Adolescent Idiopathic ScoliosisNCT02590380
Comparing Pedicle Screw Systems for the Treatment of Adolescent Paediatric Spine Deformity
A study testing MESA Rail Deformity System and DePuy Synthes USS II System in people with Adolescent Idiopathic Scoliosis, run by K2M, Inc. at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 11 to 21 years
- Conditions the study is for
- Adolescent Idiopathic Scoliosis
- What is being tested?
- MESA Rail Deformity System and DePuy Synthes USS II System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Sep 2022to Sep 2030
- Phase
- Interventional
- 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 11 to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 18Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
University Hospital Southampton
Southampton, S)16 6YD
About this study
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
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.
Read the 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.
- Conditions
- Adolescent Idiopathic Scoliosis
- Being tested
- MESA Rail Deformity System, DePuy Synthes USS II System
- Keywords
- Adolescent, paediatric, pediatric, scoliosis, spine deformity
- Medical subject headings
- Scoliosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MESA Rail Deformity SystemDevice
Also called MESA Rail, K2M MESA Rail, MESA, K2M MESA
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.
DePuy Synthes USS II SystemDevice
Also called DePuy, DePuy Synthes, Synthes, USS II, Universal Stainless
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.
| Study group | Role | What they receive |
|---|---|---|
| treatment group (MESA) | Active comparator | Patients randomized to the treatment group will receive surgery with the MESA Rail Deformity System. Receives: Device: MESA Rail Deformity System |
| control group (USS II) | Active comparator | Patients randomized to the control group will receive surgery with the DePuy Synthes USS II System. Receives: Device: DePuy Synthes USS II System |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Change from pre-operative to 3 months, 12 months and 24 months post-procedure
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.
Measured: Change from pre-operative to 3 months, 12 months and 24 months post-procedure
Secondary outcomes (7)
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.
Measured: Initial follow-up (2 weeks to 8 weeks), 3 months, 12 months and 24 months post-procedure.
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.
Measured: Initial follow-up (2 weeks to 8 weeks), 3 months, 12 months and 24 months post-procedure.
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.
Measured: 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.
Length of Hospital Stay
The length of hospital stay from the date of admission to the date of discharge will be calculated.
Measured: 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.
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.
Measured: Initial follow-up (2 weeks to 8 weeks), 3 months, 12 months and 24 months post-procedure.
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.
Measured: Initial follow-up (2 weeks to 8 weeks), 3 months, 12 months and 24 months post-procedure.
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.
Measured: Initial follow-up (2 weeks to 8 weeks), 3 months, 12 months and 24 months post-procedure.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2015 (estimated)
- Study startSep 2022 (estimated)
- Primary completionSep 2028 (estimated)
- Study completionSep 2030 (estimated)
Why it stopped: Study was not started
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adolescent Idiopathic ScoliosisStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- K2M, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02590380
- Sponsor's protocol ID
- CAS-029
- Status last verified
- Oct 2021
- First submitted
- 22 Oct 2015
- Last updated
- 21 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02590380
- Acronym / sponsor ID
- CAS-029
- Conditions
- Adolescent Idiopathic Scoliosis
- Keywords
- Adolescent, paediatric, pediatric, scoliosis, spine deformity
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study was not started
- Enrolment
- 0 participants (actual)
- Lead sponsor
- K2M, Inc.Industry (pharma, biotech, devices)
- Study start
- Sep 2022 (estimated)
- Primary completion
- Sep 2028 (estimated)
- Study completion
- Sep 2030 (estimated)
- First posted
- 29 Oct 2015 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| treatment group (MESA) | Active comparator | Device: MESA Rail Deformity SystemPatients randomized to the treatment group will receive surgery with the MESA Rail Deformity System. |
| control group (USS II) | Active comparator | Device: DePuy Synthes USS II SystemPatients randomized to the control group will receive surgery with the DePuy Synthes USS II System. |
Who may qualify
- Ages
- 11 to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (18 listed)
- 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.
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 |
|---|---|---|
| MESA Rail Deformity SystemAlso: MESA Rail, K2M MESA Rail, MESA, K2M MESAThe 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. | Device | treatment group (MESA) |
| DePuy Synthes USS II SystemAlso: DePuy, DePuy Synthes, Synthes, USS II, Universal StainlessThe 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. | Device | control group (USS II) |
Primary outcome
Correction and Maintenance of Spinal Deformity (coronal)
Time frame: Change from pre-operative to 3 months, 12 months and 24 months post-procedure
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)
Time frame: Change from pre-operative to 3 months, 12 months and 24 months post-procedure
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.
7 secondary outcomes
Back and Leg Pain 10cm Visual Analog Scale (VAS)
Time frame: Initial follow-up (2 weeks to 8 weeks), 3 months, 12 months and 24 months post-procedure.
SRS-22
Time frame: Initial follow-up (2 weeks to 8 weeks), 3 months, 12 months and 24 months post-procedure.
Estimated Blood Volume Loss/Salvage Return
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.
Length of Hospital Stay
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.
Return to Work/School
Time frame: Initial follow-up (2 weeks to 8 weeks), 3 months, 12 months and 24 months post-procedure.
Return to Sport/Physical Activity
Time frame: Initial follow-up (2 weeks to 8 weeks), 3 months, 12 months and 24 months post-procedure.
Use of Analgesia Post-Surgery
Time frame: Initial follow-up (2 weeks to 8 weeks), 3 months, 12 months and 24 months post-procedure.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2021.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MESA Rail Deformity System and DePuy Synthes USS II System in people with Adolescent Idiopathic Scoliosis, run by K2M, Inc. at 1 site in United Kingdom.
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 4 inclusion and 18 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: withdrawn, as of the sponsor's last update on 21 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. 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 was withdrawn before enrolling participants, so there are no results.
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?
Correction and Maintenance of Spinal Deformity (coronal) (time frame: Change from pre-operative to 3 months, 12 months and 24 months post-procedure). The study lists 2 primary outcomes in all. 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 21 Oct 2021.