Multicentric Observational Study on the Use of a Human Bone Graft in Osteochondral Defects
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Medical University of Vienna
- Enrollment
- 20
- Locations
- 5
- Primary Endpoint
- incidence of surgical revisions
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 8 Years to 99 Years (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
incidence of surgical revisions
Time Frame: 1 year
Was a surgical revision done postoperatively? YES/NO
incidence of postoperative pseudoarthrosis
Time Frame: 1 year
based on x-rays or MRI: Is a postoperative pseudoarthrosis visible? YES/NO
incidence of loosening of the osteochondral fragment
Time Frame: 1 year
based on x-rays or MRI: Is a loosening of the osteochondral fragment visible? YES/NO
incidence of loosening of the screw
Time Frame: 1 year
based on x-rays or MRI: Is a loosening of the screw visible? YES/NO
incidence of cracking of the osteochondral fragment
Time Frame: 1 year
based on x-rays or MRI: Is a cracking of the osteochondral fragment visible? YES/NO
time to healing of the osteochondral fragment
Time Frame: 1 year
based on x-rays or MRI: Has the osteochondral fragment healed into the surrounding area? YES/NO
incidence of cracking of the screw
Time Frame: 1 year
based on x-rays or MRI: Is a cracking of the screw visible? YES/NO
evaluation 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.
duration of postoperative job-related incapacity
Time Frame: 1 year
evaluation of duration
Secondary Outcomes
- patient satisfaction (VAS)(1 year)
- Knee Outcome Survey - Activities of Daily Living Scale (KOS-ADL)(1 year)
- International Knee Documentation Committee Subjective Knee Form (IKDC Score)(1 year)
Investigators
Catharina Chiari
Univ. Prof. Dr. Catharina Chiari, MSc
Medical University of Vienna