Actively Recruiting
Non Fusion Surgery in Adolescent Idiopathic Scoliosis Patients
Led by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) · Updated on 2024-07-30
18
Participants Needed
1
Research Sites
447 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The primary objective of the study is to monitor the effectiveness of a minimal invasive non-fusion double rod bipolar posterior spinal implant (Nemost growing domino) to correct the scoliotic curve in growing patients suffering from progressive adolescent idiopathic scoliosis (AIS) who have failed conservative treatment.
CONDITIONS
Official Title
Non Fusion Surgery in Adolescent Idiopathic Scoliosis Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adolescent idiopathic scoliosis
- Primary Cobb angle greater than 30 degrees
- Failed non-operative treatment with curve progression greater than 5 degrees per year
- Skeletally immature (Risser grade 2 or less and skeletal age of hand and wrist X-rays 14 years or less)
- For girls, either pre-menarchal or post-menarchal by no more than 1 year
- Age over 10 years
- Non rigid spinal curve
- Any Lenke type scoliosis
- No previous spine surgery
You will not qualify if you...
- Non-idiopathic scoliosis caused by musculoskeletal or neurologic conditions (e.g., neuromuscular, congenital, or syndromic scoliosis)
- History of previous spine surgery
- Risser sign greater than 2
- Conditions affecting device stability (e.g., inadequate pedicle anatomy, trauma or tumor in fixation area, severe osteoporosis, bone destruction, poor bone quality)
- Non-reducible scoliosis
- Known allergy or intolerance to materials in the device
- Acute or chronic local or systemic infections
- Absence or insufficiency of covering tissues
- Pathological obesity
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
AmsterdamUMC, location AMC
Amsterdam, North Holland, Netherlands, 1105AZ
Actively Recruiting
Research Team
B
BJ Van Royen, MD, PhD
CONTACT
A
AMC AmsterdamUMC
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here