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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT01028469
Other study ID # KP026
Secondary ID
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. completion date
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


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
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