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A New Type of Bioabsorbable Screw in the Hallux Valgus Surgery

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ClinicalTrials.gov Identifier: NCT03133039
Recruitment Status : Recruiting
First Posted : April 28, 2017
Last Update Posted : May 1, 2017
Sponsor:
Information provided by (Responsible Party):
Nikke Partio, Tampere University Hospital

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.

Condition or disease Intervention/treatment Phase
Hallux Valgus Hallux Rigidus Procedure: surgery, bioabsorbable screw Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 2 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Comparative Experimental and Clinical Study: a New Type of Bioabsorbable Screw and the Titanium Screw in the Hallux Valgus Surgery
Actual Study Start Date : October 1, 2015
Estimated Primary Completion Date : December 1, 2019
Estimated Study Completion Date : December 1, 2020

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




Primary Outcome Measures :
  1. AOFAS score [ Time Frame: 2 years ]
    score



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03133039


Contacts
Contact: Nkke Partio, M.D +3583 311611 partio.nikke.n@student.uta.fi
Contact: Heikki Mäenpää, M.D, Ph.D.

Locations
Finland
Faculty of Medicine Recruiting
Tampere, Pirkanmaa, Finland, FI-33014
Contact: Nikke Partio, M.D.    +358 3 355 111    partio.nikke.n@student.uta.fi   
Sponsors and Collaborators
Tampere University Hospital

Responsible Party: Nikke Partio, Resident Surgery (MD), Tampere University Hospital
ClinicalTrials.gov Identifier: NCT03133039     History of Changes
Other Study ID Numbers: R16143
First Posted: April 28, 2017    Key Record Dates
Last Update Posted: May 1, 2017
Last Verified: April 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Hallux Valgus
Bunion
Hallux Rigidus
Hallux Limitus
Foot Deformities
Musculoskeletal Diseases
Foot Deformities, Acquired
Joint Diseases
Foot Injuries
Leg Injuries
Wounds and Injuries