Artelon Metatarsophalangeal (MTP) Spacer

Osteoarthritis Clinical Trial

Official title:

Artelon MTP Spacer - Surgical Treatment of Mild to Moderate Hallux Rigidus

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01028469
• Other study ID #: KP026
• Status: Recruiting
• Phase: Phase 4
• First received: December 8, 2009
• Last updated: December 14, 2009
• Start date: December 2009

Study information

• Verified date: December 2009
• Source: Artimplant AB
• Contact: Martin Alund, M.D.
• Email: martin.alund[@]vgregion.se
• Is FDA regulated: No
• Health authority: Sweden: Medical Products Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 15
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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.

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hallux Limitus
• Hallux Rigidus
• Osteoarthritis

Intervention

Device:
• Artelon MTP Spacer
Metatarsophalangeal hemi-implant

Locations

Country	Name	City	State
Sweden	Sahlgrenska Universitetssjukhuset, Område Ortopedi, Mölndal	Mölndal

Sponsors (1)

Lead Sponsor	Collaborator
Artimplant AB

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain, function and alignment of the treated toe evaluated by the investigator using the American Orthopeadic Foot & Ankle Society (AOFAS) clinical rating system.		pre-treatment and 12 months post-op	No