Shark Screw® - Hand- and Foot Surgery Study

Completed

• Conditions: Osteotomy; Arthrodesis

• Registration Number: NCT04109469
• Lead Sponsor: Klinik Diakonissen Linz GmbH

Brief Summary

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

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 Timeline

• Study Start: 2018-08-27
• Primary Completion: 2019-02-07
• Study Completion: 2019-02-07
• Status Verified: 2019-09
• Study First Submitted: 2019-09-27
• Study First Submitted QC: 2019-09-27
• Last Update Submitted: 2019-09-27
• Study First Posted: 2019-09-30
• Last Update Posted: 2019-09-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Osseous consolidation of the transplant	1 year	Absence of radiolucent lines around the transplant in the x-ray
Evaluation pre- and postoperative pain (VAS)	1 year	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.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Klinik Diakonissen Linz GmbH; 🇦🇹 Linz, Austria