Anterior Vertebral Body Tethering (AVBT) Using Zimmer Biomet Tether System or Dynesys System Components to Treat Pediatric Scoliosis

• Sponsor: Mayo Clinic (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT03506334
• Collaborator: (none)
• Enrollment: 80
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 79.2
• Patients Per Site Per Month: 1

Study Details

Study Description

Brief Summary

The Researchers want to assess the short-term safety of Anterior Vertebral Body Tethering (AVBT) in skeletally immature subjects with moderate to severe scoliosis and compare them with a fusion cohort.

Condition or Disease	Intervention/Treatment	Phase
Scoliosis	Device: AVBT using Dynesys System Components; Procedure: Spine fusion	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 80 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Tether group 40 patients and Fusion (control) group 40 patientsTether group 40 patients and Fusion (control) group 40 patients
• Masking: None (Open Label)
• Primary Purpose: Device Feasibility
• Official Title: Prospective Pilot Study of Anterior Vertebral Body Tethering Using Zimmer Biomet Tether System or Dynesys System Components to Treat Pediatric Scoliosis
• Actual Study Start Date: Apr 25, 2018
• Anticipated Primary Completion Date: Dec 1, 2022
• Anticipated Study Completion Date: Dec 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Pediatric Scoliosis Patients Tether group	Device: AVBT using Dynesys System Components; Zimmer Biomet Tether System and Dynesys System components are intended to treat scoliosis in skeletally immature children.
Active Comparator: Pediatric Scoliosis Control Patients Fusion (control) group	Procedure: Spine fusion; Children with scoliosis undergoing fusion surgery will form the control arm

Outcome Measures

Primary Outcome Measures

1. Revision spine surgery within 2 years of index procedure [2 years]

   yes/no parameter, was revision surgery performed within 2 years of index procedure

Secondary Outcome Measures

1. Major cobb angle curve progression greater than 10 degrees and curve magnitude < 50 degrees at latest f/u after 1st erect postop film (Tether arm) [1 year]

   yes/no parameter, did major Cobb angle worsen by 10 degrees and curve magnitude < 50 degrees at latest f/u after 1st erect postop film

2. Curve progression no greater than 10 degrees at latest f/u after 1st erect postop film (Fusion arm) [1 year]

   yes/no parameter, did major Cobb angle worsen by 10 degrees at latest f/u after 1st erect postop film

3. Curve flexibility over instrumented vertebra > 5 degrees [At least 1 year postoperatively]

   Flexibility films will be obtained in patients postoperatively to assess flexibility

4. Spinal disc health utilizing MRI [At least 1 year postoperatively]

   Spinal disc health will be assessed in Tether patients post-operatively using an MRI in conjunction with the Pfirrmann classification (scored I to V, where I indicated normal and V indicated the worst degeneration).

Eligibility Criteria

Criteria

• Ages Eligible for Study: 10 Years to 16 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. Male & female, age 10 years to 16 years.

2. Scoliosis curve between 40-70 degrees.

3. At least 1 year of growth remaining measured by Sanders bone age 4 or less or Risser stage 2 or less.

4. Adolescent idiopathic scoliosis.

5. Lenke 1, 2, 3C, 5 (thoracic, thoracolumbar, or thoracic and lumbar).

6. Parents must be able to understand the study and sign the consent document. Assent will be obtained and documented as age appropriate.

7. Patients and parents must be able to comply with study procedures and visits, including 3-month, 1-year, and 2-year follow-up visits.

Exclusion Criteria:

1. Congenital, neuromuscular or syndromic scoliosis.

2. Underlying neuromuscular disease.

3. Pregnancy.

4. Nonflexible curves (bending films show residual curve greater than 40 degrees).

5. Prior surgery for scoliosis treatment.

6. Patients with active systemic infection.

7. Known, reported allergies to titanium, PET, or PCU. Known, reported substance abuse, including alcohol.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Mayo Clinic	Rochester	Minnesota	United States	55905

Sponsors and Collaborators

• Mayo Clinic

Investigators

• Principal Investigator: A. Noelle Larson, MD, Mayo Clinic

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Mayo Clinic Clinical Trials

Publications

None provided.

• Responsible Party: A. Noelle Larson, Principal Investigator, Mayo Clinic
• ClinicalTrials.gov Identifier: NCT03506334
• Other Study ID Numbers: 17-007801
• First Posted: Apr 24, 2018
• Last Update Posted: Jun 27, 2022
• Last Verified: Jun 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Additional relevant MeSH terms: Scoliosis

Study Results

No Results Posted as of Jun 27, 2022