Comparing Pedicle Screw Systems for the Treatment of Adolescent Paediatric Spine Deformity

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.

Study Overview

• Status: Withdrawn
• Conditions: Adolescent Idiopathic Scoliosis
• Intervention / Treatment: Device: MESA Rail Deformity System; Device: DePuy Synthes USS II 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 Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Southampton, United Kingdom, S)16 6YD
    • University Hospital Southampton

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 7 years to 17 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. 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.
2. Willingness and ability to comply with the requirements of the protocol including follow-up requirements.
3. 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.
4. Age range of ≥ 11 years old and ≤ 21 years old at time of surgery.

Exclusion Criteria:

1. Previous anterior or posterior spine surgery at the index levels.
2. Previous posterior spine surgery (e.g., posterior element decompression) that destabilizes the cervical/thoracic/lumbar spine.
3. Active systemic infection or infection at the operative site.
4. Any sign of any spinal dysrhaphism (any cord abnormality).
5. Co-morbid medical conditions of the spine or upper/lower extremities that may affect the thoracic or lumbar spine neurological and/or pain assessment.
6. Metabolic bone disease such as osteoporosis that contradicts spinal surgery.
7. History of an osteoporotic fracture.
8. History of an endocrine or metabolic disorder (e.g., Paget's disease) known to affect bone and mineral metabolism.
9. Taking medications that may interfere with bony/soft tissue healing including chronic oral steroid use.
10. Known allergy to titanium or cobalt chrome.
11. Rheumatoid arthritis or other autoimmune disease or a systemic disorder such as HIV, active hepatitis B or C or fibromyalgia.
12. Insulin-dependent type 1 or type 2 diabetes.
13. Medical condition (e.g., unstable cardiac disease, cancer) that may result in patient death or have an effect on outcomes prior to study completion.
14. Pregnant, or intend to become pregnant, during the course of the study.
15. Severe obesity (Body Mass Index > 40).
16. 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.
17. Incarcerated at the time of study enrollment.
18. Current participation in an investigational study that may impact study outcomes.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: treatment group (MESA); Patients randomized to the treatment group will receive surgery with the MESA Rail Deformity System.	Device: MESA Rail Deformity System; 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.; Other Names: MESA Rail, K2M MESA Rail, MESA, K2M MESA
Active Comparator: control group (USS II); Patients randomized to the control group will receive surgery with the DePuy Synthes USS II System.	Device: DePuy Synthes USS II System; 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.; Other Names: DePuy, DePuy Synthes, Synthes, USS II, Universal Stainless

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	Change from pre-operative to 3 months, 12 months and 24 months post-procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	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.	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.	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.	Initial follow-up (2 weeks to 8 weeks), 3 months, 12 months and 24 months post-procedure.

Collaborators and Investigators

• Sponsor: K2M, Inc.

Study record dates

Study Major Dates

• Study Start (Anticipated): September 1, 2022
• Primary Completion (Anticipated): September 1, 2028
• Study Completion (Anticipated): September 1, 2030

Study Registration Dates

• First Submitted: October 22, 2015
• First Submitted That Met QC Criteria: October 27, 2015
• First Posted (Estimate): October 29, 2015

Study Record Updates

• Last Update Posted (Actual): October 21, 2021
• Last Update Submitted That Met QC Criteria: October 14, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Keywords: Adolescent; pediatric; scoliosis; paediatric; spine deformity
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Spinal Diseases; Bone Diseases; Spinal Curvatures; Congenital Abnormalities; Scoliosis
• Other Study ID Numbers: CAS-029

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No