ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 106 for:    Recruiting, Not yet recruiting, Available Studies | "Bone Transplantation"
Previous Study | Return to List | Next Study

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03777735
Recruitment Status : Recruiting
First Posted : December 17, 2018
Last Update Posted : December 17, 2018
Sponsor:
Collaborator:
surgebright GmbH
Information provided by (Responsible Party):
Catharina Chiari, Medical University of Vienna

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.

Condition or disease Intervention/treatment
Osteochondral Defect Procedure: human bone graft screw

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 Type : Observational
Estimated Enrollment : 20 participants
Observational Model: Cohort
Time Perspective: Prospective
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, 2019
Estimated Study Completion Date : April 1, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bone Grafts

Group/Cohort Intervention/treatment
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.




Primary Outcome Measures :
  1. incidence of surgical revisions [ Time Frame: 1 year ]
    Was a surgical revision done postoperatively? YES/NO

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. incidence of postoperative pseudoarthrosis [ Time Frame: 1 year ]
    based on x-rays or MRI: Is a postoperative pseudoarthrosis visible? YES/NO

  8. 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.

  9. duration of postoperative job-related incapacity [ Time Frame: 1 year ]
    evaluation of duration


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   8 Years to 99 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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

Information from the National Library of Medicine

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


Contacts
Contact: Catharina Chiari, MD +43140400 ext 40900 catharina.chiari@meduniwien.ac.at
Contact: Sandra Hacker, MSc +43140400 ext 40900 sandra.hacker@meduniwien.ac.at

Locations
Austria
LKH-Univ.Klinikum Graz Recruiting
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         
Sponsors and Collaborators
Medical University of Vienna
surgebright GmbH
Investigators
Principal Investigator: Catharina Chiari, MD Medical University Vienna

Responsible Party: Catharina Chiari, Univ. Prof. Dr. Catharina Chiari, MSc, Medical University of Vienna
ClinicalTrials.gov Identifier: NCT03777735     History of Changes
Other Study ID Numbers: OD1
First Posted: December 17, 2018    Key Record Dates
Last Update Posted: December 17, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Catharina Chiari, Medical University of Vienna:
human bone graft screw
osteochondral defect
knee

Additional relevant MeSH terms:
Osteochondrosis
Bone Diseases
Musculoskeletal Diseases