Spine ConditionNCT01979094
Spinal Arthrodesis and Spinal Arthroplasty Database Study
An observational study of Spine Condition, run by Stephanus Viljoen at 1 site in United States.
Trial summary
To collect and organize data into a repository for future research. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Spine Condition
- How many people
- 1,296 participants
- Where
- 1 siteUnited States
- Study dates
- May 2013to 4 Jan 2024
- 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
- No healthy volunteers
- Child, Adult, Older adult
Study population: Spinal arthrodesis and/or spinal arthroplasty 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 or will undergo a spinal arthrodesis and/or spinal arthroplasty procedure at Ohio State University
Who cannot join
- N/A
Trial locations and contacts
1 site in 1 country.
About this study
Official title: General Spinal Arthrodesis and Spinal Arthroplasty Database
To collect and organize data into a repository for future research.
Read the detailed description
To collect and organize data into a repository from the Principal Investigator's (H. Francis Farhadi, MD, PhD) patients who are undergoing spinal arthrodesis and/or spinal arthroplasty procedures at Ohio State University for future research, as yet to be identified. This comprehensive database of patients will allow for gathering of relevant information for potential future research use.
- Conditions
- Spine Condition
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 |
|---|---|---|
| spinal arthrodesis and/or arthroplasty procedures | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
clinical prospective review- Prospective Database study for future studies
Collecting clinical measurements. Examples of these clinical measurements are the VAS Pain Scale, SF-36, NDI, and ODI.
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 completion4 Jan 2024
- Study completion4 Jan 2024
Why it stopped: Process changes. New data base will be activated
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spine 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
- Prospective
- Enrolment
- 1,296 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stephanus Viljoen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Stephanus Viljoen, Ohio State University
- Investigators
- H. Francis Farhadi, MD, PhD, Principal investigator, Ohio State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01979094
- Sponsor's protocol ID
- 2013H0104
- Status last verified
- Mar 2024
- First submitted
- 24 Oct 2013
- Last updated
- 5 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- General Spinal Arthrodesis and Spinal Arthroplasty Database
- ClinicalTrials.gov ID
- NCT01979094
- Acronym / sponsor ID
- 2013H0104
- Conditions
- Spine Condition
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Process changes. New data base will be activated
- Enrolment
- 1,296 participants (actual)
- Lead sponsor
- Stephanus ViljoenUniversity, hospital or other
- Study start
- May 2013
- Primary completion
- 4 Jan 2024 (actual)
- Study completion
- 4 Jan 2024 (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.
To collect and organize data into a repository for future research.
Detailed description
To collect and organize data into a repository from the Principal Investigator's (H. Francis Farhadi, MD, PhD) patients who are undergoing spinal arthrodesis and/or spinal arthroplasty procedures at Ohio State University for future research, as yet to be identified. This comprehensive database of patients will allow for gathering of relevant information for potential future research use.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| spinal arthrodesis and/or arthroplasty procedures | – | – |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Spinal arthrodesis and/or spinal arthroplasty 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 or will undergo a spinal arthrodesis and/or spinal arthroplasty procedure at Ohio State University
Key exclusion criteria (1 listed)
- N/A
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
clinical prospective review- Prospective Database study for future studies
Time frame: 5 years
Collecting clinical measurements. Examples of these clinical measurements are the VAS Pain Scale, SF-36, NDI, and ODI.
Results and safety
The study was stopped early (reason given: Process changes. New data base will be activated). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2024.
Related trials for Spine Condition
Active, not recruitingObservational study
Longitudinal Changes in Spinopelvic Alignment and Sagittal Balance After Bariatric Surgery in Patients With Morbid Obesity: A Prospective Observational Study
Obesity, Spine Condition
Recruiting
Trans-Auricular Stimulation for Postoperative Inflammation in Spine Surgery
Spinal Fusion, Hyperglycemia
Recruiting
Post-Market Clinical Study of Functional Motion Outcomes in Subjects Treated With the Minuteman Device
Degenerative Conditions of the Lumbar Spine, Lumbar Spinal Stenosis
Enrolling by invitationObservational study
Influence of Flexion Distraction Manipulation on Measures of Performance and Postural Control
Spine Condition, Low Back Pain
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.
H. Francis Farhadi, MD, PhD 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 Spine Condition, run by Stephanus Viljoen 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: stopped early, as of the sponsor's last update on 5 Mar 2024. 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 was stopped early (reason given: Process changes. New data base will be activated). 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?
clinical prospective review- Prospective Database study for future studies (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 5 Mar 2024; AzTrials last refreshed its copy on 28 Oct 2026.