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Feasibility Evaluation Study of the MID-C Device (MID-C)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03071471
Recruitment Status : Completed
First Posted : March 7, 2017
Last Update Posted : March 7, 2017
Sponsor:
Information provided by (Responsible Party):
Apifix

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 Intervention/treatment
Adolescent Idiopathic Scoliosis (AIS) Device: MID-C

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 24-month enrollment period.

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Study Type : Observational [Patient Registry]
Actual Enrollment : 7 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)
Study Start Date : June 2014
Actual Primary Completion Date : July 2016
Actual Study Completion Date : July 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Scoliosis


Intervention Details:
  • Device: MID-C

    The MID-C system is designed to correct the deformity step by step along a period of time, giving the skeletal and soft tissues 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 complication thanks to the three points above.
    • Minimal spinal mobility loss


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

Secondary Outcome Measures :
  1. Minimum of 40% deformity correction within 6 months [ Time Frame: 6 months ]
  2. Evaluate the correction period by X-ray Evaluate the correction period [ Time Frame: 6 months, 1 year, 2 years ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   11 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
The study is designed as a European, observational study with a 12-month follow-up period. Consecutive patients undergoing treatment of AIS by the MID-C system in daily practice will be included during a 6-month enrollment period.
Criteria

Inclusion Criteria:

  1. Adolescence aged 11 years old to 17 years inclusive
  2. Minimum of 35 degrees Cobb angle, confirmed by X-ray. Lenke type 1 or 5, with flexible secondary curve.
  3. Completed at least 6 months of conservative therapy (e.g., P.T., bracing, traction, or others).
  4. Risser sign of 1 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).

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 Page 9 of 18
  8. Systemic disease that would affect the subject's welfare or overall outcome of the study.
  9. Mentally compromised

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03071471


Locations
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Israel
Asaf Harofe Medical Center
Rishon Le Zion, Israel, 70300
Sponsors and Collaborators
Apifix
Investigators
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Principal Investigator: Yigal Mirovsky, MD Asaf Harofe |Medical Center
Additional Information:

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Responsible Party: Apifix
ClinicalTrials.gov Identifier: NCT03071471    
Other Study ID Numbers: AF-01 Asaf Harofe
First Posted: March 7, 2017    Key Record Dates
Last Update Posted: March 7, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Scoliosis
Spinal Curvatures
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases