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Recruiting

NCT Number: NCT03328611

MCJR Joint Replacement Clinical Outcomes Database

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.

Recruiting

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Key information

Conditions

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Hip and Knee Joint Replacement

Device

Hip and Knee Joint Replacement

Primary outcomes

  1. Oxford Knee Score

    Time frame: Change in OKS from Baseline at 1 year, assessed up to 30 years

    OKS - PROM

  2. HOOS

    Time frame: Change in HOOS from Baseline at 1 year, assessed up to 30 years

    Hip Outcome scores

  3. KOOS

    Time frame: Change in HOOS from Baseline at 1 year, assessed up to 30 years

    Knee Outcome scores

Secondary outcomes

  1. radiographic findings

    Time frame: Change in radiographic findings from Baseline at 1 year, assessed up to 30 years

    x-ray reports of joint replacements

Study contacts

Contact information is provided by the study sponsor or research team.

Grant Foley, MBA

CONTACT

[email protected]

3174550164

Haley Schwartz, BS

CONTACT

[email protected]

3174551064

Sponsors and collaborators

Lead sponsor

Midwest Center for Joint Replacement

Other

Collaborators

  • University of Oxford

Registry information

Important dates

Study start
2021
Primary completion
2050
Study completion
2050
First posted
Nov 1, 2017
Registry last updated
Sep 2, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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