The general aim of this study is to develop and evaluate imaging techniques of tendon properties of the hand that can be used in clinical studies or standard clinical care in patients with flexor tendon injuries. Specific aims:1. Develop a protocol…
ID
Source
Brief title
Condition
- Tendon, ligament and cartilage disorders
- Soft tissue therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
From the MRI images, we will establish tendon diameter, tendon volume, length
of the tendon gap, maximal excursion of the tendon, diameter of the A2 annular
pulley, distance between the repair site to the A2 pulley, and amount of
adhesion.
From the ultrasound images, we will establish parameters such as tendon
diameter, and length of the tendon gap. In addition, we will include a number
of new measurements and imaging processing techniques that have recently been
developed to quantify dynamics of the tendons such as tendon excursion and
tendon stiffness.
Clinical data will be collected on the number of re-ruptures, tendon adhesions
(based on decrease range of motion of the hand) and additional surgical
interventions that might be needed. In addition, we will measure a number of
standard clinical outcome parameters: range of motion of the involved joints,
hand strength and activities of daily living.
Secondary outcome
not applicable
Background summary
The hand is involved in approximately 35% of all trauma, frequently leading to
traumatic rupturing of flexor tendons. Ruptured tendons are surgically
repaired, followed by a long rehabilitation period. In many cases, outcome of
flexor tendon injuries is poor due to adhesion formation or re-ruptures of the
tendon. During the first 3 weeks after recovery, clinical examination cannot
detect such problems due to edema of the hand. As a result, the appropriate
treatment may be delayed several weeks, which may further increase the
problems. Both ultrasound and MRI are able to image tendon tissue and both have
a number of advantages and disadvantages. Ultrasound is a relatively cheap and
easy to use and has a high spatial resolution. In addition, ultrasound can
obtain dynamic images of, for example, movement of the tendon in its
surrounding tissue. However, image quality of ultrasound is limited and some
structures cannot easily be visualized. In addition, use of ultrasound in the
hand is sometimes limited due to difficulties with placing the probe.
Alternatively, MRI shows clear contrast between the different structures in the
hand. In addition, MRI images can be obtained with the hand in a plaster cast.
Disadvantages of MRI are that it is relatively expensive and that static images
are obtained. The ability of both techniques to detect early problems in
recovery has not been studied.
Study objective
The general aim of this study is to develop and evaluate imaging techniques of
tendon properties of the hand that can be used in clinical studies or standard
clinical care in patients with flexor tendon injuries.
Specific aims:
1. Develop a protocol for ultrasound and MRI imaging of the tendon
characteristic in the hand.
2. Determine the reliability of the imaging data in a group of healthy control
subjects.
3. Prospectively measure a cohort of flexor tendon injury patients using both
MRI and ultrasound. Data from this cohort can be used to
a. Co-validate MRI and ultrasound imaging of tendon properties and to establish
the specific benefits of each of the two techniques
b. Relate imaging findings shortly after tendon repair with long-term
functional outcome.
Study design
Thirty control subjects will be included in this study to establish reliability
of the imaging protocols. In addition, we will measure thirty patients with
hand tendon injuries in zone II that are surgically repaired. MRI and
ultrasound imaging will be performed at 1, 6 and 12 weeks after surgical
repair. Findings will be related to long-term functional outcome of the
patients in terms of hand function.
Study burden and risks
There are no known risks associated with the imaging protocols and the hand
function measurements. The burden for the patients is the three assessments of
about 75 minutes each. There are no directs benefits for the subjects for
participating in the study.
Postbus 2040
3000 CA Rotterdam
NL
Postbus 2040
3000 CA Rotterdam
NL
Listed location countries
Age
Inclusion criteria
Patients with hand tendon injuries that are surgically repaired
Exclusion criteria
patients that also have a nerve injury (medianus of ulnaris zenuw)
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 | NL19746.078.08 |