Osteoarthritis, KneeMBJRFREGNCT03484325
Surgical Joint Registry MBJRF
An observational study of Osteoarthritis, Knee and Osteoarthritis, Hip, run by Memorial Bone and Joint Research Foundation at 1 site in United States.
Trial summary
The purpose of this study is to follow the patient's short term and long term clinical outcome after undergoing joint replacement surgery. Read more about this study
- Who is it for?
- Ages 18 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Osteoarthritis, Knee, Osteoarthritis, Hip
- How many people
- 990 participants
- Where
- 1 siteUnited States
- Study dates
- May 2009to Dec 2030
- 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 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Hip and knee replacement patients treated by the principal investigator.
Who may be able to join
- Inclusion criteria will be limited to subjects who have consented to undergo elective total joint replacement, hip resurfacing and partial knee surgery, arthroscopy and Femoro-actabular impingement (FAI) release performed by the PI.
- All patients of legal adult age will be eligible for the study. All patients will have an equal chance to participate in the study regardless of race or gender. Patients will be enrolled in the order as they are diagnosed by the PI.
Who cannot join
- Exclusion criteria will be limited to morbid obesity, active infection, heart failure, lung failure, severe bleeding abnormalities, subject with known metal allergy, subject who cannot legally decide for themselves.
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
Memorial Bone & Joint Research Foundation
Houston, Texas, 77043
About this study
Official title: Surgical Joint Registry
The purpose of this study is to follow the patient's short term and long term clinical outcome after undergoing joint replacement surgery.
Read the detailed description
This is a registry database. Consented subjects will have their medical data collected via a patient questionnaire in either paper or web based application form. Data will be collected prospectively and retrospectively and will be entered into the database generated by Memorial Bone and Joint Research Foundation. Collection of data will start during the initial clinic visit as part of standard of care. Subjects will be asked to fill out a 4-page "pre-operative hip questionnaire" or "pre-operative knee questionnaire", which includes questions for self-assessment from the Hip Disability and Osteoarthritis Outcome Score (HOOS), Knee disability and Osteoarthritis Outcome Score (KOOS), EQ-5D and University of California, Los Angeles Activity (UCLA) questionnaires. Demographic, intra-operative and additional data will also be collected to correctly identify the subject's specific disease process and treatment plan. Subjects will be asked to fill out a post-operative hip and knee questionnaire that is similar to the pre-operative questionnaire to evaluate the improvement in their clinical outcomes. The subjects will be requested to complete the post-operative questionnaires at 6 months and annually thereafter.
- Conditions
- Osteoarthritis, Knee, Osteoarthritis, Hip
- Keywords
- Registry, Joint Registry, OA, Osteoarthritis, Osteo arthritis, knee, hip, tka, tha
- Medical subject headings
- Osteoarthritis, Knee, Osteoarthritis, Hip, Osteoarthritis
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of Knee Society Scores with KOOS survey
The purpose of this study is to follow the patient's short term and long term clinical outcome after undergoing knee replacement surgery.
These clinical outcomes will be assessed by using the KSS along with the KOOS survey for knee replacement cases. The scores obtained at each time point will be compared to the baseline. Therefore the outcome is the change of scores over time.
Measured: Pre-operatively (baseline) and at 6 months, 12 months, 24 months, 36 months, 48 months, 60 months, 72 months, 84 months, 96 months, 108 months, 120 months
Change of Hip Society Scores with HOOS survey
The purpose of this study is to follow the patient's short term and long term clinical outcome after undergoing hip replacement surgery.
These clinical outcomes will be assessed by using the HSS for hips along with the HOOS survey for hip replacement cases. The scores obtained at each time point will be compared to the baseline. Therefore the outcome is the change of scores over time.
Measured: Pre-operatively (baseline) and at 6 months, 12 months, 24 months, 36 months, 48 months, 60 months, 72 months, 84 months, 96 months, 108 months, 120 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2018
- Study startMay 2009
- Primary completionDec 2020 (estimated)
- Study completionDec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis, KneeStudies 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
- 990 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Memorial Bone and Joint Research Foundation
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stefan Kreuzer MD, Memorial Bone and Joint Research Foundation
- Investigators
- Stefan Kreuzer, MD, Principal investigator, Memorial Bone and Joint Research Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03484325
- Sponsor's protocol ID
- HSC-GEN-09-0143
- Acronym
- MBJRFREG
- Status last verified
- Aug 2019
- First submitted
- 22 Jul 2011
- Last updated
- 15 Aug 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Surgical Joint Registry
- ClinicalTrials.gov ID
- NCT03484325
- Acronym / sponsor ID
- MBJRFREG / HSC-GEN-09-0143
- Conditions
- Osteoarthritis, Knee, Osteoarthritis, Hip
- Keywords
- Registry, Joint Registry, OA, Osteoarthritis, Osteo arthritis, knee, hip, tka
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 990 participants (estimated)
- Lead sponsor
- Memorial Bone and Joint Research FoundationUniversity, hospital or other
- Study start
- May 2009
- Primary completion
- Dec 2020 (estimated)
- Study completion
- Dec 2030 (estimated)
- First posted
- 30 Mar 2018 (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 purpose of this study is to follow the patient's short term and long term clinical outcome after undergoing joint replacement surgery.
Detailed description
This is a registry database. Consented subjects will have their medical data collected via a patient questionnaire in either paper or web based application form. Data will be collected prospectively and retrospectively and will be entered into the database generated by Memorial Bone and Joint Research Foundation. Collection of data will start during the initial clinic visit as part of standard of care. Subjects will be asked to fill out a 4-page "pre-operative hip questionnaire" or "pre-operative knee questionnaire", which includes questions for self-assessment from the Hip Disability and Osteoarthritis Outcome Score (HOOS), Knee disability and Osteoarthritis Outcome Score (KOOS), EQ-5D and University of California, Los Angeles Activity (UCLA) questionnaires. Demographic, intra-operative and additional data will also be collected to correctly identify the subject's specific disease process and treatment plan. Subjects will be asked to fill out a post-operative hip and knee questionnaire that is similar to the pre-operative questionnaire to evaluate the improvement in their clinical outcomes. The subjects will be requested to complete the post-operative questionnaires at 6 months and annually thereafter.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Hip and knee replacement patients treated by the principal investigator.
Key inclusion criteria (2 listed)
- Inclusion criteria will be limited to subjects who have consented to undergo elective total joint replacement, hip resurfacing and partial knee surgery, arthroscopy and Femoro-actabular impingement (FAI) release performed by the PI.
- All patients of legal adult age will be eligible for the study. All patients will have an equal chance to participate in the study regardless of race or gender. Patients will be enrolled in the order as they are diagnosed by the PI.
Key exclusion criteria (1 listed)
- Exclusion criteria will be limited to morbid obesity, active infection, heart failure, lung failure, severe bleeding abnormalities, subject with known metal allergy, subject who cannot legally decide for themselves.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change of Knee Society Scores with KOOS survey
Time frame: Pre-operatively (baseline) and at 6 months, 12 months, 24 months, 36 months, 48 months, 60 months, 72 months, 84 months, 96 months, 108 months, 120 months
The purpose of this study is to follow the patient's short term and long term clinical outcome after undergoing knee replacement surgery. These clinical outcomes will be assessed by using the KSS along with the KOOS survey for knee replacement cases. The scores obtained at each time point will be compared to the baseline. Therefore the outcome is the change of scores over time.
Change of Hip Society Scores with HOOS survey
Time frame: Pre-operatively (baseline) and at 6 months, 12 months, 24 months, 36 months, 48 months, 60 months, 72 months, 84 months, 96 months, 108 months, 120 months
The purpose of this study is to follow the patient's short term and long term clinical outcome after undergoing hip replacement surgery. These clinical outcomes will be assessed by using the HSS for hips along with the HOOS survey for hip replacement cases. The scores obtained at each time point will be compared to the baseline. Therefore the outcome is the change of scores over time.
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 15 Aug 2019.
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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.
Stefan Kreuzer, MD principal investigator
Memorial Bone and Joint Research Foundation
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, Knee and Osteoarthritis, Hip, run by Memorial Bone and Joint Research Foundation 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 2 inclusion and 1 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: enrolling by invitation, as of the sponsor's last update on 15 Aug 2019. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of Knee Society Scores with KOOS survey (time frame: Pre-operatively (baseline) and at 6 months, 12 months, 24 months, 36 months, 48 months, 60 months, 72 months, 84 months, 96 months, 108 months, 120 months). The study lists 2 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 15 Aug 2019.