Idiopathic Scoliosis in Children and Adolescents: Emerging Techniques in Surgical Treatment.
Zoe B Cheung, Stephen Selverian, Brian H Cho...
https://pubmed.ncbi.nlm.nih.gov/31284059Actively Recruiting
Age: 0Years - 30Years
All Genders
ID05830825
The Tether 22 - Vertebral Body Tethering System Post-Market Clinical Follow-Up Study in UK
Led by LDR Médical SAS · Updated on 2025-03-21
100
Participants Needed
3
Research Sites
43 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are collecting information about The Tether 22 device in people with progressive idiopathic scoliosis who have Lenke Type 1 curves. This observational study aims to evaluate the ongoing safety and possible benefits of The Tether 22 device used during spine surgery. Participants who undergo surgery with The Tether 22 will attend follow-up visits as part of their standard care. The study is prospective and will follow participants for five years after their surgery. Patients will be enrolled over 36 months, and data will be collected at several key points: the first follow-up after hospital discharge, then again at 6, 12, 24, 36, 48, and 60 months after surgery. The main treatment evaluated is Vertebral Body Tethering (VBT) surgery using The Tether 22 device. Participants will be monitored through regular follow-up visits that include assessments of safety, spine curvature, device integrity, and physical function. Researchers will measure serious and overall adverse events, rate of reoperations, progression of spine curves, trunk shape and flexibility, pulmonary function, and patient-reported quality of life using validated questionnaires. The study will provide detailed long-term information about outcomes and device performance over five years post-surgery.
CONDITIONS
Brief Title
PMCF (Post-Market Clinical Follow-up) Study on The Tether™ in UK (United Kingdom)
Who Can Participate
Age: 0Years - 30Years
All Genders
Eligibility Criteria
You may qualify if you...
- Diagnosis of progressive idiopathic scoliosis
- Skeletally immature based on Risser (<5) and Sanders (<8) assessments
- Major Cobb angle between 30� and 65�
- Adequate bone size for screw fixation as seen on imaging
- Failed bracing or unable to tolerate brace wear
- Lenke Type 1 main thoracic curves
- Signed informed consent by legal guardian or patient if 16 years or older
- Decision to treat with The Tether�22 made by clinician outside this study
You will not qualify if you...
- Presence of any systemic or local infection or skin issues at surgical site
- Prior spinal surgery at the treated level
- Poor bone quality with T-score -1.5 or less
- Skeletal maturity
- Medical or surgical conditions preventing spinal surgery benefit, including coagulation disorders or implant allergies
- Unwillingness or inability to attend follow-up visits
- Pregnancy at time of enrollment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Surgery and Immediate Post-operative Care
Duration - Initial surgical period plus hospital discharge
Participants undergo Vertebral Body Tethering surgery with the Tether™ device and receive immediate post-operative care.
1 surgery visit and 1 follow-up visit post discharge
Long-term Monitoring
Duration - 5 years post-surgery
Participants are followed for 5 years after surgery with scheduled assessments to monitor safety, device integrity, and clinical outcomes.
Visits at first follow-up post discharge, 6, 12, 24, 36, 48, and 60 months
Trial Site Locations
Total: 3 locations
1
Saint George's Hospital
London, United Kingdom, SW17 0QT
Actively Recruiting
2
Freeman Hospital
Newcastle upon Tyne, United Kingdom
Actively Recruiting
3
University Southampton Hospital
Southampton, United Kingdom
Actively Recruiting
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Research Team
D
Delphine Lebrasseur-Longuet
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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Published Research Related To This Trial
Update on evaluation and treatment of scoliosis.
Ron El-Hawary, Chukwudi Chukwunyerenwa
https://pubmed.ncbi.nlm.nih.gov/25439021Etiology of Adolescent Idiopathic Scoliosis: A Literature Review.
Sina Rashidi Kikanloo, Sandip Parshottam Tarpada, Woojin Cho
https://pubmed.ncbi.nlm.nih.gov/30744305