- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02359786
RAHM Foundation Retrospective Study of Various Diseases
February 4, 2015 updated by: Rahm Foundation
Retrospective Registry To Enhance the Understanding of the Variability, Progression and Treatment of Various Disorders
This is a retrospective data collection on treatment of various disorders.
This registry will include a variety of different products, implants, technologies and procedures.
The registry will also collect any adverse events/complications that occur during or following treatment of these conditions.
The data may be utilized to develop strategic treatment pathways and/or benchmarking that will improve patient care.
Ultimately, the goal of the registry is to enhance the understanding of healthcare and the treatment in these disease states.
Study Overview
Status
Unknown
Detailed Description
The purpose is to collect data on patients with a variety of disorders.
This includes point of care (primary care, internal medicine, pain management providers, etc.) as well as a variety of specialty providers including neurosurgeons, orthopedic surgeons, oncologists, and dermatologists.
The retrospective data collection will consist of a core set of data if available.
The registry will attempt to collect data prior to surgery/treatment/procedures, during surgery, and various time points following surgery/treatment/procedures.
The data will include, but is not limited to demographic data, past medical history, previous treatments, time off of work, type of surgery performed, products/implants/procedures/technology used during surgery, treatments/procedures/technology used for non-surgical conditions, anesthesia used during surgery, complications/adverse events following surgery and or treatment, outcome tools, imaging results, pain assessment, pain medication utilization, length of hospital stay, unplanned hospital admissions, revision surgery, adjacent level disease, genetic testing, urinary drug testing, other diagnostic or assessment testing, patient return to work and patient return to normal activity.
The data collected will vary depending on disease state and treatment.
This registry will also allow for comparisons on different treatments, procedures, etc. with a goal of developing the best pathways for a variety of different disease states.
Study Type
Observational
Enrollment (Anticipated)
10000
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
Patients with various disorders
Description
Inclusion Criteria:
- Subjects who meet eligibility criteria across 1 of the 6 therapeutic areas
Exclusion Criteria:
- Subjects who do not meet eligibility criteria for any of the 6 therapeutic areas
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
|---|
|
Genetic Testing Subjects undergoing genetic testing
|
|
Topicals Subjects using topical compounds
|
|
Patients undergoing Spinal Surgery using IOM
|
|
Spine Patients undergoing cervical or lumbar surgery
|
|
Total Joint Patients undergoing knee and hip replacement
|
|
UDT (unrinary drug test) Patients who are given a UDT
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
sensory and motor deficits analysis, adverse events, changes in pain, changes in disability, return to work/usual activities, lenttgh of stays, hospital readmission rates, medication compliance rates
Time Frame: 60 months
|
60 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2011
Primary Completion (Anticipated)
December 1, 2016
Study Completion (Anticipated)
December 1, 2016
Study Registration Dates
First Submitted
January 29, 2015
First Submitted That Met QC Criteria
February 4, 2015
First Posted (Estimate)
February 10, 2015
Study Record Updates
Last Update Posted (Estimate)
February 10, 2015
Last Update Submitted That Met QC Criteria
February 4, 2015
Last Verified
January 1, 2015
More Information
Terms related to this study
Other Study ID Numbers
- RAHM 1002 v.6
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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