UnknownPhase 4

Artelon Metatarsophalangeal (MTP) Spacer

Sweden15 participantsStarted 2009-12

Plain-language summary

The aim of this prospective, case series is to evaluate the surgical treatment of painful and disabling osteoarthrosis in the MTP-I joint by insertion of an Artelon MTP Spacer.

Who can participate

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 experiences pain and limitations of the great toe dorsiflexion at the MTP-I joint. * The patient has a clinically and radiographically verified arthritis in the MTP-I joint indicating the need for surgical treatment. * The patient reads, understands and is able to complete the study questionnaires in Swedish. * The patient has received written and oral information regarding the study and has signed the informed consent form. Exclusion criteria: * The patient has a pronounced hallux rigidus without mobility in the MTP-I joint (ROM = 0°). * The patient has previously received surgical treatment affecting the anatomy of the MTP-I joint. * The patient has a systemic rheumatic disease, ongoing infection, hallux valgus or is seriously ill.

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

Pain, function and alignment of the treated toe evaluated by the investigator using the American Orthopeadic Foot & Ankle Society (AOFAS) clinical rating system.

Timeframe: pre-treatment and 12 months post-op

Trial details

NCT IDNCT01028469

SponsorArtimplant AB

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2011-12

Contact for this trial

Martin Alund, M.D.

martin.alund@vgregion.se

View on ClinicalTrials.gov More Osteoarthritis trials

Who can participate

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.