Adolescent Idiopathic ScoliosisNCT02062606

MESA Rail™ AIS Study - Preservation of Curve Correction

An observational study of Adolescent Idiopathic Scoliosis, run by K2M, Inc..

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Trial summary

To evaluate the restoration and maintenance of thoracic kyphosis and coronal curve correction demonstrated through the surgical implantation of the K2M MESA Rail™ Deformity System as compared to literature reported outcomes for standard Cobalt Chrome (CoCr) rod systems in the treatment of Adolescent Idiopathic… 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
Type of treatment: Medical device
How many people: 188 participants
Where: No sites listed yet
Study dates: May 2014to 23 Feb 2020
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

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

Study population: Two-hundred four (204) total subjects with the MESA Rail Deformity System at up to 18 clinical sites, geographically distributed worldwide.

Who may be able to join

Diagnosis of AIS 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.
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.

Show all 14Show fewer

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 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).

About this study

Official title: Preservation of Thoracic Kyphosis and Coronal Curve Correction as a Function of Rod Stiffness in the Surgical Treatment of Adolescent Idiopathic Scoliosis (AIS) With the Use of the K2M MESA Rail™ Deformity System

Read the detailed description

Patients treated with the Ø5.5mm or Ø4.5mm MESA Rail™ Deformity System that had:

Diagnosis of AIS requiring surgical treatment for selective non-cervical 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 (lumbar modifiers and thoracic sagittal profiles will be noted but not restrictive).

Age at time of surgery of ≥ 11 years old and ≤ 21 years old.

Conditions: Adolescent Idiopathic Scoliosis
Being tested: MESA Rail™ Deformity System
Keywords: Scoliosis, Spinal Curvatures, Spinal Diseases, Adolescent Idiopathic Scoliosis, Spinal Deformity
Medical subject headings: Scoliosis, Spinal Curvatures, Spinal Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

MESA Rail™ Deformity SystemDevice
MESA Rail™ (cross-sectioned rod) with MESA pedicle screws compared to traditional rod use in the literature

Study groups in NCT02062606
Study group	Role	What they receive
AIS		Surgical implantation of the K2M MESA Rail™ Deformity System in the treatment of Adolescent Idiopathic Scoliosis (AIS). Receives: Device: MESA Rail™ Deformity System

What is being measured

The primary outcome is the main question the study is designed to answer.

Change From Baseline in Thoracic Kyphosis and Coronal Curve Correction on X-ray at 24 Months
Restoration and maintenance of thoracic kyphosis and coronal curve correction.
Thoracic kyphosis (Coronal Curve): measurement of curvature from the upper endplate of T4 to the lower endplate of T12.
Measured: Baseline (up to 90 days before surgery), 24 months
Number of Participants With Adverse Events
Number of participants with SAE and AE for the various intervals
Measured: Up to 24 months

Secondary outcomes (10)

Change From Baseline in Pain Scores on the Visual Analog Scale (VAS) at 24 Months
Evaluation of the improvement of the Back VAS and Hip/Leg VAS (assessed together) at the 24 month post-operative visit as compared to pre-op time periods. Information on all reports of pain/numbness /tingling and the location of symptoms were captured and evaluated.
VAS scale ranged from 0 - 100mm with the 100mm accounting for the highest level of pain.
Measured: Baseline (up to 90 days before surgery), 24 months
Change From Baseline in Quality of Life Scores on the SRS-22r at 24 Months
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.
Measured: Baseline (up to 90 days before surgery), 24 months
Patient Satisfaction
At the 12 month and 24 month follow-up visits, subjects were asked whether they were satisfied with the outcome of their surgery (Yes/No) and whether they would repeat the operation (Yes/No).
Measured: 12 months and 24 months
Investigator's Rating of Subject's Clinical Disposition Using Odom's Criteria
At the 24 month follow-up visit, the Investigator rated the clinical disposition of each study subject according to Odom's Criteria as follows:
Excellent: all pre-operative symptoms relieved, able to carry out daily occupations without impairment.
Good: minimum persistence of pre-operative symptoms, able to carry out daily occupations without significant interference.
Fair/Satisfactory: relief of some pre-operative symptoms but physical activity is significantly limited.
Poor: symptoms or signs unchanged or worsened.
Measured: 24 months
Length of Surgery Time
The length of the surgical procedure from the initial incision to final closure were captured.
Measured: During surgery
Length of Anesthesia Time
The length of time the patient is under anesthesia was captured.
Measured: During surgery
Estimated Blood Loss
The amount of blood loss over the entire length of the surgery was captured.
Measured: During surgery
Length of Hospital Stay
The length of the hospital stay from the date of admission to the date of discharge.
Measured: Admission to Discharge
Change in Percentage of Participants Able to 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 by looking at the change in percentage of participants who were able to return to work without any restrictions
Measured: Pre-Op to 24 months
Use of Narcotics Post-surgery
The types and dosages of any narcotics taken by the patient pre- and post-surgery was documented.
Measured: Pre-Op to 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

May 201423 Feb 2020

First posted13 Feb 2014 (estimated)
Study startMay 2014
Primary completion23 Feb 2020
Study completion23 Feb 2020

Why it stopped: The study terminated early due to slow enrollment that significantly extended the expected study duration.

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (3)Papers the sponsor has linked to this study.
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: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 188 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02062606
Sponsor's protocol ID: CA-001
Status last verified: Apr 2021
First submitted: 31 Jan 2014
Last updated: 12 Apr 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

Wattenbarger JM, Richards BS, Herring JA. A comparison of single-rod instrumentation with double-rod instrumentation in adolescent idiopathic scoliosis. Spine (Phila Pa 1976). 2000 Jul 1;25(13):1680-8. doi: 10.1097/00007632-200007010-00011.
PubMed 10870143
Newton PO, Yaszay B, Upasani VV, Pawelek JB, Bastrom TP, Lenke LG, Lowe T, Crawford A, Betz R, Lonner B; Harms Study Group. Preservation of thoracic kyphosis is critical to maintain lumbar lordosis in the surgical treatment of adolescent idiopathic scoliosis. Spine (Phila Pa 1976). 2010 Jun 15;35(14):1365-70. doi: 10.1097/BRS.0b013e3181dccd63.
PubMed 20505560
Kim YJ, Lenke LG, Bridwell KH, Kim J, Cho SK, Cheh G, Yoon J. Proximal junctional kyphosis in adolescent idiopathic scoliosis after 3 different types of posterior segmental spinal instrumentation and fusions: incidence and risk factor analysis of 410 cases. Spine (Phila Pa 1976). 2007 Nov 15;32(24):2731-8. doi: 10.1097/BRS.0b013e31815a7ead.
PubMed 18007253

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

Active, not recruiting
Diaphragm Mobilization in Adolescent Idiopathic Scoliosis
Adolescent Idiopathic Scoliosis
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Tranexamic Acid in Pediatric Idiopathic Scoliosis Surgery
Scoliosis Idiopathic, Scoliosis; Adolescence
RecruitingObservational study
Turkish Adaptation and Validation of the Scoliosis Misconception Scale in Adolescents With Idiopathic Scoliosis
Adolescent Idiopathic Scoliosis (AIS)
Not yet recruitingObservational study
Clinical and Biological Parameters in Adolescent Idiopathic Scoliosis
Adolescent Idiopathic Scoliosis (AIS)
Recruiting
Studying Melatonin and Recovery in Teens
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All Adolescent Idiopathic Scoliosis trials

Study at a glance

From the registry record, last updated by the sponsor on 12 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Preservation of Thoracic Kyphosis and Coronal Curve Correction as a Function of Rod Stiffness in the Surgical Treatment of Adolescent Idiopathic Scoliosis (AIS) With the Use of the K2M MESA Rail™ Deformity System
ClinicalTrials.gov ID: NCT02062606
Acronym / sponsor ID: CA-001
Conditions: Adolescent Idiopathic Scoliosis
Keywords: Scoliosis, Spinal Curvatures, Spinal Diseases, Adolescent Idiopathic Scoliosis, Spinal Deformity
Study type: Observational
Recruitment status: TerminatedReason stopped: The study terminated early due to slow enrollment that significantly extended the expected study duration.
Enrolment: 188 participants (actual)
Lead sponsor: K2M, Inc.Industry (pharma, biotech, devices)
Study start: May 2014
Primary completion: 23 Feb 2020 (actual)
Study completion: 23 Feb 2020 (actual)
First posted: 13 Feb 2014 (estimated)
Results: Posted 12 Apr 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Patients treated with the Ø5.5mm or Ø4.5mm MESA Rail™ Deformity System that had:

AIS cases must be classified as a Lenke type 1 or type 2 curve (lumbar modifiers and thoracic sagittal profiles will be noted but not restrictive).

Age at time of surgery of ≥ 11 years old and ≤ 21 years old.

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
AIS	–	Device: MESA Rail™ Deformity SystemSurgical implantation of the K2M MESA Rail™ Deformity System in the treatment of Adolescent Idiopathic Scoliosis (AIS).

Who may qualify

Ages: 11 to 21 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult
Study population: Two-hundred four (204) total subjects with the MESA Rail Deformity System at up to 18 clinical sites, geographically distributed worldwide.

Key inclusion criteria (4 listed)

Diagnosis of AIS 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 (14 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.
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.

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 SystemMESA Rail™ (cross-sectioned rod) with MESA pedicle screws compared to traditional rod use in the literature	Device	AIS

Primary outcome

Change From Baseline in Thoracic Kyphosis and Coronal Curve Correction on X-ray at 24 Months
Time frame: Baseline (up to 90 days before surgery), 24 months
Restoration and maintenance of thoracic kyphosis and coronal curve correction. Thoracic kyphosis (Coronal Curve): measurement of curvature from the upper endplate of T4 to the lower endplate of T12.
Number of Participants With Adverse Events
Time frame: Up to 24 months
Number of participants with SAE and AE for the various intervals

10 secondary outcomes

Change From Baseline in Pain Scores on the Visual Analog Scale (VAS) at 24 Months
Time frame: Baseline (up to 90 days before surgery), 24 months
Change From Baseline in Quality of Life Scores on the SRS-22r at 24 Months
Time frame: Baseline (up to 90 days before surgery), 24 months
Patient Satisfaction
Time frame: 12 months and 24 months
Investigator's Rating of Subject's Clinical Disposition Using Odom's Criteria
Time frame: 24 months
Length of Surgery Time
Time frame: During surgery
Length of Anesthesia Time
Time frame: During surgery
Estimated Blood Loss
Time frame: During surgery
Length of Hospital Stay
Time frame: Admission to Discharge
Change in Percentage of Participants Able to Return to Work/School
Time frame: Pre-Op to 24 months
Use of Narcotics Post-surgery
Time frame: Pre-Op to 24 months

Results and safety

Results posted to the registry on 12 Apr 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
K2M MESA Rail™ Deformity System	188	99

Primary outcome: Change From Baseline in Thoracic Kyphosis and Coronal Curve Correction on X-ray at 24 Months

Time frame: Baseline (up to 90 days before surgery), 24 months. Mean (95% Confidence Interval). Unit: degrees

Measure	All Patients n = 98
Value	-3.84 (-5.91 to -1.76)

Population analysed: 98 of the 99 participants who returned at 24 Months had the thoracic kyphosis measurement.

Primary outcome: Number of Participants With Adverse Events

Time frame: Up to 24 months. Number. Unit: participants

Measure	Up to Post-Operative n = 188	Post-Operative to 3 Months n = 160	3 to 6 Months n = 147	6 to 12 Months n = 135	12 to 24+ Months n = 99	Overall n = 188
Any AE	62	7	21	25	36	98
Any AE : Procedure Related	44	0	12	9	18	67
Any AE : Device Related	16	0	3	6	7	26
Any AE : Mild	44	6	17	20	29	79
Any AE : Moderate	19	1	4	5	10	31
Any AE : Severe	5	1	0	1	0	7
Any SAE	10	1	0	4	3	17
Any SAE : Procedure Related	8	0	0	1	2	11

Population analysed: This is an analysis of the number of participants that reported any form of adverse event. Overall participants with any AE or SAE. 5 of the 17 SAE participants did not experience a non-SAE events. The other 12 participants had events in both categories. The study did not establish a frequency threshold, therefore, all AEs are listed.

10 secondary outcomes are reported in the full results.

Adverse events

Time frame: From Operative to 24+ Months. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Participants With Adverse Events	17 of 188 (9%)	93 of 188 (49.5%)	0 of 188

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 10870143Wattenbarger JM, Richards BS, Herring JA. A comparison of single-rod instrumentation with double-rod instrumentation in adolescent idiopathic scoliosis. Spine (Phila Pa 1976). 2000 Jul 1;25(13):1680-8. doi: 10.1097/00007632-200007010-00011.
Background: PubMed 20505560Newton PO, Yaszay B, Upasani VV, Pawelek JB, Bastrom TP, Lenke LG, Lowe T, Crawford A, Betz R, Lonner B; Harms Study Group. Preservation of thoracic kyphosis is critical to maintain lumbar lordosis in the surgical treatment of adolescent idiopathic scoliosis. Spine (Phila Pa 1976). 2010 Jun 15;35(14):1365-70. doi: 10.1097/BRS.0b013e3181dccd63.
Background: PubMed 18007253Kim YJ, Lenke LG, Bridwell KH, Kim J, Cho SK, Cheh G, Yoon J. Proximal junctional kyphosis in adolescent idiopathic scoliosis after 3 different types of posterior segmental spinal instrumentation and fusions: incidence and risk factor analysis of 410 cases. Spine (Phila Pa 1976). 2007 Nov 15;32(24):2731-8. doi: 10.1097/BRS.0b013e31815a7ead.

Related trials for Adolescent Idiopathic Scoliosis

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Diaphragm Mobilization in Adolescent Idiopathic Scoliosis
Adolescent Idiopathic Scoliosis
Recruiting
Tranexamic Acid in Pediatric Idiopathic Scoliosis Surgery
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RecruitingObservational study
Turkish Adaptation and Validation of the Scoliosis Misconception Scale in Adolescents With Idiopathic Scoliosis
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Clinical and Biological Parameters in Adolescent Idiopathic Scoliosis
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Recruiting
Studying Melatonin and Recovery in Teens
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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.

Questions about this trial

What is this clinical trial studying?

An observational study of Adolescent Idiopathic Scoliosis, run by K2M, Inc..

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 14 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: stopped early, as of the sponsor's last update on 12 Apr 2021. 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.

Are results available for this study?

Yes. Results are posted in the registry (first posted 12 Apr 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Change From Baseline in Thoracic Kyphosis and Coronal Curve Correction on X-ray at 24 Months (time frame: Baseline (up to 90 days before surgery), 24 months). 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?

On the ClinicalTrials.gov record for NCT02062606, which also lists 3 linked publications.

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 12 Apr 2021.