MCJR Joint Replacement Clinical Outcomes Database

NCT ID: NCT03328611

Last Updated: 2020-09-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

2000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-08-01

Study Completion Date

2050-12-31

Brief Summary

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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

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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

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Joint Replacement

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Hip and Knee Joint Replacement

Hip and Knee Joint Replacement

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Oxford

OTHER

Sponsor Role collaborator

Midwest Center for Joint Replacement

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Midwest Center for Joint Replacement

Indianapolis, Indiana, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Haley Schwartz, BS

Role: CONTACT

3174551064

Grant Foley, MBA

Role: CONTACT

3174550164

Facility Contacts

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Haley Schwartz, BS

Role: primary

317-455-0164

Grant Foley

Role: backup

3174550164

Other Identifiers

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OMB No. 0990-0279

Identifier Type: -

Identifier Source: org_study_id

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