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
Sponsor:
Information provided by:
Artimplant AB
ClinicalTrials.gov Identifier:
NCT01028469
First received: December 8, 2009
Last updated: December 14, 2009
Last verified: December 2009

December 8, 2009
December 14, 2009
December 2009
December 2011   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT01028469 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Artelon Metatarsophalangeal (MTP) Spacer
Artelon MTP Spacer - Surgical Treatment of Mild to Moderate Hallux Rigidus

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.

Not Provided
Interventional
Phase 4
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Osteoarthritis
  • Hallux Rigidus
Device: Artelon MTP Spacer
Metatarsophalangeal hemi-implant
Experimental: Artelon MTP Spacer
Metatarsophalageal hemi-implant
Intervention: Device: Artelon MTP Spacer
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
15
Not Provided
December 2011   (final data collection date for primary outcome measure)

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.
Both
Not Provided
No
Contact: Martin Alund, M.D. martin.alund@vgregion.se
Sweden
 
NCT01028469
KP026
No
Katrin Gisselfalt, Chief Research & Development, Artimplant
Artimplant AB
Not Provided
Principal Investigator: Martin Alund, M.D. Sahlgrenska University Hospital, Mölndal, Sweden
Artimplant AB
December 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP