A New Type of Bioabsorbable Screw in the Hallux Valgus Su... | NCT03133039

Studies
A New Type of Bioabsorbable Screw in the Hallux Valgus Surgery

NCT03133039

Sponsor

Tampere University Hospital

Status

Unknown status

Last Update Posted

Aug 28, 2019Actual

Enrollment

2Estimated

Phase

Not Applicable

Conditions

Hallux Valgus
Hallux Rigidus

Interventions

surgery, bioabsorbable screw

Countries

Finland

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

Aug 2019

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

Oct 1, 2015Actual

Primary Completion Date

Dec 1, 2020Estimated

Completion Date

Dec 1, 2021Estimated

First Submitted Date

Apr 25, 2017

First Submission Date that Met QC Criteria

Apr 25, 2017

First Posted Date

Apr 28, 2017Actual

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

Aug 26, 2019

Last Update Posted Date

Aug 28, 2019Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Nikke Partio, Resident Surgery (MD), Tampere University HospitalPrincipal Investigator

Lead Sponsor

Tampere University HospitalOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

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 investigators sought to determine whether bioabsorbable cannulated screws could perform as well as titanium cannulated screws in the Lapidus procedure and MTP1-joint arthorodesis in anatomical models and clinical series of the foot.

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

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

2Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
bioabsorbable screw	Active Comparator		Procedure: surgery, bioabsorbable screw
titanium screw	Active Comparator		Procedure: surgery, bioabsorbable screw

Interventions

Name	Type	Description	Arm Group Labels	Other Names
surgery, bioabsorbable screw	Procedure	In this study we compare bioabsorbable and titanium screw in the hallux valgus and hallux rigidus surgery	bioabsorbable screw

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
AOFAS score	score	2 years

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

valuntary 18-65-yers-old, patient have hallux valgus or hallux rigidus deformity which need surgery treatment

Exclusion Criteria:

Over 65 yers-old or less than 18-years-old, diabetes, rheumatism, smoker or lack of co-operation

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Nkke Partio, M.D	Contact	+3583 311611		partio.nikke.n@student.uta.fi
Heikki Mäenpää, M.D, Ph.D.	Contact

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Faculty of Medicine	Recruiting	Tampere	Pirkanmaa	FI-33014	Finland

Condition Browse Module

MeSH Terms

ID	Term
D006215	Hallux Valgus
D020859	Hallux Rigidus

Ancestor Terms

ID	Term
D005530	Foot Deformities
D009140	Musculoskeletal Diseases
D005531	Foot Deformities, Acquired
D007592	Joint Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D013514	Surgical Procedures, Operative

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided