Performance and Safety Evaluation of Inion CompressOn Screw in Foot and Ankle Surgeries. PMCF Investigation

NCT05555459 | Recruiting

• 1 other identifier: CompressOn1-2022
• Study Type: interventional
• Target: 125
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Medial Malleolus Fracture; Lisfranc Injury; Lisfranc Fracture; Talus Fracture; Navicular Fracture; Deformity, Foot; Ankle Fractures; Foot Fracture; Fractures, Bone; Fracture of Foot; Foot Deformities; Foot Injury; Feet Deformity Tarsus; Metatarsalgia; Hallux Rigidus; Hallux Valgus; Deformity of Toe; Deformity of Foot; Calcaneus Fracture

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

Outcome Measures

Primary Outcomes (3)

• Bone healing (ossification) of the fracture, osteotomy and arthrodesis lines

  X-ray evaluation of bone healing (ossification) of the fracture, osteotomy and arthrodesis lines

  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

  During 4-year follow-up

• Occurrence of revision surgeries

  Assessment of occurrence of revision surgeries related to study device

  During 4-year follow-up

Secondary Outcomes (5)

• Subjective functionality of the operated foot or ankle (VAS foot and ankle)

  Change from baseline to 4 years

• Subjective functionality of the operated foot or ankle (EFAS)

  Change from baseline to 4 years

• Wound and soft tissue healing

  Change from operation to 3 months

• Fixation strength

  Change from operation to 4 years

• Bone formation in screw tunnel

  Change from operation to 4 years

Study Arms (1)

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.

Procedure: Operation

Interventions

Operation PROCEDURE

Bone fixation operation in foot or ankle area using bioabsorbable headless screw/s

CompressOn group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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
• Pregnancy
• Patients who refuse to participate
• Lower limb tumor or metastasis
• Complex Regional Pain Syndrome (CRPS) in operated foot

Sponsors & Collaborators

• Inion Oy: lead

Study Sites (1)

Tampere University Hospital

Tampere, 33520, Finland

RECRUITING

MeSH Terms

Conditions

Ankle Fractures; Foot Deformities; Fractures, Bone; Foot Injuries; Metatarsalgia; Hallux Rigidus; Hallux Valgus; Ankylosis

Interventions

Surgical Procedures, Operative

Condition Hierarchy (Ancestors)

Wounds and Injuries; Ankle Injuries; Leg Injuries; Musculoskeletal Diseases; Foot Diseases; Joint Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Foot Deformities, Acquired

Study Officials

• Mäenpää

  Tampere University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marika Manni, MD

CONTACT

+358 50 366 9994; marika.manni@inion.com

Kati Marttinen

CONTACT

+358 40 841 6217; kati.marttinen@inion.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: September 8, 2022
• First Posted: September 26, 2022
• Study Start: March 7, 2023
• Primary Completion (Estimated): December 31, 2031
• Study Completion (Estimated): April 30, 2032
• Last Updated: March 13, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

FI (1)