An observational study in Limb Length Discrepancy, sponsored by NuVasive. Enrolling by invitation at 1 site in United States. Open to participants aged 0 Months to 12 Years. Per ClinicalTrials.gov, last updated 2025-12-22.
Sponsored by NuVasive (part of Globus Medical) · Observational
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.
As a retrospective chart review, all patients involved in this study will have undergone surgery for their limb length discrepancy according to the standard of care of the practitioner using either the Precice IMLL or an external fixator. Under this protocol, available patient outcomes, plain radiographs, and complications will be obtained from the existing medical records of all eligible index surgeries. An index surgery is defined as the first limb lengthening surgery performed by a study investigator on the index bone with either the Precice IMLL or an external fixator. Each patient may have up to 4 eligible index surgeries (right and left femur, right and left tibia) and be included in both the Precice IMLL and external fixator groups.
NuVasive is the lead sponsor of 38 studies on the registry; 8 are open to participants now.
First submitted after NuVasive became part of Globus Medical.
Counted across the registry records on this site, refreshed daily.
Pediatric (12 years and under) population
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All potential index surgeries must meet the inclusion criteria below in order to be considered for enrollment:
Exclusion Criteria:
Index surgeries will be excluded from consideration for the study if they meet any of the following criteria:
Patients 12 years of age or younger received Precice IMLL for correction of limb length discrepancy.
Device: Intramedullary Limb Lengthening Device
Patients 12 years of age or younger received an external fixator for correction of limb length discrepancy.
Device: External Fixator Limb Lengthening Device
The Precice IMLL System is composed of the Precice nail, screws, and uses an external remote controller (ERC) for rod distraction. The Precice IMLL System is designed to fit the anatomy of long bones and is intended to be placed internally in an intramedullary manner. It achieves limb correction through gradual lengthening or compression and providing intramedullary fixation for fractures of long bones.
External fixator devices consist of an external frame (ring, half-ring, monolateral, and rail); bone fixation is accomplished by the transcutaneous bone fixations implants (pins, wires, cables, screws), and the lengthening is accomplished by the vertical components (struts). Generally, femoral lengthening devices are monolateral and tibial lengthening devices have ring or half-ring frames. The external fixators are made of a variety of materials, including stainless steel, titanium, carbon fiber, and aluminum.
Bone (femur or tibia) lengthening
Achievement of targeted limb length
Time frame: At least 1 yr post-op
Osteotomy Healing
Assessment of osteotomy healing using the following descriptors: * Premature healing: Defined as osteotomy healing before the target length is achieved. * Healed (consolidated): Defined as the presence of full corticalization (ossified) of regenerate bone of three of four cortices seen on AP and lateral radiographs. * Delayed union (consolidation): Defined as bone union taking greater than 6 months but with progressive improvement on radiographs and the osteotomy eventually healed. * Partial union (consolidation): Defined as incomplete bone healing, i.e., radiographic healing at only 1 or 2 cortices on AP and lateral views. * Nonunion (pseudarthrosis): Defined as lack of complete healing within 6 months of the end of the lengthening period.
Time frame: At least 1 yr post-op
Frequency of device related complications
Review of investigator-reported device-related complications
Time frame: Post-op through at least 1 year post-op
Plan to share: No
No publications or documents are linked to this record.
Started Mar 2025 (actual). Primary completion is estimated for Jul 2026, 16 months after the start.
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