OsteoarthritisNCT06687109
A Prospective Total Joint Surgery Registry to Monitor Short- and Long-Term Clinical Outcomes
An observational study of Osteoarthritis, run by Spokane Joint Replacement Center at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Osteoarthritis
- What is being tested?
- Total Knee Arthroplasty and Total Hip Arthroplasty
- Type of treatment
- Surgery or procedure
- How many people
- 10,000 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Jan 2020to 1 Jan 2030
- How long will I take part?
- 2 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
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).
Who may be able to join
- Patients who are scheduled to undergo TJA by the Principal Investigator
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Spokane Joint Replacement Center
Spokane, Washington, 99218
Annalise R McInelly, MPH, 509-466-6393 ext. 51, Annalise@orthospecialtyclinic.com
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.
Read the 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.
- Conditions
- Osteoarthritis
- Being tested
- Total Knee Arthroplasty, Total Hip Arthroplasty
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Total Knee ArthroplastyProcedure or surgery
Total Knee Arthroplasty
Total Hip ArthroplastyProcedure or surgery
Total Hip Arthroplasty
| Study group | Role | What they receive |
|---|---|---|
| Registry Knee | Subjects receiving total knee arthroplasty. Receives: Procedure: Total Knee Arthroplasty | |
| Registry Hip | Subjects receiving total hip arthroplasty. Receives: Procedure: Total Hip Arthroplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Pre-op, 6 weeks, 6 months, 1 year, 2 years, and 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2024
- Study start10 Jan 2020
- Primary completion1 Jan 2030 (estimated)
- Study completion1 Jan 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteoarthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 10,000 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Spokane Joint Replacement Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, David F. Scott, MD, Spokane Joint Replacement Center
- Investigators
- David Scott, MD, Principal investigator, Spokane Joint Replacement Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06687109
- Sponsor's protocol ID
- SJRC-REG
- Status last verified
- Apr 2026
- First submitted
- 5 Mar 2024
- Last updated
- 29 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Total Joint Surgery Registry to Monitor Short- and Long-Term Clinical Outcomes
- ClinicalTrials.gov ID
- NCT06687109
- Acronym / sponsor ID
- SJRC-REG
- Conditions
- Osteoarthritis
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 10,000 participants (estimated)
- Lead sponsor
- Spokane Joint Replacement CenterUniversity, hospital or other
- Study start
- 10 Jan 2020 (actual)
- Primary completion
- 1 Jan 2030 (estimated)
- Study completion
- 1 Jan 2030 (estimated)
- First posted
- 13 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 2 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Registry Knee | – | Procedure: Total Knee ArthroplastySubjects receiving total knee arthroplasty. |
| Registry Hip | – | Procedure: Total Hip ArthroplastySubjects receiving total hip arthroplasty. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- 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).
Key inclusion criteria (1 listed)
- Patients who are scheduled to undergo TJA by the Principal Investigator
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Total Knee ArthroplastyTotal Knee Arthroplasty | Procedure or surgery | Registry Knee |
| Total Hip ArthroplastyTotal Hip Arthroplasty | Procedure or surgery | Registry Hip |
Primary outcome
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.
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).
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.
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.
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.
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.
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.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
David Scott, MD principal investigator
Spokane Joint Replacement Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Osteoarthritis, run by Spokane Joint Replacement Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact David F Scott, MD (509-466-6393 ext. 15, dfscott@mac.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Knee Society Score (time frame: Pre-op, 6 weeks, 6 months, 1 year, 2 years, and 5 years). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2026.