NCT07473947

Brief 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. 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
78mo left

Started May 2026

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress1%
May 2026Dec 2032

First Submitted

Initial submission to the registry

March 11, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 16, 2026

Completed
2 months until next milestone

Study Start

First participant enrolled

May 29, 2026

Completed
5.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2032

Expected
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2032

Last Updated

June 3, 2026

Status Verified

March 1, 2026

Enrollment Period

5.7 years

First QC Date

March 11, 2026

Last Update Submit

June 1, 2026

Conditions

Knee FracturesAnkle FracturesElbow Fractures

Keywords

bioabsorbableresorbableankle fractureknee fractureelbow fracturefracture fixation

Outcome Measures

Primary Outcomes (3)

  • 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

Secondary Outcomes (2)

  • Subjective functionality of the operated limb (Visual Analogue Scale, VAS)

    Change from baseline to 4 years

  • Subjective functionality of the operated area (Lower Extremity Functional Scale, LEFS/Upper Extremity Functional Index, UEFI)

    Change from baseline to 4 years

Study Arms (1)

CompressOn group

EXPERIMENTAL

Participants undergo a surgical fracture fixation procedure using the bioabsorbable Inion CompressOn Screw according to the device instructions for use.

Device: Fracture fixation operation

Interventions

Fracture fixation operationDEVICE

Fracture fixation operation in using bioabsorbable headless Inion CompressOn Screw/s according to instructions for use

CompressOn group

Eligibility Criteria

AgeUp to 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • \. 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Turku University Hospital/Lighthouse hospital

Turku, 20520, Finland

RECRUITING

MeSH Terms

Conditions

Ankle FracturesKnee FracturesElbow Fractures

Condition Hierarchy (Ancestors)

Fractures, BoneWounds and InjuriesAnkle InjuriesLeg InjuriesKnee InjuriesElbow InjuriesArm Injuries

Study Officials

  • Olli Pajulo, MD

    Turku University Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Marika Manni, MD

CONTACT

+358503669994marika.manni@inion.com

Kati Marttinen

CONTACT

+358 40 841 6217kati.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

Study Record Dates

First Submitted

March 11, 2026

First Posted

March 16, 2026

Study Start

May 29, 2026

Primary Completion (Estimated)

February 1, 2032

Study Completion (Estimated)

December 1, 2032

Last Updated

June 3, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations

FI(1)