The aim of this study is to visualize and to quantitatively document the regeneration process of osteochondral defects in the human ankle following bone marrow stimulation by longitudinal monitoring at short intervals in time with ultrasound.
ID
Source
Brief title
Condition
- Bone and joint therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
-Degree of filling of the osteochondral defect over time.
-Type and degree of irregularity of cartilage surface
-Loomer/Berndt and Harty classification of the lesion (pre-op)
-ICRS Cartilage Repair Assessment system
-ICRS Grade
-Location of the lesion in relation to possible visualisation with ultrasound
-Description of characteristic signs of an OCD as visualized by ultrasound at
all sample events
Secondary outcome
N.A.
Background summary
The separation of a fragment of cartilage and its subchondral bone in a joint
is named an osteochondral defect (OCD). OCDs are mostly caused by a traumatic
event and can involve all joints, but in practice the knee, the ankle and the
elbow are most frequently damaged1-3. These OCDs cause impairment because of
deep joint pain and may contribute to premature development of
osteoarthritis3-5. The latter is a major cause of disability and represents a
high socioeconomic burden to society.
Diagnosis takes place with MRI- or CT-scan. Bone marrow stimulation is the
first-line treatment option where loose cartilage pieces are removed and holes
are drilled in the underlying bone to stimulate an intrinsic healing process.
Although the treatment is quite successful, the results are fair to poor for
about 10% of the patients. This can only be partially explained by factors such
as defect size. Additionally, little is known about the true nature of the
healing process in vivo in patients. So, there is a need for in vivo monitoring
of the regeneration to optimize treatment of osteochondral defects. A previous
pilot patient study showed that ultrasound can visualize OCDs in the anterior
part of the talar dome. Ultrasound is desired as monitoring tool because it is
truly noninvasive and relatively cheap, which allows an increased sample
frequency to monitor in vivo cartilage regeneration.
Study objective
The aim of this study is to visualize and to quantitatively document the
regeneration process of osteochondral defects in the human ankle following bone
marrow stimulation by longitudinal monitoring at short intervals in time with
ultrasound.
Study design
In total, 5 patients with a CT confirmed anterior OCD of the talus
(Berndt-Hardy-Loomer grade II-V) are recruited. Patients should be older than
18 years, competent and scheduled for a BMS treatment of the OCD.
Preoperatively, a 3D ultrasound sweep will be acquired to collect a 3D volume
of the entire visible talar surface including the OCD. Postoperatively the
patients are imaged with the 3D ultrasound sweep executed at 2, 3, 4, 5 and 6
weeks. After that there will be an ultrasound at 8, 10 and 12 weeks.
Furthermore, 2 more echo sweeps will take place at 6 months and one year at
regular follow up appointments. These 3D ultrasound volumes will all be
registered to MRI- or CT-data as part of the routine diagnostic protocol,
which serve as reference. A routine control CT scan will also be performed at
one year.
Study burden and risks
Patients that participate in the study could benefit from the additional
imaging with ultrasound as it might assist in achieving adequate diagnosis. As
ultrasound is a truly noninvasive imaging modality, no additional risks or
complications are expected. The disadvantage for patients is that they have to
be present longer than the time scheduled for a follow up appointment to
execute the ultrasound. This will take approximately 30 minutes per ultrasound
sweep. Next to the standard care appointments there will also be 6 additional
appointments for an ultrasound sweep. In total, patients will undergo 11
ultrasound sweeps. This correlates with 5 * hours of additional time needed
divided over a period of 12 months.
Meibergdreef 9 Meibergdreef 9
Amsterdam Zuidoost 1105AZ
NL
Meibergdreef 9 Meibergdreef 9
Amsterdam Zuidoost 1105AZ
NL
Listed location countries
Age
Inclusion criteria
-Patients should have an age 18 years or older
-Patients should be able to read the patient information
-Patients who have received or are scheduled for a routine CT-scan of the ankle which shows an OCD of the ankle and are on the waiting list to receive bone marrow stimulation treatment surgical for the OCD
-OCDs grade II-V according to the Berndt-Hardy-Loomer classification located at the anterior section of the talar dome.
Exclusion criteria
-Patients with suspected multiple pathologies in the ankle joint
-Patients that are not able to or did not receive a CT-scan
-Patients younger than 18 years
-Patients who have not signed the informed consent form
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
CCMO | NL60518.018.17 |