This study is designed to evaluate the effectiveness and safety of the MID-C System.
ID
Source
Brief title
Condition
- Musculoskeletal and connective tissue deformities (incl intervertebral disc disorders)
- Bone and joint therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Effectiveness:
1. Correction of primary curve Cobb angle at 6 months follow-up (percentage and
absolute degrees).
Secondary outcome
Safety:
1. Curve progression above or below the implant over time at all follow-ups;
2. Vertebral rotation based on Bunnell Scoliometer;
3. Vertebral rotation based on AP X-ray using the Nash and Moe method [7], and;
4. (Serious) adverse event.
Effectiveness:
1. Patient reported outcome (SRS-22);
2. Correction of primary curve Cobb angle to <35 degrees Cobb angle at 6 months
follow-up;
3. Correction of primary curve Cobb angle over time at all follow-ups, and;
4. Correction of secondary curve Cobb angle over time at all follow-ups.
Background summary
Adolescent idiopathic scoliosis (AIS) is a complex three-dimensional deformity
of the spine, which can cause significant physical and psychological problems.
Currently there are two treatment options available for adolescent idiopathic
scoliosis (AIS): bracing and spinal correction of the scoliosis with spinal
fusion.
Bracing is indicated for curves between 25 and 40 degrees Cobb angle in
patients with significant growth potential (Risser stage 1-2). The treatment
causes significant discomfort and problems with appearance for this young
patient group, resulting in compliance problems and thus a negative effect on
treatment success. Long spinal fusion is indicated for curves greater than 45
degrees Cobb angle preferably when patients have stopped growing but for
reasons of the magnitude of the curve in some cases also during growth. During
this procedure, the curve is corrected and the spine is fused stiff using
screws and rods. This is complex and invasive surgery and significant
complication rates are reported up to 5.1%.
ApiFix LtD has developed a novel spinal implant for a less invasive surgical
treatment of AIS: the MID-C system. It is indicated for patients with a
scoliosis of 40 to 55 degrees Cobb angle. Thus, it bridges the gap between the
indication for bracing (25 to 40 degrees) and posterior fusion (>45 degrees)
and overlaps the indication for both bracing and posterior fusion. The MID-C
system is a novel scoliosis correction device, which provides a gradual
correction of the deformity. This gives the skeletal and soft tissues the
opportunity to accommodate incremental correction. The MID-C system has several
potential benefits: smaller scar, quicker healing period and better spine
mobility over the years.
Study objective
This study is designed to evaluate the effectiveness and safety of the MID-C
System.
Study design
This study is a prospective, open label, non-randomized cohort study.
Intervention
The spinal deformity of the patients will be surgically corrected using the
ApiFix system and sequential correction exercises.
Study burden and risks
As compared to standard posterior fusion surgery, treatment with the MID-C is
expected to have significantly less postoperative physical burdens for the
patient. Postoperative pain management is similar to the protocol of
traditional spinal fusion surgery. Compared to traditional treatment, patients
have one extra follow-up visit, two extra x-rays and three extra clinical
photographs.
Based on the pre-clinical tests, clinical experience with 37 patients (operated
outside The Netherlands), and the risk analysis documents we conclude that the
risks are expected to be low. Potential risks of gradual correction with MID-C
as compared to standard posterior fusion are: 1) untreated compensatory curve
may not be corrected, 2) curve progression above and below the implant, 3)
implant failure (breakage or loosening) and 4) untreated vertebral rotation may
not be corrected.
The potential benefits of surgical correction with the MID-C system as compared
to traditional fusion surgery are as follows: less impaired (more
physiological) spinal movement, gradual correction of the deformity and a
decreased risk of surgery associated complications due to the minimally
invasive nature of the procedure (i.e. shorter incision, shorter surgery time,
less blood loss, less infection risk and decreased risk of neurological injury
and proximal junctional kyphosis).
Boelelaan 1117
Amsterdam 1081 HV
NL
Boelelaan 1117
Amsterdam 1081 HV
NL
Listed location countries
Age
Inclusion criteria
1. Adolescent idiopathic scoliosis patients (10 years - 17 years old);
2. Standing X-ray: 40 to 55 degrees Cobb angle, Lenke type 1 or 5, Risser stage 1-4;
3. Lateral bending X-ray: primary curve should be reduced to <35 degrees Cobb angle after lateral bending;
4. Subject has good general health;
5. Subject and both subject*s guardians/legal representatives are willing to sign a written informed consent form;
6. Vertebral rotation <15 degrees (based on Bunnell Scoliometer), and;
7. Compliance for exercise therapy (based on verbal confirmation of patient)
Exclusion criteria
1. Other non-idiopathic form of scoliosis;
2. Primary curve Cobb angle >50 degrees;
3. Adolescent idiopathic scoliosis which is not defined as Lenke type 1 or 5;
4. Previous spine surgery;
5. Known allergy to titanium;
6. Active systemic disease, such as AIDS, HIV, or active infection;
7. Systemic disease that would affect the subject*s welfare or overall outcome of the study, or;
8. Mentally compromised.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL53495.029.15 |