An interventional study of Operation in Medial Malleolus Fracture, Lisfranc Injury and Lisfranc Fracture, sponsored by Inion Oy. Recruiting at 1 site in Finland. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-03-13.
Sponsored by Inion Oy · Not applicable, Interventional, and Treatment
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.
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:
The study is a single center single group study which is conducted in Tampere University Hospital (TAYS) in Finland.
202 studies on the registry are indexed under Ankle Fractures; 44 are open to participants now.
This study's planned enrollment of 125 is above the median of 90 across 150 interventional studies indexed under Ankle Fractures.
Browse Ankle Fractures studies →Inion Oy is the lead sponsor of 4 studies on the registry; 2 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
125 participant patients undergoing bone fixation surgical operation specified in the study description. All bone fixation surgeries are performed using Inion CompressOn screws.
Procedure: Operation
Bone fixation operation in foot or ankle area using bioabsorbable headless screw/s
Bone healing (ossification) of the fracture, osteotomy and arthrodesis lines
X-ray evaluation of bone healing (ossification) of the fracture, osteotomy and arthrodesis lines
Time frame: 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
Time frame: During 4-year follow-up
Occurrence of revision surgeries
Assessment of occurrence of revision surgeries related to study device
Time frame: During 4-year follow-up
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
Time frame: 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
Time frame: 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)
Time frame: Change from operation to 3 months
Fixation strength
X-ray evaluation of the maintaining of fixation position
Time frame: Change from operation to 4 years
Bone formation in screw tunnel
X-ray evaluation of the level of bone formation in screw tunnel
Time frame: Change from operation to 4 years
Plan to share: No
No publications or documents are linked to this record.
Started Mar 2023 (actual). Primary completion is estimated for Dec 2031, 105 months after the start.
Of 72 interventional studies with no phase under Ankle Fractures, half reached primary completion within 45 months of starting (the median), counting those still running; a quarter within 23 and three quarters within 61. This study's planned 105 months is above that.
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