Osteochondral DefectNCT03777735
Human Bone Graft for Fixation of Osteochondral Defects in the Knee Joint
An observational study of Osteochondral Defect, run by Medical University of Vienna at 5 sites in Austria.
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. Read more about this study
- Who is it for?
- Ages 8 to 99 years
- Conditions the study is for
- Osteochondral Defect
- What is being tested?
- human bone graft screw
- Type of treatment
- Surgery or procedure
- How many people
- 20 participants
- Where
- 5 sitesAustria
- Study dates
- 24 Apr 2018to 1 Apr 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 99 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Austria5 sites, 5 recruiting
- Recruiting
LKH-Univ.Klinikum Graz
Graz, 8036
Matthias Sperl, MD
- Recruiting
Barmherzige Schwestern Hospital Ried
Ried im Innkreis, 4910
Norbert Freund, MD
- Recruiting
General Hospital Vienna
Vienna, 1090
Sandra Hacker, MSc, +43 1 40400 ext. 40900
Catharina Chiari, MD
- Recruiting
Orthopedic Center Otto-Wagner-Spital
Vienna, 1140
Peter Zenz, MD
- Recruiting
Hospital Wels- Grieskirchen
Wels, 4600
Klemens Trieb, MD
About this study
Official title: Multicentric Observational Study on the Use of a Human Bone Graft in Osteochondral Defects
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.
Read the 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
- Being tested
- human bone graft screw
- Keywords
- human bone graft screw, osteochondral defect, knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
human bone graft screwProcedure or surgery
All patients undergo surgical treatment of osteochondral defects in the knee joint with human bone graft screws.
| Study group | Role | What they receive |
|---|---|---|
| human bone graft screw | The patients will receive human bone graft screws surgically. Receives: Procedure: human bone graft screw |
What is being measured
The primary outcome is the main question the study is designed to answer.
incidence of surgical revisions
Was a surgical revision done postoperatively? YES/NO
Measured: 1 year
incidence of loosening of the screw
based on x-rays or MRI: Is a loosening of the screw visible? YES/NO
Measured: 1 year
incidence of cracking of the screw
based on x-rays or MRI: Is a cracking of the screw visible? YES/NO
Measured: 1 year
incidence of loosening of the osteochondral fragment
based on x-rays or MRI: Is a loosening of the osteochondral fragment visible? YES/NO
Measured: 1 year
incidence of cracking of the osteochondral fragment
based on x-rays or MRI: Is a cracking of the osteochondral fragment visible? YES/NO
Measured: 1 year
time to healing of the osteochondral fragment
based on x-rays or MRI: Has the osteochondral fragment healed into the surrounding area? YES/NO
Measured: 1 year
incidence of postoperative pseudoarthrosis
based on x-rays or MRI: Is a postoperative pseudoarthrosis visible? YES/NO
Measured: 1 year
evaluation postoperative pain (VAS)
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.
Measured: 1 year
duration of postoperative job-related incapacity
evaluation of duration
Measured: 1 year
Secondary outcomes (3)
patient satisfaction (VAS)
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.
Measured: 1 year
Knee Outcome Survey - Activities of Daily Living Scale (KOS-ADL)
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.
Measured: 1 year
International Knee Documentation Committee Subjective Knee Form (IKDC Score)
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.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2018
- Study start24 Apr 2018
- Primary completion1 Apr 2023 (estimated)
- Study completion1 Apr 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteochondral DefectStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Collaborators
- Surgebright Gmbh
- Responsible party
- Principal investigator, Catharina Chiari, Medical University of Vienna
- Investigators
- Catharina Chiari, MD, Principal investigator, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03777735
- Sponsor's protocol ID
- OD1
- Status last verified
- Aug 2022
- First submitted
- 5 Dec 2018
- Last updated
- 24 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicentric Observational Study on the Use of a Human Bone Graft in Osteochondral Defects
- ClinicalTrials.gov ID
- NCT03777735
- Acronym / sponsor ID
- OD1
- Conditions
- Osteochondral Defect
- Keywords
- human bone graft screw, osteochondral defect, knee
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Collaborators
- Surgebright Gmbh
- Study start
- 24 Apr 2018 (actual)
- Primary completion
- 1 Apr 2023 (estimated)
- Study completion
- 1 Apr 2024 (estimated)
- First posted
- 17 Dec 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| human bone graft screw | – | Procedure: human bone graft screwThe patients will receive human bone graft screws surgically. |
Who may qualify
- Ages
- 8 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (8 listed)
- Insufficient knowledge of the German language
- Alcohol and drug abuse
- Pregnant or breastfeeding woman
- Foreseeable compliance issues
- Neoplastic diseases, malignant bone tumors, rheumatoid arthritis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| human bone graft screwAll patients undergo surgical treatment of osteochondral defects in the knee joint with human bone graft screws. | Procedure or surgery | human bone graft screw |
Primary outcome
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
3 secondary outcomes
patient satisfaction (VAS)
Time frame: 1 year
Knee Outcome Survey - Activities of Daily Living Scale (KOS-ADL)
Time frame: 1 year
International Knee Documentation Committee Subjective Knee Form (IKDC Score)
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2022.
- Individual participant dataSharing planned: No
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A Study of MACI in Patients Aged 17 to 65 Years With Symptomatic Chondral or Osteochondral Defects of the Ankle
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Catharina Chiari, MD principal investigator
Medical University of Vienna
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Osteochondral Defect, run by Medical University of Vienna at 5 sites in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Catharina Chiari, MD (+43140400 ext. 40900, catharina.chiari@meduniwien.ac.at), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
incidence of surgical revisions (time frame: 1 year). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Aug 2022.