Human Bone Graft for Fixation of Osteochondral Defects in the Knee Joint
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|ClinicalTrials.gov Identifier: NCT03777735|
Recruitment Status : Recruiting
First Posted : December 17, 2018
Last Update Posted : September 7, 2020
|Condition or disease||Intervention/treatment|
|Osteochondral Defect||Procedure: human bone graft screw|
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 Type :||Observational|
|Estimated Enrollment :||20 participants|
|Official Title:||Multicentric Observational Study on the Use of a Human Bone Graft in Osteochondral Defects|
|Actual Study Start Date :||April 24, 2018|
|Estimated Primary Completion Date :||April 1, 2022|
|Estimated Study Completion Date :||April 1, 2022|
human bone graft screw
The patients will receive human bone graft screws surgically.
Procedure: human bone graft screw
All patients undergo surgical treatment of osteochondral defects in the knee joint with human bone graft screws.
- incidence of surgical revisions [ Time Frame: 1 year ]Was a surgical revision done postoperatively? 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 screw [ Time Frame: 1 year ]based on x-rays or MRI: Is a cracking of the screw 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 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 postoperative pseudoarthrosis [ Time Frame: 1 year ]based on x-rays or MRI: Is a postoperative pseudoarthrosis 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
- patient satisfaction (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 = very satisfied - 100mm = not satisfied at all). A higher score indicates less satisfaction.
- Knee Outcome Survey - Activities of Daily Living Scale (KOS-ADL) [ Time Frame: 1 year ]The KOS ADL score includes 14 questions and is divided in 2 subscales, symptoms (6 items, max. score 30) and functional restrictions (8 items, max. score 40). The scores of the answers range from 0 to 5 points. 0 points mean no impairment of everyday activities, while 5 points represent the greatest possible impairment. All points are summed up. From this, the KOS-ADL score is calculated as the proportion of the total response points from the possible maximum score (70) in percent. KOS ADL Score [%] = ( symptoms pts. + functional restrictions pts.)*100/70. The percentage ranges from 0-100%. 0% means no impairment, while 100% represents the greatest possible impairment.
- International Knee Documentation Committee Subjective Knee Form (IKDC Score) [ Time Frame: 1 year ]The IKDC Score contains 19 questions (7 questions for symptomatology, 10 concerning function, 2 about sport activity). The lowest function level or the highest symptom level receives the score value 1. The highest function level or the lowest symptom level is given the number n according to the number n of possible answers. With the exception of question 10 "Functioning before knee injury", the remaining 18 response points are summed up. This gives the "raw sum". The lowest possible score is 18 and the maximum possible score is 87. The raw sum is converted into a scale of 0 to 100 using the following formula: ((raw score - lowest possible score)/score range)*100. 0 points mean the greatest possible impairment, while 100 points mean complete freedom from symptoms and functioning. The IKDC score can only be calculated if at least 16 of the 18 questions have been answered.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03777735
|Contact: Catharina Chiari, MD||+43140400 ext firstname.lastname@example.org|
|Contact: Sandra Hacker, MSc||+43140400 ext email@example.com|
|Graz, Austria, 8036|
|Contact: Matthias Sperl, MD|
|Barmherzige Schwestern Hospital Ried||Recruiting|
|Ried Im Innkreis, Austria, 4910|
|Contact: Norbert Freund, MD|
|General Hospital Vienna||Recruiting|
|Vienna, Austria, 1090|
|Contact: Sandra Hacker, MSc +43 1 40400 ext 40900|
|Principal Investigator: Catharina Chiari, MD|
|Orthopedic Center Otto-Wagner-Spital||Recruiting|
|Vienna, Austria, 1140|
|Contact: Peter Zenz, MD|
|Hospital Wels- Grieskirchen||Recruiting|
|Wels, Austria, 4600|
|Contact: Klemens Trieb, MD|
|Principal Investigator:||Catharina Chiari, MD||Medical University Vienna|