A New Type of Bioabsorbable Screw in the Hallux Valgus Surgery

August 26, 2019 updated by: Nikke Partio, Tampere University Hospital

Comparative Experimental and Clinical Study: a New Type of Bioabsorbable Screw and the Titanium Screw in the Hallux Valgus Surgery

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

2

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Finland
    • Pirkanmaa
      • Tampere, Pirkanmaa, Finland, FI-33014
        • Recruiting
        • Faculty of medicine
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: bioabsorbable screw
Procedure: surgery, bioabsorbable screw
In this study we compare bioabsorbable and titanium screw in the hallux valgus and hallux rigidus surgery
Active Comparator: titanium screw
Procedure: surgery, bioabsorbable screw
In this study we compare bioabsorbable and titanium screw in the hallux valgus and hallux rigidus surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
AOFAS score
Time Frame: 2 years
score
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tampere University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2015

Primary Completion (Anticipated)

December 1, 2020

Study Completion (Anticipated)

December 1, 2021

Study Registration Dates

First Submitted

April 25, 2017

First Submitted That Met QC Criteria

April 25, 2017

First Posted (Actual)

April 28, 2017

Study Record Updates

Last Update Posted (Actual)

August 28, 2019

Last Update Submitted That Met QC Criteria

August 26, 2019

Last Verified

August 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R16143

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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