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| Name | Class |
|---|---|
| Oulu University Hospital | OTHER |
| Bioretec Ltd. | INDUSTRY |
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There are disadvantages in Elastic Stable Intramedullary Nailing (ESIN) of forearm shaft fractures, such as soft tissue irritation and the need of implant removal. A new mini-invasive technique of intramedullary nailing with biodegradable material (BESIN) has been developed. The nails are tapped into the medullary cavity and left in place. The aim of this study was to compare BESIN technique with ESIN.
This is a prospective, randomized, controlled clinical trial including the patients (aged 5-15 years) who required operative treatment for forearm shaft fractures in two pediatric trauma centers, in Finland. The patients were randomized to be treated by BESIN or ESIN. Thirteen patients were required for each group, according to power analysis but altogether 35 were enrolled for potential drop-outs. Biodegradable polylactide-co-glycolide (PLGA) nails (ActivaNail ®, Bioretec ltd, Finland) were used in 19 and titanium nails (TEN ®, Synthes ltd, USA) in 16 patients. Pain and the range of motion (ROM) of forearm, elbow and wrist were primary outcomes. Radiographs and potential complications were analyzed of all and magnetic resonance imagines (MRI) of a randomly selected subgroup in BESIN group (N=13).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PLGA implant, Bioretec ltd. Finland | Experimental | Treatment with biodegradable elastic stable intramedullary nail in unstable forearm shaft fracture in paediatric population |
|
| Titanium elastic stable nail | Active Comparator | Treatment with titanium elastic stable intramedullary nail in unstable forearm shaft fracture in paediatric population |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PLGA implant, Bioretec ltd. Finland | Device | The investigational implant is an ultra-high-strength biodegradable intramedullary (IM) nail of poly(lactide-co-glycolide) (PLGA)/tricalcium-phosphate (β-TCP) which was manufactured by Bioretec Ltd. (Hartmaninkatu 2, Tampere, Finland) |
| Measure | Description | Time Frame |
|---|---|---|
| The range of motion (ROM) of forearm measured by goniometer | The ROMs of forearm | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| The range of motion (ROM) of elbow and wrist measured by goniometer | The ROMs of elbow and wrist | 2 years |
| Pain measured with visual analogue scale | general pain or pain at the fracture site in mm +/- SD , scale is from 0-100mm in visual scale where child can point the proper level of pain. 0 equals "no pain", 100 equals "the highest imaginable pain" |
| Measure | Description | Time Frame |
|---|---|---|
| adverse events | all implant or treatment related adverse events like tissue reactions or re-factures | 2 years |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Juhani Merikanto, Ph.D. associate professor | Central Finland, Central Hospital, Tampere, Finland | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Oulu University Hospital | Oulu | Finland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23542745 | Background | Baldwin K, Morrison MJ 3rd, Tomlinson LA, Ramirez R, Flynn JM. Both bone forearm fractures in children and adolescents, which fixation strategy is superior - plates or nails? A systematic review and meta-analysis of observational studies. J Orthop Trauma. 2014 Jan;28(1):e8-e14. doi: 10.1097/BOT.0b013e31829203ea. | |
| 2549074 | Background |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Apr 25, 2019 | |
| Reset | Jul 11, 2019 | |
| Release | Jun 14, 2023 | |
| Reset | Feb 7, 2024 |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_ICF | Yes | No | Yes | Study Protocol and Informed Consent Form | Feb 5, 2018 | Mar 21, 2018 | Prot_ICF_000.pdf |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Apr 25, 2019 | Jul 11, 2019 | |||
| Jun 14, 2023 |
The patients were randomised to 2 groups, titanium nailing or biodegradable nailing.
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The patient was informed about the treatment method that he or she was randomised. The operating surgeon knew the group and treatment that the patient belonged to.
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|
|
| Titanium elastic stable nail | Device | Elastic stable intramedullary nail to stabilize unstable forearm shaft fractures in children |
|
|
| 2 years |
| Radiographic bone union | plain radiographs in anterior posterior (AP) and lateral projections | 2 years |
| Radiographic bone deformity | plain radiographs in anterior posterior and lateral projections | 2 years |
| Magnetic resonance imagining, bone healing | MRIs in intervention group | 2 years |
| Implant degeneration in Magnetic resonance imagining | degrading of the implant | 2 years |
| Magnetic resonance imagining, soft tissue reaction | soft tissue reaction | 2 years |
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| Feb 7, 2024 |