Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Early Onset Scoliosis (EOS) is defined as scoliosis with onset under the age of ten years, regardless of etiology. It is a complex three-dimensional deformity of the spine which can cause significant physical and psychological problems. Currently there are two basic treatment options available for EOS: non-surgical and surgical. ApiFix Ltd. has developed a novel growing rod system for surgical treatment of EOS, the MID-C system. It is indicated for patients with a scoliosis of 35 to 75 degrees Cobb angle
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment | Experimental | MID-C EOS implant will be implanted for the correction of the spine deformity in children found eligible for the study |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MID-C | Device | The MID-C system is being connected to the spine via standard unilateral posterior approach. Pedicle screws above and below the main curve are being used to attach the device to the selected vertebra. |
| Measure | Description | Time Frame |
|---|---|---|
| Maintenance of the major curvature ≤ 50 degrees at 24 months | curve progression will be evaluated by X-ray as in the standard of care | 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| No progression of the primary curve ≥ 10 degrees Cobb angle from correction at time of surgery over time at all follow-up visits | curve progression will be evaluated by X-ray as in the standard of care | 6 months, 12 months, 24 months |
| No progression of the secondary (compensatory) curves ≥ 50 degrees Cobb angle over time at all follow-up visits |
| Measure | Description | Time Frame |
|---|---|---|
| Device related serious adverse events | AE will be monitored routinely | 6 Weeks, 3 months, 6 months, 12 months, 24 months |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Daphna Zaaroor Regev, PhD | Contact | +972-523763653 | Daphna@apifix.com | |
| Uri Arnin | Contact | Uri@apifix.com |
| Name | Affiliation | Role |
|---|---|---|
| Ron El-Hawary, MD | Chief of Orthopaedics. IWK Health Centre.Associate Professor, Dpt. of Surgery, Dalhousie University, Canada | Study Director |
| Ioanna Paspati, MD | Spine surgeon | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Paidon Pentelis Hospital | Recruiting | Athens | Greece |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D012600 | Scoliosis |
| ID | Term |
|---|---|
| D013121 | Spinal Curvatures |
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
curve progression will be evaluated by X-ray as in the standard of care |
| 6 months, 12 months, 24 months |
| Blood loss during surgery | Data will be collected from the hospital surgery records | Baseline - week 0 |
| Duration of surgery | Data will be collected from the hospital surgery records | Baseline - week 0 |
| Duration of hospitalisation | Data will be collected from the hospital records | Baseline - week 0 |
| Number of reoperations | in case the patient requires a re-operation it will be documented in the study CRF | 6 Weeks, 3 months, 6 months, 12 months, 24 months |