Human Bone Graft for Fixation of Osteochondral Defects in the Knee Joint

Last updated: August 23, 2022
Sponsor: Medical University of Vienna
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

N/A

Clinical Study ID

NCT03777735
OD1
  • Ages 8-99
  • All Genders

Study Summary

This observational study is to document the application of a human bone graft in the surgical repair of bone fragment detachment in the knee joint (osteochondral defect) and its subsequent healing process.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Indication for the use of a human bone graft in the surgical treatment ofosteochondral defects
  • legal capability of adults, guardians and adolescents aged 14 to 17 years,age-appropriate perceptivity for children 8 to 13 years old
  • Written consent to participation in the study after previous written and oraleducation (additional consent for participation of minors in the study after priorwritten and oral education by at least one parent)
  • Age ≥ 8 years

Exclusion

Exclusion Criteria:

  • Insufficient knowledge of the German language
  • Alcohol and drug abuse
  • Pregnant or breastfeeding woman
  • Foreseeable compliance issues
  • Neoplastic diseases, malignant bone tumors, rheumatoid arthritis
  • Active osteomyelitis
  • Ulcerations in the area of the skin of the surgical area
  • Immunosuppressive drugs that can not be discontinued

Study Design

Total Participants: 20
Study Start date:
April 24, 2018
Estimated Completion Date:
April 01, 2024

Study Description

For the treatment of bone fractures metal screws have been used for decades. Removal of material is the major disadvantage of conventional osteosynthesis and requires a second intervention, with all the complications and risks for each patient. In order to avoid this second surgery, it is possible to use human bone screw grafts instead of metal screws.

The bone graft helps to create a solid, bony connection. This connection leads to an extension, a bone remodeling, bone installation and optimal reparation process in the affected area.

The comparatively rare occurrence of suitable patients contributes to the fact that there has not been enough systematic research to objectively confirm the benefits of the product, which is why this observational study is being conducted.

In total, 20 patients will be enrolled in several centers in Austria. The low number of cases and the multicenter design is due to the rarity of suitable patients.

This observational study will use Shark Screw® grafts without exception at all participating centers. These grafts are manufactured by two tissue banks, the Austrian Tissue Bank surgebright and the German Institute for Cell and Tissue Replacement (DZIG) and were approved by the competent Austrian authority (AGES) in 2016.

All patients participating in this observational study, due to a medical indication, undergo surgical treatment of osteochondral defects using the bone screws mentioned above.

Postoperatively, the patients are observed over a period of 24 months. In total, there are five follow-up examinations during which clinical examinations, x-rays and a magnetic resonance tomography (MRI) is performed. In addition the KOS-ADL and IKDC Score are collected.

Connect with a study center

  • LKH-Univ.Klinikum Graz

    Graz, 8036
    Austria

    Active - Recruiting

  • Barmherzige Schwestern Hospital Ried

    Ried Im Innkreis, 4910
    Austria

    Active - Recruiting

  • General Hospital Vienna

    Vienna, 1090
    Austria

    Active - Recruiting

  • Orthopedic Center Otto-Wagner-Spital

    Vienna, 1140
    Austria

    Active - Recruiting

  • Hospital Wels- Grieskirchen

    Wels, 4600
    Austria

    Active - Recruiting

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