CompletedNot Applicable

ARTEBONE Bone Void Filler in Arthrodesis Procedure of the Ankle

Finland, Poland34 participantsStarted 2014-01

Plain-language summary

The purpose of this investigation is to assess safety and performance of ARTEBONE Bone Void Filler in the single arthrodesis procedure.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. The patient has signed the independent ethics committee approved informed consent form specific to this investigation prior to enrollment.
. The patient is diagnosed with primary or secondary osteoarthritis requiring fusion of the ankle joint (tibiotalar) or the subtalar joint.
. The fusion site should be able to be rigidly stabilized with two or three screws across the fusion site.
. The patient is independent, ambulatory, and could comply with all post-operative evaluations and visits.
. The patient is at least 18 years of age and considered to be skeletally mature.

Exclusion criteria

. The patient has undergone previous fusion surgery of the proposed fusion site.
. The fusion site requires other than screw fixation, more than three screws across the fusion site to achieve rigid fixation, or more than one kit (3 cc) of graft material.
. There is radiographic evidence of bone cysts, segmental defects or growth plate fracture around the fusion site that may negatively impact bony fusion.
. The patient currently has untreated malignant neoplasm(s) at the surgical site, or is currently undergoing radio- or chemotherapy.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

The incidence of unanticipated serious adverse device effects

Timeframe: Before or at 12 months

Bone fusion rates

Timeframe: At 6 months (plus or minus 2 weeks)

Bone fusion rates

Timeframe: At 12 months (plus or minus 2 weeks)

Trial details

NCT IDNCT02480868

SponsorBBS-Bioactive Bone Substitutes Oy

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2017-12-14

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