Retrospective Study on the Use of a Human Bone Graft (Shark Screw®) in Hand- and Foot Surgery
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Klinik Diakonissen Linz GmbH
- Enrollment
- 32
- Locations
- 1
- Primary Endpoint
- Osseous consolidation of the transplant
Study Overview
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 Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Retrospective
Eligibility Criteria
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
Osseous consolidation of the transplant
Time Frame: 1 year
Absence of radiolucent lines around the transplant in the x-ray
Evaluation pre- and postoperative pain (VAS)
Time Frame: 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 Outcomes
- Incidence of postoperative complication and soft tissue irritation(1 year)
- Incidence of surgical revision(1 year)
- Duration of post-operative analgesic medication(1 year)
- Incidence of cracking or loosening of the screw(1 year)
- Cellular contact to the recipient bone(1 year)
- Resorptive processes in the recipient bone(1 year)
- Patient satisfaction(1 year)
- Incidence of postoperative pseudarthrosis(1 year)