty, Replacement; Arthroplasty; Orthopedic Procedures; Surgical Procedures, Operative; Plastic Surgery Procedures; Prosthesis Implantation

Study Officials

• David Scott, MD

  Spokane Joint Replacement Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

David F Scott, MD

CONTACT

509-466-6393; dfscott@mac.com

Annalise R McInelly, MPH

CONTACT

509-466-6393; Annalise@orthospecialtyclinic.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: March 5, 2024
• First Posted: November 13, 2024
• Study Start: January 10, 2020
• Primary Completion (Estimated): January 1, 2030
• Study Completion (Estimated): January 1, 2030
• Last Updated: April 29, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)