Back to resultsA New Type of Bioabsorbable Screw in the Hallux Valgus Surgery
Primary Purpose
Hallux Valgus, Hallux Rigidus
Status
Unknown status
Phase
Not Applicable
Locations
Finland
Study Type
Interventional
Intervention
surgery, bioabsorbable screw
Sponsored by
About this trial
This is an interventional treatment trial for Hallux Valgus
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
Sites / Locations
- Faculty of MedicineRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
bioabsorbable screw
titanium screw
Arm Description
Outcomes
Primary Outcome Measures
AOFAS score
score
Secondary Outcome Measures
Full Information
NCT ID
NCT03133039
First Posted
April 25, 2017
Last Updated
August 26, 2019
Sponsor
Tampere University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03133039
Brief Title
A New Type of Bioabsorbable Screw in the Hallux Valgus Surgery
Official Title
Comparative Experimental and Clinical Study: a New Type of Bioabsorbable Screw and the Titanium Screw in the Hallux Valgus Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
August 2019
Overall Recruitment Status
Unknown status
Study Start Date
October 1, 2015 (Actual)
Primary Completion Date
December 1, 2020 (Anticipated)
Study Completion Date
December 1, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tampere University Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hallux Valgus, Hallux Rigidus
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
2 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
bioabsorbable screw
Arm Type
Active Comparator
Arm Title
titanium screw
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
surgery, bioabsorbable screw
Intervention Description
In this study we compare bioabsorbable and titanium screw in the hallux valgus and hallux rigidus surgery
Primary Outcome Measure Information:
Title
AOFAS score
Description
score
Time Frame
2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nkke Partio, M.D
Phone
+3583 311611
Email
partio.nikke.n@student.uta.fi
First Name & Middle Initial & Last Name or Official Title & Degree
Heikki Mäenpää, M.D, Ph.D.
Facility Information:
Facility Name
Faculty of Medicine
City
Tampere
State/Province
Pirkanmaa
ZIP/Postal Code
FI-33014
Country
Finland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nikke Partio, M.D.
Phone
+358 3 355 111
Email
nikke.partio@tuni.fi
12. IPD Sharing Statement
Learn more about this trial
A New Type of Bioabsorbable Screw in the Hallux Valgus Surgery
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