Artelon Metatarsophalangeal (MTP) Spacer
Phase 4
- Conditions
- OsteoarthritisHallux Rigidus
- Interventions
- Device: Artelon MTP Spacer
- Registration Number
- NCT01028469
- Lead Sponsor
- Artimplant AB
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 15
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.
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Artelon MTP Spacer Artelon MTP Spacer Metatarsophalageal hemi-implant
- Primary Outcome Measures
Name Time Method 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
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Sahlgrenska Universitetssjukhuset, Område Ortopedi, Mölndal
🇸🇪Mölndal, Sweden