NCT03777735

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Apr 2018

Longer than P75 for all trials

Geographic Reach
1 country

5 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 24, 2018

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

December 5, 2018

Completed
12 days until next milestone

First Posted

Study publicly available on registry

December 17, 2018

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2023

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2024

Completed
Last Updated

August 24, 2022

Status Verified

August 1, 2022

Enrollment Period

4.9 years

First QC Date

December 5, 2018

Last Update Submit

August 23, 2022

Conditions

Osteochondral Defect

Keywords

human bone graft screwosteochondral defectknee

Outcome Measures

Primary Outcomes (9)

  • 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 Outcomes (3)

  • 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

Study Arms (1)

human bone graft screw

The patients will receive human bone graft screws surgically.

Procedure: human bone graft screw

Interventions

human bone graft screwPROCEDURE

All patients undergo surgical treatment of osteochondral defects in the knee joint with human bone graft screws.

human bone graft screw

Eligibility Criteria

Age8 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

LKH-Univ.Klinikum Graz

Graz, 8036, Austria

RECRUITING

Barmherzige Schwestern Hospital Ried

Ried im Innkreis, 4910, Austria

RECRUITING

General Hospital Vienna

Vienna, 1090, Austria

RECRUITING

Orthopedic Center Otto-Wagner-Spital

Vienna, 1140, Austria

RECRUITING

Hospital Wels- Grieskirchen

Wels, 4600, Austria

RECRUITING

Study Officials

  • Catharina Chiari, MD

    Medical University Vienna

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Catharina Chiari, MD

CONTACT

+43140400catharina.chiari@meduniwien.ac.at

Sandra Hacker, MSc

CONTACT

+43140400sandra.hacker@meduniwien.ac.at

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Univ. Prof. Dr. Catharina Chiari, MSc

Study Record Dates

First Submitted

December 5, 2018

First Posted

December 17, 2018

Study Start

April 24, 2018

Primary Completion

April 1, 2023

Study Completion

April 1, 2024

Last Updated

August 24, 2022

Record last verified: 2022-08

Data Sharing

IPD Sharing
Will not share

Locations

AU(5)