Feasibility Study of MID-C for AIS (MID-C)

• Sponsor: Apifix
• Information provided by (Responsible Party): Apifix

Study Description

Brief Summary:

Adolescent idiopathic scoliosis (AIS) is a common disorder of unknown etiology in which the vertebrae and discs gradually develop a curvature that is first detected in patients between 11 and 20 years of age. The deformity is 3-dimensional, with a coronal curve measured from radiographs by the Cobb angle .

The Cobb angle measurement of scoliosis represents the sum of the angular wedging of each vertebra and disc between the superior and inferior end vertebrae . Although a small curve is well tolerated and does not require treatment, a large curve can progress to the point that it is cosmetically unacceptable, interferes with chest wall mechanics, and produces cardiac and pulmonary compromises. The natural history of AIS apparently includes 2 stages: the initiation of the curve and its subsequent progression. The factors responsible for the initiation of the curve are unknown, but the subsequent progression of the curve is clearly associated with the adolescent growth spurt . The primary risk factors for progression include age at onset and the magnitude of the curve; young patients with large curves are at the highest risk .

Although numerous treatment methods have been recommended for patients with AIS, the only accepted treatment includes bracing for skeletally immature patients with curves between 25 and 40 degrees and operative correction with spinal fusion for patients with curves greater than 45 degrees. For many teenagers, the cosmetic and social concerns associated with bracing has caused compliance problems with wearing the brace and many patients only wear the brace at home . While operative intervention completely corrects the scoliosis or rib hump, it eliminates segmental spinal motion, and concentrates stresses at the ends of the fusion potentially leading to disc degeneration and back pain.

Despite satisfactory short-term results of operative instrumentation and fusion, a less invasive technique preserving more motion with a smaller scar represents a major improvement. Realizing this goal is contingent on treating curves early, before they progress to an irreversible deformity, and when there is still enough residual growth and remodeling potential.

ApiFix Ltd has developed a novel implant for less invasive treatment of AIS. The MID-C system is designed to correct the deformity step by step along a period of time, giving the skeletal and soft tissues time to accommodate any incremental correction.

The MID-C System inherent benefits are:

• Only two screws are used
• Incision size is much smaller
• Simpler operation with shorter operative time
• Less complications (attributed to the three points above).
• Minimal spinal mobility loss.

All the device components are made of materials well accepted in the orthopedic field and are fully biocompatible (see Investigator Brochure).

The unique concept of the system and the materials used may provide favorable results as follows: Smaller scare, quicker healing period and better spine mobility over the years.

This study is designed to demonstrate that the MID-C System is safe and effective.

Condition or disease
Adolescent Idiopathic Scoliosis (AIS)

Detailed Description:

The study is designed as an observational study with a 24-month follow-up period. Consecutive patients undergoing treatment of AIS by the MID-C system in daily practice will be included during a 1-year enrollment period.

Study Design

Layout table for study information

Study Type :	Observational [Patient Registry]
Actual Enrollment :	13 participants
Observational Model:	Cohort
Time Perspective:	Prospective
Target Follow-Up Duration:	2 Years
Official Title:	Safety and Effectiveness Evaluation of the Minimal Invasive Deformity Correction (MID-C) System in Adolescent Idiopathic Scoliosis (AIS)
Actual Study Start Date :	April 2012
Actual Primary Completion Date :	April 2016
Actual Study Completion Date :	April 2016

Groups and Cohorts

Outcome Measures

Primary Outcome Measures :

1. No Device related Serious Adverse Event [ Time Frame: 2 years ]
2. No significant curve progression above or below the implant [ Time Frame: 6 months, 1 year, 2 years ]

Secondary Outcome Measures :

1. Minimum of 50% deformity correction within 6 months [ Time Frame: 6 months ]
2. Evaluate the correction period using X-ray [ Time Frame: 2 years ]

Eligibility Criteria

Layout table for eligibility information

Ages Eligible for Study:	11 Years to 20 Years (Child, Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

The study is designed as a prospective, non randomized, open label study with a 24-month follow-up period. Consecutive patients undergoing treatment of AIS by the MID-C system will be included during a 1-years enrollment period.

Criteria

Inclusion Criteria:

1. Adolescence above and inclusive 11 years old
2. Minimum of 35 degrees Cobb angle, confirmed by X-ray. Lenke type 1 or 5
3. Completed at least 6 months of conservative therapy (e.g., P.T., bracing, traction, or others).
4. Reisser sign of 2 to 4
5. Appropriate candidate for posterior surgical approach
6. Subject has Good general health.
7. Subject has no hypersensitivity and allergies to Titanium
8. Subject guardians willing to sign a written informed consent form (ICF).surgeon

Exclusion Criteria:

1. Cobb angle over 55 degrees
2. Other non idiopathic scoliosis.
3. AIS which is not defined as Lenke type 1 or 5
4. Previous spine surgery.
5. Allergy to any component of the device.
6. Active systemic disease, such as AIDS, HIV, or active infection
7. Back or leg pain of unknown etiology
8. Systemic disease that would affect the subject's welfare or overall outcome of the study.
9. Mentally compromised

Contacts and Locations

Locations

Layout table for location information

Hungary
University of Pecs
Pecs, Hungary, H-7632
Romania
Maria Sklodowska Curie
Bucharest, Romania
Spitalul de Copii Sf. Maria
Iasi, Romania

Sponsors and Collaborators

Apifix

Investigators

Layout table for investigator information

Principal Investigator:	Sergiu Straticiuc-ciongradi, MD	Spitalul de Copii Sf. Maria Lasi
Principal Investigator:	Peter Than, MD	University of Pecs Medical School Hungary
Principal Investigator:	Gheorghe Burnei, MD, PhD	Maria Sklodowska Curie, Bucharest

More Information

Additional Information:

Layout table for additonal information

Responsible Party:	Apifix
ClinicalTrials.gov Identifier:	NCT03071445 History of Changes
Other Study ID Numbers:	AF-01
First Posted:	March 7, 2017
Last Update Posted:	March 7, 2017
Last Verified:	February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	No

Layout table for additional information

Studies a U.S. FDA-regulated Drug Product:		No
Studies a U.S. FDA-regulated Device Product:		No

Additional relevant MeSH terms:

Layout table for MeSH terms

Scoliosis; Spinal Curvatures; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases