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Artelon Metatarsophalangeal (MTP) Spacer

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ClinicalTrials.gov Identifier: NCT01028469
Recruitment Status : Unknown
Verified December 2009 by Artimplant AB.
Recruitment status was:  Recruiting
First Posted : December 9, 2009
Last Update Posted : December 15, 2009
Sponsor:
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Osteoarthritis Hallux Rigidus Device: Artelon MTP Spacer Phase 4

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Artelon MTP Spacer - Surgical Treatment of Mild to Moderate Hallux Rigidus
Study Start Date : December 2009
Estimated Primary Completion Date : December 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Artelon MTP Spacer
Metatarsophalageal hemi-implant
Device: Artelon MTP Spacer
Metatarsophalangeal hemi-implant



Primary Outcome Measures :
  1. 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 ]


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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Katrin Gisselfalt, Chief Research & Development, Artimplant
ClinicalTrials.gov Identifier: NCT01028469     History of Changes
Other Study ID Numbers: KP026
First Posted: December 9, 2009    Key Record Dates
Last Update Posted: December 15, 2009
Last Verified: December 2009

Additional relevant MeSH terms:
Osteoarthritis
Hallux Rigidus
Hallux Limitus
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Foot Deformities, Acquired
Foot Deformities
Foot Injuries
Leg Injuries
Wounds and Injuries