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

November 17, 2015 updated by: SportWelding GmbH

Prospective Clinical Evaluation of the Bioabsorbable SportWelding FijiAnchor® for Ligament Repair of the Hand and Hand Wrist

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
    • Tyrol
      • Innsbruck, Tyrol, Austria, 6020
        • Univ.-Klinik für Unfallchirurgie

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: SportWelding Fiji Anchor
Device: SportWelding Fiji Anchor

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Operation success
Time Frame: Day 1
Technical success confirmed at the end of surgery by mean of an assessment form (e.g anchor insertion without breaking and suture without pulling off from the tissue during surgery).
Day 1
Procedure success
Time Frame: 12 weeks
No dislodged/broken anchor nor ruptured sutures observed at 2, 6 and 12 weeks post operative evaluation
12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical function
Time Frame: 3 and 6 months
Dash (Disabilities of the Arm, Shoulder and Hand) Score, PRWE (Patient-Related-Wrist-Evaluation) Score and strength of the operated and the non-operated control hand will be recorded after 6 and 12 months.
3 and 6 months
Adverse events
Time Frame: From Day 1 to 12 months
All adverse events will be recorded
From Day 1 to 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

SportWelding GmbH

Investigators

  • Principal Investigator: Rohit Arora, MD, Univ.-Klinik für Unfallchirurgie Innsbruck, Austria

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2014

Primary Completion (Anticipated)

June 1, 2016

Study Completion (Anticipated)

June 1, 2016

Study Registration Dates

First Submitted

January 9, 2014

First Submitted That Met QC Criteria

January 20, 2014

First Posted (Estimate)

January 23, 2014

Study Record Updates

Last Update Posted (Estimate)

November 18, 2015

Last Update Submitted That Met QC Criteria

November 17, 2015

Last Verified

November 1, 2015

More Information

Terms related to this study

Other Study ID Numbers

  • Spo-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Lesion of Ligament of Wrist and/or Hand

Clinical Trials on SportWelding Fiji Anchor

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Oman

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe