Clinical Research Directory

Multistage Additive Manufacturing for Complex Limb Bone Deformity Reconstruction

Complex deformities of the limb bones may involve abnormal angulation, limb or bone shortening, abnormal rotation and structural bone loss. These deformities can result from previous trauma, bone nonunion, infection, tumour resection, congenital or developmental conditions, previous surgery or failed reconstruction. Treatment is challenging because correction of the deformity and reconstruction of the remaining bone defect often require several coordinated surgical stages. This multicentre prospective observational cohort study will evaluate the clinical outcomes of a multistage treatment pathway that incorporates three-dimensional imaging, computer-assisted surgical planning, additive manufacturing and patient-specific porous Ti6Al4V implants. Treatment decisions and the selection of surgical procedures will be made by the treating multidisciplinary team according to each patient's clinical condition and will not be assigned by the study. The study will include 30 adults with complex deformity of a major upper- or lower-limb bone. Participants will be followed for 12 months after definitive reconstruction. The study will evaluate maintenance of deformity correction and implant stability, restoration of bone length, angular and rotational correction, radiographic bone-implant integration, limb function, pain, progression to functional loading, reoperations and adverse events.

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

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.

A Study of Precice Intramedullary Limb Lengthening System (IMLL) Limb Lengthening Procedures

The Sponsor is conducting a survey to understand how parents or legal guardians feel about the benefits of using the Precice IMLL System to lengthen limbs in children who are 12 years old or younger.

Ultrasound Use to Measure Magnetically Controlled Growing Rods

The goal of this clinical trial is to learn if an ultrasound can measure the length of an internal tibia and femur lengthening rod. The main questions it aims to answer are: Can an ultrasound be used to measure the length of an internal magnetic lengthening nail in a tibia or femur? Can an ultrasound measure the rod lengthening as well as an ultrasound? Researchers will compare the length of an internal magnetic lengthening rod with both x-rays and ultrasound Participants will: Have standard x-rays every week They will also have an ultrasound of the femur or tibia