To assess the efficacy of treatment of acute ACL ruptures with the Ligamys device.
ID
Source
Brief title
Condition
- Tendon, ligament and cartilage disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Our primaire endpoint is the stability compared to the contralateral leg
measured by a KT1000 test will be performed. This non invasive test provides an
objective assessment of the amount of increased anterior knee translation
between 20 and 30 degrees of knee flexion.
Secondary outcome
Our secondary endpoints are the Tegner, IKDC, NRS pain and NRS instability
scores. These are knee specific questionnaires specifically designed to measure
outcome after knee surgery.
Background summary
In the last decades ACL reconstruction has become widely accepted as a valid
option in the treatment for chronic ACL rupture. In case of an acute ACL
rupture there have been several treatment options mentioned in recent history.
One of these options is the Ligamys device. The Ligamys is a CE certified
device to repair and internally brace an acute ACL rupture.
Study objective
To assess the efficacy of treatment of acute ACL ruptures with the Ligamys
device.
Study design
The study design is a prospective case serie assessing the clinical outcome,
range of motion and objective stability after treatment of acute ACL rupture
with the Ligamys device. Inclusion will start in 2015, with a maximum follow up
of 5 years per patient. The study will be conducted in the Haga Hospital,
Annatommie, Amstelland hospital and Slotervaart Hospital.
Study burden and risks
All patient will be seen at regular follow up intervals identical to the normal
ACL reconstruction follow up.
All patients will be treated according to standard ACL protocol, with an
implant that is available on the market and has a CE marking. Bearing this in
mind we judge the study as safe.
The extra burden for these patients will be the questionnaires required at each
follow up, requiring a total of 15 minutes per questionnaire. Additionally a
scheduled follow up visit at one year follow up contains an extra measurement
with the KT-1000 to measure stability of the ACL, this is a non-invasive
testing which is performed in 10 minutes.
The 2 and 5 year follow up will be performed with an online form.
Laarderhoogtweg 12
Amsterdam 1101AE
NL
Laarderhoogtweg 12
Amsterdam 1101AE
NL
Listed location countries
Age
Inclusion criteria
* Acute primary rupture of the anterior cruciate ligament
* Signed patient informed consent
* Willingness to present for follow-up
* Age between 18 and 50 years at the time of inclusion in the study
* Injury - surgery time interval of 21 days or less
* BMI <35
* Tegner score 6 or more
Exclusion criteria
* Co-morbidity influencing the outcome of the implant.
* Hypersensetivity to metals.
* Not being able to fill in the Dutch Questionnaires.
* Osteo arthritis Kelgren grade 2 or more on conventional x-ray
* Medical non-compliance
* Unwillingness to follow the rehabilitation programme
* Traumatic cartilage lesion requiring cartilage repair procedure
(Microfracturing, MACI, ACT) or degenerative cartilage lesions (Outerbridge >ll
and defect >1cm2)
* Non-repairable meniscus lesions requiring a resection of >20%
* Previous tendon removal on injured leg
* Relevant permanent medication (Steroids, cytostatic drugs, ...)
* Pregnancy
* Reumatoid arthritis
* Instability of the contralateral leg
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 | NL51958.048.14 |