Back to resultsArtelon Metatarsophalangeal (MTP) Spacer
Primary Purpose
Osteoarthritis, Hallux Rigidus
Status
Unknown status
Phase
Phase 4
Locations
Sweden
Study Type
Interventional
Intervention
Artelon MTP Spacer
Sponsored by
About this trial
This is an interventional treatment trial for Osteoarthritis
Eligibility Criteria
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.
Sites / Locations
- Sahlgrenska Universitetssjukhuset, Område Ortopedi, MölndalRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Artelon MTP Spacer
Arm Description
Metatarsophalageal hemi-implant
Outcomes
Primary Outcome Measures
Pain, function and alignment of the treated toe evaluated by the investigator using the American Orthopeadic Foot & Ankle Society (AOFAS) clinical rating system.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01028469
Brief Title
Artelon Metatarsophalangeal (MTP) Spacer
Official Title
Artelon MTP Spacer - Surgical Treatment of Mild to Moderate Hallux Rigidus
Study Type
Interventional
2. Study Status
Record Verification Date
December 2009
Overall Recruitment Status
Unknown status
Study Start Date
December 2009 (undefined)
Primary Completion Date
December 2011 (Anticipated)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Artimplant AB
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis, Hallux Rigidus
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Artelon MTP Spacer
Arm Type
Experimental
Arm Description
Metatarsophalageal hemi-implant
Intervention Type
Device
Intervention Name(s)
Artelon MTP Spacer
Intervention Description
Metatarsophalangeal hemi-implant
Primary Outcome Measure Information:
Title
Pain, function and alignment of the treated toe evaluated by the investigator using the American Orthopeadic Foot & Ankle Society (AOFAS) clinical rating system.
Time Frame
pre-treatment and 12 months post-op
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Martin Alund, M.D.
Email
martin.alund@vgregion.se
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Martin Alund, M.D.
Organizational Affiliation
Sahlgrenska University Hospital, Mölndal, Sweden
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sahlgrenska Universitetssjukhuset, Område Ortopedi, Mölndal
City
Mölndal
Country
Sweden
Individual Site Status
Recruiting
12. IPD Sharing Statement
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Artelon Metatarsophalangeal (MTP) Spacer
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