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Completed

NCT Number: NCT04109469

Shark Screw® - Hand- and Foot Surgery Study

This observational study aims to determine the efficacy and safety of the Shark Screw® transplant for osteotomy and arthrodesis in hand and foot surgery.

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Key information

Conditions

Arthrodesis Ankylosis Joint Diseases Musculoskeletal Diseases Osteotomy

Sex eligibility

All sexes

Study type

Observational

Primary location

Klinik Diakonissen Linz GmbH

Linz, 4020, Austria

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Shark Screw® transplant

Device

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

Primary outcomes

  1. Osseous consolidation of the transplant

    Time frame: 1 year

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

  2. 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

  1. Incidence of postoperative complication and soft tissue irritation

    Time frame: 1 year

    Did wound healing disorder or soft tissue irritation occur?

  2. Incidence of surgical revision

    Time frame: 1 year

    Was a surgical revision done postoperatively?

  3. Incidence of postoperative pseudarthrosis

    Time frame: 1 year

    Based on x-rays or MRI: Is a postoperative pseudarthrosis visible?

  4. Duration of post-operative analgesic medication

    Time frame: 1 year

    How long did the patient take analgesics after surgery?

  5. Cellular contact to the recipient bone

    Time frame: 1 year

    Absence of sclerosis around the transplant in the x-ray

  6. Resorptive processes in the recipient bone

    Time frame: 1 year

    Absence of cystic lucency in the x-ray

  7. Incidence of cracking or loosening of the screw

    Time frame: 1 year

    Based on x-rays: Is a loosening or cracking of the screw visible?

  8. Patient satisfaction

    Time frame: 1 year

    Patient satisfaction was classified as "very satisfied", "satisfied" and "not satisfied"

Sponsors and collaborators

Lead sponsor

Klinik Diakonissen Linz GmbH

Other

Collaborators

  • Surgebright Gmbh

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Sep 30, 2019
Registry last updated
Sep 30, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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