Clinical trial NCT05830825: PMCF (Post-Market Clinical Follow-up) Study on The Tether™ in UK (United Kingdom)
Official title: The Tether™ - Vertebral Body Tethering System Post-Market Clinical Follow-Up Study in UK
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Scoliosis Idiopathic
Keywords: Vertebral Body Tethering
Fusionless Spine Surgery
Lead sponsor: Highridge Medical
Sponsor class: INDUSTRY
First posted: 2023-04-26
Enrollment: 100
Sex: ALL
Minimum age (years): 0
Maximum age (years): 30
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Skeletally immature patients that require surgical treatment to obtain and maintain correction of progressive idiopathic scoliosis (Lenke Type 1 curves), with a major Cobb angle of 30 to 65 degrees whose osseous structure is dimensionally adequate to accommodate screw fixation, as determined by radiographic imaging. Patients should have failed bracing and/or be intolerant to brace wear.

Brief summary: The goal of this observational study is to collect information about The Tether™ device in participants with progressive idiopathic scoliosis, Lenke Type 1 curves. The main purpose is to provide assessment of:

* ongoing safety
* probable benefits Participants who will receive The Tether™ during spine surgery will have to attend follow-up visits which are part of standard-of-care.

Detailed description: This study is designed to be prospective. After the initial visit, followed by the surgery, the participant is expected to take part in the study for a time period of 5 years post-surgery.

Patients will be enrolled during a period of 36 months, and the study will last until complete collection of the 5-year follow-up data. Data will be collected at: first follow-up post discharge, 6, 12, 24, 36, 48 and 60 months.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of progressive idiopathic scoliosis;
* Skeletally immature, based on both Risser (\<5) and Sanders (\<8) assessments;
* Major Cobb angle ≥30° and ≤65°;
* Osseous structure dimensionally adequate to accommodate screw fixation, as determined by radiographic imaging;
* Failed bracing and/or be intolerant to brace wear;
* Lenke Type 1 curves (i.e., main thoracic);
* Signed Informed Consent Form by legal guardian or by the patient if ≥ 16 years old.
* The decision to treat patients with The Tether™ - VBT System was made by the patient's clinician outside of this research

Exclusion Criteria:

* Presence of any systemic infection, local infection, or skin compromise at the surgical site;
* Prior spinal surgery at the level(s) to be treated;
* Known poor bone quality defined as a T-score -1.5 or less;
* Skeletal maturity;
* Any other medical or surgical condition which would preclude the potential benefit of spinal surgery, such as coagulation disorders, allergies to the implant materials, and patients unwillingness or inability to cooperate with post-operative care instructions;
* Unwillingness, inability, or living situation (e.g., custody arrangements, homelessness, detention) that would preclude ability to return to the study site for follow-up visits as described in protocol and Informed Consent;
* Patients who are pregnant at the time of enrollment.

Primary outcomes:
measure: Rate of serious adverse events, and device- and/or procedure-related adverse events
timeFrame: 5 years
measure: Percentage of patients with maintenance of the major Cobb angle ≤ 40 degrees
timeFrame: 60 months post-surgery
Secondary outcomes:
measure: Rate of overall adverse events, relatedness, severity, time to event
timeFrame: 5 years
measure: Rate and types of reoperations
timeFrame: 5 years
measure: Progression of secondary curves
timeFrame: Pre-operative, first follow-up, 6, 12, 24, 36, 48 and 60 months post-surgery
measure: Development of new curves
timeFrame: First follow-up, 6, 12, 24, 36, 48 and 60 months post-surgery
measure: Device integrity failures
timeFrame: First follow-up, 6, 12, 24, 36, 48 and 60 months post-surgery
measure: Maintenance/change in Sagittal alignment, lumbar lordosis
timeFrame: Pre-operative, first follow-up, 6, 12, 24, 36, 48 and 60 months post-surgery
measure: Patient Reported Outcome Measures (PROMs): Scoliosis Research Society Health-Related Quality of Life Questionnaire (SRS-22r) and EuroQol 5 Dimensions Young (EQ-5D-Y)
timeFrame: Pre-operative, first follow-up, 6, 12, 24, 36, 48 and 60 months post-surgery
measure: Pulmonary function
timeFrame: Pre-operative, 24 and 60 months post-surgery
measure: Trunk shape
timeFrame: Pre-operative, first follow-up, 6, 12, 24, 36, 48 and 60 months post-surgery
measure: Trunk flexibility
timeFrame: Pre-operative, first follow-up, 6, 12, 24, 36, 48 and 60 months post-surgery
measure: Spine mobility
timeFrame: Pre-operative, first follow-up, 6, 12, 24, 36, 48 and 60 months post-surgery
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Saint George's Hospital
city: Newcastle Upon Tyne
country: United Kingdom
facility: Freeman Hospital
city: Southampton
country: United Kingdom
facility: University Southampton Hospital
Study officials:
affiliation: Saint George's Hospital, London
name: Jason Bernard, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Cheung ZB, Selverian S, Cho BH, Ball CJ, Kang-Wook Cho S. Idiopathic Scoliosis in Children and Adolescents: Emerging Techniques in Surgical Treatment. World Neurosurg. 2019 Oct;130:e737-e742. doi: 10.1016/j.wneu.2019.06.207. Epub 2019 Jul 5.
citation: El-Hawary R, Chukwunyerenwa C. Update on evaluation and treatment of scoliosis. Pediatr Clin North Am. 2014 Dec;61(6):1223-41. doi: 10.1016/j.pcl.2014.08.007. Epub 2014 Sep 12.
citation: Kikanloo SR, Tarpada SP, Cho W. Etiology of Adolescent Idiopathic Scoliosis: A Literature Review. Asian Spine J. 2019 Jun;13(3):519-526. doi: 10.31616/asj.2018.0096. Epub 2019 Feb 13.