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

Limb Length Discrepancy Clinical Trial

— PINS  

Official title:

A Post-Market Prospective Evaluation of the Performance and Safety of the Ellipse PRECICE Intramedullary Limb Lengthening System

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01601301
• Other study ID #: PR0035
• Status: Active, not recruiting
• Phase: N/A
• First received: May 14, 2012
• Last updated: January 31, 2018
• Start date: July 2012
• Est. completion date: June 2018

Study information

• Verified date: January 2018
• Source: Ellipse Technologies, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 32
• Est. completion date: June 2018
• Est. primary completion date: June 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Limb Length Discrepancy

Intervention

Device:
• PRECICE System
Lenthening of either the tibia or femur with the PRECICE System.

Locations

Country	Name	City	State
United States	Sinai Hospital of Baltimore	Baltimore	Maryland
United States	Cincinnati Children's Hospital Medical Center	Cincinnati	Ohio
United States	Loma Linda University	Loma Linda	California
United States	Hospital for Special Surgery	New York	New York
United States	Nemours Children's Hospital	Orlando	Florida
United States	Paley Advanced Limb Lengthening Institute	West Palm Beach	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Ellipse Technologies, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Pain	Pain measured by the SF-36v2, American Academy of Orthopaedic Surgeons Lower Limb Outcomes Questionnaire, and medication use.	Up to 24 months post-consolidation of the treated limb, an expected total average of 29 months
Secondary	Healing Index	The total treatment period with the PRECICE System in situ, divided by the length of bone growth in centimeters.	Up to 24 months post-consolidation of the treated limb, an expected total average of 29 months
Secondary	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
Secondary	Number of days to complete full weight bearing		Up to an expected average of 99 days.
Secondary	Number of days to full consolidation		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
Secondary	Adverse Events		Up to 24 months post-consolidation of the treated limb, an expected total average of 29 months
Secondary	Device-related complications		Up to 24 months post-consolidation of the treated limb, an expected total average of 29 months
Secondary	Procedure-related complications		Up to 24 months post-consolidation of the treated limb, an expected total average of 29 months

External Links

•   Ellipse Technologies Website