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

Status Recruiting

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Osteochondral Defect

Clinical Trial Details

NCT number	NCT03777735
Study type	Observational
Source	Medical University of Vienna
Contact	Catharina Chiari, MD
Phone	+43140400
Email	catharina.chiari@meduniwien.ac.at
Status	Recruiting
Phase
Start date	April 24, 2018
Completion date	April 1, 2024

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT06078072` - Biomaterials and Mesenchymal Stem/Stromal Cells in the Treatment of Knee Articular Surface Lesions
Terminated	`NCT00945399` - Comparison of Microfracture Treatment and CARTIPATCH® Chondrocyte Graft Treatment in Femoral Condyle Lesions	Phase 3
Recruiting	`NCT06225674` - Clinical Investigation on the Outcome of Episealer Talus Post-operation for Treatment of Focal Osteochondral Defects
Completed	`NCT03385642` - Follow-Up Study Evaluating the Long Term Outcome of ChondroMimetic in the Treatment of Osteochondral Defects in the Knee
Recruiting	`NCT05124613` - The Impact of Covid-19 on Patients Waiting for Knee Surgery
Not yet recruiting	`NCT06216756` - Evaluating Cryopreserved Osteochondral Allograft Cores for the Treatment of Osteochondral Lesions in the Knee	N/A
Recruiting	`NCT04236492` - Study Protocol to Evaluate Clinical and Imaging Results of Knee Fresh Osteochondral Allografts
Recruiting	`NCT03625180` - An Observational, Prospective Study of Patients With Chondral and/or Osteochondral Defects of the Knee Treated With NAMIC
Recruiting	`NCT03696394` - A Study to Evaluate the Efficacy of BioCartilage® Micronized Cartilage Matrix in Microfracture Treatment of Osteochondral Defects	N/A
Recruiting	`NCT04364334` - Knee Registry (Knieregister)
Completed	`NCT03452098` - Post-Operative Rehabilitation of Knee Osteochondral Defect: A Case Series
Terminated	`NCT03036878` - ReNu™ Marrow Stimulation Augmentation	N/A
Recruiting	`NCT03908931` - Descriptive Study of the Reconstruction of Osteochondral Lesions of the Knee: Clinical and Imaging Results	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.