Artelon Metatarsophalangeal (MTP) Spacer

Artimplant AB15 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Osteoarthritis Hallux Rigidus

Interventions

Artelon MTP SpacerDEVICE

Metatarsophalangeal hemi-implant

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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.

Locations (1)

Sahlgrenska Universitetssjukhuset, Område Ortopedi, Mölndal

Mölndal, Sweden

RECRUITING

Outcomes

Primary Outcomes

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

Central Contacts

Martin Alund, M.D.

CONTACT

martin.alund@vgregion.se

Data from ClinicalTrials.gov

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