Health TrialsbyHealthPanel

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

ConditionScoliosis Idiopathic
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age0-30
SponsorLDR Médical SAS

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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;

Disqualifiers

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;

Trial 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.

Trial design

Design model

Case-only

Time perspective

Prospective

Treatments tested in this trial

  • Vertebral Body Tethering (VBT)

    Procedure/Surgery

    Vertebral Body Tethering surgery with the Tether™ in UK

Treatment groups

No treatment groups listed

Trial outcomes

Primary outcomes

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

Time frame
5 years
2

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

Major Cobb angle will be measured by x-rays

Time frame
60 months post-surgery

Secondary outcomes

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

Time frame
5 years
2

Rate and types of reoperations

Reoperations will be registered at any post-operative time point

Time frame
5 years
3

Progression of secondary curves

Secondary curves will be assessed by x-rays

Time frame
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

Time frame
First follow-up, 6, 12, 24, 36, 48 and 60 months post-surgery

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

LDR Médical SAS

Lead sponsor

Source ClinicalTrials.gov
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