A New Type of Bioabsorbable Screw in the Hallux Valgus Surgery

NCT ID: NCT03133039

Last Updated: 2019-08-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

2 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-10-01

Study Completion Date

2021-12-01

Brief Summary

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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

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Conditions

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Hallux Valgus Hallux Rigidus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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bioabsorbable screw

Group Type ACTIVE_COMPARATOR

surgery, bioabsorbable screw

Intervention Type PROCEDURE

In this study we compare bioabsorbable and titanium screw in the hallux valgus and hallux rigidus surgery

titanium screw

Group Type ACTIVE_COMPARATOR

surgery, bioabsorbable screw

Intervention Type PROCEDURE

In this study we compare bioabsorbable and titanium screw in the hallux valgus and hallux rigidus surgery

Interventions

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surgery, bioabsorbable screw

In this study we compare bioabsorbable and titanium screw in the hallux valgus and hallux rigidus surgery

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Tampere University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Nikke Partio

Resident Surgery (MD)

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Faculty of Medicine

Tampere, Pirkanmaa, Finland

Site Status RECRUITING

Countries

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Finland

Central Contacts

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Nkke Partio, M.D

Role: CONTACT

+3583 311611

Heikki Mäenpää, M.D, Ph.D.

Role: CONTACT

Facility Contacts

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Nikke Partio, M.D.

Role: primary

+358 3 355 111

Other Identifiers

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R16143

Identifier Type: -

Identifier Source: org_study_id

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