Clinical trial NCT03777735: Human Bone Graft for Fixation of Osteochondral Defects in the Knee Joint
Official title: Multicentric Observational Study on the Use of a Human Bone Graft in Osteochondral Defects
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Osteochondral Defect
Keywords: human bone graft screw
osteochondral defect
knee
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
Collaborators: name: Surgebright Gmbh
First posted: 2018-12-17
Enrollment: 20
Sex: ALL
Minimum age (years): 8
Maximum age (years): 99
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients from all participating sites scheduled for an OD treatment with human bone graft screws get information about this observational study and have the possibility to participate.

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.

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

Primary outcomes:
measure: incidence of surgical revisions
timeFrame: 1 year
measure: incidence of loosening of the screw
timeFrame: 1 year
measure: incidence of cracking of the screw
timeFrame: 1 year
measure: incidence of loosening of the osteochondral fragment
timeFrame: 1 year
measure: incidence of cracking of the osteochondral fragment
timeFrame: 1 year
measure: time to healing of the osteochondral fragment
timeFrame: 1 year
measure: incidence of postoperative pseudoarthrosis
timeFrame: 1 year
measure: evaluation postoperative pain (VAS)
timeFrame: 1 year
measure: duration of postoperative job-related incapacity
timeFrame: 1 year
Secondary outcomes:
measure: patient satisfaction (VAS)
timeFrame: 1 year
measure: Knee Outcome Survey - Activities of Daily Living Scale (KOS-ADL)
timeFrame: 1 year
measure: International Knee Documentation Committee Subjective Knee Form (IKDC Score)
timeFrame: 1 year
Other outcomes:
Locations:
city: Graz
country: Austria
facility: LKH-Univ.Klinikum Graz
city: Ried Im Innkreis
country: Austria
facility: Barmherzige Schwestern Hospital Ried
city: Vienna
country: Austria
facility: General Hospital Vienna
city: Vienna
country: Austria
facility: Orthopedic Center Otto-Wagner-Spital
city: Wels
country: Austria
facility: Hospital Wels- Grieskirchen
Study officials:
affiliation: Medical University Vienna
name: Catharina Chiari, MD
role: PRINCIPAL_INVESTIGATOR
References: