Shark Screw® - Hand- and Foot Surgery Study

Osteotomy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04109469
• Other study ID #: 1099/2018
• Status: Completed
• Start date: August 27, 2018
• Est. completion date: February 7, 2019

Study information

• Verified date: September 2019
• Source: Klinik Diakonissen Linz GmbH
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: February 7, 2019
• Est. primary completion date: February 7, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Arthrodesis
• Osteotomy

Intervention

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

Locations

Country	Name	City	State
Austria	Klinik Diakonissen Linz GmbH	Linz

Sponsors (2)

Lead Sponsor	Collaborator
Klinik Diakonissen Linz GmbH	surgebright GmbH

Country where clinical trial is conducted

Austria, 

Outcome

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