Clinical trial NCT03328611: MCJR Joint Replacement Clinical Outcomes Database
Official title: MCJR Joint Replacement Clinical Outcomes Database
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Joint Replacement
Lead sponsor: Midwest Center for Joint Replacement
Sponsor class: OTHER
Collaborators: name: University of Oxford
First posted: 2017-11-01
Enrollment: 2000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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.

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

Primary outcomes:
measure: Oxford Knee Score
timeFrame: Change in OKS from Baseline at 1 year, assessed up to 30 years
measure: HOOS
timeFrame: Change in HOOS from Baseline at 1 year, assessed up to 30 years
measure: KOOS
timeFrame: Change in HOOS from Baseline at 1 year, assessed up to 30 years
Secondary outcomes:
measure: radiographic findings
timeFrame: Change in radiographic findings from Baseline at 1 year, assessed up to 30 years
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Midwest Center for Joint Replacement
state: Indiana
Study officials:
References: