Pain, Spinal Surgeries, Hip and Knee Joint Replacement, Adverse EventsNCT02359786
RAHM Foundation Retrospective Study of Various Diseases
An observational study of Pain, Spinal Surgeries, Hip and Knee Joint Replacement, Adverse Events, run by Rahm Foundation.
Trial summary
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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Pain, Spinal Surgeries, Hip and Knee Joint Replacement, Adverse Events
- How many people
- 10,000 participants
- Where
- No sites listed yet
- Study dates
- Jan 2011to Dec 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Patients with various disorders
Who may be able to join
- Subjects who meet eligibility criteria across 1 of the 6 therapeutic areas
Who cannot join
- Subjects who do not meet eligibility criteria for any of the 6 therapeutic areas
About this study
Official title: 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.
Read the 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.
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Genetic Testing Subjects undergoing genetic testing | Not described | |
| Topicals Subjects using topical compounds | Not described | |
| Patients undergoing Spinal Surgery using IOM | Not described | |
| Spine Patients undergoing cervical or lumbar surgery | Not described | |
| Total Joint Patients undergoing knee and hip replacement | Not described | |
| UDT (unrinary drug test) Patients who are given a UDT | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 60 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2015 (estimated)
- Study startJan 2011
- Primary completionDec 2016 (estimated)
- Study completionDec 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain, Spinal Surgeries, Hip and Knee Joint Replacement, Adverse EventsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Retrospective
- Enrolment
- 10,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rahm Foundation
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02359786
- Sponsor's protocol ID
- RAHM 1002 v.6
- Status last verified
- Jan 2015
- First submitted
- 29 Jan 2015
- Last updated
- 10 Feb 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective Registry To Enhance the Understanding of the Variability, Progression and Treatment of Various Disorders
- ClinicalTrials.gov ID
- NCT02359786
- Acronym / sponsor ID
- RAHM 1002 v.6
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 10,000 participants (estimated)
- Lead sponsor
- Rahm FoundationUniversity, hospital or other
- Study start
- Jan 2011
- Primary completion
- Dec 2016 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 10 Feb 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Time perspective
- Retrospective
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| 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 | – | – |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with various disorders
Key inclusion criteria (1 listed)
- Subjects who meet eligibility criteria across 1 of the 6 therapeutic areas
Key exclusion criteria (1 listed)
- Subjects who do not meet eligibility criteria for any of the 6 therapeutic areas
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2015.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Pain, Spinal Surgeries, Hip and Knee Joint Replacement, Adverse Events, run by Rahm Foundation.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Feb 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2015; AzTrials last refreshed its copy on 6 Nov 2026.