Shark Screw® - Hand- and Foot Surgery Study

Klinik Diakonissen Linz GmbH

Status: Completed

Conditions: Arthrodesis; Osteotomy

Treatments: Device: Shark Screw® transplant

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT04109469

1099/2018

Details and patient eligibility

About

This observational study aims to determine the efficacy and safety of the Shark Screw® transplant for osteotomy and arthrodesis in hand and foot surgery.

Full description

The Shark Screw® transplant (surgebright GmbH) is a human cortical bone allograft for osteosynthesis and can replace metal or bioabsorbable devices in various procedures. In total, the clinical records from 32 patients who had undergone surgical procedure at the hand or foot between October 2016 and January 2018 with the use of a Shark Screw® transplant for joint arthrodesis or for the stabilization of osteotomies serve as data sources for this study. The aim of this study is to evaluate the efficacy and safety of the Shark Screw® transplant in hand and foot surgery by analyzing the recovery, wound and bone healing process.

Enrollment: 32 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• Application of the human bone graft Shark Screw® in a Hand- or Foot surgical procedure between October 2016 and January 2018
• Data from at least 1 follow-up examination after surgery around the 6th post-operative week or other information about the health status of the patient in the first 6 post-operative weeks

Exclusion criteria

• not enough data for an objective analysis