Artelon Metatarsophalangeal (MTP) Spacer

A

Artimplant AB

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)

15 participants in 1 patient group

Artelon MTP Spacer
Experimental group
Description:
Metatarsophalageal hemi-implant
Treatment:
Device: Artelon MTP Spacer

Trial contacts and locations

1

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Central trial contact

Martin Alund, M.D.

Data sourced from clinicaltrials.gov

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