Back to resultsComparing Pedicle Screw Systems for the Treatment of Adolescent Paediatric Spine Deformity
Primary Purpose
Adolescent Idiopathic Scoliosis
Status
Withdrawn
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
MESA Rail Deformity System
DePuy Synthes USS II System
Sponsored by
About this trial
This is an interventional treatment trial for Adolescent Idiopathic Scoliosis focused on measuring Adolescent, paediatric, pediatric, scoliosis, spine deformity
Eligibility Criteria
Inclusion Criteria:
- Diagnosis of Adolescent Idiopathic Scoliosis (AIS) with no associated syndrome requiring surgical treatment for selective thoracic/lumbar fusion with a minimum of five (5) instrumented vertebrae between T1-S1 as confirmed by patient history and radiographic studies. AIS cases must be classified as a Lenke type 1 or type 2 curve. No cervical vertebrae are to be incorporated into the construct.
- Willingness and ability to comply with the requirements of the protocol including follow-up requirements.
- Willing and able to sign a study specific informed consent form or, in the case of a patient who is a minor, provide assent and the minor patient's parent/legal guardian provides written consent to participate.
- Age range of ≥ 11 years old and ≤ 21 years old at time of surgery.
Exclusion Criteria:
- Previous anterior or posterior spine surgery at the index levels.
- Previous posterior spine surgery (e.g., posterior element decompression) that destabilizes the cervical/thoracic/lumbar spine.
- Active systemic infection or infection at the operative site.
- Any sign of any spinal dysrhaphism (any cord abnormality).
- Co-morbid medical conditions of the spine or upper/lower extremities that may affect the thoracic or lumbar spine neurological and/or pain assessment.
- Metabolic bone disease such as osteoporosis that contradicts spinal surgery.
- History of an osteoporotic fracture.
- History of an endocrine or metabolic disorder (e.g., Paget's disease) known to affect bone and mineral metabolism.
- Taking medications that may interfere with bony/soft tissue healing including chronic oral steroid use.
- Known allergy to titanium or cobalt chrome.
- Rheumatoid arthritis or other autoimmune disease or a systemic disorder such as HIV, active hepatitis B or C or fibromyalgia.
- Insulin-dependent type 1 or type 2 diabetes.
- Medical condition (e.g., unstable cardiac disease, cancer) that may result in patient death or have an effect on outcomes prior to study completion.
- Pregnant, or intend to become pregnant, during the course of the study.
- Severe obesity (Body Mass Index > 40).
- Physical or mental condition (e.g., psychiatric disorder, senile dementia, Alzheimer's disease, alcohol or drug addiction) that would interfere with patient self-assessment of function, pain or quality of life.
- Incarcerated at the time of study enrollment.
- Current participation in an investigational study that may impact study outcomes.
Sites / Locations
- University Hospital Southampton
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
treatment group (MESA)
control group (USS II)
Arm Description
Patients randomized to the treatment group will receive surgery with the MESA Rail Deformity System.
Patients randomized to the control group will receive surgery with the DePuy Synthes USS II System.
Outcomes
Primary Outcome Measures
Correction and Maintenance of Spinal Deformity (coronal)
Radiographic analysis of the spinal deformity in the coronal plane at the indicated time periods will be compared to the pre-operative measurements (OVERALL CHANGE from baseline at each timepoint). Later post-operative measurements will be compared to the initial correction values to establish maintenance of surgical correction over time.
Correction and Maintenance of Spinal Deformity (sagittal)
Radiographic analysis of the spinal deformity in the sagittal plane at the indicated time periods will be compared to the pre-operative measurements (OVERALL CHANGE from baseline at each timepoint). Later post-operative measurements will be compared to the initial correction values to establish maintenance of surgical correction over time.
Secondary Outcome Measures
Back and Leg Pain 10cm Visual Analog Scale (VAS)
The severity of back and leg pain will be evaluated in all study subjects using a 10-cm visual analog scale (VAS). The study will employ a 15% improvement for success. OVERALL CHANGE from baseline will be assessed at each timepoint.
SRS-22
Scoliosis and its treatment have a great impact on the quality of life of the affected patients. The Revised Scoliosis Research Society-22 (SRS-22r) is a specific questionnaire for spine conditions. It is applied to patients with idiopathic scoliosis, whose conditions and treatments have a great impact on their quality of life. The SRS-22r was created and revised with the purpose of evaluating this impact from the patient's point of view. The reviewed version contains 22 questions distributed into five domains: function/activity (FA), pain (P), self-image/appearance (SA), mental health (MH) and satisfaction with treatment (ST). The scores vary from 1 to 5, in which 5 is the best health quality of life of patients. OVERALL CHANGE from baseline will be assessed at each timepoint.
Estimated Blood Volume Loss/Salvage Return
The amount of blood loss over the entire length of the surgery as well as salvage return volumes will be captured intraoperatively.
Length of Hospital Stay
The length of hospital stay from the date of admission to the date of discharge will be calculated.
Return to Work/School
The ability to and the time it takes for the subject to be cleared to return to work/school from the date of surgery will be documented. Once the subject has returned to the "baseline" status this question will not be asked.
Return to Sport/Physical Activity
The ability to return to sport as performed by the individual patient pre operatively. Time to walking unaided, running, swimming, trampoline, contact sport, normal social interactions with peer group. Once the subject has returned to the "baseline" status this question will not be asked.
Use of Analgesia Post-Surgery
The types and dosages of any analgesia taken by the patient post-surgery will be documented. Overall change from baseline (pre-operative medications) will be analyzed at each interval - anticipation is that use of analgesia decreases and/or ends after surgery.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02590380
Brief Title
Comparing Pedicle Screw Systems for the Treatment of Adolescent Paediatric Spine Deformity
Official Title
A Randomized Controlled Trial: Comparison of a Top Loading MESA® Spinal System With MESA Rail™ and a Side Locking Pedicle Screw System for the Treatment of Adolescent Paediatric Spine Deformity
Study Type
Interventional
2. Study Status
Record Verification Date
October 2021
Overall Recruitment Status
Withdrawn
Why Stopped
Study was not started
Study Start Date
September 2022 (Anticipated)
Primary Completion Date
September 2028 (Anticipated)
Study Completion Date
September 2030 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
K2M, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Evaluation of the efficacy of the K2M MESA Rail™ Deformity System at improving coronal and sagittal correction of the adolescent idiopathic spine deformity in comparison to the side loading DePuy Synthes USS II pedicle screw system.
Detailed Description
Evaluation of the efficacy of the K2M MESA Rail™ Deformity System at improving coronal and sagittal correction of the adolescent idiopathic spine deformity in comparison to the side loading DePuy Synthes USS II pedicle screw system. This is a single-center, single-surgeon randomized controlled trial with follow-up evaluations of patients conducted at initial follow-up (2 weeks to 8 weeks), 3 months, 12 months and 24 months post-procedure. Adverse events will be monitored continuously.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adolescent Idiopathic Scoliosis
Keywords
Adolescent, paediatric, pediatric, scoliosis, spine deformity
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
treatment group (MESA)
Arm Type
Active Comparator
Arm Description
Patients randomized to the treatment group will receive surgery with the MESA Rail Deformity System.
Arm Title
control group (USS II)
Arm Type
Active Comparator
Arm Description
Patients randomized to the control group will receive surgery with the DePuy Synthes USS II System.
Intervention Type
Device
Intervention Name(s)
MESA Rail Deformity System
Other Intervention Name(s)
MESA Rail, K2M MESA Rail, MESA, K2M MESA
Intervention Description
The spinal deformity will be correction via a standard of care procedure performed by the principal investigator. The correction will be fixated with the MESA Rail Deformity System.
Intervention Type
Device
Intervention Name(s)
DePuy Synthes USS II System
Other Intervention Name(s)
DePuy, DePuy Synthes, Synthes, USS II, Universal Stainless
Intervention Description
The spinal deformity will be correction via a standard of care procedure performed by the principal investigator. The correction will be fixated with the DePuy Synthes USS II system.
Primary Outcome Measure Information:
Title
Correction and Maintenance of Spinal Deformity (coronal)
Description
Radiographic analysis of the spinal deformity in the coronal plane at the indicated time periods will be compared to the pre-operative measurements (OVERALL CHANGE from baseline at each timepoint). Later post-operative measurements will be compared to the initial correction values to establish maintenance of surgical correction over time.
Time Frame
Change from pre-operative to 3 months, 12 months and 24 months post-procedure
Title
Correction and Maintenance of Spinal Deformity (sagittal)
Description
Radiographic analysis of the spinal deformity in the sagittal plane at the indicated time periods will be compared to the pre-operative measurements (OVERALL CHANGE from baseline at each timepoint). Later post-operative measurements will be compared to the initial correction values to establish maintenance of surgical correction over time.
Time Frame
Change from pre-operative to 3 months, 12 months and 24 months post-procedure
Secondary Outcome Measure Information:
Title
Back and Leg Pain 10cm Visual Analog Scale (VAS)
Description
The severity of back and leg pain will be evaluated in all study subjects using a 10-cm visual analog scale (VAS). The study will employ a 15% improvement for success. OVERALL CHANGE from baseline will be assessed at each timepoint.
Time Frame
Initial follow-up (2 weeks to 8 weeks), 3 months, 12 months and 24 months post-procedure.
Title
SRS-22
Description
Scoliosis and its treatment have a great impact on the quality of life of the affected patients. The Revised Scoliosis Research Society-22 (SRS-22r) is a specific questionnaire for spine conditions. It is applied to patients with idiopathic scoliosis, whose conditions and treatments have a great impact on their quality of life. The SRS-22r was created and revised with the purpose of evaluating this impact from the patient's point of view. The reviewed version contains 22 questions distributed into five domains: function/activity (FA), pain (P), self-image/appearance (SA), mental health (MH) and satisfaction with treatment (ST). The scores vary from 1 to 5, in which 5 is the best health quality of life of patients. OVERALL CHANGE from baseline will be assessed at each timepoint.
Time Frame
Initial follow-up (2 weeks to 8 weeks), 3 months, 12 months and 24 months post-procedure.
Title
Estimated Blood Volume Loss/Salvage Return
Description
The amount of blood loss over the entire length of the surgery as well as salvage return volumes will be captured intraoperatively.
Time Frame
Operative Data - to be collected immediately after case is completed. Estimated blood loss will be noted by the surgical/anesthesia team and this value can then be immediately collected.
Title
Length of Hospital Stay
Description
The length of hospital stay from the date of admission to the date of discharge will be calculated.
Time Frame
At discharge (up to one week post surgery) - Once the subject has been released from the hospital, the length of hospital stay can be calculated using the intake and discharge dates.
Title
Return to Work/School
Description
The ability to and the time it takes for the subject to be cleared to return to work/school from the date of surgery will be documented. Once the subject has returned to the "baseline" status this question will not be asked.
Time Frame
Initial follow-up (2 weeks to 8 weeks), 3 months, 12 months and 24 months post-procedure.
Title
Return to Sport/Physical Activity
Description
The ability to return to sport as performed by the individual patient pre operatively. Time to walking unaided, running, swimming, trampoline, contact sport, normal social interactions with peer group. Once the subject has returned to the "baseline" status this question will not be asked.
Time Frame
Initial follow-up (2 weeks to 8 weeks), 3 months, 12 months and 24 months post-procedure.
Title
Use of Analgesia Post-Surgery
Description
The types and dosages of any analgesia taken by the patient post-surgery will be documented. Overall change from baseline (pre-operative medications) will be analyzed at each interval - anticipation is that use of analgesia decreases and/or ends after surgery.
Time Frame
Initial follow-up (2 weeks to 8 weeks), 3 months, 12 months and 24 months post-procedure.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
11 Years
Maximum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Diagnosis of Adolescent Idiopathic Scoliosis (AIS) with no associated syndrome requiring surgical treatment for selective thoracic/lumbar fusion with a minimum of five (5) instrumented vertebrae between T1-S1 as confirmed by patient history and radiographic studies. AIS cases must be classified as a Lenke type 1 or type 2 curve. No cervical vertebrae are to be incorporated into the construct.
Willingness and ability to comply with the requirements of the protocol including follow-up requirements.
Willing and able to sign a study specific informed consent form or, in the case of a patient who is a minor, provide assent and the minor patient's parent/legal guardian provides written consent to participate.
Age range of ≥ 11 years old and ≤ 21 years old at time of surgery.
Exclusion Criteria:
Previous anterior or posterior spine surgery at the index levels.
Previous posterior spine surgery (e.g., posterior element decompression) that destabilizes the cervical/thoracic/lumbar spine.
Active systemic infection or infection at the operative site.
Any sign of any spinal dysrhaphism (any cord abnormality).
Co-morbid medical conditions of the spine or upper/lower extremities that may affect the thoracic or lumbar spine neurological and/or pain assessment.
Metabolic bone disease such as osteoporosis that contradicts spinal surgery.
History of an osteoporotic fracture.
History of an endocrine or metabolic disorder (e.g., Paget's disease) known to affect bone and mineral metabolism.
Taking medications that may interfere with bony/soft tissue healing including chronic oral steroid use.
Known allergy to titanium or cobalt chrome.
Rheumatoid arthritis or other autoimmune disease or a systemic disorder such as HIV, active hepatitis B or C or fibromyalgia.
Insulin-dependent type 1 or type 2 diabetes.
Medical condition (e.g., unstable cardiac disease, cancer) that may result in patient death or have an effect on outcomes prior to study completion.
Pregnant, or intend to become pregnant, during the course of the study.
Severe obesity (Body Mass Index > 40).
Physical or mental condition (e.g., psychiatric disorder, senile dementia, Alzheimer's disease, alcohol or drug addiction) that would interfere with patient self-assessment of function, pain or quality of life.
Incarcerated at the time of study enrollment.
Current participation in an investigational study that may impact study outcomes.
Facility Information:
Facility Name
University Hospital Southampton
City
Southampton
ZIP/Postal Code
S)16 6YD
Country
United Kingdom
12. IPD Sharing Statement
Learn more about this trial
Comparing Pedicle Screw Systems for the Treatment of Adolescent Paediatric Spine Deformity
We'll reach out to this number within 24 hrs