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.

Study Overview

• Status: Recruiting
• Conditions: Joint Replacement
• Intervention / Treatment: Device: Hip and Knee Joint Replacement

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 Type: Observational
• Enrollment (Anticipated): 2000

Contacts and Locations

• Study Contact: Name: Haley Schwartz, BS; Phone Number: 3174551064; Email: hschwartz@mcjr.com
• Study Contact Backup: Name: Grant Foley, MBA; Phone Number: 3174550164; Email: gfoley@mcjr.com

Study Locations

• United States
  • Indiana
    • Indianapolis, Indiana, United States, 46241
      • Recruiting
      • Midwest Center for Joint Replacement
      • Contact: Haley Schwartz, BS; Phone Number: 317-455-0164; Email: hschwartz@mcjr.com
      • Contact: Grant Foley; Phone Number: 3174550164; Email: gfoley@mcjr.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: ADULT; OLDER_ADULT; CHILD
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Joint Replacement Patients: Clinical diagnosis of degenerative joint disease requiring treatment with a joint replacement of the hip and knee

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Oxford Knee Score	OKS - PROM	Change in OKS from Baseline at 1 year, assessed up to 30 years
HOOS	Hip Outcome scores	Change in HOOS from Baseline at 1 year, assessed up to 30 years
KOOS	Knee Outcome scores	Change in HOOS from Baseline at 1 year, assessed up to 30 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
radiographic findings	x-ray reports of joint replacements	Change in radiographic findings from Baseline at 1 year, assessed up to 30 years

Collaborators and Investigators

• Sponsor: Midwest Center for Joint Replacement
• Collaborators: University of Oxford

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): August 1, 2021
• Primary Completion (ANTICIPATED): December 31, 2050
• Study Completion (ANTICIPATED): December 31, 2050

Study Registration Dates

• First Submitted: October 24, 2017
• First Submitted That Met QC Criteria: October 29, 2017
• First Posted (ACTUAL): November 1, 2017

Study Record Updates

• Last Update Posted (ACTUAL): September 2, 2020
• Last Update Submitted That Met QC Criteria: August 31, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: OMB No. 0990-0279

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Only de-indentified or anonymous data will be shared with other researchers through HIPPA compliant server.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes