Medial Malleolus FractureNCT05555459
Performance and Safety Evaluation of Inion CompressOn Screw in Foot and Ankle Surgeries. PMCF Investigation
A study testing Operation in people with Medial Malleolus Fracture and Lisfranc Injury, 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 evaluate the safety and performance of bioabsorbable headless compression screw Inion CompressOn in selected fracture, osteotomy and arthrodeses operations of the foot and ankle. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Medial Malleolus Fracture, Lisfranc Injury, Lisfranc Fracture
- What is being tested?
- Operation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 125 participants
- Where
- 1 siteFinland
- Study dates
- 7 Mar 2023to 30 Apr 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Read the patient information bulletin on the study and signed the patient consent form
- Adult patient (over 18-year-old)
- Suitable and in need for surgical lower limb operation listed in the indications of this study that requires fastening of bone structures with screws (or an alternative attachment method) in the ankle or foot area, according to a statement of the investigator surgeon
- Ability to fill in questionnaires.
- Willingness to comply with rehabilitation instructions.
- 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 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.)
- High-load bearing indications (e.g., diaphyseal fractures of long bones) unless used in conjunction with traditional rigid fixation
- Patients with significant neuropathy
Show all 10Show fewer
- Pregnancy
- Patients who refuse to participate
- Lower limb tumor or metastasis
- Complex Regional Pain Syndrome (CRPS) in operated foot
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
Tampere University Hospital
Tampere, 33520
Heikki Mäenpää, MD, +358 3 311 611, heikki.maenpaa@pshp.fi
Nikke Partio, MD
About this study
Official title: The Performance and Safety Evaluation of Bioabsorbable Headless Inion CompressOn Screws in Selected Fracture, Osteotomy and Artrodesis Surgeries of the Foot and Ankle
The study in question is a post market clinical follow up (PMCF) study to evaluate the safety and performance of bioabsorbable headless compression screw Inion CompressOn in selected fracture, osteotomy and arthrodeses operations of the foot and ankle. The study recruits 125 adult 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 Tampere University Hospital (TAYS) in Finland. The main focus of the study in terms of performance is to evaluate 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 evaluate the safety and performance of bioabsorbable headless compression screw Inion CompressOn in selected fracture, osteotomy and arthrodeses operations of the foot and ankle. The main focus of the study in terms of performance is to evaluate 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-hydroxy acids 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 two to four years. The Inion CompressOn™ products are intended for maintenance of alignment and fixation of bone fractures, comminuted fractures, osteotomies, arthrodeses or bone grafts (i.e., autografts or allografts) in the presence of appropriate additional immobilization (e.g., rigid fixation implants, cast or brace).
In the field of foot and ankle traumatology the surgical indications of this study include medial malleolar fractures, Lisfranc injuries, talus fractures, calcaneal fractures and navicular bone fractures. In the field of foot and ankle orthopaedics the surgical indications of the study include arthrodesis of the talonavicular joint, calcaneacuboideal joint, tarsometatarsal joint and first metatarsophalangeal (MTP1) joint, and osteotomies of the first metatarsal bone, second metatarsal bone (weil) and calcaneal bone.
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 has the same indications for use. Inion CompressOn Screw has new design features such as headless design, and threading which allows compression to the fracture line. Also new sizes are introduced.
The study recruits 125 adult 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 (6 weeks after operation +/- 1 week),
- post-operative follow-up 2 (3 months after operation +/- 2 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 Tampere University Hospital (TAYS) in Finland.
- Conditions
- Medial Malleolus Fracture, Lisfranc Injury, Lisfranc Fracture, Talus Fracture, Calcaneus Fracture, Navicular Fracture
- Being tested
- Operation
- Keywords
- bioabsorbable screw, compression screw, headless screw, orthopaedic screw, bone fixation, bioabsorbable screw study, resorbable, biodegradable, bioabsorbable, fracture fixation with resorbable implants, inion, post-market follow-up study, orthopedic bone fixation, arthrodesis, osteotomy
- Medical subject headings
- Ankle Fractures, Foot Deformities, Fractures, Bone, Foot Injuries, Metatarsalgia, Hallux Rigidus, Hallux Valgus, Ankylosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OperationProcedure or surgery
Bone fixation operation in foot or ankle area using bioabsorbable headless screw/s
| Study group | Role | What they receive |
|---|---|---|
| CompressOn group | Experimental | 125 participant patients undergoing bone fixation surgical operation specified in the study description. All bone fixation surgeries are performed using Inion CompressOn screws. Receives: Procedure: Operation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bone healing (ossification) of the fracture, osteotomy and arthrodesis lines
X-ray evaluation of bone healing (ossification) of the fracture, osteotomy and arthrodesis lines
Measured: Change from operation to 4 years
Occurrence of adverse events (AEs)
Assessment of occurrence of adverse events (AE), 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 (5)
Subjective functionality of the operated foot or ankle (VAS foot and ankle)
Evaluation of subjective pain of the operated foot or ankle during follow-up
Measured: Change from baseline to 4 years
Subjective functionality of the operated foot or ankle (EFAS)
Evaluation of subjective functionality of the operated foot or ankle during follow-up
Measured: Change from baseline to 4 years
Wound and soft tissue healing
Assessment of post-operative complications (wound and soft tissue healing based on inspection and palpation)
Measured: Change from operation to 3 months
Fixation strength
X-ray evaluation of the maintaining of fixation position
Measured: Change from operation to 4 years
Bone formation in screw tunnel
X-ray evaluation of the level of bone formation in screw tunnel
Measured: Change from operation 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 posted26 Sep 2022
- Study start7 Mar 2023
- Primary completion31 Dec 2031 (estimated)
- Study completion30 Apr 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Medial Malleolus FractureStudies 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
- A single group study including 125 adult patient participants. All patients undergo a bone fixation surgical operation in foot/ankle area. Indications are specified in the study description. All operations are performed in the one study center using Inion CompressOn screws.
- Masking
- None (open label)
- Enrolment
- 125 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Inion Oy
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mäenpää, Principal investigator, Tampere University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05555459
- Sponsor's protocol ID
- CompressOn1-2022
- Status last verified
- Mar 2026
- First submitted
- 8 Sep 2022
- Last updated
- 13 Mar 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 13 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Performance and Safety Evaluation of Bioabsorbable Headless Inion CompressOn Screws in Selected Fracture, Osteotomy and Artrodesis Surgeries of the Foot and Ankle
- ClinicalTrials.gov ID
- NCT05555459
- Acronym / sponsor ID
- CompressOn1-2022
- Conditions
- Medial Malleolus Fracture, Lisfranc Injury, Lisfranc Fracture, Talus Fracture, Calcaneus Fracture, Navicular Fracture
- Keywords
- bioabsorbable screw, compression screw, headless screw, orthopaedic screw, bone fixation, bioabsorbable screw study, resorbable, biodegradable
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 125 participants (estimated)
- Lead sponsor
- Inion OyIndustry (pharma, biotech, devices)
- Study start
- 7 Mar 2023 (actual)
- Primary completion
- 31 Dec 2031 (estimated)
- Study completion
- 30 Apr 2032 (estimated)
- First posted
- 26 Sep 2022 (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 evaluate the safety and performance of bioabsorbable headless compression screw Inion CompressOn in selected fracture, osteotomy and arthrodeses operations of the foot and ankle. The study recruits 125 adult 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 Tampere University Hospital (TAYS) in Finland. The main focus of the study in terms of performance is to evaluate 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 evaluate the safety and performance of bioabsorbable headless compression screw Inion CompressOn in selected fracture, osteotomy and arthrodeses operations of the foot and ankle. The main focus of the study in terms of performance is to evaluate 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-hydroxy acids 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 two to four years. The Inion CompressOn™ products are intended for maintenance of alignment and fixation of bone fractures, comminuted fractures, osteotomies, arthrodeses or bone grafts (i.e., autografts or allografts) in the presence of appropriate additional immobilization (e.g., rigid fixation implants, cast or brace).
In the field of foot and ankle traumatology the surgical indications of this study include medial malleolar fractures, Lisfranc injuries, talus fractures, calcaneal fractures and navicular bone fractures. In the field of foot and ankle orthopaedics the surgical indications of the study include arthrodesis of the talonavicular joint, calcaneacuboideal joint, tarsometatarsal joint and first metatarsophalangeal (MTP1) joint, and osteotomies of the first metatarsal bone, second metatarsal bone (weil) and calcaneal bone.
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 has the same indications for use. Inion CompressOn Screw has new design features such as headless design, and threading which allows compression to the fracture line. Also new sizes are introduced.
The study recruits 125 adult 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 (6 weeks after operation +/- 1 week),
- post-operative follow-up 2 (3 months after operation +/- 2 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 Tampere University Hospital (TAYS) in Finland.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- A single group study including 125 adult patient participants. All patients undergo a bone fixation surgical operation in foot/ankle area. Indications are specified in the study description. All operations are performed in the one study center using Inion CompressOn screws.
| Arm | Type | Receives |
|---|---|---|
| CompressOn group | Experimental | Procedure: Operation125 participant patients undergoing bone fixation surgical operation specified in the study description. All bone fixation surgeries are performed using Inion CompressOn screws. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Read the patient information bulletin on the study and signed the patient consent form
- Adult patient (over 18-year-old)
- Suitable and in need for surgical lower limb operation listed in the indications of this study that requires fastening of bone structures with screws (or an alternative attachment method) in the ankle or foot area, according to a statement of the investigator surgeon
- Ability to fill in questionnaires.
- Willingness to comply with rehabilitation instructions.
Key exclusion criteria (10 listed)
- Active infection
- Patient conditions including limited blood supply (e.g. patients with severe circulatory disorder of the lower 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.)
- High-load bearing indications (e.g., diaphyseal fractures of long bones) unless used in conjunction with traditional rigid fixation
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 |
|---|---|---|
| OperationBone fixation operation in foot or ankle area using bioabsorbable headless screw/s | Procedure or surgery | CompressOn group |
Primary outcome
Bone healing (ossification) of the fracture, osteotomy and arthrodesis lines
Time frame: Change from operation to 4 years
X-ray evaluation of bone healing (ossification) of the fracture, osteotomy and arthrodesis lines
Occurrence of adverse events (AEs)
Time frame: During 4-year follow-up
Assessment of occurrence of adverse events (AE), 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
5 secondary outcomes
Subjective functionality of the operated foot or ankle (VAS foot and ankle)
Time frame: Change from baseline to 4 years
Subjective functionality of the operated foot or ankle (EFAS)
Time frame: Change from baseline to 4 years
Wound and soft tissue healing
Time frame: Change from operation to 3 months
Fixation strength
Time frame: Change from operation to 4 years
Bone formation in screw tunnel
Time frame: Change from operation 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 13 Mar 2026.
- Individual participant dataSharing planned: No
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Correlation Between Intraoperative Tourniquet Use and Limb pH, Functional Measures and Patient-reported Outcomes After Ankle Fracture Surgery
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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.
Mäenpää principal investigator
Tampere 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 Operation in people with Medial Malleolus Fracture and Lisfranc Injury, 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 6 inclusion and 10 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 13 Mar 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 (+358 50 366 9994, 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, osteotomy and arthrodesis lines (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 13 Mar 2026.