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

S

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)

30 participants in 1 patient group

SportWelding Fiji Anchor
Experimental group
Treatment:
Device: SportWelding Fiji Anchor

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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