Overview

This trial is active, not recruiting.

Condition lesion of ligament of wrist and/or hand
Treatment sportwelding fiji anchor
Sponsor SportWelding GmbH
Start date January 2014
End date June 2016
Trial size 30 participants
Trial identifier NCT02042846, Spo-01

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
sportwelding fiji anchor

Primary Outcomes

Measure
Operation success
time frame: Day 1
Procedure success
time frame: 12 weeks

Secondary Outcomes

Measure
Clinical function
time frame: 3 and 6 months
Adverse events
time frame: From Day 1 to 12 months

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title Prospective Clinical Evaluation of the Bioabsorbable SportWelding FijiAnchor® for Ligament Repair of the Hand and Hand Wrist
Principal investigator Rohit Arora, MD
Trial information was received from ClinicalTrials.gov and was last updated in November 2015.
Information provided to ClinicalTrials.gov by SportWelding GmbH.