Femur FracturePLNNCT00725894
Pediatric Locking Nail for the Treatment of Femoral Fractures in Children
An observational study of Femur Fracture, run by Zimmer Biomet at 3 sites in United States.
Trial summary
The purpose of this multi-center prospective clinical outcomes study is to determine validity and safety of the pediatric locking nail for femoral fracture management in children with open physes. Read more about this study
- Who is it for?
- Ages 8 to 16 years
- Conditions the study is for
- Femur Fracture
- What is being tested?
- Pediatric Locking Nail
- Type of treatment
- Medical device
- How many people
- 33 participants
- Where
- 3 sitesUnited States
- Study dates
- Nov 2007to Nov 2013
- Phase
- Observational
- 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 8 to 16 years
- All sexes
- No healthy volunteers
- Child
Study population: Pediatric femoral fractures in patients 8-16 years of age where a nail is preferred
Who may be able to join
- Subject, representative willing to sign informed consent.
- Ability and willingness of the subject to follow postoperative care instructions until healing is complete
- Subject age must be between 8-16 inclusive.
- Subjects with a minimal canal diameter of 9mm or greater
- And any of the following fracture types
- Non-comminuted and comminuted mid-shaft fractures
Show all 9Show fewer
- Distal third fractures 4 cm above the distal physis
- Fractures that are open or closed
- Subtrochanteric fractures
Who cannot join
- A subject has a bone or soft tissue infection.
- Subject has a systemic infection.
- Subject has a distal (supracondylar) fracture.
- Subject with pathological bone (osteogenesis imperfecta and other conditions resulting in abnormal bone quality).
- Subjects with mental or neurological condition who are unwilling or incapable of following postoperative care instructions.
- Subject with conditions including blood supply limitation, and insufficient quantity or quality of bone.
- Foreign body sensitivity, where material sensitivity is suspected, testing is to be completed prior to implantation of device if at all practical or the subject should be excluded.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Orthopedic Clinical Research
Charlotte, North Carolina, 28204
Arnold Palmer Hospital for Children/OH Pediatric Orthopedics Clinic
Orlando, Florida, 32806
Phoenix Childrens Hospital
Phoenix, Arizona, 85016
About this study
Official title: A Prospective Multi-Center Clinical Outcomes Study To Assess The Safety and Effectiveness Of The Pediatric Locking Nail For Treatment Of Femoral Fractures In Children
The purpose of this multi-center prospective clinical outcomes study is to determine validity and safety of the pediatric locking nail for femoral fracture management in children with open physes.
- Conditions
- Femur Fracture
- Being tested
- Pediatric Locking Nail
- Medical subject headings
- Femoral Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pediatric Locking NailDevice
The nail is pre contoured with a nine-degree anterior bow and is universal for right and left femoral.
| Study group | Role | What they receive |
|---|---|---|
| 1 | The Pediatric Locking Nail was designed to provide stable sub-rigid fixation of femoral fractures in children Receives: Device: Pediatric Locking Nail |
What is being measured
The primary outcome is the main question the study is designed to answer.
limb alignment
Measured: 48 months
Secondary outcomes (1)
length of healing, weight-bearing time (time to full weight bearing), and length of hospital stay and absence of complications
Measured: 48 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2008 (estimated)
- Study startNov 2007
- Primary completionMay 2013
- Study completionNov 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Femur FractureStudies of the same condition, open and under way.
- More trials run by Zimmer BiometThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zimmer Biomet
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Russell Schenck, PhD, Study director, Zimmer Biomet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00725894
- Sponsor's protocol ID
- CS-010
- Acronym
- PLN
- Status last verified
- Jun 2017
- First submitted
- 29 Jul 2008
- Last updated
- 21 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Multi-Center Clinical Outcomes Study To Assess The Safety and Effectiveness Of The Pediatric Locking Nail For Treatment Of Femoral Fractures In Children
- ClinicalTrials.gov ID
- NCT00725894
- Acronym / sponsor ID
- PLN / CS-010
- Conditions
- Femur Fracture
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Zimmer BiometIndustry (pharma, biotech, devices)
- Study start
- Nov 2007
- Primary completion
- May 2013 (actual)
- Study completion
- Nov 2013 (actual)
- First posted
- 31 Jul 2008 (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 multi-center prospective clinical outcomes study is to determine validity and safety of the pediatric locking nail for femoral fracture management in children with open physes.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | Device: Pediatric Locking NailThe Pediatric Locking Nail was designed to provide stable sub-rigid fixation of femoral fractures in children |
Who may qualify
- Ages
- 8 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Pediatric femoral fractures in patients 8-16 years of age where a nail is preferred
Key inclusion criteria (9 listed)
- Subject, representative willing to sign informed consent.
- Ability and willingness of the subject to follow postoperative care instructions until healing is complete
- Subject age must be between 8-16 inclusive.
- Subjects with a minimal canal diameter of 9mm or greater
- And any of the following fracture types
Key exclusion criteria (7 listed)
- A subject has a bone or soft tissue infection.
- Subject has a systemic infection.
- Subject has a distal (supracondylar) fracture.
- Subject with pathological bone (osteogenesis imperfecta and other conditions resulting in abnormal bone quality).
- Subjects with mental or neurological condition who are unwilling or incapable of following postoperative care instructions.
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 |
|---|---|---|
| Pediatric Locking NailThe nail is pre contoured with a nine-degree anterior bow and is universal for right and left femoral. | Device | 1 |
Primary outcome
limb alignment
Time frame: 48 months
1 secondary outcome
length of healing, weight-bearing time (time to full weight bearing), and length of hospital stay and absence of complications
Time frame: 48 Months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jun 2017.
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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.
Russell Schenck, PhD study director
Zimmer Biomet
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Femur Fracture, run by Zimmer Biomet at 3 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 9 inclusion and 7 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: finished, as of the sponsor's last update on 21 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
limb alignment (time frame: 48 months). 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 21 Jun 2017.