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.

Study Overview

• Status: Recruiting
• Conditions: Osteoarthritis
• Intervention / Treatment: Procedure: Total Knee Arthroplasty; Procedure: Total Hip Arthroplasty

Detailed Description

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.

• Study Type: Observational
• Enrollment (Estimated): 10000

Contacts and Locations

• Study Contact: Name: David F Scott, MD; Phone Number: 15 509-466-6393; Email: dfscott@mac.com
• Study Contact Backup: Name: Annalise R McInelly, MPH; Phone Number: 51 509-466-6393; Email: Annalise@orthospecialtyclinic.com

Study Locations

• United States
  • Washington
    • Spokane, Washington, United States, 99218
      • Recruiting
      • Spokane Joint Replacement Center
      • Contact: Annalise R McInelly, MPH; Phone Number: 51 509-466-6393; Email: Annalise@orthospecialtyclinic.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: N/A

• 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).

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Registry Knee; Subjects receiving total knee arthroplasty.	Procedure: Total Knee Arthroplasty; Total Knee Arthroplasty
Registry Hip; Subjects receiving total hip arthroplasty.	Procedure: Total Hip Arthroplasty; Total Hip Arthroplasty

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Spokane Joint Replacement Center
• Investigators: Principal Investigator: David Scott, MD, Spokane Joint Replacement Center

Study record dates

Study Major Dates

• Study Start (Actual): January 10, 2020
• Primary Completion (Estimated): January 1, 2030
• Study Completion (Estimated): January 1, 2030

Study Registration Dates

• First Submitted: March 5, 2024
• First Submitted That Met QC Criteria: November 11, 2024
• First Posted (Actual): November 13, 2024

Study Record Updates

• Last Update Posted (Actual): April 29, 2026
• Last Update Submitted That Met QC Criteria: April 23, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Arthritis; Joint Diseases; Rheumatic Diseases; Osteoarthritis; Surgical Procedures, Operative; Arthroplasty, Replacement; Arthroplasty; Orthopedic Procedures; Plastic Surgery Procedures; Prosthesis Implantation; Arthroplasty, Replacement, Knee; Arthroplasty, Replacement, Hip
• Other Study ID Numbers: SJRC-REG

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No