NCT03133039

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
2

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2015

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2015

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

April 25, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 28, 2017

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2020

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2021

Completed
Last Updated

August 28, 2019

Status Verified

August 1, 2019

Enrollment Period

5.2 years

First QC Date

April 25, 2017

Last Update Submit

August 26, 2019

Conditions

Hallux ValgusHallux Rigidus

Outcome Measures

Primary Outcomes (1)

  • AOFAS score

    score

    2 years

Study Arms (2)

bioabsorbable screw

ACTIVE COMPARATOR
Procedure: surgery, bioabsorbable screw

titanium screw

ACTIVE COMPARATOR
Procedure: surgery, bioabsorbable screw

Interventions

surgery, bioabsorbable screwPROCEDURE

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

bioabsorbable screwtitanium screw

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Medicine

Tampere, Pirkanmaa, FI-33014, Finland

RECRUITING

MeSH Terms

Conditions

Hallux ValgusHallux Rigidus

Interventions

Surgical Procedures, Operative

Condition Hierarchy (Ancestors)

Foot DeformitiesMusculoskeletal DiseasesFoot Deformities, AcquiredJoint Diseases

Central Study Contacts

Nkke Partio, M.D

CONTACT

+3583 311611partio.nikke.n@student.uta.fi

Heikki Mäenpää, M.D, Ph.D.

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resident Surgery (MD)

Study Record Dates

First Submitted

April 25, 2017

First Posted

April 28, 2017

Study Start

October 1, 2015

Primary Completion

December 1, 2020

Study Completion

December 1, 2021

Last Updated

August 28, 2019

Record last verified: 2019-08

Locations

FI(1)