NCT01028469

Brief 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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2009

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

December 8, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 9, 2009

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
Last Updated

December 15, 2009

Status Verified

December 1, 2009

Enrollment Period

2 years

First QC Date

December 8, 2009

Last Update Submit

December 14, 2009

Conditions

OsteoarthritisHallux Rigidus

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

Artelon MTP Spacer

EXPERIMENTAL

Metatarsophalageal hemi-implant

Device: Artelon MTP Spacer

Interventions

Artelon MTP SpacerDEVICE

Metatarsophalangeal hemi-implant

Artelon MTP Spacer

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sahlgrenska Universitetssjukhuset, Område Ortopedi, Mölndal

Mölndal, Sweden

RECRUITING

MeSH Terms

Conditions

OsteoarthritisHallux Rigidus

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesFoot Deformities, AcquiredFoot Deformities

Study Officials

  • Martin Alund, M.D.

    Sahlgrenska University Hospital, Mölndal, Sweden

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Martin Alund, M.D.

CONTACT

martin.alund@vgregion.se

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

December 8, 2009

First Posted

December 9, 2009

Study Start

December 1, 2009

Primary Completion

December 1, 2011

Last Updated

December 15, 2009

Record last verified: 2009-12

Locations

SE(1)