ArthrodesisNCT04109469
Shark Screw® - Hand- and Foot Surgery Study
An observational study of Arthrodesis and Osteotomy, run by Klinik Diakonissen Linz GmbH at 1 site in Austria.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Arthrodesis, Osteotomy
- What is being tested?
- Shark Screw® transplant
- Type of treatment
- Medical device
- How many people
- 32 participants
- Where
- 1 siteAustria
- Study dates
- 27 Aug 2018to 7 Feb 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: patients who underwent hand- or foot surgery with the application of a Shark Screw® transplant
Who may be able to join
- 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
Who cannot join
- not enough data for an objective analysis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Arthrodesis, Osteotomy
- Being tested
- Shark Screw® transplant
- Medical subject headings
- Ankylosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Shark Screw® transplantDevice
Application of a Shark Screw® transplant for osteosynthesis or arthrodesis in hand- or foot surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Osseous consolidation of the transplant
Absence of radiolucent lines around the transplant in the x-ray
Measured: 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.
Measured: 1 year
Secondary outcomes (8)
Incidence of postoperative complication and soft tissue irritation
Did wound healing disorder or soft tissue irritation occur?
Measured: 1 year
Incidence of surgical revision
Was a surgical revision done postoperatively?
Measured: 1 year
Incidence of postoperative pseudarthrosis
Based on x-rays or MRI: Is a postoperative pseudarthrosis visible?
Measured: 1 year
Duration of post-operative analgesic medication
How long did the patient take analgesics after surgery?
Measured: 1 year
Cellular contact to the recipient bone
Absence of sclerosis around the transplant in the x-ray
Measured: 1 year
Resorptive processes in the recipient bone
Absence of cystic lucency in the x-ray
Measured: 1 year
Incidence of cracking or loosening of the screw
Based on x-rays: Is a loosening or cracking of the screw visible?
Measured: 1 year
Patient satisfaction
Patient satisfaction was classified as "very satisfied", "satisfied" and "not satisfied"
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2019
- Study start27 Aug 2018
- Primary completion7 Feb 2019
- Study completion7 Feb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ArthrodesisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Klinik Diakonissen Linz GmbH
- Sponsor type
- University, hospital or other
- Collaborators
- Surgebright Gmbh
- Responsible party
- Sponsor
- Investigators
- Klaus Pastl, Dr. med., Principal investigator, Klinik Diakonissen Linz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04109469
- Sponsor's protocol ID
- 1099/2018
- Status last verified
- Sep 2019
- First submitted
- 27 Sep 2019
- Last updated
- 30 Sep 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective Study on the Use of a Human Bone Graft (Shark Screw®) in Hand- and Foot Surgery
- ClinicalTrials.gov ID
- NCT04109469
- Acronym / sponsor ID
- 1099/2018
- Conditions
- Arthrodesis, Osteotomy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Klinik Diakonissen Linz GmbHUniversity, hospital or other
- Collaborators
- Surgebright Gmbh
- Study start
- 27 Aug 2018 (actual)
- Primary completion
- 7 Feb 2019 (actual)
- Study completion
- 7 Feb 2019 (actual)
- First posted
- 30 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- patients who underwent hand- or foot surgery with the application of a Shark Screw® transplant
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (1 listed)
- not enough data for an objective analysis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Shark Screw® transplantApplication of a Shark Screw® transplant for osteosynthesis or arthrodesis in hand- or foot surgery | Device | – |
Primary outcome
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.
8 secondary outcomes
Incidence of postoperative complication and soft tissue irritation
Time frame: 1 year
Incidence of surgical revision
Time frame: 1 year
Incidence of postoperative pseudarthrosis
Time frame: 1 year
Duration of post-operative analgesic medication
Time frame: 1 year
Cellular contact to the recipient bone
Time frame: 1 year
Resorptive processes in the recipient bone
Time frame: 1 year
Incidence of cracking or loosening of the screw
Time frame: 1 year
Patient satisfaction
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Klaus Pastl, Dr. med. principal investigator
Klinik Diakonissen Linz
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Arthrodesis and Osteotomy, run by Klinik Diakonissen Linz GmbH at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Osseous consolidation of the transplant (time frame: 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2019; AzTrials last refreshed its copy on 29 Oct 2026.