MCJR Joint Replacement Clinical Outcomes Database

Joint Replacement Clinical Trial

Official title:

MCJR Joint Replacement Clinical Outcomes Database

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03328611
• Other study ID #: OMB No. 0990-0279
• Status: Recruiting
• Start date: August 1, 2021
• Est. completion date: December 31, 2050

Study information

• Verified date: August 2020
• Source: Midwest Center for Joint Replacement
• Contact: Haley Schwartz, BS
• Phone: 3174551064
• Email: hschwartz[@]mcjr.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2000
• Est. completion date: December 31, 2050
• Est. primary completion date: December 31, 2050
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Joint Replacement

Intervention

Device:
• Hip and Knee Joint Replacement
Hip and Knee Joint Replacement

Locations

Country	Name	City	State
United States	Midwest Center for Joint Replacement	Indianapolis	Indiana

Sponsors (2)

Lead Sponsor	Collaborator
Midwest Center for Joint Replacement	University of Oxford

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Oxford Knee Score	OKS - PROM	Change in OKS from Baseline at 1 year, assessed up to 30 years
Primary	HOOS	Hip Outcome scores	Change in HOOS from Baseline at 1 year, assessed up to 30 years
Primary	KOOS	Knee Outcome scores	Change in HOOS from Baseline at 1 year, assessed up to 30 years
Secondary	radiographic findings	x-ray reports of joint replacements	Change in radiographic findings from Baseline at 1 year, assessed up to 30 years