Intramedullary Limb Lengthening for Limb Length Discrepancy
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to evaluate the safety and effectiveness of surgeries for children with one leg shorter than the other. It compares two treatments: the Precice Intramedullary Limb Lengthening (IMLL) System and external fixator devices, both designed to lengthen the shorter leg. The trial targets children 12 years old and younger with a leg length difference of at least 2 cm due to birth conditions or other causes. As a Phase 2 trial, it measures the effectiveness of these treatments in an initial, smaller group of children, providing an opportunity to contribute to significant medical advancements.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
What prior data suggests that these limb lengthening devices are safe for children?
Research has shown that the Precice Intramedullary Limb Lengthening (IMLL) System is generally well-received by patients. It has been used in over 1,000 cases worldwide, with more than 250 cases reporting excellent results. Patients often experience less pain and encounter fewer problems compared to older methods. This system also requires fewer surgeries, which is a significant advantage.
External fixator devices offer another safe and effective way to correct limb length differences in children. They allow gradual limb lengthening, which can lead to good results. These devices have been successfully used in children, proving reliable for managing moderate limb length differences.
Both treatments have strong safety records, making them good options for those considering limb lengthening procedures.12345Why are researchers excited about this trial's treatments?
The Precice Intramedullary Limb Lengthening (IMLL) System is unique because it offers a less invasive option for correcting limb length discrepancies in children. Unlike traditional methods like external fixators, which require hardware to be attached outside the body and often involve discomfort and a higher risk of infection, the Precice system is implanted inside the bone. This internal approach allows for more precise control over the lengthening process and a more streamlined recovery, making it a promising alternative for young patients needing limb correction. Researchers are excited because it could potentially reduce complications and improve quality of life compared to existing treatments.
What evidence suggests that the Precice IMLL System and external fixator devices are effective for limb length discrepancy?
Research has shown that the Precice Intramedullary Limb Lengthening (IMLL) System, one of the treatments in this trial, effectively lengthens limbs. It has been used in over 1,000 cases worldwide, with more than 250 published cases demonstrating excellent results. Specifically, these results include less pain and fewer complications compared to older methods. Patients using Precice have required fewer surgeries than those with previous standard treatments. The External Fixator, another treatment option in this trial, also effectively corrects differences in limb length. It can adjust both limb length and shape simultaneously, making it a reliable choice. Both methods have successfully achieved the desired limb length in various studies.23678
Who Is on the Research Team?
Kyle Malone
Principal Investigator
Globus Medical
Are You a Good Fit for This Trial?
Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Surgery
Patients undergo limb lengthening surgery using either the Precice IMLL or an external fixator
Post-operative Monitoring
Monitoring of bone lengthening and osteotomy healing, including radiographic assessments and review of complications
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- External Fixator Limb Lengthening Device
- Precice Intramedullary Limb Lengthening (IMLL) System
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Patients 12 years of age or younger received Precice IMLL for correction of limb length discrepancy.
Patients 12 years of age or younger received an external fixator for correction of limb length discrepancy.
Find a Clinic Near You
Who Is Running the Clinical Trial?
NuVasive
Lead Sponsor
Citations
Outcome of limb lengthening as a treatment for shortening ...
Results: A total of 21 patients with a mean age of 42.71 ± 7.96 years, consisting of 17 males (80.9%) and 4 females (19.1%), were successfully ...
Long-Term Radiological and Clinical Outcomes of ...
The Ilizarov EF is an effective and modern treatment approach that enables simultaneous correction of limb length discrepancies and deformities in patients of ...
Results of Lower Limb Bone Lengthening by Using ...
Conclusion: This study confirms that intramedullary nail PRECICE 2 and FITBONE systems are reliable and effective lengthening devices for ...
Are internal lengthening devices effective and associated...
Internal lengthening devices became more popular than external fixators. This was attributed to their effectiveness and lower complication rates.
Tibial lengthening with LRS fixator in a pediatric patient ...
This case demonstrates that gradual limb lengthening using external fixation is a safe and effective method for correcting moderate limb length discrepancies in ...
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reachyourheight.com
reachyourheight.com/wp-content/uploads/2022/01/2016Pitfalls-in-automatic-limb-lengthening.pdfPitfalls in automatic limb lengthening
Automatic bone lengthening with intramedullary nails provide good short- term outcome. Patients and methods. Ten patients with limb length discrepancy of lower ...
Outcome and challenges of management of limb length ...
Limb discrepancies of less than 4 cm may be treated with shoe raise; whereas LLD of 5 cm to 12 cm may be treated with vascularised bone grafts where the skill ...
Limb Lengthening for Children Leg Length Differences
Both devices allow simultaneous correction of the limb length discrepancy. Circular external fixation frames. A child wearing a tibial ...
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