Artelon Metatarsophalangeal (MTP) Spacer | NCT01028469

Studies
Artelon Metatarsophalangeal (MTP) Spacer

NCT01028469

Sponsor

Artimplant AB

Status

Unknown status

Last Update Posted

Dec 15, 2009Estimated

Enrollment

15Estimated

Phase

Phase 4

Conditions

Osteoarthritis
Hallux Rigidus

Interventions

Artelon MTP Spacer

Countries

Sweden

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2009

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2009

Primary Completion Date

Dec 2011Estimated

Completion Date

Not provided

First Submitted Date

Dec 8, 2009

First Submission Date that Met QC Criteria

Dec 8, 2009

First Posted Date

Dec 9, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 14, 2009

Last Update Posted Date

Dec 15, 2009Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

15Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Artelon MTP Spacer	Experimental	Metatarsophalageal hemi-implant	Device: Artelon MTP Spacer

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Artelon MTP Spacer	Device	Metatarsophalangeal hemi-implant	Artelon MTP Spacer

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Martin Alund, M.D.	Contact			martin.alund@vgregion.se

Overall Officials

Name	Affiliation	Role
Martin Alund, M.D.	Sahlgrenska University Hospital, Mölndal, Sweden	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Sahlgrenska Universitetssjukhuset, Område Ortopedi, Mölndal	Recruiting	Mölndal			Sweden

Condition Browse Module

MeSH Terms

ID	Term
D010003	Osteoarthritis
D020859	Hallux Rigidus

Ancestor Terms

ID	Term
D001168	Arthritis
D007592	Joint Diseases
D009140	Musculoskeletal Diseases
D012216	Rheumatic Diseases

Browse Leaves

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Browse Branches

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