Lumbar or Thoraco-lumbar Adult DeformityNCT01635322
Sagittal Plane Correction With Pass-LP Device in Adult Deformity Patients
An observational study of Lumbar or Thoraco-lumbar Adult Deformity, run by Medicrea International at 2 sites in 2 countries.
Trial summary
The purpose of this study is to evaluate the correlation between the restoration of the sagittal balance and the improvement of the Quality of Life for patients with adult scoliosis, treated with a polyaxial system (PASS® LP system) during the 2 years after a spinal fusion surgery. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Lumbar or Thoraco-lumbar Adult Deformity
- What is being tested?
- Polyaxial posterior spinal fusion system
- Type of treatment
- Medical device
- How many people
- 54 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Jul 2012to Nov 2016
- 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult with a lumbar or thoraco-lumbar spine deformity
Who may be able to join
- Lumbar or thoraco-lumbar Adult Deformity requiring posterior spinal instrumentation and fusion like:
- Scoliosis
- Kyphosis
- Kyphoscoliosis
- Patient with a Cobb angle ≥ 30° and/or confirmed sagittal imbalance defined as sagittal vertical axis (SVA) more or equal to 5cm and/or a loss of lumbar lordosis versus the pelvic incidence
- Patient ≥ 21 years old
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- Surgery that requires 4 or more levels to be operated
- Patient with complete pre-operative radiographic data: antero-posterior and lateral standing full spine x-rays (from hips to C2) and lateral bending x-rays (standing)
- Patient able to complete a self-administered questionnaire
- Patient able to sign a consent form
Who cannot join
- Patient operated with posterior spinal fusion without PASS LP device
- Patients who required a Vertebral Column Resection technique surgery
- Neuromuscular scoliosis or diseases and any neuro-related pathology
- Spinal cord abnormalities with any neurologic symptoms or signs
- Primary abnormalities of bones (e.g. osteogenesis imperfecta)
- Recent significant trauma
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- Patient is involved in current medical litigation
- Metabolic spinal pathology
- Pathologic obesity (BMI > 40)
- Patients with infection (in particularly osteomyelitis)
- Patient < 21 years old
- Pregnancy or intended to get pregnant during the next 3 years
- Insulin-dependent diabetes
- All other contra-indications given in the PASS® LP System instructions for use
- Patient unable to sign an informed consent form
- Patient unable to complete a self-administered questionnaire
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
Official title: The Relationship Between Sagittal Plane Correction and Quality of Life in Adult Deformity Patients Treated With Posterior Instrumentation
The purpose of this study is to evaluate the correlation between the restoration of the sagittal balance and the improvement of the Quality of Life for patients with adult scoliosis, treated with a polyaxial system (PASS® LP system) during the 2 years after a spinal fusion surgery.
- Conditions
- Lumbar or Thoraco-lumbar Adult Deformity
- Being tested
- Polyaxial posterior spinal fusion system
- Keywords
- deformity, adult, lumbar, thoraco-lumbar, Sagittal vertebral Alignement (SVA), Oswestry Disability Index (ODI)
- Medical subject headings
- Congenital Abnormalities
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Polyaxial posterior spinal fusion systemDevice
Also called PASS® LP system
posterior correction and fusion of the thoraco-lumbar or lumbar spine
| Study group | Role | What they receive |
|---|---|---|
| Lumbar or thoraco-lumbar Adult Deformity | Lumbar or thoraco-lumbar Adult Deformity Receives: Device: Polyaxial posterior spinal fusion system |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation between correction of SVA and improvement ODI
The primary objective is to evaluate the correlation between:
- the correction of the Sagittal Vertical Alignement (SVA), expressed in centimeters - SVA is the distance between C7 plumbline and the posterior of the superior endplate of S1)
- the improvement of the Oswestry Disability Index (ODI) is the positive difference of the preoperative score and the postoperative score - expressed in % or a score (/50)
Measured: preop, 3 months, 6 months, 12 months, 24 months
Secondary outcomes (8)
Correction of the sagittal parameters
Sagittal parameters are evaluated by:
- Cobb angle: Thoracic kyphosis measured from T5 to T12 and between the 2 inflexion points of the curve Lumbar lordosis measured from T12 to S1 and between the 2 inflexion points of the curve
- Pelvic Incidence (PI)
- Pelvic Tilt (PT)
- Sacral Slope (SS)
- Proximal junction Cobb angle
- T1 spinopelvic inclination (T1-SPI)
Measured: preop, 24 months
improvement of Quality of life
- The effect that the patient's pathology has on his/her daily life evaluated by the Scoliosis Research Society (SRS-22) questionnaire designed and recommended by the Scoliosis Research Society
- Pain reduction for back and leg by the Visual Analogue Scale (VAS)
- Patient satisfaction with the results of their operation using a simple questionnaire (Patient Satisfaction Index - PSI) which was designed and recommended by the North American Spine Society (NASS)
Measured: preop, 3 months, 6 months, 12 months, 24 months
Complications associated with the device
Per and Post-operative device complications:
Screw pull-out Loosening, breakage and pseudarthrosis based on x-rays analysis
Measured: preop, 3 months, 6 months, 12 months, 24 months
Complications associated with the surgery
Peri-operative data: length of operative time, length of correction time, blood loss … Surgical complications
Measured: preop, 3 months, 6 months, 12 months, 24 months
Coronal correction
- A pre/post-operative comparison of regular Cobb angles
- A pre/post-operative comparison of C7 plumb line (Coronal balance)
- A pre/post-operative comparison of Apical Vertebra Translation (AVT)
Measured: preop, 3 months, 6 months, 12 months, 24 months
Vertebra rotation
- A pre/post-operative comparison of Rotary Vertebra Subluxation (olisthesis)
- A pre/post-operative comparison of Apical Vertebra Rotation (AVR) - Nash Moe
Measured: preop, 24 months
Adjacent levels degeneration
preoperative and post-operative comparison of the disc height of the upper and lower adjacent levels
Measured: preop, 24 months
Fusion
standing X-Rays observations (osseous formation)
Measured: preop, 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2012 (estimated)
- Study startJul 2012
- Primary completionNov 2016
- Study completionNov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lumbar or Thoraco-lumbar Adult 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
- Prospective
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medicrea International
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Evalina BURGER, MD, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01635322
- Sponsor's protocol ID
- 0309
- Status last verified
- Mar 2017
- First submitted
- 1 Mar 2012
- Last updated
- 28 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Relationship Between Sagittal Plane Correction and Quality of Life in Adult Deformity Patients Treated With Posterior Instrumentation
- ClinicalTrials.gov ID
- NCT01635322
- Acronym / sponsor ID
- 0309
- Conditions
- Lumbar or Thoraco-lumbar Adult Deformity
- Keywords
- deformity, adult, lumbar, thoraco-lumbar, Sagittal vertebral Alignement (SVA), Oswestry Disability Index (ODI)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Medicrea InternationalIndustry (pharma, biotech, devices)
- Study start
- Jul 2012 (actual)
- Primary completion
- Nov 2016 (actual)
- Study completion
- Nov 2016 (actual)
- First posted
- 9 Jul 2012 (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 purpose of this study is to evaluate the correlation between the restoration of the sagittal balance and the improvement of the Quality of Life for patients with adult scoliosis, treated with a polyaxial system (PASS® LP system) during the 2 years after a spinal fusion surgery.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lumbar or thoraco-lumbar Adult Deformity | – | Device: Polyaxial posterior spinal fusion systemLumbar or thoraco-lumbar Adult Deformity |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult with a lumbar or thoraco-lumbar spine deformity
Key inclusion criteria (10 listed)
- Lumbar or thoraco-lumbar Adult Deformity requiring posterior spinal instrumentation and fusion like:
- Patient with a Cobb angle ≥ 30° and/or confirmed sagittal imbalance defined as sagittal vertical axis (SVA) more or equal to 5cm and/or a loss of lumbar lordosis versus the pelvic incidence
- Patient ≥ 21 years old
- Surgery that requires 4 or more levels to be operated
- Patient with complete pre-operative radiographic data: antero-posterior and lateral standing full spine x-rays (from hips to C2) and lateral bending x-rays (standing)
Key exclusion criteria (16 listed)
- Patient operated with posterior spinal fusion without PASS LP device
- Patients who required a Vertebral Column Resection technique surgery
- Neuromuscular scoliosis or diseases and any neuro-related pathology
- Spinal cord abnormalities with any neurologic symptoms or signs
- Primary abnormalities of bones (e.g. osteogenesis imperfecta)
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 |
|---|---|---|
| Polyaxial posterior spinal fusion systemAlso: PASS® LP systemposterior correction and fusion of the thoraco-lumbar or lumbar spine | Device | Lumbar or thoraco-lumbar Adult Deformity |
Primary outcome
Correlation between correction of SVA and improvement ODI
Time frame: preop, 3 months, 6 months, 12 months, 24 months
The primary objective is to evaluate the correlation between: * the correction of the Sagittal Vertical Alignement (SVA), expressed in centimeters - SVA is the distance between C7 plumbline and the posterior of the superior endplate of S1) * the improvement of the Oswestry Disability Index (ODI) is the positive difference of the preoperative score and the postoperative score - expressed in % or a score (/50)
8 secondary outcomes
Correction of the sagittal parameters
Time frame: preop, 24 months
improvement of Quality of life
Time frame: preop, 3 months, 6 months, 12 months, 24 months
Complications associated with the device
Time frame: preop, 3 months, 6 months, 12 months, 24 months
Complications associated with the surgery
Time frame: preop, 3 months, 6 months, 12 months, 24 months
Coronal correction
Time frame: preop, 3 months, 6 months, 12 months, 24 months
Vertebra rotation
Time frame: preop, 24 months
Adjacent levels degeneration
Time frame: preop, 24 months
Fusion
Time frame: preop, 24 months
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 28 Mar 2017.
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.
Evalina BURGER, MD principal investigator
University of Colorado, Denver
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lumbar or Thoraco-lumbar Adult Deformity, run by Medicrea International at 2 sites in 2 countries.
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 10 inclusion and 16 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 28 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States, 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?
Correlation between correction of SVA and improvement ODI (time frame: preop, 3 months, 6 months, 12 months, 24 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 28 Mar 2017.