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The study in question is a post market clinical follow up (PMCF) study to follow up the safety and performance of bioabsorbable headless compression screw Inion CompressOn in fracture fixation of the ankle, knee and elbow of pediatric and adolescent patients. The study aims to recruit 80 patients who meet the acceptance criteria. The follow-up time for each study patient is 4 years. The study is a single center single group study which is conducted in Lighthouse Hospital at Turku University Hospital (TYKS) in Finland. The main focus of the study in terms of performance is to follow up the bone healing/ossification of operated areas. The main focus of the study in terms of safety is to evaluate the occurrence of adverse events and required revision surgeries that are or might be related to the study device.
The study in question is a post market clinical follow-up study to follow-up the safety and performance of the bioabsorbable headless Inion CompressOn Screw in fracture fixation operations of the ankle, knee and elbow of pediatric and adolescent patients. The main focus of the study in terms of performance is to follow-up the bone healing/ossification of operated areas. The main focus of the study in terms of safety is to evaluate the occurrence of adverse events and required revision surgeries that are or might be related to the study device.
The Inion CompressOn™ Screws are cannulated headless compression screws made of degradable co-polymers composed of L-lactic acid and D-lactic acid. These polymers have a long history of safe medical use and they degrade in vivo by hydrolysis into alpha-hydroxyacids that are metabolised by the body. The screws retain their initial strength up to 12 weeks after implantation and gradually lose their strength thereafter. Bioabsorption takes place within four years.
The clinical data collection acquired from this study is a requirement of the EU Notified Body as part of the admitted CE mark certification, in cases when the device is initially approved based on the clinical data of an equivalent device. In this case, the equivalent device has been Inion FreedomScrew, which is made of the same material composition and is used for the same indications. Inion CompressOn Screw has new design features such as headless design, and threading which allows compression to the fracture line. Also new sizes have been introduced.
The study recruits 80 pediatric/adolescent patients who meet the acceptance criteria and have signed the informed consent. The follow-up time for each study patient is 4 years. Each patient has 6 follow-up time points related to the study. These time points consist of:
The study is a single center single group study which is conducted in Turku University Hospital (TYKS) in Finland.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CompressOn group | Experimental | Participants undergo a surgical fracture fixation procedure using the bioabsorbable Inion CompressOn Screw according to the device instructions for use. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fracture fixation operation | Device | Fracture fixation operation in using bioabsorbable headless Inion CompressOn Screw/s according to instructions for use |
|
| Measure | Description | Time Frame |
|---|---|---|
| Bone healing (ossification) of the fracture line(s) | X-ray evaluation of bone healing (ossification) of the fracture line(s) | Change from operation to 4 years |
| Occurrence of device-related adverse events | Assessment of occurrence of adverse events (AE), that are or might be related to the study device such as non-union of bone, fixation failure, mechanical irritation and tissue reactions related to implant bioabsorption | During 4-year follow-up |
| Occurrence of revision surgeries | Assessment of occurrence of revision surgeries related to study device | During 4-year follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| Subjective functionality of the operated limb (Visual Analogue Scale, VAS) | Evaluation of subjective pain of the operated area during follow-up. 10-cm (100-mm) horizontal line used to measure pain intensity, ranging from "no pain" (0) to "worst imaginable pain" (100 mm) | Change from baseline to 4 years |
| Subjective functionality of the operated area (Lower Extremity Functional Scale, LEFS/Upper Extremity Functional Index, UEFI) |
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Inclusion Criteria:
1. Informed consent signed by parents or legal guardians, and assent from the child if of appropriate age and cognitive ability < 18 years 3. Suitable and in need for an operation indicated for subject device 4. Ability to give adequate input for the PROM questionnaires 5. Willingness and ability to comply with rehabilitation instructions. 6. Availability for follow-up visits.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Marika Manni, MD | Contact | +358503669994 | marika.manni@inion.com | |
| Kati Marttinen | Contact | +358 40 841 6217 | kati.marttinen@inion.com |
| Name | Affiliation | Role |
|---|---|---|
| Olli Pajulo, MD | Turku University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Turku University Hospital/Lighthouse hospital | Recruiting | Turku | 20520 | Finland |
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Evaluation of subjective functionality of the operated area follow-up. UEFI: The scores given to the 20 questions are added to give a highest possible score of 80. The lowest possible score is 0. A lower score indicates that the person is reporting increased difficulty with the activities as a result of their upper limb condition. LEFS: Contains 20 questions about a person's ability to perform everyday tasks. The maximum score is 80. The lower the score the greater the disability. |
| Change from baseline to 4 years |
| ID | Term |
|---|---|
| D064386 | Ankle Fractures |
| D000092443 | Knee Fractures |
| D000092482 | Elbow Fractures |
| ID | Term |
|---|---|
| D050723 | Fractures, Bone |
| D014947 | Wounds and Injuries |
| D016512 | Ankle Injuries |
| D007869 | Leg Injuries |
| D007718 | Knee Injuries |
| D000092464 | Elbow Injuries |
| D001134 | Arm Injuries |
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