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Artelon Metatarsophalangeal (MTP) Spacer

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified December 2009 by Artimplant AB.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01028469
First Posted: December 9, 2009
Last Update Posted: December 15, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Artimplant AB
  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: None (Open Label)
Primary Purpose: Treatment
Official Title: Artelon MTP Spacer - Surgical Treatment of Mild to Moderate Hallux Rigidus

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 ]

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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.
  Contacts and Locations
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
  More Information

Responsible Party: Katrin Gisselfalt, Chief Research & Development, Artimplant
ClinicalTrials.gov Identifier: NCT01028469     History of Changes
Other Study ID Numbers: KP026
First Submitted: December 8, 2009
First Posted: December 9, 2009
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