Shark Screw® - Hand- and Foot Surgery Study

Retrospective Study on the Use of a Human Bone Graft (Shark Screw®) in Hand- and Foot Surgery

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

Study Overview

• Status: Completed
• Conditions: Arthrodesis; Osteotomy
• Intervention / Treatment: Device: Shark Screw® transplant

Detailed 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.

• Study Type: Observational
• Enrollment (Actual): 32

Contacts and Locations

Study Locations

• Austria
  • Linz, Austria, 4020
    • Klinik Diakonissen Linz GmbH

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

patients who underwent hand- or foot surgery with the application of a Shark Screw® transplant

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Osseous consolidation of the transplant	Absence of radiolucent lines around the transplant in the x-ray	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.	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of postoperative complication and soft tissue irritation	Did wound healing disorder or soft tissue irritation occur?	1 year
Incidence of surgical revision	Was a surgical revision done postoperatively?	1 year
Incidence of postoperative pseudarthrosis	Based on x-rays or MRI: Is a postoperative pseudarthrosis visible?	1 year
Duration of post-operative analgesic medication	How long did the patient take analgesics after surgery?	1 year
Cellular contact to the recipient bone	Absence of sclerosis around the transplant in the x-ray	1 year
Resorptive processes in the recipient bone	Absence of cystic lucency in the x-ray	1 year
Incidence of cracking or loosening of the screw	Based on x-rays: Is a loosening or cracking of the screw visible?	1 year
Patient satisfaction	Patient satisfaction was classified as "very satisfied", "satisfied" and "not satisfied"	1 year

Collaborators and Investigators

• Sponsor: Klinik Diakonissen Linz GmbH
• Collaborators: Surgebright Gmbh
• Investigators: Principal Investigator: Klaus Pastl, Dr. med., Klinik Diakonissen Linz

Study record dates

Study Major Dates

• Study Start (Actual): August 27, 2018
• Primary Completion (Actual): February 7, 2019
• Study Completion (Actual): February 7, 2019

Study Registration Dates

• First Submitted: September 27, 2019
• First Submitted That Met QC Criteria: September 27, 2019
• First Posted (Actual): September 30, 2019

Study Record Updates

• Last Update Posted (Actual): September 30, 2019
• Last Update Submitted That Met QC Criteria: September 27, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: 1099/2018

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No