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

Ellipse Technologies

Status

Unknown

Conditions

Limb Length Discrepancy

Treatments

Device: PRECICE System

Study type

Interventional

Funder types

Industry

Identifiers

NCT01601301

PR0035

Details and patient eligibility

About

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.

Full description

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

Enrollment

32 patients

Sex

All

Volunteers

No Healthy Volunteers

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