Fracture Fixation, IntramedullaryNCT04941612
Use of the Bioabsorbable Activa IM-Nail™ in Pediatric Diaphyseal Forearm Fractures
A study testing Activa IM-Nail in people with Fracture Fixation, Intramedullary and Forearm Fracture, run by Children's Fractures Interest Group, Denmark at 1 site in Denmark.
Trial summary
Background Pediatric diaphyseal forearm fractures are common and one of the most frequent reasons for orthopedic care. Fractures in need of surgery are often treated with metal Elastic Stable Intramedullary Nails (ESIN). Nail removal after 6-12 months is generally advocated. Read more about this study
- Who is it for?
- Ages 2 to 18 years
- Conditions the study is for
- Fracture Fixation, Intramedullary, Forearm Fracture, Fracture Healing
- What is being tested?
- Activa IM-Nail
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteDenmark
- Study dates
- 25 May 2021to 25 May 2025
- 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 2 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Acute traumatic diaphyseal forearm fracture of the radius, ulna or both
- Fractures need to be complete (not unicortical or green stick)
- Displaced more than 50% of bone width or angulated more than 10° in any plane or irreducible or unstable after reduction
Who cannot join
- We exclude patients
- with fractures that are well managed conservatively (undisplaced or minimally displaced)
- with previous ipsilateral forearm fracture
- with fractures unsuited for intramedullary nailing (e.g. multifragmentary, metaphyseal or epiphyseal)
- with fractures with ipsilateral wrist or elbow involvement (e.g. Monteggia or Galeazzi variants)
- unable to participate in follow-up
- with existing bone pathology (e.g. tumor, osteogenesis imperfecta, degenerative disease)
- in whom internal fixation is otherwise contraindicated (e.g. active or potential infection)
Trial locations and contacts
1 site in 1 country.
Denmark1 site, 1 recruiting
- Recruiting
Herlev and Gentofte University Hospital
Herlev, Capital Region, 2730
Morten J Andersen, MD, 004538681479, morten.jon.andersen@regionh.dk
About this study
Official title: Use of the Bioabsorbable Activa IM-Nail™ in Pediatric Diaphyseal Forearm Fractures: a Cohort Study of 30 Patients
Background
Pediatric diaphyseal forearm fractures are common and one of the most frequent reasons for orthopedic care. Fractures in need of surgery are often treated with metal Elastic Stable Intramedullary Nails (ESIN). Nail removal after 6-12 months is generally advocated. Surgical hardware removal has few complications; however, it is a substantial burden on the child, the family and healthcare economy. Bioabsorbable Intramedullary Nails (BIN) have been developed for the same indications as metal ESIN. The use of bioabsorbable implants would deem hardware removal unnecessary and relieve the child of further surgery and reduce healthcare costs.
Read more
Methods
The investigators aim to recruit all children in the catchment area of Herlev and Gentofte University Hospital (Copenhagen, Denmark) with acute unstable diaphyseal forearm fractures. Participants will be operated with BIN and followed consecutively for 2 years with interim analysis of data after 6 months. The investigators will report radiological healing using the Radiographic Union Score (RUS) 3 months after surgery together with any adverse events during follow-up.
Discussion
This study will provide important preliminary data and asses the feasibility of using the bioabsorbable Activa IM-Nail™ in pediatric diaphyseal forearm fractures. This study is a pilot study for initiating an RCT comparing BIN to metal ESIN hypothesizing that BIN is not an inferior treatment.
- Conditions
- Fracture Fixation, Intramedullary, Forearm Fracture, Fracture Healing, Child, Only, Implant Complication
- Being tested
- Activa IM-Nail
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Activa IM-NailDevice
PLGA bioabsorbable intramedullary nail
| Study group | Role | What they receive |
|---|---|---|
| Activa IM-Nail | Experimental | Activa IM-Nail Receives: Device: Activa IM-Nail |
What is being measured
The primary outcome is the main question the study is designed to answer.
Radiographic Union Score (RUS)
RUS is a score derived from assessing AP and lateral radiographs. Each bone cortex (anterior, posterior, medial and lateral) is assigned a score of 1 to 3. A cortex with a visible fracture line and no callus is given a score of 1, a cortex with callus but a visible fracture line is scored as 2 and a cortex with bridging callus and no visible fracture line is scored as 3. Scores are added to give a minimum score of 4 (definitely not healed) and a maximum of 12 (definitely healed). 12 is best.
Measured: 3 months
Secondary outcomes (3)
Faces Pain Scale - Revised (FPS-R)
To measure the outcome of pain in children below 8 years of age. Pain evaluated by the child selecting 1 of 6 faces that represents their feeling of pain. Faces are scored 0, 2, 4, 6, 8 or 10. Scale 0-10 with 2 point increments. 0 = no pain, 10= very much pain. 0 is best.
Measured: 3 months
Bilateral elbow and forearm range of motion
Measured in degrees by goniometer
Measured: 3 months
Visual Analogue Scale (VAS)
Pain evaluated by the child putting a mark on a 10 cm long line. Most left=no pain, most right=worst possible pain. Distance from most left to the child's mark is measured with a ruler. 1 mm = 1 point. Value is given with 1 decimal, e.g. 64 mm = 6,4 points.
Scale 0.0-10.0. With 0 = no pain, 10= worst possible pain. 0 is best.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2021
- Study start25 May 2021
- Primary completion31 Aug 2023 (estimated)
- Study completion25 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fracture Fixation, IntramedullaryStudies 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
- Model description
- Cohort study
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Children's Fractures Interest Group, Denmark
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Morten Jon Andersen, Children's Fractures Interest Group, Denmark
- Investigators
- Morten J Andersen, MD, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04941612
- Sponsor's protocol ID
- H-21004012
- Status last verified
- Jun 2021
- First submitted
- 24 May 2021
- Last updated
- 28 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of the Bioabsorbable Activa IM-Nail™ in Pediatric Diaphyseal Forearm Fractures: a Cohort Study of 30 Patients
- ClinicalTrials.gov ID
- NCT04941612
- Acronym / sponsor ID
- H-21004012
- Conditions
- Fracture Fixation, Intramedullary, Forearm Fracture, Fracture Healing, Child, Only, Implant Complication
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Children's Fractures Interest Group, DenmarkUniversity, hospital or other
- Study start
- 25 May 2021 (actual)
- Primary completion
- 31 Aug 2023 (estimated)
- Study completion
- 25 May 2025 (estimated)
- First posted
- 28 Jun 2021 (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.
Background
Pediatric diaphyseal forearm fractures are common and one of the most frequent reasons for orthopedic care. Fractures in need of surgery are often treated with metal Elastic Stable Intramedullary Nails (ESIN). Nail removal after 6-12 months is generally advocated. Surgical hardware removal has few complications; however, it is a substantial burden on the child, the family and healthcare economy. Bioabsorbable Intramedullary Nails (BIN) have been developed for the same indications as metal ESIN. The use of bioabsorbable implants would deem hardware removal unnecessary and relieve the child of further surgery and reduce healthcare costs.
Methods
The investigators aim to recruit all children in the catchment area of Herlev and Gentofte University Hospital (Copenhagen, Denmark) with acute unstable diaphyseal forearm fractures. Participants will be operated with BIN and followed consecutively for 2 years with interim analysis of data after 6 months. The investigators will report radiological healing using the Radiographic Union Score (RUS) 3 months after surgery together with any adverse events during follow-up.
Discussion
This study will provide important preliminary data and asses the feasibility of using the bioabsorbable Activa IM-Nail™ in pediatric diaphyseal forearm fractures. This study is a pilot study for initiating an RCT comparing BIN to metal ESIN hypothesizing that BIN is not an inferior treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Cohort study
| Arm | Type | Receives |
|---|---|---|
| Activa IM-Nail | Experimental | Device: Activa IM-NailActiva IM-Nail |
Who may qualify
- Ages
- 2 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Acute traumatic diaphyseal forearm fracture of the radius, ulna or both
- Fractures need to be complete (not unicortical or green stick)
- Displaced more than 50% of bone width or angulated more than 10° in any plane or irreducible or unstable after reduction
Key exclusion criteria (8 listed)
- We exclude patients
- with fractures that are well managed conservatively (undisplaced or minimally displaced)
- with previous ipsilateral forearm fracture
- with fractures unsuited for intramedullary nailing (e.g. multifragmentary, metaphyseal or epiphyseal)
- with fractures with ipsilateral wrist or elbow involvement (e.g. Monteggia or Galeazzi variants)
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 |
|---|---|---|
| Activa IM-NailPLGA bioabsorbable intramedullary nail | Device | Activa IM-Nail |
Primary outcome
Radiographic Union Score (RUS)
Time frame: 3 months
RUS is a score derived from assessing AP and lateral radiographs. Each bone cortex (anterior, posterior, medial and lateral) is assigned a score of 1 to 3. A cortex with a visible fracture line and no callus is given a score of 1, a cortex with callus but a visible fracture line is scored as 2 and a cortex with bridging callus and no visible fracture line is scored as 3. Scores are added to give a minimum score of 4 (definitely not healed) and a maximum of 12 (definitely healed). 12 is best.
3 secondary outcomes
Faces Pain Scale - Revised (FPS-R)
Time frame: 3 months
Bilateral elbow and forearm range of motion
Time frame: 3 months
Visual Analogue Scale (VAS)
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2021.
- Individual participant dataSharing planned: No
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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.
Morten J Andersen, MD principal investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Activa IM-Nail in people with Fracture Fixation, Intramedullary and Forearm Fracture, run by Children's Fractures Interest Group, Denmark at 1 site in Denmark.
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 3 inclusion and 8 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 28 Jun 2021. 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 Denmark. 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 Morten J Andersen, MD (004538681479, mortenjonandersen@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Radiographic Union Score (RUS) (time frame: 3 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 28 Jun 2021.