Shark Screw® - Hand- and Foot Surgery Study

Klinik Diakonissen Linz GmbH32 enrolled

Overview

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

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Arthrodesis Osteotomy

Interventions

Shark Screw® transplantDEVICE

Application of a Shark Screw® transplant for osteosynthesis or arthrodesis in hand- or foot surgery

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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

Locations (1)

Klinik Diakonissen Linz GmbH

Linz, Austria

Outcomes

Primary Outcomes

Osseous consolidation of the transplant

Absence of radiolucent lines around the transplant in the x-ray

Time frame: 1 year

Evaluation pre- and postoperative pain (VAS)

The visual analogue scale (VAS) is a vertical line, 10 centimeters (100 mm) in length, anchored by 2 verbal descriptors, one for each symptom extremes (0mm = no pain - 100mm = worst imaginable pain). A higher score indicates more pain.

Time frame: 1 year

Secondary Outcomes

Incidence of postoperative complication and soft tissue irritation

Did wound healing disorder or soft tissue irritation occur?

Time frame: 1 year

Incidence of surgical revision

Was a surgical revision done postoperatively?

Time frame: 1 year

Incidence of postoperative pseudarthrosis

Based on x-rays or MRI: Is a postoperative pseudarthrosis visible?

Time frame: 1 year

Duration of post-operative analgesic medication

How long did the patient take analgesics after surgery?

Time frame: 1 year

Cellular contact to the recipient bone

Absence of sclerosis around the transplant in the x-ray

Time frame: 1 year

Resorptive processes in the recipient bone

Absence of cystic lucency in the x-ray

Data from ClinicalTrials.gov

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