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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorSpokane Joint Replacement Center

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients who are scheduled to undergo TJA by the Principal Investigator

Disqualifiers

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

Trial 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).

Trial design

Design model

Other

Time perspective

Prospective

Treatments tested in this trial

  • Total Knee Arthroplasty

    Procedure/Surgery

    Total Knee Arthroplasty

  • Total Hip Arthroplasty

    Procedure/Surgery

    Total Hip Arthroplasty

Treatment groups

10,000 Participants
are divided into 2 treatment groups
Group A: Registry Knee1 intervention
Group B: Registry Hip1 intervention

Trial outcomes

Primary outcomes

1

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.

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

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).

Time frame
Pre-op, 6 weeks, 6 months, 1 year, 2 years, and 5 years
3

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.

Time frame
Pre-op, 6 weeks, 6 months, 1 year, 2 years, and 5 years
4

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.

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

Secondary outcomes

Other outcomes

Sponsors and contacts

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