Joint ReplacementNCT03328611
MCJR Joint Replacement Clinical Outcomes Database
An observational study of Joint Replacement, run by Midwest Center for Joint Replacement at 1 site in United States.
Trial summary
The purpose of this research study is to develop a database of information regarding the diagnosis, treatment, and outcome of participants who have had a joint replacement. The more information gathered, the better the investigators will be able to treat future patients who need a joint replacement. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Joint Replacement
- What is being tested?
- Hip and Knee Joint Replacement
- Type of treatment
- Medical device
- How many people
- 2,000 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2021to 31 Dec 2050
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Joint Replacement Patients: Clinical diagnosis of degenerative joint disease requiring treatment with a joint replacement of the hip and knee
Inclusion Criteria: Clinical diagnosis of degenerative joint disease requiring treatment with a joint replacement
Exclusion Criteria: Clinical diagnosis of degenerative joint disease not requiring treatment with a joint replacement
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
Midwest Center for Joint Replacement
Indianapolis, Indiana, 46241
Haley Schwartz, BS, 317-455-0164, hschwartz@mcjr.com
Grant Foley, 3174550164, gfoley@mcjr.com
About this study
The purpose of this research study is to develop a database of information regarding the diagnosis, treatment, and outcome of participants who have had a joint replacement. The more information gathered, the better the investigators will be able to treat future patients who need a joint replacement. For example the investigators learn what works well to help design implants and treatment protocols for the future. The investigators publish manuscripts and present research findings around the world to help other investigators and clinicians learn what is discovered. Furthermore, implant manufacturers may be able to use this information in the database to evaluate the success rates of specific joint replacement products.
Read the detailed description
As part of our growing clinical tracking EMR system the investigators plan to collect preoperative and postoperative Patient Reported Outcome Measures (PROMS) on all patients with degenerative hip and knee disease. The investigators will collect PROMS along with implant device specific revision rates. This will be used for implant surveillance, clinical outcome tracking, return to work outcome metrics and failure modes and rates of various hip and knee implants. Information generated during regular hospital and clinic visits will be entered into the database. For example, x-ray findings done before surgery will be entered into the database. Surgery information will be entered into the database. The investigators will also enter demographic information into the database such as name, email, birthdate, gender, height, and weight. Medical co-morbidities such as diabetes, high blood pressure, and prior surgeries will also be entered.
The investigators will collect this information before surgery, during the operation, and at annual follow-up visits. The investigators will also contact patients via email with short outcome score surveys (known as Patient Reported Outcome Measures or PROM's). This will save many hours of return visits if scores indicate the joint replacements are doing well. Also this will trigger additional follow-up measures if PROMS scores drop off.
- Conditions
- Joint Replacement
- Being tested
- Hip and Knee Joint Replacement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hip and Knee Joint ReplacementDevice
Hip and Knee Joint Replacement
What is being measured
The primary outcome is the main question the study is designed to answer.
Oxford Knee Score
OKS - PROM
Measured: Change in OKS from Baseline at 1 year, assessed up to 30 years
HOOS
Hip Outcome scores
Measured: Change in HOOS from Baseline at 1 year, assessed up to 30 years
KOOS
Knee Outcome scores
Measured: Change in HOOS from Baseline at 1 year, assessed up to 30 years
Secondary outcomes (1)
radiographic findings
x-ray reports of joint replacements
Measured: Change in radiographic findings from Baseline at 1 year, assessed up to 30 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2017
- Study start1 Aug 2021 (estimated)
- Primary completion31 Dec 2050 (estimated)
- Study completion31 Dec 2050 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Joint ReplacementStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Midwest Center for Joint Replacement
- Sponsor type
- University, hospital or other
- Collaborators
- University of Oxford
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03328611
- Sponsor's protocol ID
- OMB No. 0990-0279
- Status last verified
- Aug 2020
- First submitted
- 24 Oct 2017
- Last updated
- 2 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: Only de-indentified or anonymous data will be shared with other researchers through HIPPA compliant server.
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MCJR Joint Replacement Clinical Outcomes Database
- ClinicalTrials.gov ID
- NCT03328611
- Acronym / sponsor ID
- OMB No. 0990-0279
- Conditions
- Joint Replacement
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Midwest Center for Joint ReplacementUniversity, hospital or other
- Collaborators
- University of Oxford
- Study start
- 1 Aug 2021 (estimated)
- Primary completion
- 31 Dec 2050 (estimated)
- Study completion
- 31 Dec 2050 (estimated)
- First posted
- 1 Nov 2017 (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 research study is to develop a database of information regarding the diagnosis, treatment, and outcome of participants who have had a joint replacement. The more information gathered, the better the investigators will be able to treat future patients who need a joint replacement. For example the investigators learn what works well to help design implants and treatment protocols for the future. The investigators publish manuscripts and present research findings around the world to help other investigators and clinicians learn what is discovered. Furthermore, implant manufacturers may be able to use this information in the database to evaluate the success rates of specific joint replacement products.
Detailed description
As part of our growing clinical tracking EMR system the investigators plan to collect preoperative and postoperative Patient Reported Outcome Measures (PROMS) on all patients with degenerative hip and knee disease. The investigators will collect PROMS along with implant device specific revision rates. This will be used for implant surveillance, clinical outcome tracking, return to work outcome metrics and failure modes and rates of various hip and knee implants. Information generated during regular hospital and clinic visits will be entered into the database. For example, x-ray findings done before surgery will be entered into the database. Surgery information will be entered into the database. The investigators will also enter demographic information into the database such as name, email, birthdate, gender, height, and weight. Medical co-morbidities such as diabetes, high blood pressure, and prior surgeries will also be entered.
The investigators will collect this information before surgery, during the operation, and at annual follow-up visits. The investigators will also contact patients via email with short outcome score surveys (known as Patient Reported Outcome Measures or PROM's). This will save many hours of return visits if scores indicate the joint replacements are doing well. Also this will trigger additional follow-up measures if PROMS scores drop off.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Joint Replacement Patients: Clinical diagnosis of degenerative joint disease requiring treatment with a joint replacement of the hip and knee
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 |
|---|---|---|
| Hip and Knee Joint ReplacementHip and Knee Joint Replacement | Device | – |
Primary outcome
Oxford Knee Score
Time frame: Change in OKS from Baseline at 1 year, assessed up to 30 years
OKS - PROM
HOOS
Time frame: Change in HOOS from Baseline at 1 year, assessed up to 30 years
Hip Outcome scores
KOOS
Time frame: Change in HOOS from Baseline at 1 year, assessed up to 30 years
Knee Outcome scores
1 secondary outcome
radiographic findings
Time frame: Change in radiographic findings from Baseline at 1 year, assessed up to 30 years
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 2 Sep 2020.
- Individual participant dataSharing planned: No. Only de-indentified or anonymous data will be shared with other researchers through HIPPA compliant server.
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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.
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 Joint Replacement, run by Midwest Center for Joint Replacement at 1 site in United States.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Sep 2020. 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 Haley Schwartz, BS (3174551064, hschwartz@mcjr.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Oxford Knee Score (time frame: Change in OKS from Baseline at 1 year, assessed up to 30 years). The study lists 3 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 2 Sep 2020.