Spinal FusionNCT03859609
Comparison of GAP-score With Schwab-score
An observational study of Spinal Fusion and Adjacent Segment Degeneration, run by Mohammad ARAB MOTLAGH at 1 site in Germany.
Trial summary
The predictive value of two different score-systems with regard to failure rate following long extent spinal fusion is subject of evaluation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spinal Fusion, Adjacent Segment Degeneration
- What is being tested?
- Spinal Fusion
- Type of treatment
- Surgery or procedure
- How many people
- 94 participants
- Where
- 1 siteGermany
- Study dates
- 1 Mar 2019to 30 Jun 2019
- 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: Patients who had fusion operation with dorsal instrumentation on at least 3 spinal levels
Who may be able to join
- 3 and more fusion levels
Who cannot join
- Neuromuscular disease
Trial locations and contacts
1 site in 1 country.
Germany1 site
Department of Orthopaedic Surgery, University Hospital Frankfurt
Frankfurt, 60528
About this study
Official title: Failure Prediction of Adult Spinal Deformity Surgery Comparing GAP-score With Schwab-score
The predictive value of two different score-systems with regard to failure rate following long extent spinal fusion is subject of evaluation.
Read the detailed description
The multilevel spinal fusion is associated with high rate of failure. This results from insufficient adaptation of the fused spine to the proper individual spinal alignment. In the recent years, comprehensive understanding of spinal alignment and definition of several parameters contributed to develop score systems to evaluate the alignment of the multilevel spinal fusion and to predict failure. In the following study the results of multilevel spinal fusion were evaluated retrospectively according to two scoring systems: GAP-score und Schwab-score. The predictive value of each score system is analyzed by the correlation of the failure rate with its corresponding score value.
- Conditions
- Spinal Fusion, Adjacent Segment Degeneration
- Being tested
- Spinal Fusion
- Keywords
- GAP-score, Schwab score, Proximal Junctional Failure, Spinal Fusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spinal FusionProcedure or surgery
Spinal alignment was evaluated according to two different score-systems
What is being measured
The primary outcome is the main question the study is designed to answer.
Radiological Evaluation
Pelvic tilt in degree, Pelvic incidence in degree, Sacral slope in degree, Lumbar lordosis in degree, L5-S1 lordosis in degree, Thoracic kyphosis in degree, Sagittal vertical axis in degree, Thoracolumbar kyphosis in degree, Global tilt in degree, Cobb angle in degree
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2019
- Study start1 Mar 2019
- Primary completion30 Apr 2019
- Study completion30 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal FusionStudies 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 94 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mohammad ARAB MOTLAGH
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Mohammad ARAB MOTLAGH, Johann Wolfgang Goethe University Hospital
- Investigators
- Mohammad Arab Motlagh, MD, PhD, Principal investigator, Goethe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03859609
- Sponsor's protocol ID
- Adult Spinal Deformity Surgery
- Status last verified
- Aug 2019
- First submitted
- 27 Feb 2019
- Last updated
- 16 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Failure Prediction of Adult Spinal Deformity Surgery Comparing GAP-score With Schwab-score
- ClinicalTrials.gov ID
- NCT03859609
- Acronym / sponsor ID
- Adult Spinal Deformity Surgery
- Conditions
- Spinal Fusion, Adjacent Segment Degeneration
- Keywords
- GAP-score, Schwab score, Proximal Junctional Failure, Spinal Fusion
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 94 participants (actual)
- Lead sponsor
- Mohammad ARAB MOTLAGHUniversity, hospital or other
- Study start
- 1 Mar 2019 (actual)
- Primary completion
- 30 Apr 2019 (actual)
- Study completion
- 30 Jun 2019 (actual)
- First posted
- 1 Mar 2019 (actual)
- 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.
The predictive value of two different score-systems with regard to failure rate following long extent spinal fusion is subject of evaluation.
Detailed description
The multilevel spinal fusion is associated with high rate of failure. This results from insufficient adaptation of the fused spine to the proper individual spinal alignment. In the recent years, comprehensive understanding of spinal alignment and definition of several parameters contributed to develop score systems to evaluate the alignment of the multilevel spinal fusion and to predict failure. In the following study the results of multilevel spinal fusion were evaluated retrospectively according to two scoring systems: GAP-score und Schwab-score. The predictive value of each score system is analyzed by the correlation of the failure rate with its corresponding score value.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who had fusion operation with dorsal instrumentation on at least 3 spinal levels
Key inclusion criteria (1 listed)
- 3 and more fusion levels
Key exclusion criteria (1 listed)
- Neuromuscular disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Spinal FusionSpinal alignment was evaluated according to two different score-systems | Procedure or surgery | – |
Primary outcome
Radiological Evaluation
Time frame: 2 months
Pelvic tilt in degree, Pelvic incidence in degree, Sacral slope in degree, Lumbar lordosis in degree, L5-S1 lordosis in degree, Thoracic kyphosis in degree, Sagittal vertical axis in degree, Thoracolumbar kyphosis in degree, Global tilt in degree, Cobb angle in degree
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 16 Aug 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.
Mohammad Arab Motlagh, MD, PhD principal investigator
Goethe 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 Fusion and Adjacent Segment Degeneration, run by Mohammad ARAB MOTLAGH at 1 site in Germany.
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 16 Aug 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 Germany. 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?
Radiological Evaluation (time frame: 2 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 16 Aug 2019.