Limb Length DiscrepancyPINSNCT01601301
Post-Market Study of the Ellipse PRECICE Intramedullary Limb Lengthening System
A study testing PRECICE System in people with Limb Length Discrepancy, run by Ellipse Technologies, Inc. at 6 sites in United States.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Limb Length Discrepancy
- What is being tested?
- PRECICE System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 6 sitesUnited States
- Study dates
- Jul 2012to Jun 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 18Show fewer
- 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
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Sinai Hospital of Baltimore
Baltimore, Maryland, 21215
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
Loma Linda University
Loma Linda, California, 92350
Hospital for Special Surgery
New York, New York, 10021
Nemours Children's Hospital
Orlando, Florida, 32827
Paley Advanced Limb Lengthening Institute
West Palm Beach, Florida, 33407
About this study
Official title: A Post-Market Prospective Evaluation of the Performance and Safety of the Ellipse PRECICE Intramedullary Limb Lengthening System
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.
Read the detailed 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
- Conditions
- Limb Length Discrepancy
- Being tested
- PRECICE System
- Keywords
- Limb, Lengthening, PRECICE, Ellipse, Technologies, Distraction, Osteogenesis, Femur, Tibia, Intramedullary, Nail, Device, Medical, Orthopedic, Implant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PRECICE SystemDevice
Lenthening of either the tibia or femur with the PRECICE System.
| Study group | Role | What they receive |
|---|---|---|
| PRECICE System | Experimental | Not described Receives: Device: PRECICE System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Distraction Control: actual distraction rate vs. target distraction rate
Measured: 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
Measured: 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
Pain measured by the SF-36v2, American Academy of Orthopaedic Surgeons Lower Limb Outcomes Questionnaire, and medication use.
Measured: Up to 24 months post-consolidation of the treated limb, an expected total average of 29 months
Healing Index
The total treatment period with the PRECICE System in situ, divided by the length of bone growth in centimeters.
Measured: Up to 24 months post-consolidation of the treated limb, an expected total average of 29 months
Number of days to complete lengthening
Measured: 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
Measured: Up to an expected average of 99 days.
Number of days to full consolidation
Measured: 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
Measured: Up to 24 months post-consolidation of the treated limb, an expected total average of 29 months
Device-related complications
Measured: Up to 24 months post-consolidation of the treated limb, an expected total average of 29 months
Procedure-related complications
Measured: Up to 24 months post-consolidation of the treated limb, an expected total average of 29 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2012 (estimated)
- Study startJul 2012
- Primary completionJun 2018 (estimated)
- Study completionJun 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Limb Length DiscrepancyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ellipse Technologies, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Stuart A Green, MD, Principal investigator, University of California, Irvine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01601301
- Sponsor's protocol ID
- PR0035
- Acronym
- PINS
- Status last verified
- Jan 2018
- First submitted
- 14 May 2012
- Last updated
- 5 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Post-Market Prospective Evaluation of the Performance and Safety of the Ellipse PRECICE Intramedullary Limb Lengthening System
- ClinicalTrials.gov ID
- NCT01601301
- Acronym / sponsor ID
- PINS / PR0035
- Conditions
- Limb Length Discrepancy
- Keywords
- Limb, Lengthening, PRECICE, Ellipse, Technologies, Distraction, Osteogenesis, Femur
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Ellipse Technologies, Inc.Industry (pharma, biotech, devices)
- Study start
- Jul 2012
- Primary completion
- Jun 2018 (estimated)
- Study completion
- Jun 2018 (estimated)
- First posted
- 18 May 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PRECICE System | Experimental | Device: PRECICE System |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (18 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PRECICE SystemLenthening of either the tibia or femur with the PRECICE System. | Device | PRECICE System |
Primary outcome
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
9 secondary outcomes
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stuart A Green, MD principal investigator
University of California, Irvine
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PRECICE System in people with Limb Length Discrepancy, run by Ellipse Technologies, Inc. at 6 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2018; AzTrials last refreshed its copy on 7 Nov 2026.