MCJR Joint Replacement Clinical Outcomes Database

Recruiting

• Conditions: Joint Replacement

• Registration Number: NCT03328611
• Lead Sponsor: Midwest Center for Joint Replacement

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.

Study Timeline

• Study First Submitted: 2017-10-24
• Study First Submitted QC: 2017-10-29
• Study First Posted: 2017-11-01
• Status Verified: 2020-08
• Last Update Submitted: 2020-08-31
• Last Update Posted: 2020-09-02
• Study Start: 2021-08-01
• Primary Completion: 2050-12-31
• Study Completion: 2050-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 2000

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
radiographic findings	Change in radiographic findings from Baseline at 1 year, assessed up to 30 years	x-ray reports of joint replacements

Trial Locations

Locations (1)

Midwest Center for Joint Replacement; 🇺🇸 Indianapolis, Indiana, United States