PMCF (Post-Market Clinical Follow-up) Study on The Tether™ in UK (United Kingdom)

Scoliosis Idiopathic Clinical Trial

Official title:

The Tether™ - Vertebral Body Tethering System Post-Market Clinical Follow-Up Study in UK

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05830825
• Other study ID #: SP-PMCF-EU-202301
• Status: Not yet recruiting
• Start date: September 5, 2023
• Est. completion date: December 2031

Study information

• Verified date: July 2023
• Source: ZimVie
• Contact: Delphine Lebrasseur-Longuet
• Phone: +33 626262240
• Email: ClinicalEMEA[@]ZimVie.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: December 2031
• Est. primary completion date: May 30, 2031
• Accepts healthy volunteers: No
• Gender: All
• Age group: 0 Years to 30 Years

Eligibility

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.

Related Conditions & MeSH terms

• Scoliosis
• Scoliosis Idiopathic

Intervention

Procedure:
• Vertebral Body Tethering (VBT)
Vertebral Body Tethering surgery with the Tether™ in UK

Locations

Country	Name	City	State
United Kingdom	Saint George's Hospital	London

Sponsors (1)

Lead Sponsor	Collaborator
LDR Médical SAS

Country where clinical trial is conducted

United Kingdom, 

References & Publications (3)

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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of serious adverse events, and device- and/or procedure-related adverse events	Serious adverse events, and device- and/or procedure-related adverse events (including intra-operative) will be registered at any post-operative time point	5 years
Primary	Percentage of patients with maintenance of the major Cobb angle = 40 degrees	Major Cobb angle will be measured by x-rays	60 months post-surgery
Secondary	Rate of overall adverse events, relatedness, severity, time to event	Adverse events (including intra-operative) will be registered at any post-operative time point	5 years
Secondary	Rate and types of reoperations	Reoperations will be registered at any post-operative time point	5 years
Secondary	Progression of secondary curves	Secondary curves will be assessed by x-rays	Pre-operative, first follow-up, 6, 12, 24, 36, 48 and 60 months post-surgery
Secondary	Development of new curves	New curves development will be assessed by x-rays at each follow-up visit	First follow-up, 6, 12, 24, 36, 48 and 60 months post-surgery
Secondary	Device integrity failures	Device integrity will be assessed by x-rays at each follow-up visit	First follow-up, 6, 12, 24, 36, 48 and 60 months post-surgery
Secondary	Maintenance/change in Sagittal alignment, lumbar lordosis	Sagittal alignment and lumbar lordosis will be assessed by x-rays	Pre-operative, first follow-up, 6, 12, 24, 36, 48 and 60 months post-surgery
Secondary	Patient Reported Outcome Measures (PROMs): Scoliosis Research Society Health-Related Quality of Life Questionnaire (SRS-22r) and EuroQol 5 Dimensions Young (EQ-5D-Y)	PROMs will be filled in by the participants at each visit. The SRS-22R measures quality of life in 5 domains: function, pain, self-image, mental health, and satisfaction/dissatisfaction. The minimum score in each domain is 1 and maximum is 5. Each item is scored from 1 (the worst) to 5 (the best). The EQ-5D-Y descriptive system will be used to assess the following five dimensions: mobility, looking after myself, doing usual activities, having pain or discomfort and feeling worried, sad or unhappy. Each dimension has 3 levels: no problems, some problems and a lot of problems. The associated Visual Analog Scale (from 0 - the worst health to 100 - the best health) can be used as a quantitative measure of health outcome that reflects the younger patient's own judgement.	Pre-operative, first follow-up, 6, 12, 24, 36, 48 and 60 months post-surgery
Secondary	Pulmonary function	Pulmonary function test, using routine spirometry, will be performed at pre-operative, 24 and 60 months post-operative visits	Pre-operative, 24 and 60 months post-surgery
Secondary	Trunk shape	Measurements of trunk shape will be collected at pre-operative and each follow-up visit with a standard scoliometer device	Pre-operative, first follow-up, 6, 12, 24, 36, 48 and 60 months post-surgery
Secondary	Trunk flexibility	Trunk flexibility will be collected at pre-operative and each follow up visit. Clinical measurements will be done for both forward and lateral bending using the "fingertip- to- floor" method	Pre-operative, first follow-up, 6, 12, 24, 36, 48 and 60 months post-surgery
Secondary	Spine mobility	Range of Motion will be evaluated by x-rays pre-operatively and at each follow-up visits	Pre-operative, first follow-up, 6, 12, 24, 36, 48 and 60 months post-surgery