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Clinical Evaluation of the SportWelding FijiAnchor® in Hand and Hand Wrist Surgery

NCT ID: NCT02042846

Last Updated: 2015-11-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-01-31

Study Completion Date

2016-06-30

Brief Summary

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The SportWelding FijiAnchor is an absorbable suture anchor which is inserted by applying ultrasonic energy. This provides an intimate bond between implant and bone delivering immediate stability.

The purpose of this study is to evaluate the surgical and clinical outcome of the SportWelding Fiji Anchor in ligament repair of the hand and hand wrist.

Detailed Description

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Conditions

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Lesion of Ligament of Wrist and/or Hand

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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SportWelding Fiji Anchor

Group Type EXPERIMENTAL

SportWelding Fiji Anchor

Intervention Type DEVICE

Interventions

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SportWelding Fiji Anchor

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Having a condition requiring (re)fixation or (re)construction of ligaments in the hand or hand wrist
* Being able to comprehend, sign, and date the written informed consent form (ICF)); and
* Being able to visit the hospital to be examined the repaired region after the procedure.

Exclusion Criteria

* Having serious concomitant disease
* Being pregnant
* Having the control hand not suitable to serve as comparator
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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SportWelding GmbH

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Rohit Arora, MD

Role: PRINCIPAL_INVESTIGATOR

Univ.-Klinik für Unfallchirurgie Innsbruck, Austria

Locations

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Univ.-Klinik für Unfallchirurgie

Innsbruck, Tyrol, Austria

Site Status

Countries

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Austria

Other Identifiers

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Spo-01

Identifier Type: -

Identifier Source: org_study_id