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MCJR Joint Replacement Clinical Outcomes Database

MCJR Joint Replacement Clinical Outcomes Database

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03328611
Enrollment
2000
Registered
2017-11-01
Start date
2021-08-01
Completion date
2050-12-31
Last updated
2020-09-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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.

Interventions

DEVICEHip and Knee Joint Replacement

Hip and Knee Joint Replacement

Sponsors

University of Oxford
CollaboratorOTHER
Midwest Center for Joint Replacement
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Oxford Knee ScoreChange in OKS from Baseline at 1 year, assessed up to 30 yearsOKS - PROM
HOOSChange in HOOS from Baseline at 1 year, assessed up to 30 yearsHip Outcome scores
KOOSChange in HOOS from Baseline at 1 year, assessed up to 30 yearsKnee Outcome scores

Secondary

MeasureTime frameDescription
radiographic findingsChange in radiographic findings from Baseline at 1 year, assessed up to 30 yearsx-ray reports of joint replacements

Countries

United States

Contacts

Primary ContactHaley Schwartz, BS
hschwartz@mcjr.com3174551064
Backup ContactGrant Foley, MBA
gfoley@mcjr.com3174550164

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026