Ankle FracturesNCT07473947
Performance and Safety Follow-up of Bioabsorbable Headless Inion CompressOnTM Screws in the Fixation of Bone Fractures in Ankle, Knee and Elbow of Pediatric and Adolescent Patients
A study testing Fracture fixation operation in people with Ankle Fractures and Knee Fractures, run by Inion Oy at 1 site in Finland.
Trial summary
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. Read more about this study
- Who is it for?
- Ages Up to 17 years
- Conditions the study is for
- Ankle Fractures, Knee Fractures, Elbow Fractures
- What is being tested?
- Fracture fixation operation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteFinland
- Study dates
- 29 May 2026to Dec 2032
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- Active infection
- Patient conditions including limited blood supply (e.g. patients with severe circulatory disorder of the lower or upper limb)
- Patient conditions including insufficient quality or quantity of bone (diagnosed osteoporosis, conditions causing secondary osteoporosis e.g. diabetes, rheumatism, eating disorder)
- Patient conditions where patient cooperation cannot be guaranteed (alcohol use, drug abuse etc.)
- Patients with known allergy to the implant constituents or its degradation products.
- Spinal and craniomaxillofacial indications.
- High-load bearing indications (e.g., diaphyseal fractures of long bones) unless used in conjunction with traditional rigid fixation
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Finland1 site, 1 recruiting
- Recruiting
Turku University Hospital/Lighthouse hospital
Turku, 20520
Olli Pajulo, MD, +358 2 313 0000, olli.pajulo@varha.fi
Olli Pajulo, MD
About this study
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.
Read the detailed description
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:
- screening visit (-180-0 days before operation),
- operation (day 0),
- post-operative follow-up 1 (4-8 weeks),
- post-operative follow-up 2 (3 months after operation +/- 3 weeks),
- post-operative follow-up 3 (2 years after operation +/- 2 months)
- post-operative follow-up 4 (4 years after operation +/- 4 months) The first 4 time points are within standard care, the last 2 time points (post-operative follow-up 3 and post-operative follow-up 4) are scheduled for study purposes only to be able to gain performance and safety data based on adequate follow-up time.
The study is a single center single group study which is conducted in Turku University Hospital (TYKS) in Finland.
- Conditions
- Ankle Fractures, Knee Fractures, Elbow Fractures
- Being tested
- Fracture fixation operation
- Keywords
- bioabsorbable, resorbable, ankle fracture, knee fracture, elbow fracture, fracture fixation
- Medical subject headings
- Ankle Fractures, Knee Fractures, Elbow Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fracture fixation operationDevice
Fracture fixation operation in using bioabsorbable headless Inion CompressOn Screw/s according to instructions for use
| Study group | Role | What they receive |
|---|---|---|
| CompressOn group | Experimental | Participants undergo a surgical fracture fixation procedure using the bioabsorbable Inion CompressOn Screw according to the device instructions for use. Receives: Device: Fracture fixation operation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bone healing (ossification) of the fracture line(s)
X-ray evaluation of bone healing (ossification) of the fracture line(s)
Measured: 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
Measured: During 4-year follow-up
Occurrence of revision surgeries
Assessment of occurrence of revision surgeries related to study device
Measured: During 4-year follow-up
Secondary outcomes (2)
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)
Measured: Change from baseline to 4 years
Subjective functionality of the operated area (Lower Extremity Functional Scale, LEFS/Upper Extremity Functional Index, UEFI)
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.
Measured: Change from baseline to 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2026
- Study start29 May 2026
- Primary completionFeb 2032 (estimated)
- Study completionDec 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ankle FracturesStudies 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
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Inion Oy
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Olli Pajulo, MD, Principal investigator, Turku University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07473947
- Sponsor's protocol ID
- CompressOn2-2025
- Status last verified
- Mar 2026
- First submitted
- 11 Mar 2026
- Last updated
- 3 Jun 2026
- 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 3 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Performance and Safety Follow-up of Bioabsorbable Headless Inion CompressOnTM Screws in the Fixation of Bone Fractures in Ankle, Knee and Elbow of Pediatric and Adolescent Patients
- ClinicalTrials.gov ID
- NCT07473947
- Acronym / sponsor ID
- CompressOn2-2025
- Conditions
- Ankle Fractures, Knee Fractures, Elbow Fractures
- Keywords
- bioabsorbable, resorbable, ankle fracture, knee fracture, elbow fracture, fracture fixation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Inion OyIndustry (pharma, biotech, devices)
- Study start
- 29 May 2026 (actual)
- Primary completion
- Feb 2032 (estimated)
- Study completion
- Dec 2032 (estimated)
- First posted
- 16 Mar 2026 (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 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.
Detailed description
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:
- screening visit (-180-0 days before operation),
- operation (day 0),
- post-operative follow-up 1 (4-8 weeks),
- post-operative follow-up 2 (3 months after operation +/- 3 weeks),
- post-operative follow-up 3 (2 years after operation +/- 2 months)
- post-operative follow-up 4 (4 years after operation +/- 4 months) The first 4 time points are within standard care, the last 2 time points (post-operative follow-up 3 and post-operative follow-up 4) are scheduled for study purposes only to be able to gain performance and safety data based on adequate follow-up time.
The study is a single center single group study which is conducted in Turku University Hospital (TYKS) in Finland.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CompressOn group | Experimental | Device: Fracture fixation operationParticipants undergo a surgical fracture fixation procedure using the bioabsorbable Inion CompressOn Screw according to the device instructions for use. |
Who may qualify
- Ages
- Up to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (7 listed)
- Active infection
- Patient conditions including limited blood supply (e.g. patients with severe circulatory disorder of the lower or upper limb)
- Patient conditions including insufficient quality or quantity of bone (diagnosed osteoporosis, conditions causing secondary osteoporosis e.g. diabetes, rheumatism, eating disorder)
- Patient conditions where patient cooperation cannot be guaranteed (alcohol use, drug abuse etc.)
- Patients with known allergy to the implant constituents or its degradation products.
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 |
|---|---|---|
| Fracture fixation operationFracture fixation operation in using bioabsorbable headless Inion CompressOn Screw/s according to instructions for use | Device | CompressOn group |
Primary outcome
Bone healing (ossification) of the fracture line(s)
Time frame: Change from operation to 4 years
X-ray evaluation of bone healing (ossification) of the fracture line(s)
Occurrence of device-related adverse events
Time frame: During 4-year follow-up
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
Occurrence of revision surgeries
Time frame: During 4-year follow-up
Assessment of occurrence of revision surgeries related to study device
2 secondary outcomes
Subjective functionality of the operated limb (Visual Analogue Scale, VAS)
Time frame: Change from baseline to 4 years
Subjective functionality of the operated area (Lower Extremity Functional Scale, LEFS/Upper Extremity Functional Index, UEFI)
Time frame: Change from baseline to 4 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2026.
- 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.
Olli Pajulo, MD principal investigator
Turku University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fracture fixation operation in people with Ankle Fractures and Knee Fractures, run by Inion Oy 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 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: looking for participants now, as of the sponsor's last update on 3 Jun 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Marika Manni, MD (+358503669994, marika.manni@inion.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bone healing (ossification) of the fracture line(s) (time frame: Change from operation to 4 years). The study lists 3 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 3 Jun 2026.