MCJR Joint Replacement Clinical Outcomes Database
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Hip and Knee Joint Replacement.
- Who it may be relevant to
- Registry conditions: Joint Replacement. Basic parameters: No limits · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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
- Device Hip and Knee Joint Replacement
Hip and Knee Joint Replacement
Primary outcome measures
- Oxford Knee Score [Time frame: Change in OKS from Baseline at 1 year, assessed up to 30 years]
- HOOS [Time frame: Change in HOOS from Baseline at 1 year, assessed up to 30 years]
- KOOS [Time frame: Change in HOOS from Baseline at 1 year, assessed up to 30 years]
Secondary outcome measures (1)
- radiographic findings [Time frame: Change in radiographic findings from Baseline at 1 year, assessed up to 30 years]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United States · 1 center
- Midwest Center for Joint Replacement — Indianapolis
Identifiers
NCT: NCT03328611 · OMB No. 0990-0279