NCT04109469

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Aug 2018

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 27, 2018

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 7, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 7, 2019

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

September 27, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 30, 2019

Completed
Last Updated

September 30, 2019

Status Verified

September 1, 2019

Enrollment Period

5 months

First QC Date

September 27, 2019

Last Update Submit

September 27, 2019

Conditions

ArthrodesisOsteotomy

Outcome Measures

Primary Outcomes (2)

  • Osseous consolidation of the transplant

    Absence of radiolucent lines around the transplant in the x-ray

    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.

    1 year

Secondary Outcomes (8)

  • Incidence of postoperative complication and soft tissue irritation

    1 year

  • Incidence of surgical revision

    1 year

  • Incidence of postoperative pseudarthrosis

    1 year

  • Duration of post-operative analgesic medication

    1 year

  • Cellular contact to the recipient bone

    1 year

  • +3 more secondary outcomes

Interventions

Shark Screw® transplantDEVICE

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

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

patients who underwent hand- or foot surgery with the application of a Shark Screw® transplant

You may qualify if:

  • 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

You may not qualify if:

  • not enough data for an objective analysis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Klinik Diakonissen Linz GmbH

Linz, 4020, Austria

Location

MeSH Terms

Conditions

Ankylosis

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal Diseases

Study Officials

  • Klaus Pastl, Dr. med.

    Klinik Diakonissen Linz

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 27, 2019

First Posted

September 30, 2019

Study Start

August 27, 2018

Primary Completion

February 7, 2019

Study Completion

February 7, 2019

Last Updated

September 30, 2019

Record last verified: 2019-09

Data Sharing

IPD Sharing
Will not share

Locations

AU(1)