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Scoliosis IdiopathicNCT05830825

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

An observational study of Scoliosis Idiopathic, run by LDR Médical SAS at 3 sites in United Kingdom.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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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… Read more about this study

Who is it for?
Ages 0 to 30 years
Conditions the study is for
Scoliosis Idiopathic
What is being tested?
Vertebral Body Tethering (VBT)
Type of treatment
Surgery or procedure
How many people
100 participants
Where
3 sitesUnited Kingdom
Study dates
18 Jul 2024to Dec 2033
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 0 to 30 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

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.

Who may be able to join

  • 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

Who cannot join

  • 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.

Trial locations and contacts

3 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Delphine Lebrasseur-Longuet contact

+33 626262240

ClinicalEMEA@highridgemedical.com

United Kingdom3 sites, 3 recruiting

  • Saint George's Hospital

    London, SW17 0QT

    Jason BERNARD, MD, jason.bernard@stgeorges.nhs.uk

    Jason BERNARD, MD

    Recruiting

  • Freeman Hospital

    Newcastle upon Tyne

    Andrew BOWEY, MD, andrew.bowey@nhs.net

    Andrew BOWEY, MD

    Recruiting

  • University Southampton Hospital

    Southampton

    Andrew COTTAM, MD, acottam@nhs.net

    Andrew COTTAM, MD

    Recruiting

Other trials in United Kingdom

About this study

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

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.
Read the 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.

Being tested
Vertebral Body Tethering (VBT)
Keywords
Vertebral Body Tethering, Fusionless Spine Surgery

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Vertebral Body Tethering (VBT)Procedure or surgery

    Also called The Tether™ - VBT System

    Vertebral Body Tethering surgery with the Tether™ in UK

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: 5 years

  2. Percentage of patients with maintenance of the major Cobb angle ≤ 40 degrees

    Major Cobb angle will be measured by x-rays

    Measured: 60 months post-surgery

Secondary outcomes (11)

  1. Rate of overall adverse events, relatedness, severity, time to event

    Adverse events (including intra-operative) will be registered at any post-operative time point

    Measured: 5 years

  2. Rate and types of reoperations

    Reoperations will be registered at any post-operative time point

    Measured: 5 years

  3. Progression of secondary curves

    Secondary curves will be assessed by x-rays

    Measured: Pre-operative, first follow-up, 6, 12, 24, 36, 48 and 60 months post-surgery

  4. Development of new curves

    New curves development will be assessed by x-rays at each follow-up visit

    Measured: First follow-up, 6, 12, 24, 36, 48 and 60 months post-surgery

  5. Device integrity failures

    Device integrity will be assessed by x-rays at each follow-up visit

    Measured: First follow-up, 6, 12, 24, 36, 48 and 60 months post-surgery

  6. Maintenance/change in Sagittal alignment, lumbar lordosis

    Sagittal alignment and lumbar lordosis will be assessed by x-rays

    Measured: Pre-operative, first follow-up, 6, 12, 24, 36, 48 and 60 months post-surgery

  7. 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.

    Measured: Pre-operative, first follow-up, 6, 12, 24, 36, 48 and 60 months post-surgery

  8. Pulmonary function

    Pulmonary function test, using routine spirometry, will be performed at pre-operative, 24 and 60 months post-operative visits

    Measured: Pre-operative, 24 and 60 months post-surgery

  9. Trunk shape

    Measurements of trunk shape will be collected at pre-operative and each follow-up visit with a standard scoliometer device

    Measured: Pre-operative, first follow-up, 6, 12, 24, 36, 48 and 60 months post-surgery

  10. 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

    Measured: Pre-operative, first follow-up, 6, 12, 24, 36, 48 and 60 months post-surgery

  11. Spine mobility

    Range of Motion will be evaluated by x-rays pre-operatively and at each follow-up visits

    Measured: Pre-operative, first follow-up, 6, 12, 24, 36, 48 and 60 months post-surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Apr 2023
  2. Study start18 Jul 2024
  3. Primary completionJan 2033 (estimated)
  4. Study completionDec 2033 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Prospective
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05830825
Sponsor's protocol ID
SP-PMCF-EU-202301
Status last verified
Jul 2026
First submitted
30 Mar 2023
Last updated
21 Jul 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 31284059

  • 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.

    PubMed 25439021

  • 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.

    PubMed 30744305

Questions about this trial

What is this clinical trial studying?

An observational study of Scoliosis Idiopathic, run by LDR Médical SAS at 3 sites in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 21 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Delphine Lebrasseur-Longuet (+33 626262240, ClinicalEMEA@highridgemedical.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Rate of serious adverse events, and device- and/or procedure-related adverse events (time frame: 5 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05830825, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jul 2026.

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