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

SportWelding

Status: Unknown

Conditions: Lesion of Ligament of Wrist and/or Hand

Treatments: Device: SportWelding Fiji Anchor

Study type: Interventional

Funder types: Industry

Identifiers

NCT02042846

Spo-01

Details and patient eligibility

About

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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

SportWelding Fiji Anchor

Experimental group

Treatment:

Device: SportWelding Fiji Anchor