A Review of Precice Intramedullary Limb Lengthening (IMLL) System for Limb Lengthening Procedures… (NCT06714110) | Clinical Trial Compass
By InvitationNot Applicable
A Review of Precice Intramedullary Limb Lengthening (IMLL) System for Limb Lengthening Procedures in Children.
United States200 participantsStarted 2025-03-13
Plain-language summary
This study will look at how safe and effective limb lengthening surgeries are for the femur and tibia in children 12 years old and younger. We will examine any complications from the surgery, the results of X-rays, and feedback from patients. The study will involve the Precice Intramedullary Limb Lengthening (IMLL) System and external fixator devices for limb lengthening.
Who can participate
Age range0 Months – 12 Years
SexALL
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Inclusion criteria
✓. Patient was 12 years of age or younger at the time of the index surgery.
✓. Diagnosis of femoral or tibial limb length discrepancy greater than or equal to 2.0 cm.
✓. Limb length discrepancy secondary to congenital or acquired etiologies.
✓. Patients received limb lengthening treatment of the femur or tibia with the Precice IMLL System or an external fixator limb lengthening device.
✓. Minimum medullary canal diameter ≥6 mm in the treated bone - Precice IMLL System treatment group only.
✓. Closed or nonfunctioning physeal growth plates in the treated bone - Precice IMLL System treatment group only.
✓. Minimum of 12 months of follow-up.
✓. Available medical and radiographic records preoperatively through consolidation.
Exclusion criteria
✕. Patients with unresolved limb lengthening-related adjacent joint contractures (loss of range of motion), subluxation, or dislocation prior to the index surgical procedure.
✕. Patients with uncorrected coronal or sagittal plane angular malalignment following the index surgical procedure.
✕. Patients with unresolved complications related to previous limb lengthening on the index or different limbs, including unhealed pin sites and/or residual bone infection (from external fixator devices) on the index limb.
What they're measuring
1
Bone (femur or tibia) lengthening
Timeframe: At least 1 yr post-op
2
Osteotomy Healing
Timeframe: At least 1 yr post-op
3
Frequency of device related complications
Timeframe: Post-op through at least 1 year post-op