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Clinical Trials/NCT03328611
NCT03328611
Recruiting
Not Applicable

MCJR Joint Replacement Clinical Outcomes Database

Midwest Center for Joint Replacement1 site in 1 country2,000 target enrollmentAugust 1, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Joint Replacement
Sponsor
Midwest Center for Joint Replacement
Enrollment
2000
Locations
1
Primary Endpoint
KOOS
Status
Recruiting
Last Updated
5 years ago

Overview

Brief 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. 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.

Registry
clinicaltrials.gov
Start Date
August 1, 2021
End Date
December 31, 2050
Last Updated
5 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Midwest Center for Joint Replacement
Responsible Party
Sponsor

Eligibility 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

Outcomes

Primary Outcomes

KOOS

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

Knee Outcome scores

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

Secondary Outcomes

  • radiographic findings(Change in radiographic findings from Baseline at 1 year, assessed up to 30 years)

Study Sites (1)

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