Artelon Metatarsophalangeal (MTP) Spacer
The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2009 by Artimplant AB.
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
Artimplant AB
Information provided by:
Artimplant AB
ClinicalTrials.gov Identifier:
NCT01028469
First received: December 8, 2009
Last updated: December 14, 2009
Last verified: December 2009
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Osteoarthritis Hallux Rigidus |
Device: Artelon MTP Spacer |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Artelon MTP Spacer - Surgical Treatment of Mild to Moderate Hallux Rigidus |
Resource links provided by NLM:
Further study details as provided by Artimplant AB:
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. [ Time Frame: pre-treatment and 12 months post-op ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 15 |
| Study Start Date: | December 2009 |
| Estimated Primary Completion Date: | December 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Artelon MTP Spacer
Metatarsophalageal hemi-implant
|
Device: Artelon MTP Spacer
Metatarsophalangeal hemi-implant
|
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01028469
Contacts
| Contact: Martin Alund, M.D. | martin.alund@vgregion.se |
Locations
| Sweden | |
| Sahlgrenska Universitetssjukhuset, Område Ortopedi, Mölndal | Recruiting |
| Mölndal, Sweden | |
Sponsors and Collaborators
Artimplant AB
Investigators
| Principal Investigator: | Martin Alund, M.D. | Sahlgrenska University Hospital, Mölndal, Sweden |
More Information
No publications provided
| Responsible Party: | Katrin Gisselfalt, Chief Research & Development, Artimplant |
| ClinicalTrials.gov Identifier: | NCT01028469 History of Changes |
| Other Study ID Numbers: | KP026 |
| Study First Received: | December 8, 2009 |
| Last Updated: | December 14, 2009 |
| Health Authority: | Sweden: Medical Products Agency |
Additional relevant MeSH terms:
|
Osteoarthritis Hallux Rigidus Hallux Limitus Arthritis Joint Diseases |
Musculoskeletal Diseases Rheumatic Diseases Foot Deformities, Acquired Foot Deformities |
ClinicalTrials.gov processed this record on May 22, 2013