Back to resultsSurgical Treatment of Spinal Deformity With Sagittal Imbalance Using Patient-specific Rods: A Multicenter, Controlled, Double- Blind Randomized Trial: The PROFILE Study (PROFILE)
Primary Purpose
Spinal Deformity With Sagittal Imbalance
Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Surgery with patient-specific rod
Conventional straight rod
Sponsored by
About this trial
This is an interventional treatment trial for Spinal Deformity With Sagittal Imbalance
Eligibility Criteria
Inclusion Criteria:
• 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
- 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);
Exclusion Criteria:
• 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.
- 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
PSR
Conventional rod
Arm Description
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.
Bras B: 167 patients in the experimental conventional rod group
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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
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
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02730507
Brief Title
Surgical Treatment of Spinal Deformity With Sagittal Imbalance Using Patient-specific Rods: A Multicenter, Controlled, Double- Blind Randomized Trial: The PROFILE Study
Acronym
PROFILE
Official Title
Surgical Treatment of Spinal Deformity With Sagittal Imbalance Using Patient-specific Rods: A Multicenter, Controlled, Double- Blind Randomized Trial: The PROFILE Study
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
October 2016 (Actual)
Primary Completion Date
February 1, 2021 (Actual)
Study Completion Date
March 1, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospices Civils de Lyon
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Deformity With Sagittal Imbalance
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
73 (Actual)
8. Arms, Groups, and Interventions
Arm Title
PSR
Arm Type
Experimental
Arm Description
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.
Arm Title
Conventional rod
Arm Type
Active Comparator
Arm Description
Bras B: 167 patients in the experimental conventional rod group
Intervention Type
Device
Intervention Name(s)
Surgery with patient-specific rod
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Conventional straight rod
Intervention Description
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.
Primary Outcome Measure Information:
Title
Proportion of patients whose sagittal profile is optimally corrected between both arms
Description
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.
Time Frame
12 months.
Secondary Outcome Measure Information:
Title
Comparison of the proportion of patients whose sagittal profile is optimally corrected between both arms.
Description
Same outcome measure as the primary outcome but at different time of follow-up
Time Frame
3 months after surgery
Title
Comparison of the proportion of patients whose sagittal profile is optimally corrected between both arms.
Description
Same outcome measure as the primary outcome but at different time of follow-up
Time Frame
6 months after surgery
Title
Comparison of the proportion of patients whose sagittal profile is optimally corrected between both arms.
Description
Same outcome measure as the primary outcome but at different time of follow-up
Time Frame
24 months after surgery
Other Pre-specified Outcome Measures:
Title
Comparison of disability index score between both arms.
Description
Disability index score will be measured using 3 questionnaires: the Owestry disability index, the SRS-22's questionnaire (Scoliosis Research Society) and the Eifel's questionnaire which corresponds to the French version of the Roland and Morris Disability Questionnaire. These three self-questionnaire will be proposed to each participant at the 3, 6, 12 and 24 months visit of follow-up
Time Frame
3 months after surgery
Title
Comparison of disability index score between both arms.
Description
Disability index score will be measured using 3 questionnaires: the Owestry disability index, the SRS-22's questionnaire (Scoliosis Research Society) and the Eifel's questionnaire which corresponds to the French version of the Roland and Morris Disability Questionnaire. These three self-questionnaire will be proposed to each participant at the 3, 6, 12 and 24 months visit of follow-up
Time Frame
6 months after surgery
Title
Comparison of disability index score between both arms.
Description
Disability index score will be measured using 3 questionnaires: the Owestry disability index, the SRS-22's questionnaire (Scoliosis Research Society) and the Eifel's questionnaire which corresponds to the French version of the Roland and Morris Disability Questionnaire. These three self-questionnaire will be proposed to each participant at the 3, 6, 12 and 24 months visit of follow-up
Time Frame
12 months after surgery
Title
Comparison of disability index score between both arms.
Description
Disability index score will be measured using 3 questionnaires: the Owestry disability index, the SRS-22's questionnaire (Scoliosis Research Society) and the Eifel's questionnaire which corresponds to the French version of the Roland and Morris Disability Questionnaire. These three self-questionnaire will be proposed to each participant at the 3, 6, 12 and 24 months visit of follow-up
Time Frame
24 months after surgery
Title
Comparison of pain level between both arms.
Description
Pain relief will be measured using a Visual Analogic Scale at 6, 12, 24 months
Time Frame
6 months after surgery
Title
Comparison of pain level between both arms.
Description
Pain relief will be measured using a Visual Analogic Scale at 6, 12, 24 months
Time Frame
12 months after surgery
Title
Comparison of pain level between both arms.
Description
Pain relief will be measured using a Visual Analogic Scale at 6, 12, 24 months
Time Frame
24 months after surgery
Title
Comparison of radiographic sagittal parameters measured on sagittal full-spine x-rays
Description
Several radiographic parameters such as Pelvic incidence, Lumbar lordosis, Real lordosis, Thoracic kyphosis, Real thoracic kyphosis, Sagittal vertical axis, Pelvic tilt, Spino-sacral angle and C7 plumb line /Sacro-femoral distance. The patients will be in a standing position when taking an x-ray. The Full spine X-Ray should include at least from C7 to femoral heads (proximal part of the femur) from both AP and lateral profiles.
Time Frame
3 months after surgery
Title
Comparison of radiographic sagittal parameters measured on sagittal full-spine x-rays
Description
Several radiographic parameters such as Pelvic incidence, Lumbar lordosis, Real lordosis, Thoracic kyphosis, Real thoracic kyphosis, Sagittal vertical axis, Pelvic tilt, Spino-sacral angle and C7 plumb line /Sacro-femoral distance. The patients will be in a standing position when taking an x-ray. The Full spine X-Ray should include at least from C7 to femoral heads (proximal part of the femur) from both AP and lateral profiles.
Time Frame
6 months after surgery
Title
Comparison of radiographic sagittal parameters measured on sagittal full-spine x-rays
Description
Several radiographic parameters such as Pelvic incidence, Lumbar lordosis, Real lordosis, Thoracic kyphosis, Real thoracic kyphosis, Sagittal vertical axis, Pelvic tilt, Spino-sacral angle and C7 plumb line /Sacro-femoral distance. The patients will be in a standing position when taking an x-ray. The Full spine X-Ray should include at least from C7 to femoral heads (proximal part of the femur) from both AP and lateral profiles.
Time Frame
12 months after surgery
Title
Comparison of radiographic sagittal parameters measured on sagittal full-spine x-rays
Description
Several radiographic parameters such as Pelvic incidence, Lumbar lordosis, Real lordosis, Thoracic kyphosis, Real thoracic kyphosis, Sagittal vertical axis, Pelvic tilt, Spino-sacral angle and C7 plumb line /Sacro-femoral distance. The patients will be in a standing position when taking an x-ray. The Full spine X-Ray should include at least from C7 to femoral heads (proximal part of the femur) from both AP and lateral profiles.
Time Frame
24 months after surgery
Title
Comparison of the proportion of peri- and postoperative complications
Description
Frequency of peri- and postoperative adverse events related to the device (especially a rod breakage) or the surgery
Time Frame
intraoperative and the follow-up visit at 3 month
Title
Comparison of the proportion of peri- and postoperative complications
Description
Frequency of peri- and postoperative adverse events related to the device (especially a rod breakage) or the surgery
Time Frame
intraoperative and the follow-up visit at 6 month
Title
Comparison of the proportion of peri- and postoperative complications
Description
Frequency of peri- and postoperative adverse events related to the device (especially a rod breakage) or the surgery
Time Frame
intraoperative and the follow-up visit at 12 month
Title
Comparison of the proportion of peri- and postoperative complications
Description
Frequency of peri- and postoperative adverse events related to the device (especially a rod breakage) or the surgery
Time Frame
intraoperative and the follow-up visit at 24 month
Title
Time of procedure evaluation
Description
Comparison of the duration in minutes of the rod bending time in the operating room
Time Frame
intraoperative
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
• 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
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);
Exclusion Criteria:
• 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.
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cedric BARREY, PHD
Organizational Affiliation
Hospices Civils de Lyon
Official's Role
Study Director
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Surgical Treatment of Spinal Deformity With Sagittal Imbalance Using Patient-specific Rods: A Multicenter, Controlled, Double- Blind Randomized Trial: The PROFILE Study
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