Spinal DeformityCYPHORACHINCT02881580
Risk Factors for Proximal Junctional Kyphosis Assessment After Spinal Instrumentation
An observational study of Spinal Deformity, run by Fondation Hôpital Saint-Joseph at 1 site in France.
Trial summary
The surgical management of spinal deformities especially in adults is complex. The conventional surgical treatment of these deformations is a scope arthrodesis of the spine. The quality of the result depends on many variables such as the choice of the vertebrae to fuse, location and the number of implants, the type of… Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Spinal Deformity
- How many people
- 314 participants
- Where
- 1 siteFrance
- Study dates
- Jun 2015to Nov 2015
- 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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients admitted to Saint Joseph Hospital
Who may be able to join
- age over 40 years
- Decline minimum 6 months
- Scoliosis degenerative etiology, neurological and idiopathic.
- segmental instrumentation over 3 levels (4 vertebrae) in the lumbar area.
- Patients operated on for the 1st time.
Who cannot join
- Lumbar spinal surgery or history of chest instrumented
- Etiology post traumatic tumor
- non-segmental instrumentation (Harrington type)
- segmental instrumentation on less than 3 levels.
- Pre and unreadable or missing postoperative radiograph
- Decline <6 months
Trial locations and contacts
1 site in 1 country.
France1 site
Groupe Hospitalier Paris Saint Joseph
Paris, Île-de-France Region, 75014
About this study
The surgical management of spinal deformities especially in adults is complex. The conventional surgical treatment of these deformations is a scope arthrodesis of the spine. The quality of the result depends on many variables such as the choice of the vertebrae to fuse, location and the number of implants, the type of material used or the type of correction maneuver used.
All these variables affect the surgical outcome and may be involved as a modifiable risk factor for possible postoperative complications. The study proposes to focus on the junctional kyphosis postoperative proximal (CJP or Proximal Junctional Kyphosis: PJK). Their prevalence in adults ranges from 20% to 43% depending on the series.
Read more
The radiographic definition of CJP's kyphosis with an angle> 10 ° measured from the lower plate of the proximal instrumented vertebra to the upper plate of the adjacent vertebra proximal not instrumented; this measure is being compared to the pre operative data.
Either the CJP are asymptomatic and do not require revision surgery either they are and thereby generate a revision surgery.
Several factors may potentially influence the development of the CJP. Among them, age, preoperative comorbidities, obesity, osteoporosis, lesions of the posterior elements, hybrid instrumentation, correction forces applied during surgery, sagittal balance pre and post operative degeneration joint capsules, etc. There are few studies on the identification and analysis of these risk factors; literature gives only single-center studies on small samples with a single surgical procedure. Review articles describe the incidence and risk factors of the CJP. However, the pathophysiological mechanisms of the CJP are still controversial to this day.
The aim of this study is to determine the incidence of occurrence of postoperative kyphosis proximal junctional and identify risk factors for developing this major complication of a multicenter population of scoliosis operated an extensive fusion.
Read the detailed description
objectives:
Determine on a homogenous population of scoliosis operated for an extended fusion of 4 or more vertebrae:
- the incidence of proximal junctional kyphosis
- Modifiable risk factors and non modifiable of occurrence of CJP.
- the rate of CJP leading to revision surgery and the surgical recovery factors.
Methodology :
This is a multicenter retrospective cohort enrolling in Chapter X of the Data Protection Act and provides, as part of this research, the collection of individual data for evaluation of care and prevention practices with authorization request to the CNIL; the opinion of CCTIRS is not required in this case.
This study concerns the data of patients operated with the techniques mentioned in addition with more than 6 months back.
Patients are aware of the potential use of their data in their files for medical research through oral information provided by the doctor at the signing by the patient's consent related to the surgery and most recently contained in the Home booklet setting for patients.
Time study: 8 months Acquisition of data: KEOPS Database (declared to CNIL)
List of data to collect:
- Epidemiological data and conventional clinics.
- Background
- Questionnaires and functional scores when available. (Some patients filled out questionnaires in the prospective follow-up of results and signed an agreement on their inclusion in the Keops database.)
- Operating data
- X-rays of the entire spine from the front and side: pre-operative, post-operative and at last follow.
- Conditions
- Spinal Deformity
- Being tested
- No intervention : descriptive study
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No intervention : descriptive studyOther
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of proximal junctional kyphosis
Measured: Day 1
Secondary outcomes (1)
Number of proximal junctional kyphosis leading to revision surgery and the surgical recovery factors.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2016 (estimated)
- Study startJun 2015
- Primary completionNov 2015
- Study completionNov 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal DeformityStudies 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
- 314 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondation Hôpital Saint-Joseph
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Guillaume P RIOUALLON, MD, Principal investigator, Fondation Hôpital Saint-Joseph
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02881580
- Sponsor's protocol ID
- CYPHORACHI
- Acronym
- CYPHORACHI
- Status last verified
- Aug 2016
- First submitted
- 24 Aug 2016
- Last updated
- 10 Aug 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Risk Factors for Proximal Junctional Kyphosis Assessment After Spinal Instrumentation
- ClinicalTrials.gov ID
- NCT02881580
- Acronym / sponsor ID
- CYPHORACHI / CYPHORACHI
- Conditions
- Spinal Deformity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 314 participants (actual)
- Lead sponsor
- Fondation Hôpital Saint-JosephUniversity, hospital or other
- Study start
- Jun 2015
- Primary completion
- Nov 2015 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 29 Aug 2016 (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.
The surgical management of spinal deformities especially in adults is complex. The conventional surgical treatment of these deformations is a scope arthrodesis of the spine. The quality of the result depends on many variables such as the choice of the vertebrae to fuse, location and the number of implants, the type of material used or the type of correction maneuver used.
All these variables affect the surgical outcome and may be involved as a modifiable risk factor for possible postoperative complications. The study proposes to focus on the junctional kyphosis postoperative proximal (CJP or Proximal Junctional Kyphosis: PJK). Their prevalence in adults ranges from 20% to 43% depending on the series.
The radiographic definition of CJP's kyphosis with an angle> 10 ° measured from the lower plate of the proximal instrumented vertebra to the upper plate of the adjacent vertebra proximal not instrumented; this measure is being compared to the pre operative data.
Either the CJP are asymptomatic and do not require revision surgery either they are and thereby generate a revision surgery.
Several factors may potentially influence the development of the CJP. Among them, age, preoperative comorbidities, obesity, osteoporosis, lesions of the posterior elements, hybrid instrumentation, correction forces applied during surgery, sagittal balance pre and post operative degeneration joint capsules, etc. There are few studies on the identification and analysis of these risk factors; literature gives only single-center studies on small samples with a single surgical procedure. Review articles describe the incidence and risk factors of the CJP. However, the pathophysiological mechanisms of the CJP are still controversial to this day.
The aim of this study is to determine the incidence of occurrence of postoperative kyphosis proximal junctional and identify risk factors for developing this major complication of a multicenter population of scoliosis operated an extensive fusion.
Detailed description
objectives:
Determine on a homogenous population of scoliosis operated for an extended fusion of 4 or more vertebrae:
- the incidence of proximal junctional kyphosis
- Modifiable risk factors and non modifiable of occurrence of CJP.
- the rate of CJP leading to revision surgery and the surgical recovery factors.
Methodology :
This is a multicenter retrospective cohort enrolling in Chapter X of the Data Protection Act and provides, as part of this research, the collection of individual data for evaluation of care and prevention practices with authorization request to the CNIL; the opinion of CCTIRS is not required in this case.
This study concerns the data of patients operated with the techniques mentioned in addition with more than 6 months back.
Patients are aware of the potential use of their data in their files for medical research through oral information provided by the doctor at the signing by the patient's consent related to the surgery and most recently contained in the Home booklet setting for patients.
Time study: 8 months Acquisition of data: KEOPS Database (declared to CNIL)
List of data to collect:
- Epidemiological data and conventional clinics.
- Background
- Questionnaires and functional scores when available. (Some patients filled out questionnaires in the prospective follow-up of results and signed an agreement on their inclusion in the Keops database.)
- Operating data
- X-rays of the entire spine from the front and side: pre-operative, post-operative and at last follow.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients admitted to Saint Joseph Hospital
Key inclusion criteria (5 listed)
- age over 40 years
- Decline minimum 6 months
- Scoliosis degenerative etiology, neurological and idiopathic.
- segmental instrumentation over 3 levels (4 vertebrae) in the lumbar area.
- Patients operated on for the 1st time.
Key exclusion criteria (6 listed)
- Lumbar spinal surgery or history of chest instrumented
- Etiology post traumatic tumor
- non-segmental instrumentation (Harrington type)
- segmental instrumentation on less than 3 levels.
- Pre and unreadable or missing postoperative radiograph
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 |
|---|---|---|
| No intervention : descriptive study | Other | – |
Primary outcome
Number of proximal junctional kyphosis
Time frame: Day 1
1 secondary outcome
Number of proximal junctional kyphosis leading to revision surgery and the surgical recovery factors.
Time frame: Day 1
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 10 Aug 2018.
- Individual participant dataSharing planned: Undecided
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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.
Guillaume P RIOUALLON, MD principal investigator
Fondation Hôpital Saint-Joseph
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 Deformity, run by Fondation Hôpital Saint-Joseph 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 5 inclusion and 6 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 10 Aug 2018. 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?
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?
Number of proximal junctional kyphosis (time frame: Day 1). 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 Aug 2018.