Artelon Metatarsophalangeal (MTP) Spacer

Artimplant

Status and phase: Unknown; Phase 4

Conditions: Hallux Rigidus; Osteoarthritis

Treatments: Device: Artelon MTP Spacer

Study type: Interventional

Funder types: Industry

Identifiers

NCT01028469

KP026

Details and patient eligibility

About

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.

Enrollment: 15 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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15 participants in 1 patient group

Artelon MTP Spacer

Experimental group

Description:

Metatarsophalageal hemi-implant

Treatment:

Device: Artelon MTP Spacer