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

NCT02590380 | Withdrawn

• 1 other identifier: CAS-029
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Adolescent Idiopathic Scoliosis

Keywords

Adolescent; paediatric; pediatric; scoliosis; spine deformity

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (7)

• Back and Leg Pain 10cm Visual Analog Scale (VAS)

  Initial follow-up (2 weeks to 8 weeks), 3 months, 12 months and 24 months post-procedure.

• SRS-22

  Initial follow-up (2 weeks to 8 weeks), 3 months, 12 months and 24 months post-procedure.

• Estimated Blood Volume Loss/Salvage Return

  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

  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

  Initial follow-up (2 weeks to 8 weeks), 3 months, 12 months and 24 months post-procedure.

Study Arms (2)

treatment group (MESA)

ACTIVE COMPARATOR

Patients randomized to the treatment group will receive surgery with the MESA Rail Deformity System.

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.

Device: DePuy Synthes USS II System

Interventions

MESA Rail Deformity System DEVICE

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.

Also known as: MESA Rail, K2M MESA Rail, MESA, K2M MESA

treatment group (MESA)

DePuy Synthes USS II System DEVICE

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.

Also known as: DePuy, DePuy Synthes, Synthes, USS II, Universal Stainless

control group (USS II)

Eligibility Criteria

• Age: 11 Years - 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• K2M, Inc.: lead

Study Sites (1)

University Hospital Southampton

Southampton, S)16 6YD, United Kingdom

Location

MeSH Terms

Conditions

Scoliosis

Condition Hierarchy (Ancestors)

Spinal Curvatures; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 22, 2015
• First Posted: October 29, 2015
• Study Start: September 1, 2022
• Primary Completion (Estimated): September 1, 2028
• Study Completion (Estimated): September 1, 2030
• Last Updated: October 21, 2021

Record last verified: 2021-10

Locations

GB (1)