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

N/AUnknownNCT02042846

SportWelding GmbH30 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Lesion of Ligament of Wrist and/or Hand

Interventions

SportWelding Fiji AnchorDEVICE

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Univ.-Klinik für Unfallchirurgie

Innsbruck, Tyrol, Austria

Outcomes

Primary Outcomes

Operation success

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).

Time frame: Day 1

Procedure success

No dislodged/broken anchor nor ruptured sutures observed at 2, 6 and 12 weeks post operative evaluation

Time frame: 12 weeks

Secondary Outcomes

Clinical function

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.

Time frame: 3 and 6 months

Adverse events

All adverse events will be recorded

Time frame: From Day 1 to 12 months

Data from ClinicalTrials.gov

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