PediatricNCT06429267
Investigation Of Bioabsorbable Screws In Pediatric Orthopedic Surgery
A study testing Bioabsorbable Screw and Metal/Titanium Screw in people with Pediatric and Fracture, run by Louisiana State University Health Sciences Center in New Orleans at 1 site in United States.
Trial summary
This study is a prospective randomized controlled trial comparing the clinical outcomes of bioabsorbable screws to conventional metal screws in pediatric patients (aged 0 to 18) undergoing surgical fixation for trauma or elective procedures. Read more about this study
- Who is it for?
- Ages Up to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Pediatric, Fracture, Orthopedic Devices Associated With Misadventures, Surgical Instruments, Materials and Devices (Including Sutures)
- What is being tested?
- Bioabsorbable Screw and Metal/Titanium Screw
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Feb 2024to Apr 2026
- 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 Up to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Primary fractures requiring fixation with cannulated screws
Who cannot join
- Children ten years old or under with a fracture requiring screws to be fixed across the growth plate (physis)
- Secondary fractures
- Non-union fractures
- Tibial tubercle osteotomies (TTOs)
- Slipped capital femoral epiphysis (SCFEs)
- Unable or unwilling to provide informed consent or parental/guardian consent for participants under 18 years of age
- Allergies or contraindications to screw materials
Trial locations and contacts
1 site in 1 country.
Carter Clement, MD, MBA contact
United States1 site, 1 recruiting
- Recruiting
Children's Hospital New Orleans
New Orleans, Louisiana, 70118
Sylvia Culpepper, MS, 228-327-0278, sculpe@lsuhsc.edu
Carter Clement, MD, MBA
About this study
Official title: Comprehensive Investigation of Bioabsorbable Screws in Pediatric Orthopedic Surgery: Mechanical Properties, Long-term Performance, and Practical Applications
This study is a prospective randomized controlled trial comparing the clinical outcomes of bioabsorbable screws to conventional metal screws in pediatric patients (aged 0 to 18) undergoing surgical fixation for trauma or elective procedures. Conducted by the pediatric orthopedic department at Children's Hospital New Orleans, the study aims to evaluate the effectiveness of these screws in bone healing over key post-operative intervals (6 weeks, 6 months, and 1 year). It seeks to determine if bioabsorbable screws offer significant advantages over metal screws in terms of reducing the need for secondary surgeries, based on their hypothesized noninferiority in complication rates. Participants will be randomly assigned to receive either bioabsorbable or metal (titanium or stainless steel) screws after obtaining informed consent from a parent or guardian.
Read the detailed description
This study is a prospective randomized controlled trial to evaluate clinical outcomes associated with the use of bioabsorbable screws compared to conventional metal screws in children aged 0 to 18 who are undergoing surgical fixation in the setting of trauma such as medial epicondyle fractures of the elbow or elective procedures. The research will be conducted within the pediatric orthopedic department at CHNOLA, and participants will be assessed at key intervals, including 6 weeks, 6 months, and 1 year post-operation post-operation. The primary objective of this study is to assess and compare the effectiveness of conventional metal screws and bioabsorbable screws in bone healing. This study aims to determine whether bioabsorbable screws are significantly superior to conventional titanium screws. The investigators hypothesize bioabsorbable screws are significantly noninferior to conventional metal screws in terms of complications based on prior surgical constructs that demonstrate bioabsorbable screws eliminate the need for a second surgery After informed consent has been obtained from the parents of patients, eligible patients undergoing cannulated screw fixation will be randomized into two groups: one group who will receive bioabsorbable screws and the other group who will receive metal screws (titanium or stainless steel).
- Conditions
- Pediatric, Fracture, Orthopedic Devices Associated With Misadventures, Surgical Instruments, Materials and Devices (Including Sutures), Patient Satisfaction
- Being tested
- Bioabsorbable Screw, Metal/Titanium Screw
- Medical subject headings
- Fractures, Bone, Patient Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bioabsorbable ScrewDevice
Also called Ossiofiber
Bioabsorbable screw that redissolves into the bone. Mineral fibers are composed of Silicon Dioxide (SiO2), Sodium Oxide, Calcium Oxide, Magnesium Oxide, Boron Trioxide, and Phosphorous Pentoxide
Metal/Titanium ScrewDevice
Also called OrthoPediatrics
Traditional metal screw used in fracture fixation that requires hardware removal
| Study group | Role | What they receive |
|---|---|---|
| Control Group (Receiving Metal Screws) | Active comparator | Patients that are randomly assigned to receive traditional, metal screws Receives: Device: Metal/Titanium Screw |
| Experimental Group (Receiving Bioabsorbable Screws) | Experimental | Patients that are randomly assigned to receive Bioabsorbable screws Receives: Device: Bioabsorbable Screw |
What is being measured
The primary outcome is the main question the study is designed to answer.
Computer Adaptive PROMIS (Patient-Reported Outcomes Measurement Information System) Surveys
Pain, Upper Extremity and Mobility. These questionnaires are scored using T scores. For pain, a higher score is a worse outcome. For mobility and upper extremity, a lower score is a worse outcome. Min value is 0 and max is 100 for all.
Measured: 6 weeks, 6 months, 1 year
Secondary outcomes (1)
Complications
Any complications of surgery (infection etc)
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2024
- Study start26 Feb 2024
- Primary completionApr 2026 (estimated)
- Study completionApr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PediatricStudies 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomized to one of two groups which will determine the type of screw (stainless steel or bioabsorbable) in their surgery.
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Louisiana State University Health Sciences Center in New Orleans
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Carter Clement, MD, MBA, Principal investigator, LSUHSC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06429267
- Sponsor's protocol ID
- 6360
- Status last verified
- May 2024
- First submitted
- 1 May 2024
- Last updated
- 24 May 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: all IPD that underlie results in a publication
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comprehensive Investigation of Bioabsorbable Screws in Pediatric Orthopedic Surgery: Mechanical Properties, Long-term Performance, and Practical Applications
- ClinicalTrials.gov ID
- NCT06429267
- Acronym / sponsor ID
- 6360
- Conditions
- Pediatric, Fracture, Orthopedic Devices Associated With Misadventures, Surgical Instruments, Materials and Devices (Including Sutures), Patient Satisfaction
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Louisiana State University Health Sciences Center in New OrleansUniversity, hospital or other
- Study start
- 26 Feb 2024 (actual)
- Primary completion
- Apr 2026 (estimated)
- Study completion
- Apr 2026 (estimated)
- First posted
- 24 May 2024 (actual)
- 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.
This study is a prospective randomized controlled trial comparing the clinical outcomes of bioabsorbable screws to conventional metal screws in pediatric patients (aged 0 to 18) undergoing surgical fixation for trauma or elective procedures. Conducted by the pediatric orthopedic department at Children's Hospital New Orleans, the study aims to evaluate the effectiveness of these screws in bone healing over key post-operative intervals (6 weeks, 6 months, and 1 year). It seeks to determine if bioabsorbable screws offer significant advantages over metal screws in terms of reducing the need for secondary surgeries, based on their hypothesized noninferiority in complication rates. Participants will be randomly assigned to receive either bioabsorbable or metal (titanium or stainless steel) screws after obtaining informed consent from a parent or guardian.
Detailed description
This study is a prospective randomized controlled trial to evaluate clinical outcomes associated with the use of bioabsorbable screws compared to conventional metal screws in children aged 0 to 18 who are undergoing surgical fixation in the setting of trauma such as medial epicondyle fractures of the elbow or elective procedures. The research will be conducted within the pediatric orthopedic department at CHNOLA, and participants will be assessed at key intervals, including 6 weeks, 6 months, and 1 year post-operation post-operation. The primary objective of this study is to assess and compare the effectiveness of conventional metal screws and bioabsorbable screws in bone healing. This study aims to determine whether bioabsorbable screws are significantly superior to conventional titanium screws. The investigators hypothesize bioabsorbable screws are significantly noninferior to conventional metal screws in terms of complications based on prior surgical constructs that demonstrate bioabsorbable screws eliminate the need for a second surgery After informed consent has been obtained from the parents of patients, eligible patients undergoing cannulated screw fixation will be randomized into two groups: one group who will receive bioabsorbable screws and the other group who will receive metal screws (titanium or stainless steel).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- Model description
- Participants will be randomized to one of two groups which will determine the type of screw (stainless steel or bioabsorbable) in their surgery.
| Arm | Type | Receives |
|---|---|---|
| Control Group (Receiving Metal Screws) | Active comparator | Device: Metal/Titanium ScrewPatients that are randomly assigned to receive traditional, metal screws |
| Experimental Group (Receiving Bioabsorbable Screws) | Experimental | Device: Bioabsorbable ScrewPatients that are randomly assigned to receive Bioabsorbable screws |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Primary fractures requiring fixation with cannulated screws
Key exclusion criteria (7 listed)
- Children ten years old or under with a fracture requiring screws to be fixed across the growth plate (physis)
- Secondary fractures
- Non-union fractures
- Tibial tubercle osteotomies (TTOs)
- Slipped capital femoral epiphysis (SCFEs)
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 |
|---|---|---|
| Bioabsorbable ScrewAlso: OssiofiberBioabsorbable screw that redissolves into the bone. Mineral fibers are composed of Silicon Dioxide (SiO2), Sodium Oxide, Calcium Oxide, Magnesium Oxide, Boron Trioxide, and Phosphorous Pentoxide | Device | Experimental Group (Receiving Bioabsorbable Screws) |
| Metal/Titanium ScrewAlso: OrthoPediatricsTraditional metal screw used in fracture fixation that requires hardware removal | Device | Control Group (Receiving Metal Screws) |
Primary outcome
Computer Adaptive PROMIS (Patient-Reported Outcomes Measurement Information System) Surveys
Time frame: 6 weeks, 6 months, 1 year
Pain, Upper Extremity and Mobility. These questionnaires are scored using T scores. For pain, a higher score is a worse outcome. For mobility and upper extremity, a lower score is a worse outcome. Min value is 0 and max is 100 for all.
1 secondary outcome
Complications
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2024.
- Individual participant dataSharing planned: Yes. all IPD that underlie results in a publication
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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.
Carter Clement, MD, MBA contact
Carter Clement, MD, MBA principal investigator
LSUHSC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bioabsorbable Screw and Metal/Titanium Screw in people with Pediatric and Fracture, run by Louisiana State University Health Sciences Center in New Orleans at 1 site 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 1 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: status not confirmed, as of the sponsor's last update on 24 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Contact Sylvia Culpepper, MS (2283270278, sculpe@lsuhsc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Computer Adaptive PROMIS (Patient-Reported Outcomes Measurement Information System) Surveys (time frame: 6 weeks, 6 months, 1 year). 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 24 May 2024.