Clinical trial NCT06687109: A Prospective Total Joint Surgery Registry to Monitor Short- and Long-Term Clinical Outcomes
Official title: A Prospective Total Joint Surgery Registry to Monitor Short- and Long-Term Clinical Outcomes
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Osteoarthritis
Lead sponsor: Spokane Joint Replacement Center
Sponsor class: OTHER
First posted: 2024-11-13
Enrollment: 10000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: PROSPECTIVE
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).

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Knee Society Score
timeFrame: Pre-op, 6 weeks, 6 months, 1 year, 2 years, and 5 years
measure: Forgotten Joint Score
timeFrame: Pre-op, 6 weeks, 6 months, 1 year, 2 years, and 5 years
measure: Joint Awareness Survey
timeFrame: Pre-op, 6 weeks, 6 months, 1 year, 2 years, and 5 years
measure: Pain Satisfaction Expectations
timeFrame: Pre-op, 6 weeks, 6 months, 1 year, 2 years, and 5 years
measure: PROMIS Global Health
timeFrame: Pre-op, 6 weeks, 6 months, 1 year, 2 years, and 5 years
measure: Koos Jr. Knee Survey
timeFrame: Pre-op, 6 weeks, 6 months, 1 year, 2 years, and 5 years
measure: Harris Hip
timeFrame: Pre-op, 6 weeks, 6 months, 1 year, 2 years, and 5 years
measure: Hoos Jr.
timeFrame: Pre-op, 6 weeks, 6 months, 1 year, 2 years, and 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Spokane
country: United States
facility: Spokane Joint Replacement Center
state: Washington
Study officials:
References: