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

NCT01601301 | Unknown

• 1 other identifier: PR0035
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 6

Brief Summary

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.

Conditions

Limb Length Discrepancy

Keywords

Limb; Lengthening; PRECICE; Ellipse; Technologies; Distraction; Osteogenesis; Femur; Tibia; Intramedullary; Nail; Device; Medical; Orthopedic; Implant

Outcome Measures

Primary Outcomes (1)

• Distraction Control: actual distraction rate vs. target distraction rate

  Postoperatively, every 7-10 days up until the subject's distraction regimen is complete, an expected average of 33 days

Secondary Outcomes (9)

• Bone Union

  Following completion of the subject's distraction regimen, every 4-6 weeks until the subject's treated limb is evaluated as consolidated, an expected average of 66 days

• Pain

  Up to 24 months post-consolidation of the treated limb, an expected total average of 29 months

• Healing Index

  Up to 24 months post-consolidation of the treated limb, an expected total average of 29 months

• Number of days to complete lengthening

  Postoperatively, every 7-10 days up until the subject's distraction regimen is complete, an expected average of 33 days

• Number of days to complete full weight bearing

  Up to an expected average of 99 days.

Study Arms (1)

PRECICE System

EXPERIMENTAL

Device: PRECICE System

Interventions

PRECICE System DEVICE

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

PRECICE System

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ellipse Technologies, Inc.: lead

Study Sites (6)

Loma Linda University

Loma Linda, California, 92350, United States

Location

Nemours Children's Hospital

Orlando, Florida, 32827, United States

Location

Paley Advanced Limb Lengthening Institute

West Palm Beach, Florida, 33407, United States

Location

Sinai Hospital of Baltimore

Baltimore, Maryland, 21215, United States

Location

Hospital for Special Surgery

New York, New York, 10021, United States

Location

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

Location

Study Officials

• Stuart A Green, MD

  University of California, Irvine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 14, 2012
• First Posted: May 18, 2012
• Study Start: July 1, 2012
• Primary Completion: June 1, 2018
• Study Completion: June 1, 2018
• Last Updated: February 5, 2018

Record last verified: 2018-01

Locations

US (6)