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

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.

Study Overview

• Status: Recruiting
• Conditions: Osteochondral Defect
• Intervention / Treatment: 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
• Enrollment (Anticipated): 20

Contacts and Locations

• Study Contact: Name: Catharina Chiari, MD; Phone Number: 40900 +43140400; Email: catharina.chiari@meduniwien.ac.at
• Study Contact Backup: Name: Sandra Hacker, MSc; Phone Number: 40900 +43140400; Email: sandra.hacker@meduniwien.ac.at

Study Locations

• Austria
  • Graz, Austria, 8036
    • Recruiting
    • LKH-Univ.Klinikum Graz
    • Contact: Matthias Sperl, MD
  • Ried Im Innkreis, Austria, 4910
    • Recruiting
    • Barmherzige Schwestern Hospital Ried
    • Contact: Norbert Freund, MD
  • Vienna, Austria, 1090
    • Recruiting
    • General hospital Vienna
    • Contact: Sandra Hacker, MSc; Phone Number: 40900 +43 1 40400
    • Principal Investigator: Catharina Chiari, MD
  • Vienna, Austria, 1140
    • Recruiting
    • Orthopedic Center Otto-Wagner-Spital
    • Contact: Peter Zenz, MD
  • Wels, Austria, 4600
    • Recruiting
    • Hospital Wels- Grieskirchen
    • Contact: Klemens Trieb, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 years to 95 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
incidence of surgical revisions	Was a surgical revision done postoperatively? YES/NO	1 year
incidence of loosening of the screw	based on x-rays or MRI: Is a loosening of the screw visible? YES/NO	1 year
incidence of cracking of the screw	based on x-rays or MRI: Is a cracking of the screw visible? YES/NO	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	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	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	1 year
incidence of postoperative pseudoarthrosis	based on x-rays or MRI: Is a postoperative pseudoarthrosis visible? YES/NO	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.	1 year
duration of postoperative job-related incapacity	evaluation of duration	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	1 year

Collaborators and Investigators

• Sponsor: Medical University of Vienna
• Collaborators: Surgebright Gmbh
• Investigators: Principal Investigator: Catharina Chiari, MD, Medical University Vienna

Study record dates

Study Major Dates

• Study Start (Actual): April 24, 2018
• Primary Completion (Anticipated): April 1, 2023
• Study Completion (Anticipated): April 1, 2024

Study Registration Dates

• First Submitted: December 5, 2018
• First Submitted That Met QC Criteria: December 13, 2018
• First Posted (Actual): December 17, 2018

Study Record Updates

• Last Update Posted (Actual): August 24, 2022
• Last Update Submitted That Met QC Criteria: August 23, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Keywords: knee; human bone graft screw; osteochondral defect
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Bone Diseases; Osteochondrosis
• Other Study ID Numbers: OD1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No