Hallux Rigidus, Osteoarthritis
Conditions
Brief 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.
Interventions
DEVICEArtelon MTP Spacer
Metatarsophalangeal hemi-implant
Sponsors
Artimplant AB
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pain, function and alignment of the treated toe evaluated by the investigator using the American Orthopeadic Foot & Ankle Society (AOFAS) clinical rating system. | pre-treatment and 12 months post-op |
Countries
Sweden
Contacts
Primary ContactMartin Alund, M.D.
Outcome results
None listed