Post-Market Study of the Ellipse PRECICE Intramedullary Limb Lengthening System

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-07-31

Study Completion Date

2018-06-30

Brief Summary

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The purpose of this study is to obtain post market performance and safety data of the Ellipse PRECICE Intramedullary Limb Lengthening System for subjects undergoing unilateral limb lengthening.

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Detailed Description

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Subject data will be reviewed at the following visits:

* Preoperative
* Operative
* Every 7 to 14 days through Distraction Phase
* Every 4 to 6 weeks through Consolidation Phase
* 6-Month Post-Consolidation
* 12-Month Post-Consolidation
* 18-Month Post-Consolidation
* 24-Month Post-Consolidation

Conditions

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Limb Length Discrepancy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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PRECICE System

Group Type EXPERIMENTAL

PRECICE System

Intervention Type DEVICE

Lenthening of either the tibia or femur with the PRECICE System.

Interventions

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PRECICE System

Lenthening of either the tibia or femur with the PRECICE System.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Leg length discrepancy ≥ 1.5 cm and ≤ 6.5 cm due to short femur or tibia
* Weight ≤ 114 kg if implanted with the 10.7 mm or 12.5 mm diameter nail, or ≤ 57 kg if implanted with the 8.5 mm diameter nail
* Skeletally mature
* Intramedullary canal without offset
* Tibia or femur sufficient to contain the implant
* Availability, willingness, and sufficient cognitive awareness to comply with protocol procedures and schedule
* Must sign informed consent to permit the use of personal health data

Exclusion Criteria

* Active infection or previous history of deep infection in the involved bone
* Metal allergies or sensitivities to the components of the device
* Distance from the nearest convenient external surface of the treated limb to the intramedullary canal \> 38 mm for the 8.5 mm PRECICE nail, \> 51 mm for the 10.7 mm PRECICE nail, or \> 76 mm for the 12.5 mm PRECICE nail
* Significant range of motion deficit of the adjacent joints
* Patients with a pacemaker, implanted cardiac defibrillator, or any other electronic or magnetic implant
* Patients who require an MRI during implantation
* Non-union
* Impassable or obstructed intramedullary canal
* Significant angular deformity that prevents device placement
* Cannot bear weight on the contralateral limb
* Procedural osteotomy cannot be made in an appropriate location
* Deformities that require multilevel osteotomies or bi-lateral implantation at the time of study index surgery
* Systemic bone disease
* Pregnant or nursing women
* Inadequate vascularity or evidence of vascular disease or peripheral neuropathy
* Malignancies or tumors in the involved bone
* Patient is a drug abuser
* Open wounds or ulcers that could compromise treatment

Eligible Sex

ALL

Accepts Healthy Volunteers

No