Overview

This trial is active, not recruiting.

Condition limb length discrepancy
Treatment precice system
Phase phase 4
Sponsor Ellipse Technologies, Inc.
Start date July 2012
End date September 2015
Trial size 32 participants
Trial identifier NCT01601301, PR0035

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
precice system
Lenthening of either the tibia or femur with the PRECICE System.

Primary Outcomes

Measure
Distraction Control: actual distraction rate vs. target distraction rate
time frame: Postoperatively, every 7-10 days up until the subject's distraction regimen is complete, an expected average of 33 days

Secondary Outcomes

Measure
Bone Union
time frame: 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
time frame: Up to 24 months post-consolidation of the treated limb, an expected total average of 29 months
Healing Index
time frame: Up to 24 months post-consolidation of the treated limb, an expected total average of 29 months
Number of days to complete lengthening
time frame: 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
time frame: Up to an expected average of 99 days.
Number of days to full consolidation
time frame: 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
Adverse Events
time frame: Up to 24 months post-consolidation of the treated limb, an expected total average of 29 months
Device-related complications
time frame: Up to 24 months post-consolidation of the treated limb, an expected total average of 29 months
Procedure-related complications
time frame: Up to 24 months post-consolidation of the treated limb, an expected total average of 29 months

Eligibility Criteria

Male or female participants of any age.

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

Additional Information

Official title A Post-Market Prospective Evaluation of the Performance and Safety of the Ellipse PRECICE Intramedullary Limb Lengthening System
Principal investigator Stuart A Green, MD
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
Trial information was received from ClinicalTrials.gov and was last updated in January 2016.
Information provided to ClinicalTrials.gov by Ellipse Technologies, Inc..