Fractures, BoneNCT04385745
Treatment of Children's Forearm Shaft Fractures With Biodegradable Intramedullary Nailing, Compared With Elastic Stable Intramedullary Nailing
A study testing Biodegradable Intramedullary Nailing (BIN) in people with Fractures, Bone and Injury Arm, run by Oulu University Hospital at 1 site in Finland.
Trial summary
The study purpose is to investigate long-term biodegradation process of the polylactide-co-glycolide (PLGA) intramedullary nails, used in treating the forearm shaft fractures in children. Read more about this study
- Who is it for?
- Ages 4 to 16 years
- Conditions the study is for
- Fractures, Bone, Injury Arm
- What is being tested?
- Biodegradable Intramedullary Nailing (BIN)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteFinland
- Study dates
- 5 Jan 2019to 1 Jan 2023
- 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 4 to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- • Patients who have participated in the previous study, concerning the surgical treatment of forearm shaft fracture and have been treated by biodegradable intramedullary nailing (BIN), using the polylactide-co-glycolide nails (ActivaNail).
Who cannot join
- • The cases that have primarily been enrolled but interrupted the first study because of new fracture and been therefore surgically fixed with traditional (metallic) implants will be excluded.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: BIODEGRADATION OF POLYLACTIDE-CO-GLYCOLIDE INTRAMEDULLARY NAILS USED IN TREATMENT OF CHILDREN'S FOREARM SHAFT FRACTURES AND CLINICAL RECOVERY OF THE PATIENTS IN THE LONG-TERM.
The study purpose is to investigate long-term biodegradation process of the polylactide-co-glycolide (PLGA) intramedullary nails, used in treating the forearm shaft fractures in children. The primary objective of the study is to determine the stage of biodegradation of the polylactide-co-glycolide intramedullary nails, compared with the time since operation.
Biodegradation is to be evaluated by using Magnetic Resonance Imaging (MRI). Potential adverse events, being related to the biodegradation process of the implant, will be recognized: fluid accumulation, sinus formation, osteolysis, swelling, cyst formation and other soft-tissue reactions in the surroundings of the former fracture will be evaluated.
Read more
Radiographic recovery at least 4 years after the implant operation is secondary aims of the study. Radiographic investigation (plain radiographs in lateral and anterior-posterior views) are taken to evaluate the signs of bone healing after the long-bone diaphysis fracture, including the resolution of the previous callus formation, tubularization of the long-bones around the previous fracture area and remodeling of the angular and rotational alignment.
Clinical recovery in the long-term (at least 4 years) is another secondary aim of the study.
Prospective observational study will be performed. The study population comprises all the cases who were participating in the previous RCT ("BIOABSORBABLE INTRAMEDULLARY NAIL FIXATION OF FOREARM FRACTURES IN CHILDREN") and were therefore treated by means of biodegradable intramedullary nailing in years 2010 to 2015 (N=16).
All these patients will be invited and at least 4-year follow-up visit is performed at out-hospital clinics in the study institutions and radiographs and MRI will be taken. Flynn's criteria, MAYO elbow performance score and mini-DASH will be used. Health-related quality of life is to be analysed by using Pediatric Quality of Life Inventory (PedsQL). Visual analogue scale will be used for determining residual pain. A comprehensive analysis concerning the radiographic bone healing, according to Lane-Sandhu -scoring is determined and biodegradation of the implants, including the tricalciumphosphate tip will be evaluated by using MRI.
Number of Patients: N=15
Diagnosis and Main Criteria for Inclusion and Exclusion:
The study cases of the previous original research, described above, will be used to comprise the study population of the current project. The subject and/or guardian are invited to the study by a postal letter and by a call in case of no show. A signed and dated informed consent is required upon the participation.
Costs: The patients are to be investigated for long-term recovery according to the normal treatment protocol and no extra costs are caused for the patients or the institutes. The reason for further long-term follow-up and further imaging at four years' mark is that the implants were still visible in the patients at their last follow-up visit in two years' mark, in the previous research that has been terminated.
Safety and ethical consideration:
There are no health-related issues in clinical investigation and MRI of the patients. The plain radiographs of the upper extremities predispose the participants to radiation, with equivalence to 1-2 days of background radiation (www.stuk.fi, radiation doses). However, radiographs are not taken of gravidae females.
The study causes burden for the participants due to follow-up visit. In case of children and adolescents, the parents' presence is appreciated. However, long-term follow-up is justified because of the history of several injury and invasive surgical treatment performed and in order to certain the final degradation of the used implant.
Statistical Methods:
The radiographic and clinical findings will be reported in descriptive means. The mean, range and standard deviation (SD) will be reported for the continous variables. The issues in the short-term recovery and the potential association between the short-term findings and long-term results are analysed by using the SND test for independent variables. Further, the association of the clinical findings and subjective symptoms with the degradation stage of the implants will be investigated. Other appropriate statistical methods may also be used. All P-values are two-tailed and the level of significance is set as <0.05.
Read the detailed description
This is a prospective observational clinical study in two centers in Finland. The study cannot be executed in a blinded fashion, because all patients treated by the study method will be invited.
The study purpose is to investigate long-term biodegradation process of the polylactide-co-glycolide intramedullary nails, used in treating the forearm shaft fractures in children. It is aimed to determine the stage of biodegradation of the polylactide-co-glycolide intramedullary nails, compared with the time since operation and the potential complications and/or radiographic and clinical recovery at least 4 years after the implant implementation.
Close clinical recovery is another objective of the study.
Potential adverse events, being related to the biodegradation process of the implant, are to be evaluated: fluid accumulation, sinus formation, osteolysis, swelling, cyst formation. Further, the soft-tissue reaction in the surroundings of the former fracture will be evaluated.
Radiographic recovery will be be evaluated in means of plain radiograph investigation (plain radiographs in lateral and anterior-posterior views). The signs of bone healing after the long-bone diaphysis fracture, including the resolution of the previous callus formation, tubularization of the long-bones around the previous fracture area, remodeling of the angular and rotational alignment will be analyzed.
- Conditions
- Fractures, Bone, Injury Arm
- Being tested
- Biodegradable Intramedullary Nailing (BIN)
- Medical subject headings
- Fractures, Bone, Arm Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biodegradable Intramedullary Nailing (BIN)Procedure or surgery
Also called Elastic Stable Intramedullary Nailing (ESIN)
Unstable forearm shaft fractures are treated by the study method (BIN) or the control method (ESIN).
| Study group | Role | What they receive |
|---|---|---|
| Elastic Stable Intramedullary Nailing | Experimental | BIN (biodegradable intramedullary nailing) method will be compared with the ESIN (elastic stable intramedullary nailing) Receives: Procedure: Biodegradable Intramedullary Nailing (BIN) |
| Biodegradable intramedullary nailing | Experimental | BIN method will be compared with the ESIN. Receives: Procedure: Biodegradable Intramedullary Nailing (BIN) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Biodegradation of the implants and remodeling. Visibility of the implant in imaging (MRI, magnetic resonance imaging)
Implant biodegradation and the remodeling of the fractured bone are to be evaluated by using different imaging modalities to view the residual implant. The biodegradation and remodeling will be described qualitatively, by the radiologist.
Measured: at least 4 years.
Biodegradation of the implants and remodeling. Visibility of the implant in imaging (radiographs)
Implant biodegradation and the remodeling of the fractured bone are to be evaluated by using different imaging modalities to view the residual implant. The biodegradation and remodeling will be described qualitatively, by the radiologist.
Measured: at least 4 years
Secondary outcomes (4)
Clinical recovery (forearm rotation motions)
Forearm rotation motion in pronation and supination (in left and right, by using a goniometer)
Measured: at least 4 years postinjury
Clinical recovery (elbow motion)
Elbow motion by measuring a goniometer in left and right sides
Measured: at least 4 years postinjury
Clinical recovery (carrying angle)
Ulno-humeral angle in degrees in left and right upper extremities
Measured: at least 4 years postinjury
Clinical recovery (grip strength)
Grip strength by measured with using a hydraulic dynamometer in left and right sides
Measured: at least 4 years postinjury
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2020
- Study start5 Jan 2019
- Primary completion1 Dec 2022
- Study completion1 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fractures, BoneStudies 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
- Prospective, randomized, controlled clinical trial.
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oulu University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Kanta-Häme Central Hospital, Bioretec Ltd.
- Responsible party
- Principal investigator, Jaakko Sinikumpu, Oulu University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04385745
- Sponsor's protocol ID
- University of Oulu
- Status last verified
- Jun 2023
- First submitted
- 4 May 2020
- Last updated
- 15 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Not applicable: there is a commercial sponsor who provided the implants and the study data is available only by request.
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- BIODEGRADATION OF POLYLACTIDE-CO-GLYCOLIDE INTRAMEDULLARY NAILS USED IN TREATMENT OF CHILDREN'S FOREARM SHAFT FRACTURES AND CLINICAL RECOVERY OF THE PATIENTS IN THE LONG-TERM.
- ClinicalTrials.gov ID
- NCT04385745
- Acronym / sponsor ID
- University of Oulu
- Conditions
- Fractures, Bone, Injury Arm
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Oulu University HospitalUniversity, hospital or other
- Collaborators
- Kanta-Häme Central Hospital, Bioretec Ltd.
- Study start
- 5 Jan 2019 (actual)
- Primary completion
- 1 Dec 2022 (actual)
- Study completion
- 1 Jan 2023 (actual)
- First posted
- 13 May 2020 (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.
The study purpose is to investigate long-term biodegradation process of the polylactide-co-glycolide (PLGA) intramedullary nails, used in treating the forearm shaft fractures in children. The primary objective of the study is to determine the stage of biodegradation of the polylactide-co-glycolide intramedullary nails, compared with the time since operation.
Biodegradation is to be evaluated by using Magnetic Resonance Imaging (MRI). Potential adverse events, being related to the biodegradation process of the implant, will be recognized: fluid accumulation, sinus formation, osteolysis, swelling, cyst formation and other soft-tissue reactions in the surroundings of the former fracture will be evaluated.
Radiographic recovery at least 4 years after the implant operation is secondary aims of the study. Radiographic investigation (plain radiographs in lateral and anterior-posterior views) are taken to evaluate the signs of bone healing after the long-bone diaphysis fracture, including the resolution of the previous callus formation, tubularization of the long-bones around the previous fracture area and remodeling of the angular and rotational alignment.
Clinical recovery in the long-term (at least 4 years) is another secondary aim of the study.
Prospective observational study will be performed. The study population comprises all the cases who were participating in the previous RCT ("BIOABSORBABLE INTRAMEDULLARY NAIL FIXATION OF FOREARM FRACTURES IN CHILDREN") and were therefore treated by means of biodegradable intramedullary nailing in years 2010 to 2015 (N=16).
All these patients will be invited and at least 4-year follow-up visit is performed at out-hospital clinics in the study institutions and radiographs and MRI will be taken. Flynn's criteria, MAYO elbow performance score and mini-DASH will be used. Health-related quality of life is to be analysed by using Pediatric Quality of Life Inventory (PedsQL). Visual analogue scale will be used for determining residual pain. A comprehensive analysis concerning the radiographic bone healing, according to Lane-Sandhu -scoring is determined and biodegradation of the implants, including the tricalciumphosphate tip will be evaluated by using MRI.
Number of Patients: N=15
Diagnosis and Main Criteria for Inclusion and Exclusion:
The study cases of the previous original research, described above, will be used to comprise the study population of the current project. The subject and/or guardian are invited to the study by a postal letter and by a call in case of no show. A signed and dated informed consent is required upon the participation.
Costs: The patients are to be investigated for long-term recovery according to the normal treatment protocol and no extra costs are caused for the patients or the institutes. The reason for further long-term follow-up and further imaging at four years' mark is that the implants were still visible in the patients at their last follow-up visit in two years' mark, in the previous research that has been terminated.
Safety and ethical consideration:
There are no health-related issues in clinical investigation and MRI of the patients. The plain radiographs of the upper extremities predispose the participants to radiation, with equivalence to 1-2 days of background radiation (www.stuk.fi, radiation doses). However, radiographs are not taken of gravidae females.
The study causes burden for the participants due to follow-up visit. In case of children and adolescents, the parents' presence is appreciated. However, long-term follow-up is justified because of the history of several injury and invasive surgical treatment performed and in order to certain the final degradation of the used implant.
Statistical Methods:
The radiographic and clinical findings will be reported in descriptive means. The mean, range and standard deviation (SD) will be reported for the continous variables. The issues in the short-term recovery and the potential association between the short-term findings and long-term results are analysed by using the SND test for independent variables. Further, the association of the clinical findings and subjective symptoms with the degradation stage of the implants will be investigated. Other appropriate statistical methods may also be used. All P-values are two-tailed and the level of significance is set as <0.05.
Detailed description
This is a prospective observational clinical study in two centers in Finland. The study cannot be executed in a blinded fashion, because all patients treated by the study method will be invited.
The study purpose is to investigate long-term biodegradation process of the polylactide-co-glycolide intramedullary nails, used in treating the forearm shaft fractures in children. It is aimed to determine the stage of biodegradation of the polylactide-co-glycolide intramedullary nails, compared with the time since operation and the potential complications and/or radiographic and clinical recovery at least 4 years after the implant implementation.
Close clinical recovery is another objective of the study.
Potential adverse events, being related to the biodegradation process of the implant, are to be evaluated: fluid accumulation, sinus formation, osteolysis, swelling, cyst formation. Further, the soft-tissue reaction in the surroundings of the former fracture will be evaluated.
Radiographic recovery will be be evaluated in means of plain radiograph investigation (plain radiographs in lateral and anterior-posterior views). The signs of bone healing after the long-bone diaphysis fracture, including the resolution of the previous callus formation, tubularization of the long-bones around the previous fracture area, remodeling of the angular and rotational alignment will be analyzed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Prospective, randomized, controlled clinical trial.
| Arm | Type | Receives |
|---|---|---|
| Elastic Stable Intramedullary Nailing | Experimental | Procedure: Biodegradable Intramedullary Nailing (BIN)BIN (biodegradable intramedullary nailing) method will be compared with the ESIN (elastic stable intramedullary nailing) |
| Biodegradable intramedullary nailing | Experimental | Procedure: Biodegradable Intramedullary Nailing (BIN)BIN method will be compared with the ESIN. |
Who may qualify
- Ages
- 4 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- • Patients who have participated in the previous study, concerning the surgical treatment of forearm shaft fracture and have been treated by biodegradable intramedullary nailing (BIN), using the polylactide-co-glycolide nails (ActivaNail).
Key exclusion criteria (1 listed)
- • The cases that have primarily been enrolled but interrupted the first study because of new fracture and been therefore surgically fixed with traditional (metallic) implants will be excluded.
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 |
|---|---|---|
| Biodegradable Intramedullary Nailing (BIN)Also: Elastic Stable Intramedullary Nailing (ESIN)Unstable forearm shaft fractures are treated by the study method (BIN) or the control method (ESIN). | Procedure or surgery | Biodegradable intramedullary nailing, Elastic Stable Intramedullary Nailing |
Primary outcome
Biodegradation of the implants and remodeling. Visibility of the implant in imaging (MRI, magnetic resonance imaging)
Time frame: at least 4 years.
Implant biodegradation and the remodeling of the fractured bone are to be evaluated by using different imaging modalities to view the residual implant. The biodegradation and remodeling will be described qualitatively, by the radiologist.
Biodegradation of the implants and remodeling. Visibility of the implant in imaging (radiographs)
Time frame: at least 4 years
Implant biodegradation and the remodeling of the fractured bone are to be evaluated by using different imaging modalities to view the residual implant. The biodegradation and remodeling will be described qualitatively, by the radiologist.
4 secondary outcomes
Clinical recovery (forearm rotation motions)
Time frame: at least 4 years postinjury
Clinical recovery (elbow motion)
Time frame: at least 4 years postinjury
Clinical recovery (carrying angle)
Time frame: at least 4 years postinjury
Clinical recovery (grip strength)
Time frame: at least 4 years postinjury
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 15 Jun 2023.
- Individual participant dataSharing planned: No. Not applicable: there is a commercial sponsor who provided the implants and the study data is available only by request.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Biodegradable Intramedullary Nailing (BIN) in people with Fractures, Bone and Injury Arm, run by Oulu University Hospital at 1 site in Finland.
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 1 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 15 Jun 2023. 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 Finland. 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?
Biodegradation of the implants and remodeling. Visibility of the implant in imaging (MRI, magnetic resonance imaging) (time frame: at least 4 years.). The study lists 2 primary outcomes in all. 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 15 Jun 2023.