Fusionless treatment of idiopathic scoliosis with the MIScoli® system during the growth period (FUTURE 2)
- Conditions
- Juvenile or adolescent idiopathic scoliosisMusculoskeletal Diseases
- Registration Number
- ISRCTN83525674
- Lead Sponsor
- Spino Modulation
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Suspended
- Sex
- All
- Target Recruitment
- 20
Candidates for this study must meet ALL of the following criteria:
1. Diagnosis of juvenile or adolescent idiopathic scoliosis
2. Male or female subjects greater than 8 years of age with significant growth remaining
3. European Risser Stage 0 or 1 and Sanders score less than or equal to (=) 5, at Visit 1
4. Major scoliosis with Cobb angle > 40° and < 70° and Lenke I, II or V curve pattern. Cobb angle measurements refer to measures taken without a brace. Subjects with Cobb angle >30° with attempted but failed brace treatment. Failure of brace treatment is defined as greater than (>) 5° of progression and/or intolerance to brace wear
5. Thoracic kyphosis (T5-T12) < 50°. 6. Instrumentation to be applied no more cephalad than T4 and no more caudal than L4 (inclusive)
7. The subject must be physically and mentally willing and able to comply with the study visit schedule and all protocol requirements
8. Subject assent and parent/legal guardian consent obtained and documented
Candidates will be excluded from the study if ANY of the following apply:
1. The vertebrae to be instrumented are less than 12mm in height (based on the MIScoli® staple size)
2. One of the vertebrae to be instrumented in less than 20.5mm in width (based on the smallest MIScoli® screw length)
3. One of the vertebrae to be instrumented is more than 44mm in width (based on the longest MIScoli® screw length)
4. Diagnosis of non-idiopathic scoliosis
5. Menarche onset > 4 months at Visit 1
6. Non-ambulatory
7. Clinical diagnosis of osteoporosis, osteopenia, osteomalacia, Paget’s disease or metabolic bone disease
8. Prior thoracic surgery for any reason
9. Abnormal neurological exam for any reason at Visit 1
10. Enrollment in an active drug or device trial that is more than minimal risk and where participation in the trial would confound the measurements for the present study
11. Enrollment in a device trial for the efficacy of a musculoskeletal device and where participation in the trial would confound the measurements for the present study
12. Less than 30 days from completion of another clinical trial of more than minimal risk or for assessment safety and efficacy 13. Any condition or therapy that the investigator believes might pose a risk to the participant or make participation in the study not in the participant’s best interest
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method