Brief Summary
This study is an opportunity to provide continued reasonable assurance of the safety and probable benefit of The Tether HUD. The study will collect long term safety and efficacy information from patients who have had their idiopathic scoliosis treated via anterior vertebral body tethering (AVBT) with The Tether.
Brief Title
The Tether™ - Vertebral Body Tethering System Post Approval Study
Detailed Description
While spinal fusion remains the standard surgical treatment for progressive idiopathic scoliosis, concerns about the long-term effects of spinal fusion have led to the investigation of growth-modulation techniques. Anterior Vertebral Body Tethering (AVBT) is one such technique that utilizes growth modulation to remodel the shape of the vertebra and straighten scoliotic curves in skeletally immature individuals. In this technique, screws are inserted at each vertebral level for the length of the convex side of the curve. A strong cord is connected through the screw tulip heads and used to initially straighten the curve as each level is fixed with a set screw. Following surgery and during the growth period the spine begins to remodel according to the Hueter-Volkmann Law, bone growth is relatively inhibited in areas of increased pressure (convex or tethered side) and relatively stimulated in areas of decreased pressure or tension (concave side). Following this principle, AVBT has been shown to alter spinal growth with the potential to correct scoliosis while maintaining spine flexibility.
The objective of the study is to assess the ongoing safety and probable benefit of The Tether HUD which was approved by the FDA under an HDE. Subject enrollment and data collection will be managed by the Harms Study Group (HSG) and Setting Scoliosis Straight Foundation (SSSF) Registry. Institutions that are HSG members or affiliates, with Investigators/surgeons that are trained and approved to perform surgeries with The Tether, will participate in the registry. Ten sites from this group will be identified as study sites specific to this Tether post-approval study (PAS). Consecutive subjects from these sites, that meet the eligibility criteria of this study, will be flagged in the registry as the PAS cohort and the study endpoints will be assessed across this population.
The objective of the study is to assess the ongoing safety and probable benefit of The Tether HUD which was approved by the FDA under an HDE. Subject enrollment and data collection will be managed by the Harms Study Group (HSG) and Setting Scoliosis Straight Foundation (SSSF) Registry. Institutions that are HSG members or affiliates, with Investigators/surgeons that are trained and approved to perform surgeries with The Tether, will participate in the registry. Ten sites from this group will be identified as study sites specific to this Tether post-approval study (PAS). Consecutive subjects from these sites, that meet the eligibility criteria of this study, will be flagged in the registry as the PAS cohort and the study endpoints will be assessed across this population.
Categories
Central Contacts
Central Contact Role
Contact
Central Contact Phone
1-303-465-8960
Central Contact Email
Monica.Barascout@zimvie.com
Central Contact Role
Contact
Central Contact Phone
1-303-465-8960
Central Contact Email
Kim.Martinez@zimvie.com
Completion Date
Completion Date Type
Estimated
Conditions
Scoliosis Idiopathic
Eligibility Criteria
Inclusion Criteria:
* Diagnosis of progressive idiopathic scoliosis
* Skeletally immature, based on both Risser (\<5) and Sanders (\<8) assessments
* Major Cobb angle ≥30° and ≤65°
* Osseous structure dimensionally adequate to accommodate screw fixation, as determined by radiographic imaging
* Failed or intolerant to bracing
Exclusion Criteria:
* Presence of any systemic infection, local infection, or skin compromise at the surgical site
* Prior spinal surgery at the level(s) to be treated
* Documented poor bone quality, defined as a T-score -1.5 or less
* Any other medical or surgical condition which would preclude the potential benefit of spinal surgery, such as coagulation disorders, allergies to the implant materials, and patient's unwillingness or inability to cooperate with post-operative care instructions
* Unwillingness, inability, or living situation (e.g. custody arrangements, homelessness, detention) that would preclude ability to return to the study site for follow-up visits as described in protocol and Informed Consent
* Unwillingness to sign Informed Consent Form and participate in study procedures
* Diagnosis of progressive idiopathic scoliosis
* Skeletally immature, based on both Risser (\<5) and Sanders (\<8) assessments
* Major Cobb angle ≥30° and ≤65°
* Osseous structure dimensionally adequate to accommodate screw fixation, as determined by radiographic imaging
* Failed or intolerant to bracing
Exclusion Criteria:
* Presence of any systemic infection, local infection, or skin compromise at the surgical site
* Prior spinal surgery at the level(s) to be treated
* Documented poor bone quality, defined as a T-score -1.5 or less
* Any other medical or surgical condition which would preclude the potential benefit of spinal surgery, such as coagulation disorders, allergies to the implant materials, and patient's unwillingness or inability to cooperate with post-operative care instructions
* Unwillingness, inability, or living situation (e.g. custody arrangements, homelessness, detention) that would preclude ability to return to the study site for follow-up visits as described in protocol and Informed Consent
* Unwillingness to sign Informed Consent Form and participate in study procedures
Inclusion Criteria
Inclusion Criteria:
* Diagnosis of progressive idiopathic scoliosis
* Skeletally immature, based on both Risser (\<5) and Sanders (\<8) assessments
* Major Cobb angle ≥30° and ≤65°
* Osseous structure dimensionally adequate to accommodate screw fixation, as determined by radiographic imaging
* Failed or intolerant to bracing
* Diagnosis of progressive idiopathic scoliosis
* Skeletally immature, based on both Risser (\<5) and Sanders (\<8) assessments
* Major Cobb angle ≥30° and ≤65°
* Osseous structure dimensionally adequate to accommodate screw fixation, as determined by radiographic imaging
* Failed or intolerant to bracing
Gender
All
Gender Based
false
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
NCT Id
NCT04505579
Org Class
Industry
Org Full Name
ZimVie
Org Study Id
RAU2019-40S
Overall Status
Recruiting
Primary Completion Date
Primary Completion Date Type
Estimated
Official Title
The Tether™ - Vertebral Body Tethering System Post Approval Study
Primary Outcomes
Outcome Description
The primary safety endpoint is the rate of Serious Adverse Events (SAEs) and device- and/or procedure-related Adverse Events (AEs)
Outcome Measure
Rate of SAEs and device- &/or procedure-related AEs
Outcome Time Frame
AVBT surgery to five year post-op
Outcome Description
The primary probable benefit endpoint is the percentage of patients with maintenance of the major Cobb angle less than or equal to 40 degrees at 60 months post-surgery
Outcome Measure
Percentage of subjects with maintenance of the major Cobb angle less than or equal to 40 degrees at 60 months post-surgery
Outcome Time Frame
AVBT surgery to five year post-op
Secondary Outcomes
Outcome Description
Rates of overall Adverse Events; relatedness, severity, time to event
Outcome Time Frame
AVBT surgery to five year post-op
Outcome Measure
Adverse Events
Outcome Description
Rates and types of reoperation
Outcome Time Frame
AVBT surgery to five year post-op
Outcome Measure
Reoperation
Outcome Description
Determined by radiographic assessment, defined as a new curve development with Cobb angle measurement greater than or equal to 40 degrees.
Outcome Time Frame
AVBT surgery to five year post-op
Outcome Measure
Number of participants with new curves that develop above or below the tethered portion of the spine.
Outcome Description
Determined by radiographic assessment, typically defined as an increase in secondary Cobb angle measurement greater than or equal to 10 degrees, or medical intervention/ intent to treat.
Outcome Time Frame
AVBT surgery to five year post-op
Outcome Measure
Number of participants with secondary curves that progress to the point of clinical significance.
Outcome Time Frame
AVBT surgery to five year post-op
Outcome Measure
Number of participants with device integrity failures including cord breakage and screw migration.
Outcome Description
Sagittal balance is assessed on the lateral radiograph by measuring the difference (i.e. distance) between posterosuperior aspect of the S1 vertebral body and the plumb line.
Outcome Time Frame
Baseline to five year post-op
Outcome Measure
Mean (SD) and distributions of sagittal balance (mm) from pre-op through last visit
Outcome Description
Lumbar lordosis is defined as the angle at the intersection of lines perpendicular to lines parallel to the superior endplate of T12 and the superior endplate of S1.
Outcome Time Frame
Baseline to five year post-op
Outcome Measure
Mean (SD) and distributions of lumbar lordosis (degrees) from pre-op through last visit.
Outcome Description
Self-reported outcomes of function, pain, self-image, mental health, and satisfaction. Mean score; 5 (Best) - 1 (Worst)
Outcome Time Frame
Baseline to five year post-op
Outcome Measure
Mean score of Scoliosis Research Society 22r Patient Questionnaire
Outcome Description
Comparison of the measured lung function (forced expiratory volume (FEV1), forced vital capacity (FVC) and FEV1/FVC) to predicted values, lower and upper limits of normal to determine if lung function is within the limits of the normal population.
Outcome Time Frame
Baseline to five year post-op
Outcome Measure
Number of participants with compromised lung function
Outcome Description
Measurements of trunk shape or rib hump will be collected preoperatively and at each follow-up visit. A standard scoliometer device will be used to measure the rib hump in the thoracic and/or lumbar regions of the spine, as applicable. The scoliometer is laid across the curve at right angles with the 0° mark at the spinous process and resting gently on the skin, not pressed down. The degrees of rotation are read and recorded.
Outcome Time Frame
Baseline to five year post-op
Outcome Measure
Measurement (degrees rotation) of trunk shape by scoliometer device. Mean (SD) [min, max] will be reported.
Outcome Time Frame
Baseline to five year post-op
Outcome Measure
Trunk flexibility as determined by distance (cm) of flexion and lateral bend using fingertip to floor method.
Start Date
Start Date Type
Actual
Status Verified Date
First Post Date
First Post Date Type
Actual
First Submit Date
First Submit QC Date
Study Population
The Tether™ - Vertebral Body Tethering System is indicated for skeletally immature patients that require surgical treatment to obtain and maintain correction of progressive idiopathic scoliosis, with a major Cobb angle of 30 to 65 degrees whose osseous structure is dimensionally adequate to accommodate screw fixation, as determined by radiographic imaging. Patients should have failed bracing and/or be intolerant to brace wear.
Std Ages
Child
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
999
Minimum Age Number (converted to Years and rounded down)
0
Investigators
Investigator Type
Principal Investigator
Investigator Name
Jaime Gomez
Investigator Email
jgomezhe@montefiore.org
Investigator Phone