A Review of Precice Intramedullary Limb Lengthening (IMLL) System for Limb Lengthening Procedures in Children.

Официальное название

A Retrospective Review of Clinical and Radiographic Outcomes Following the Use of the Precice Intramedullary Limb Lengthening (IMLL) System in Pediatric Limb Lengthening Procedures

Обзор

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.

Подробное описание

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.

Вмешательства

• Устройство Intramedullary 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.
• Устройство External Fixator Limb Lengthening Device
  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

Первичные конечные точки

• Bone (femur or tibia) lengthening [Срок оценки: At least 1 yr post-op]
• Osteotomy Healing [Срок оценки: At least 1 yr post-op]
• Frequency of device related complications [Срок оценки: Post-op through at least 1 year post-op]

Критерии участия

Критерии включения

• All potential index surgeries must meet the inclusion criteria below in order to be considered for enrollment:

• 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.

Критерии исключения

• Index surgeries will be excluded from consideration for the study if they meet any of the following 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.
• Patients with femoral head osteonecrosis from a previous implantation of a femoral nail prior to the index surgical procedure.
• Patients with a previous implantation of a femoral or tibial nail across an open physeal growth plate prior to the index surgical procedure.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

США · 1 центр

• Paley Institute — West Palm Beach

Идентификаторы

NCT: NCT06714110 · NUVA.ILL0723

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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