Spinal ConditionNCT01978847
Retrospective Review of Anterior and Posterior Cervical, Thoracic, and Lumbar Instrumented Arthrodesis Surgeries
An observational study of Spinal Condition, run by H Francis Farhadi, MD, PhD at 1 site in United States.
Trial summary
Retrospective review will allow for an evaluation of potential patient- or procedure-related factors that are associated with the development of either radiologic or clinical adjacent-segment pathology. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spinal Condition
- How many people
- 500 participants
- Where
- 1 siteUnited States
- Study dates
- May 2013to 1 May 2018
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Spinal arthrodesis can be performed through either anterior, posterior, or lateral approaches for a variety of traumatic, degenerative, or deformity conditions.
Who may be able to join
- Must have had a Spinal arthrodesis procedure at Ohio State University
Who cannot join
- NA
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Proposal for Retrospective Review of Anterior&Posterior Cervical, Thoracic, and Lumbar Instrumented Arthrodesis Surgeries Performed at OSU.
Retrospective review will allow for an evaluation of potential patient- or procedure-related factors that are associated with the development of either radiologic or clinical adjacent-segment pathology.
Read the detailed description
Spinal arthrodesis can be performed through either anterior, posterior, or lateral approaches for a variety of traumatic, degenerative, or deformity conditions. In recent years, the development of more sophisticated segmental instrumentation techniques and hardware has allowed for incorporation of multiple spinal levels in single settings. The long-term consequences for spinal motion segments adjacent to such fusions remain unknown.
The investigators propose to undertake a retrospective case study analysis evaluating both radiologic and clinical parameters indicative of adjacent-segment pathology in patients who have undergone instrumented arthrodesis procedures at Ohio State University, performed by either Dr. Francis Farhadi, James B. Elder, or Gary Rea.
- Conditions
- Spinal Condition
What is being measured
The primary outcome is the main question the study is designed to answer.
The number of patients with radiologic evidence of fusion
Radiologic review will include X-Rays, CT, and MRI at pre-surgery, as well as X-rays at 6 weeks, 3, 6, 12, 24, 36, 48 and 60 months post-operatively.
Measured: 5 years
Secondary outcomes (1)
The number of patient with clinical evidences of fusions
examples of clinical measurement are Pain Scores and the Visual Analog Scale
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2013 (estimated)
- Study startMay 2013
- Primary completion1 May 2018
- Study completion1 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal ConditionStudies 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
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 500 participants (actual)
Sponsor and investigators
- Lead sponsor
- H Francis Farhadi, MD, PhD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, H Francis Farhadi, MD, PhD, Ohio State University
- Investigators
- Francis Farhadi, MDPHD, Principal investigator, Ohio State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01978847
- Sponsor's protocol ID
- 2013H0153
- Status last verified
- Sep 2019
- First submitted
- 24 Oct 2013
- Last updated
- 19 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Proposal for Retrospective Review of Anterior&Posterior Cervical, Thoracic, and Lumbar Instrumented Arthrodesis Surgeries Performed at OSU.
- ClinicalTrials.gov ID
- NCT01978847
- Acronym / sponsor ID
- 2013H0153
- Conditions
- Spinal Condition
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 500 participants (actual)
- Lead sponsor
- H Francis Farhadi, MD, PhDUniversity, hospital or other
- Study start
- May 2013
- Primary completion
- 1 May 2018 (actual)
- Study completion
- 1 May 2018 (actual)
- First posted
- 8 Nov 2013 (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.
Retrospective review will allow for an evaluation of potential patient- or procedure-related factors that are associated with the development of either radiologic or clinical adjacent-segment pathology.
Detailed description
Spinal arthrodesis can be performed through either anterior, posterior, or lateral approaches for a variety of traumatic, degenerative, or deformity conditions. In recent years, the development of more sophisticated segmental instrumentation techniques and hardware has allowed for incorporation of multiple spinal levels in single settings. The long-term consequences for spinal motion segments adjacent to such fusions remain unknown.
The investigators propose to undertake a retrospective case study analysis evaluating both radiologic and clinical parameters indicative of adjacent-segment pathology in patients who have undergone instrumented arthrodesis procedures at Ohio State University, performed by either Dr. Francis Farhadi, James B. Elder, or Gary Rea.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Spinal arthrodesis can be performed through either anterior, posterior, or lateral approaches for a variety of traumatic, degenerative, or deformity conditions.
Key inclusion criteria (1 listed)
- Must have had a Spinal arthrodesis procedure at Ohio State University
Key exclusion criteria (1 listed)
- NA
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
The number of patients with radiologic evidence of fusion
Time frame: 5 years
Radiologic review will include X-Rays, CT, and MRI at pre-surgery, as well as X-rays at 6 weeks, 3, 6, 12, 24, 36, 48 and 60 months post-operatively.
1 secondary outcome
The number of patient with clinical evidences of fusions
Time frame: 5 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2019.
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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.
Francis Farhadi, MDPHD principal investigator
Ohio State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Spinal Condition, run by H Francis Farhadi, MD, PhD at 1 site in United States.
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: finished, as of the sponsor's last update on 19 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
The number of patients with radiologic evidence of fusion (time frame: 5 years). 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 19 Sep 2019.