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Comparative Study of Osteosynthesis for Chevron Osteotomy of Hallux Valgus Using Degradable Versus Non-degradable Metallic Device

Primary Purpose

Hallux Valgus

Status

Completed

Phase

Not Applicable

Locations

Germany

Study Type

Interventional

Intervention

Fracture compressing screw ZfW 102 Königsee Implantate GmbH

Fracture compressing screw titanium Königsee Implantate GmbH

About this trial

This is an interventional treatment trial for Hallux Valgus

Eligibility Criteria

40 Years - 79 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Female and male patients with an age of 40 to 79 years at the day of surgery
Symptomatic Hallux Valgus
Radiological criterium area of proximal joint angle
Normal motorically functions
Female patients of childbearing age must be using two reliable contraception methods

Exclusion Criteria:

Previous bone and/or soft tissue surgeries of the the first metatarsal of the respective foot
BMI > 32
Cysts of the first metatarsal of the respective foot
Neurological disorders with modified motorically functions
Clinical evidence of osteoporosis
Chronic renal impairment
Known hypersensitivity to components of the implants
Regular administration of medications containing the metallic elements of the degradable implant
Pregnant or lactating women
Current participation in another clinical trial or within 30 days before surgery

Sites / Locations

Clinic for Orthopaedic Surgery (in the Annastift Hospital)

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

degradable metallic device

non-degradable metallic device

Arm Description

Outcomes

Primary Outcome Measures

difference of metatarsal angles in degree post surgery and 6 months after surgery

Secondary Outcome Measures

Full Information

NCT ID

NCT01535144

First Posted

February 1, 2012

Last Updated

February 29, 2012

Sponsor

Syntellix AG

1. Study Identification

Unique Protocol Identification Number

NCT01535144

Brief Title

Comparative Study of Osteosynthesis for Chevron Osteotomy of Hallux Valgus Using Degradable Versus Non-degradable Metallic Device

Study Type

Interventional

2. Study Status

Record Verification Date

February 2012

Overall Recruitment Status

Completed

Study Start Date

February 2010 (undefined)

Primary Completion Date

February 2012 (Actual)

Study Completion Date

February 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Syntellix AG

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

The purpose of the study is to show the equivalence of a new degradable metallic device to a non-degradable metallic device in patients with Hallux Valgus.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hallux Valgus

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

26 (Actual)

8. Arms, Groups, and Interventions

Arm Title

degradable metallic device

Arm Type

Experimental

Arm Title

non-degradable metallic device

Arm Type

Active Comparator

Intervention Type

Device

Intervention Name(s)

Fracture compressing screw ZfW 102 Königsee Implantate GmbH

Intervention Description

Comparison of two metallic implantable fracture compressing screws

Intervention Type

Device

Intervention Name(s)

Fracture compressing screw titanium Königsee Implantate GmbH

Intervention Description

Comparison of two metallic implantable fracture compressing screws

Primary Outcome Measure Information:

Title

difference of metatarsal angles in degree post surgery and 6 months after surgery

Time Frame

up to 6 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

40 Years

Maximum Age & Unit of Time

79 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Female and male patients with an age of 40 to 79 years at the day of surgery Symptomatic Hallux Valgus Radiological criterium area of proximal joint angle Normal motorically functions Female patients of childbearing age must be using two reliable contraception methods Exclusion Criteria: Previous bone and/or soft tissue surgeries of the the first metatarsal of the respective foot BMI > 32 Cysts of the first metatarsal of the respective foot Neurological disorders with modified motorically functions Clinical evidence of osteoporosis Chronic renal impairment Known hypersensitivity to components of the implants Regular administration of medications containing the metallic elements of the degradable implant Pregnant or lactating women Current participation in another clinical trial or within 30 days before surgery

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Henning Windhagen, Prof., MD

Organizational Affiliation

Clinic for Orthopaedic Surgery (in the Annastift Hospital)

Official's Role

Principal Investigator

Facility Information:

Facility Name

Clinic for Orthopaedic Surgery (in the Annastift Hospital)

City

Hanover

State/Province

Lower Saxony

ZIP/Postal Code

30625

Country

Germany

12. IPD Sharing Statement

Learn more about this trial

Comparative Study of Osteosynthesis for Chevron Osteotomy of Hallux Valgus Using Degradable Versus Non-degradable Metallic Device

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