MCJR Joint Replacement Clinical Outcomes Database

NCT03328611 | Recruiting FDA Device

• 1 other identifier: OMB No. 0990-0279
• Study Type: observational
• Target: 2,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Joint Replacement

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (1)

• radiographic findings

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

Interventions

Hip and Knee Joint Replacement DEVICE

Hip and Knee Joint Replacement

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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

Sponsors & Collaborators

• Midwest Center for Joint Replacement: lead
• University of Oxford: collaborator

Study Sites (1)

Midwest Center for Joint Replacement

Indianapolis, Indiana, 46241, United States

RECRUITING

Central Study Contacts

Haley Schwartz, BS

CONTACT

3174551064; hschwartz@mcjr.com

Grant Foley, MBA

CONTACT

3174550164; gfoley@mcjr.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 24, 2017
• First Posted: November 1, 2017
• Study Start: August 1, 2021
• Primary Completion (Estimated): December 31, 2050
• Study Completion (Estimated): December 31, 2050
• Last Updated: September 2, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)