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

NCT ID: NCT03777735

Last Updated: 2022-08-24

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 20 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-04-24
• Study Completion Date: 2024-04-01

Brief 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.

Detailed 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.

Conditions

Osteochondral Defect

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

human bone graft screw

The patients will receive human bone graft screws surgically.

human bone graft screw

Intervention Type: PROCEDURE

All patients undergo surgical treatment of osteochondral defects in the knee joint with human bone graft screws.

Interventions

human bone graft screw

All patients undergo surgical treatment of osteochondral defects in the knee joint with human bone graft screws.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Indication for the use of a human bone graft in the surgical treatment of osteochondral 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 oral education (additional consent for participation of minors in the study after prior written and oral education by at least one parent)
• Age ≥ 8 years

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

• Minimum Eligible Age: 8 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Surgebright Gmbh

INDUSTRY

Sponsor Role: collaborator

Medical University of Vienna

OTHER

Sponsor Role: lead

Responsible Party

Catharina Chiari

Univ. Prof. Dr. Catharina Chiari, MSc

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Catharina Chiari, MD

Role: PRINCIPAL_INVESTIGATOR

Medical University Vienna

Locations

LKH-Univ.Klinikum Graz

Graz, , Austria

Site Status: RECRUITING

Barmherzige Schwestern Hospital Ried

Ried im Innkreis, , Austria

Site Status: RECRUITING

General Hospital Vienna

Vienna, , Austria

Site Status: RECRUITING

Orthopedic Center Otto-Wagner-Spital

Vienna, , Austria

Site Status: RECRUITING

Hospital Wels- Grieskirchen

Wels, , Austria

Site Status: RECRUITING

Countries

Austria

Central Contacts

Catharina Chiari, MD

Role: CONTACT

catharina.chiari@meduniwien.ac.at

+43140400 ext. 40900

Sandra Hacker, MSc

Role: CONTACT

sandra.hacker@meduniwien.ac.at

+43140400 ext. 40900

Facility Contacts

Matthias Sperl, MD

Role: primary

Norbert Freund, MD

Role: primary

Sandra Hacker, MSc

Role: primary

+43 1 40400 ext. 40900

Peter Zenz, MD

Role: primary

Klemens Trieb, MD

Role: primary

Other Identifiers

OD1

Identifier Type: -

Identifier Source: org_study_id