Osteotomy Clinical Trial
Official title:
Retrospective Study on the Use of a Human Bone Graft (Shark Screw®) in Hand- and Foot Surgery
NCT number | NCT04109469 |
Other study ID # | 1099/2018 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | August 27, 2018 |
Est. completion date | February 7, 2019 |
Verified date | September 2019 |
Source | Klinik Diakonissen Linz GmbH |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
This observational study aims to determine the efficacy and safety of the Shark Screw® transplant for osteotomy and arthrodesis in hand and foot surgery.
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 |
Country | Name | City | State |
---|---|---|---|
Austria | Klinik Diakonissen Linz GmbH | Linz |
Lead Sponsor | Collaborator |
---|---|
Klinik Diakonissen Linz GmbH | surgebright GmbH |
Austria,
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 |
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