The primary aim of this study is to investigate if these innovative surgical solutions are effective in maintaining curve reduction without repeat lengthening procedures and complications. Secondary aims are to investigate growth of the instrumented…
ID
Source
Brief title
Condition
- Joint disorders
- Nervous system, skull and spine therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
To assess the limited-efficacy and safety of SDS and MID-C EOS for treatment of
progressive early onset scoliosis in ambulant patients. The limited- efficacy
will be determined in terms of maintenance of correction and will be compared
with a cohort of 17 patients previously treated by us with an MCGR system.
Safety will be assessed in terms of treatment related SAEs and compared to the
previous cohort and literature
Secondary outcome
1 To assess limited-efficacy in terms of length gain, Th1-Th12, T1-S1. The
instrumented segment length will be measured on calibrated AP X-rays. Length
gain will be compared to our previous cohort of MGCR patients and literature,
including normal growth.
2 To compare the two systems with respect to:
a) limited-efficacy (maintenance of correction and lenght gain) and safety
(SAEs)
b) Surgical parameters: surgery time, blood loss, length of hospital stay,
recovery time, treatment related complications / reoperations
c) Bone density changes of the bypassed vertebrae, as assessed with DEXA post
op and 12 +/-3 months
d) Parent reported) QOL and performance with the EOSQ-24 questionnaire
e) Flexibility and 3D rotation of the spine based on echography
f) 3D development of the spine based on MRI
g) Patient overall appearance (shoulder balance, sagittal balance)
Background summary
Several innovative solutions have been developed to treat growing children with
a progressive scoliosis. The SDS device was developed internally at the dpt. of
orthopedics at UMC Utrecht, the Netherlands, the MID-C device was developed by
ApiFix Ltd in Israel.
Study objective
The primary aim of this study is to investigate if these innovative surgical
solutions are effective in maintaining curve reduction without repeat
lengthening procedures and complications. Secondary aims are to investigate
growth of the instrumented spine and to compare these devices.
Study design
A multicentre study with two prospective cohorts according an open label
randomized clinical trial (RCT) design.
Intervention
Implantation with SDS or MID-C according to a randomized scheme
Study burden and risks
Both SDS and MID-C have been used in the clinical setting. For SDS, patients
were included in the GRADS study at the UMC Utrecht and followed up
prospectively. Until now 18 patients have been operated with a maximum FU of 10
months. MID-C has a longer track record for application in adolescents and is
CE marked for that purpose.
Burden: There is no extra burden with respect to the surgical procedure which
is 2-4 hours and similar to other growing rod procedures. As part of this
study, patients and parents will be asked to fill in questionnaires (2 per
visit about 10 minutes), have 1 extra X-ray, 2 DEXA scans, 1 extra MRI and 3
echographies of the spine.
Risks: The biggest risk is that the implants will not maintain correction of
the curve and/or not allow growth of the spine as intended. Another issue is
that specific complications cannot be excluded. As compared to the MCGRs, the
clinical data on growth is sparse. However, based on the early results of the
GRADS study, curves are maintained and spinal growth is comparable to MCGR
patients. The MID-C system is less invasive and less robust. This system is
based on the AIS version, which has been successfully implanted for longer
periods in adolescents and growth has been observed in young patients. If
spinal growth is insufficient a small repeat operation may be needed for closed
or open manual distraction. This is similar to the standard bi-annual procedure
in conventional growing rods.
Benefits: The currently used MCGR and TGR have the disadvantage of the need for
repeated lengthening procedures until skeletal maturity is reached. This is an
extra burden for the patient although already much less when MCGR is used
instead of TGR. However, the forced lengthenings are always non-physiological
and may induce damage and/or spontaneous fusion of the spine. Also, each
periodic lengthening causes a considerable stress on the construct which is
related to both failure of the attachment to the spine (screw pull-out) and the
instrumentation (rod fractures). In our own experience and supported by the
literature, material failure rates of about 30% are reported for MCGR in 1-2
years. These problems can likely be diminished with the much more dynamic
continuous self-growing systems.
Risk benefit analysis: The risk of complications compared to the conventional
treatment strategies is minimal. This study can only be done in children with a
growing spine as this is the essence of the treatment strategy.
Heidelberglaan 100
Utrecht 3584 CX
NL
Heidelberglaan 100
Utrecht 3584 CX
NL
Listed location countries
Age
Inclusion criteria
1. Ambulant skeletally immature children, 6-12 yrs. of age, with open triradiate cartilages on X-ray
2. Scoliosis diagnosis prior to the age 10
3. Diagnosis of idiopathic or mild syndromic scoliosis (e.g. 22q11DS, Trisomy 21 or 9, Coffin-Siris)
4. Progressive scoliosis qualified for growth system surgery
5. One curve for treatment with an apex below Th5 and a proximal end vertebra below Th2
6. The primary curve must be between 35 and 75 degrees coronal Cobb angle
7. The primary curve must be non-rigid (i.e. the curve reduces on bending X-rays to <35 degrees or >30% of the curve)
8. Normal or hypokyphotic sagittal alignment (Th5 -Th12 < 50 degrees) on lateral X-rays
Exclusion criteria
1. Patients with an obvious neuromuscular disease
2. Patients that are severely mentally retarded
3. Patients with a scoliosis that extends to the pelvis or the cervicothoracic region
4. Patients with a main curve of more than 8 vertebra Cobb to Cobb
5. Patients with a skeletal dysplasia that effects growth (e.g. achondroplasia, SED)
6. Patients with a systemic disease which severely influences bone quality (e.g. osteogenesis imperfecta, metabolic diseases)
7. Patients with soft tissue weakness (e.g. Ehler Danlos, Marfan, Neurofibromatosis, Prader Willi)
8. Patients with an active systemic disease such as JIA, HIV or oncologic treatment
9. Patients with a previous surgical fusion of the spine
10. Known allergy to titanium
11. Patients weighing less than 11.4 kg or morbidly obese
12. Patients that are expected to be lost to FU due to e.g. immigration
13. Patient (or parents) that are expected to be non-compliant
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 | NL63511.041.17 |
| Other | Zodra de studie is goedgekeurd door de METC komt hier het NTC nummer |