Limb Length DiscrepancyNCT06714110
A Review of Precice Intramedullary Limb Lengthening (IMLL) System for Limb Lengthening Procedures in Children.
An observational study of Limb Length Discrepancy, run by NuVasive at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 0 months to 12 years
- Conditions the study is for
- Limb Length Discrepancy
- What is being tested?
- Intramedullary Limb Lengthening Device and External Fixator Limb Lengthening Device
- Type of treatment
- Medical device
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Mar 2025to Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 months to 12 years
- All sexes
- No healthy volunteers
- Child
Study population: Pediatric (12 years and under) population
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Retrospective Review of Clinical and Radiographic Outcomes Following the Use of the Precice Intramedullary Limb Lengthening (IMLL) System in Pediatric Limb Lengthening Procedures
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.
Read the detailed description
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.
- Conditions
- Limb Length Discrepancy
- Being tested
- Intramedullary Limb Lengthening Device, External Fixator Limb Lengthening Device
- Keywords
- Precice IMLL, external fixator, Limb length discrepancy surgery, index bone, femur, tibia, surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intramedullary Limb Lengthening DeviceDevice
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 Limb Lengthening DeviceDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Precice IMLL System | Patients 12 years of age or younger received Precice IMLL for correction of limb length discrepancy. Receives: Device: Intramedullary Limb Lengthening Device | |
| External Fixator | Patients 12 years of age or younger received an external fixator for correction of limb length discrepancy. Receives: Device: External Fixator Limb Lengthening Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bone (femur or tibia) lengthening
Achievement of targeted limb length
Measured: 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.
Measured: At least 1 yr post-op
Frequency of device related complications
Review of investigator-reported device-related complications
Measured: Post-op through at least 1 year post-op
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2024
- Study start13 Mar 2025
- Primary completion30 Jul 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Limb Length DiscrepancyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- NuVasive
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kyle Malone, Study director, Globus Medical
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06714110
- Sponsor's protocol ID
- NUVA.ILL0723
- Status last verified
- Dec 2025
- First submitted
- 7 Nov 2024
- Last updated
- 22 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Retrospective Review of Clinical and Radiographic Outcomes Following the Use of the Precice Intramedullary Limb Lengthening (IMLL) System in Pediatric Limb Lengthening Procedures
- ClinicalTrials.gov ID
- NCT06714110
- Acronym / sponsor ID
- NUVA.ILL0723
- Conditions
- Limb Length Discrepancy
- Keywords
- Precice IMLL, external fixator, Limb length discrepancy surgery, index bone, femur, tibia, surgery
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- NuVasiveIndustry (pharma, biotech, devices)
- Study start
- 13 Mar 2025 (actual)
- Primary completion
- 30 Jul 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 3 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Precice IMLL System | – | Device: Intramedullary Limb Lengthening DevicePatients 12 years of age or younger received Precice IMLL for correction of limb length discrepancy. |
| External Fixator | – | Device: External Fixator Limb Lengthening DevicePatients 12 years of age or younger received an external fixator for correction of limb length discrepancy. |
Who may qualify
- Ages
- 0 months to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Pediatric (12 years and under) population
Key inclusion criteria (9 listed)
- All potential index surgeries must meet the inclusion criteria below in order to be considered for enrollment:
Key exclusion criteria (6 listed)
- Index surgeries will be excluded from consideration for the study if they meet any of the following criteria:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intramedullary Limb Lengthening DeviceThe 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. | Device | Precice IMLL System |
| External Fixator Limb Lengthening DeviceExternal 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. | Device | External Fixator |
Primary outcome
Bone (femur or tibia) lengthening
Time frame: At least 1 yr post-op
Achievement of targeted limb length
Osteotomy Healing
Time frame: At least 1 yr post-op
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.
Frequency of device related complications
Time frame: Post-op through at least 1 year post-op
Review of investigator-reported device-related complications
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Kyle Malone study director
Globus Medical
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Limb Length Discrepancy, run by NuVasive at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 22 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bone (femur or tibia) lengthening (time frame: At least 1 yr post-op). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Dec 2025.