ArthrodesisOTPNCT05100732
Corrections of Anterior Imbalances by Posterior Instrumentation and Osteotomies
An observational study of Arthrodesis, run by University Hospital, Strasbourg, France at 1 site in France.
Trial summary
Several deformities of the spine exist such as the anterior imbalance. These deformities can generate functional discomfort and limit the patient's quality of life. In the event of severe trunk imbalance and progression of the deformity, operative correction of the spinal deformity by instrumentation and posterior… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Arthrodesis
- How many people
- 150 participants
- Where
- 1 siteFrance
- Study dates
- 21 Oct 2020to 21 Mar 2023
- 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
- Adult, Older adult
Study population: Major subjects with a surgical indication for arthrodesis and surgical correction of anterior imbalance by transpedicular osteotomy
Who may be able to join
- Major subjects> 18 years old
- Subject operated at HUS between 01/01/2010 to 31/12/2020
- Subject with a surgical indication for arthrodesis and surgical correction of anterior imbalance by transpedicular osteotomy
- Subject not having expressed his opposition, after information, to the reuse of his data for the purposes of this research.
Who cannot join
- Subject having expressed opposition to participating in the study
- Subject under guardianship or guardianship
- Subject under safeguard of justice
Trial locations and contacts
1 site in 1 country.
Saïd CHAYER, PhD, HDR contact
France1 site, 1 recruiting
- Recruiting
Service de Chirurgie du Rachis - Hôpitaux Universitaires de Strasbourg
Strasbourg, 67091
Yann Philippe CHARLES, MD, PhD, 33 3 68 76 52 68, YannPhilippe.CHARLES@chru-strasbourg.fr
Saïd CHAYER, PhD, HDR
About this study
Official title: Analysis of Corrections of Anterior Imbalances by Posterior Instrumentation and Osteotomies
Several deformities of the spine exist such as the anterior imbalance. These deformities can generate functional discomfort and limit the patient's quality of life.
In the event of severe trunk imbalance and progression of the deformity, operative correction of the spinal deformity by instrumentation and posterior arthrodesis may be indicated.
Read more
Surgical techniques and instrumentation have evolved over the past 5 years. These changes in surgical strategies have a potential impact on the patient's quality of life and the correction results in the medium and long term.
the aim of the study is to analyze the surgical corrections obtained by transpedicular osteotomy and radiological changes over time with classic 2-rod techniques versus modern 4-rod instrumentation techniques
- Conditions
- Arthrodesis
- Keywords
- Arthrodesis, degenerative lumbar scoliosis, Scoliosis, spinal dysmorphism
- Medical subject headings
- Ankylosis, Scoliosis
What is being measured
The primary outcome is the main question the study is designed to answer.
Retrospective analysis of corrections of anterior imbalances by posterior instrumentation and osteotomies
Measured: Files analysed retrospectively from January 01, 2010 to December 31, 2010 will be examined]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2021
- Study start21 Oct 2020
- Primary completionMar 2023 (estimated)
- Study completion21 Mar 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ArthrodesisStudies of the same condition, open and under way.
- More trials run by University Hospital, Strasbourg, FranceThe sponsor's other registered studies.
- 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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05100732
- Sponsor's protocol ID
- 7963
- Acronym
- OTP
- Status last verified
- Oct 2021
- First submitted
- 21 Oct 2021
- Last updated
- 29 Oct 2021
- 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 29 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of Corrections of Anterior Imbalances by Posterior Instrumentation and Osteotomies
- ClinicalTrials.gov ID
- NCT05100732
- Acronym / sponsor ID
- OTP / 7963
- Conditions
- Arthrodesis
- Keywords
- Arthrodesis, degenerative lumbar scoliosis, Scoliosis, spinal dysmorphism
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- 21 Oct 2020 (actual)
- Primary completion
- Mar 2023 (estimated)
- Study completion
- 21 Mar 2023 (estimated)
- First posted
- 29 Oct 2021 (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.
Several deformities of the spine exist such as the anterior imbalance. These deformities can generate functional discomfort and limit the patient's quality of life.
In the event of severe trunk imbalance and progression of the deformity, operative correction of the spinal deformity by instrumentation and posterior arthrodesis may be indicated.
Surgical techniques and instrumentation have evolved over the past 5 years. These changes in surgical strategies have a potential impact on the patient's quality of life and the correction results in the medium and long term.
the aim of the study is to analyze the surgical corrections obtained by transpedicular osteotomy and radiological changes over time with classic 2-rod techniques versus modern 4-rod instrumentation techniques
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Major subjects with a surgical indication for arthrodesis and surgical correction of anterior imbalance by transpedicular osteotomy
Key inclusion criteria (4 listed)
- Major subjects> 18 years old
- Subject operated at HUS between 01/01/2010 to 31/12/2020
- Subject with a surgical indication for arthrodesis and surgical correction of anterior imbalance by transpedicular osteotomy
- Subject not having expressed his opposition, after information, to the reuse of his data for the purposes of this research.
Key exclusion criteria (3 listed)
- Subject having expressed opposition to participating in the study
- Subject under guardianship or guardianship
- Subject under safeguard of justice
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
Retrospective analysis of corrections of anterior imbalances by posterior instrumentation and osteotomies
Time frame: Files analysed retrospectively from January 01, 2010 to December 31, 2010 will be examined]
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2021.
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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.
Saïd CHAYER, PhD, HDR contact
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 Arthrodesis, run by University Hospital, Strasbourg, France at 1 site in France.
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 4 inclusion and 3 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 29 Oct 2021. 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 France. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yann Philippe CHARLES, MD, PhD (33 3 68 76 52 68, YannPhilippe.CHARLES@chru-strasbourg.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Retrospective analysis of corrections of anterior imbalances by posterior instrumentation and osteotomies (time frame: Files analysed retrospectively from January 01, 2010 to December 31, 2010 will be examined]). 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 29 Oct 2021.