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
  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
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, see Learn About Clinical Studies.

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 July 20, 2014