Spinal Deformity With Sagittal ImbalancePhase 3PROFILENCT02730507
Surgical Treatment of Spinal Deformity With Sagittal Imbalance Using Patient-specific Rods: A Multicenter, Controlled, Double- Blind Randomized Trial: The PROFILE Study
A Phase 3 study testing Surgery with patient-specific rod and Conventional straight rod in people with Spinal Deformity With Sagittal Imbalance, run by Hospices Civils de Lyon.
Trial summary
Lumbar degenerative diseases (LDD) are an increasingly common condition affecting millions of patients worldwide. LDD can impact not only function, but can also become markedly disabling and cause severe chronic pain. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spinal Deformity With Sagittal Imbalance
- What is being tested?
- Surgery with patient-specific rod and Conventional straight rod
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 73 participants
- Where
- No sites listed yet
- Study dates
- Oct 2016to 1 Mar 2022
- Phase
- Phase 3
- 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
Who may be able to join
- • Adult sagittal deformity of the spine defined as
- a loss of lumbar lordosis versus the pelvic incidence (LL- PI) outside of the range of ±20°
- PT>25° or SVA>50mm
- Patients with functional impairment defined as an Oswestry Disability Index over 40/100
- Spinal posterior fusion and instrumentation indicated for the patient
- Surgery indicated for 4 or more lumbar levels: from T12 to S1
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- Patients in whom an optimal correction of the sagittal profile is considered to be feasible according to the following criteria:
- 10°≤ LL-PI≤10°
- PT < 20°
- SVA < 40mm.
- Patients older or equal to 18 years
- Patients able to sign an informed consent form
- Patients able to fill out a self-administered questionnaire
- Patient has to be the beneficiary of the social security system (order n° 2006-477 from April 26th 2006);
Who cannot join
- • Coronal deformity without sagittal imbalance
- Patients who required a vertebrectomy
- Patients who do not required a bone graft or a bone fusion
- Patient with congenital metabolic bone abnormalities
- Patient with recent (less than 1month) lumbar vertebrae fracture
- Patients with insufficient tissue coverage of the surgical site, an insufficient bone quality and quantity.
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- History of an osteoporotic fracture, joint disease with fast evolution, bone resorption, osteopenia
- Pathologic obesity (BMI > 40)
- Patients with active or chronic infection, fever or leukocytosis.
- Suspected or known allergy or intolerance to the medical device used and requesting a combination of different metals.
- Patient with a medical contraindication to the material used or for which the use of the device could interfere with anatomical structures or expected physiological function.
- Patients with ongoing treatment of any cancer or history of any cancer of less than 5 years
- Chronic inflammatory disease
- Women who are pregnant
- Patients unable to understand the purpose of the trial or refusing to follow post-surgery instructions.
- Participation to another trial
- Patients under legal protection
About this study
Lumbar degenerative diseases (LDD) are an increasingly common condition affecting millions of patients worldwide. LDD can impact not only function, but can also become markedly disabling and cause severe chronic pain. Recent studies support the idea that analysis of sagittal balance is a crucial keypoint to optimize the management of lumbar degenerative diseases, especially when spinal instrumentation is intended.
The first treatment of these pathologies is a medical treatment (medications, physical therapy and exercise). Surgical treatment is frequently necessary if the symptoms worsen and is generally a posterior spinal fusion with instrumentation (screws, hooks and rods) and bone graft. Basic principle of the surgery is to realign the spine along the rod.
Read more
Despite documented techniques for surgical planning, it appears that a significant number of patients are ultimately under-corrected after surgery Realignment failure has not only been associated with poor functional outcome but also major complications, such as pseudoarthrosis and rod breakage, which often results in additional surgical procedures.
From a pragmatic point of view, there are two main reasons for realignment failure: poor surgical planning and poor execution. One of the assumptions is that perioperative manual bending of the rod may not always allow the surgeon to restore the sagittal parameters as intended.
A new concept of patient-specific rod (PSR) is now being proposed by a French manufacturer in order to enable an optimal correction and surgical stabilization of the spine. PSR are designed to fit with the patient's unique sagittal spine profile and with surgeons' surgical planning. However, no relevant clinical data is currently available to support the expected medical benefit of this new technology.
The objective of the study is therefore to carry out a study hypothesizing that the use of PSR could improve the percentage of patients whose sagittal profile is optimally corrected after spinal surgery, as well as the patient's quality of life.
- Conditions
- Spinal Deformity With Sagittal Imbalance
- Being tested
- Surgery with patient-specific rod, Conventional straight rod
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surgery with patient-specific rodDevice
Bras A: PSRs must be used with the appropriate instrumentation designed by the same manufacturer. In order to minimize potential bias derived from using different spinal systems or reduction techniques, the posterior instrumentation must be the same (except the use of standard straight rod) in both groups. The surgical method to implement the PSR will be the same as the one to implement the conventional rod. Except for the bending procedure (patient specific rod or conventional rod with perioperative manual bending), the characteristics of implantable devices (biomaterial and diameter of the rod, design, type of screw, etc.) will be the same in each center.
Conventional straight rodDevice
Bras B: The control group is composed of patients operated with standard straight rods, which are bent in the operating room by the surgeon. In order to minimize potential bias derived from using different spinal systems or reduction techniques, the posterior instrumentation used in the control group must be the same (except the use of PSRs) than the experimental group.
| Study group | Role | What they receive |
|---|---|---|
| PSR | Experimental | Bras A : 167 patients in the experimental PSR group. Surgery with patient-specific rod, which are designed according to the preoperative surgical planning of the surgeon in collaboration with the manufacturer. Receives: Device: Surgery with patient-specific rod |
| Conventional rod | Active comparator | Bras B: 167 patients in the experimental conventional rod group Receives: Device: Conventional straight rod |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients whose sagittal profile is optimally corrected between both arms
The primary end point is the proportion of patients whose sagittal profile is optimally corrected 12 months after a spine-surgery. The optimally corrected sagittal profile definition is based on the following composite criteria:
- Lombar Lordosis (LL), measured between the superior endplate of L1 and the sacral plate, is equal to the Pelvic Incidence of the patient ± 10° (-10°≤ LL - Pelvic Incidence≤10°)
- Pelvic Tilt is less than 20°
- Sagittal Vertical Axis is less than 40mm. These 3 criteria will be measured and combined to define an optimal sagittal profile, by 3 members of an independent committee. Radiographic parameters will be measured on sagittal full-spine x-rays. The patient positioning will be standardized in order to obtain comparable and reproducible images. The positioning is standing both feet on the same alignment, 20-25 cm between the two feet, upper arm fingers tip on the clavicle.
Measured: 12 months.
Secondary outcomes (3)
Comparison of the proportion of patients whose sagittal profile is optimally corrected between both arms.
Same outcome measure as the primary outcome but at different time of follow-up
Measured: 3 months after surgery
Comparison of the proportion of patients whose sagittal profile is optimally corrected between both arms.
Same outcome measure as the primary outcome but at different time of follow-up
Measured: 6 months after surgery
Comparison of the proportion of patients whose sagittal profile is optimally corrected between both arms.
Same outcome measure as the primary outcome but at different time of follow-up
Measured: 24 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2016 (estimated)
- Study startOct 2016
- Primary completion1 Feb 2021
- Study completion1 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Deformity With Sagittal ImbalanceStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 73 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Cedric BARREY, PHD, Study director, Hospices Civils de Lyon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02730507
- Sponsor's protocol ID
- 69HCL14-0444
- Acronym
- PROFILE
- Status last verified
- May 2022
- First submitted
- 23 Mar 2016
- Last updated
- 5 May 2022
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Surgical Treatment of Spinal Deformity With Sagittal Imbalance Using Patient-specific Rods: A Multicenter, Controlled, Double- Blind Randomized Trial: The PROFILE Study
- ClinicalTrials.gov ID
- NCT02730507
- Acronym / sponsor ID
- PROFILE / 69HCL14-0444
- Conditions
- Spinal Deformity With Sagittal Imbalance
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 73 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- Oct 2016 (actual)
- Primary completion
- 1 Feb 2021 (actual)
- Study completion
- 1 Mar 2022 (actual)
- First posted
- 6 Apr 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.
Lumbar degenerative diseases (LDD) are an increasingly common condition affecting millions of patients worldwide. LDD can impact not only function, but can also become markedly disabling and cause severe chronic pain. Recent studies support the idea that analysis of sagittal balance is a crucial keypoint to optimize the management of lumbar degenerative diseases, especially when spinal instrumentation is intended.
The first treatment of these pathologies is a medical treatment (medications, physical therapy and exercise). Surgical treatment is frequently necessary if the symptoms worsen and is generally a posterior spinal fusion with instrumentation (screws, hooks and rods) and bone graft. Basic principle of the surgery is to realign the spine along the rod.
Despite documented techniques for surgical planning, it appears that a significant number of patients are ultimately under-corrected after surgery Realignment failure has not only been associated with poor functional outcome but also major complications, such as pseudoarthrosis and rod breakage, which often results in additional surgical procedures.
From a pragmatic point of view, there are two main reasons for realignment failure: poor surgical planning and poor execution. One of the assumptions is that perioperative manual bending of the rod may not always allow the surgeon to restore the sagittal parameters as intended.
A new concept of patient-specific rod (PSR) is now being proposed by a French manufacturer in order to enable an optimal correction and surgical stabilization of the spine. PSR are designed to fit with the patient's unique sagittal spine profile and with surgeons' surgical planning. However, no relevant clinical data is currently available to support the expected medical benefit of this new technology.
The objective of the study is therefore to carry out a study hypothesizing that the use of PSR could improve the percentage of patients whose sagittal profile is optimally corrected after spinal surgery, as well as the patient's quality of life.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PSR | Experimental | Device: Surgery with patient-specific rodBras A : 167 patients in the experimental PSR group. Surgery with patient-specific rod, which are designed according to the preoperative surgical planning of the surgeon in collaboration with the manufacturer. |
| Conventional rod | Active comparator | Device: Conventional straight rodBras B: 167 patients in the experimental conventional rod group |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- • Adult sagittal deformity of the spine defined as
Key exclusion criteria (17 listed)
- • Coronal deformity without sagittal imbalance
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 |
|---|---|---|
| Surgery with patient-specific rodBras A: PSRs must be used with the appropriate instrumentation designed by the same manufacturer. In order to minimize potential bias derived from using different spinal systems or reduction techniques, the posterior instrumentation must be the same (except the use of standard straight rod) in both groups. The surgical method to implement the PSR will be the same as the one to implement the conventional rod. Except for the bending procedure (patient specific rod or conventional rod with perioperative manual bending), the characteristics of implantable devices (biomaterial and diameter of the rod, design, type of screw, etc.) will be the same in each center. | Device | PSR |
| Conventional straight rodBras B: The control group is composed of patients operated with standard straight rods, which are bent in the operating room by the surgeon. In order to minimize potential bias derived from using different spinal systems or reduction techniques, the posterior instrumentation used in the control group must be the same (except the use of PSRs) than the experimental group. | Device | Conventional rod |
Primary outcome
Proportion of patients whose sagittal profile is optimally corrected between both arms
Time frame: 12 months.
The primary end point is the proportion of patients whose sagittal profile is optimally corrected 12 months after a spine-surgery. The optimally corrected sagittal profile definition is based on the following composite criteria: * Lombar Lordosis (LL), measured between the superior endplate of L1 and the sacral plate, is equal to the Pelvic Incidence of the patient ± 10° (-10°≤ LL - Pelvic Incidence≤10°) * Pelvic Tilt is less than 20° * Sagittal Vertical Axis is less than 40mm. These 3 criteria will be measured and combined to define an optimal sagittal profile, by 3 members of an independent committee. Radiographic parameters will be measured on sagittal full-spine x-rays. The patient positioning will be standardized in order to obtain comparable and reproducible images. The positioning is standing both feet on the same alignment, 20-25 cm between the two feet, upper arm fingers tip on the clavicle.
3 secondary outcomes
Comparison of the proportion of patients whose sagittal profile is optimally corrected between both arms.
Time frame: 3 months after surgery
Comparison of the proportion of patients whose sagittal profile is optimally corrected between both arms.
Time frame: 6 months after surgery
Comparison of the proportion of patients whose sagittal profile is optimally corrected between both arms.
Time frame: 24 months after surgery
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 5 May 2022.
- Individual participant dataSharing planned: No
Related trials for Spinal Deformity With Sagittal Imbalance
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Gait and Paraspinal sEMG in Degenerative Spinal Diseases
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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.
Cedric BARREY, PHD study director
Hospices Civils de Lyon
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Surgery with patient-specific rod and Conventional straight rod in people with Spinal Deformity With Sagittal Imbalance, run by Hospices Civils de Lyon.
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 14 inclusion and 17 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 5 May 2022. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Proportion of patients whose sagittal profile is optimally corrected between both arms (time frame: 12 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 5 May 2022.