Evaluation of the safety and effectiveness of the MID- C system in adolescent idiopathic scoliosis.

Safety and effectiveness evaluation of the Minimal Invasive Deformity Correction (MID-C) System in adolescent idiopathic scoliosis

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON21786

Enrollment

Registered

2015-07-15

Start date

2015-08-01

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Surgical treatment of adolescent idiopathic scoliosis (AIS).

Interventions

The spinal deformity of the patients will be surgically corrected using the ApiFix system and sequential correction exercises.

Eligibility

Inclusion criteria

Inclusion criteria: 1. Adolescent AIS patients (12 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

Exclusion criteria: 1. Other non-idiopathic form of scoliosis; 2. Primary curve Cobb angle >55 degrees; 3. AIS 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 outcomes

Primary

Measure	Time frame
1.Correction of primary curve Cobb angle at 6 months follow-up (percentage and absolute degrees).	—

Secondary

Measure	Time frame
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.	—

Measure

Time frame

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.

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Contacts

Public ContactTsjitske Haanstra

Dpt. of Orthopedic Surgery VU University Medical Center

t.haanstra@vumc.nl+31(0)20-4445028

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)