To compare the results of a traditional placement of reconstruction of an anterior cruciate ligament versus computer assisted surgery.
ID
Source
Brief title
Condition
- Tendon, ligament and cartilage disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
the tunnel position of the transplant using conventional surgery will be
compared to the computer assisted technique.
Secondary outcome
The two groups will also be compared using IKDC score, knee disability and
outcome score, VAS pain score, Lysholm and Tegner score, objective stability,
isokinetic testing, health care consumption and cost and in final satisfaction
of treatment.
Background summary
An anterior cruciate ligament rupture is a frequent injury, which is one of the
most frequent reasons in a young and active population for a orthopedic
reconstructive surgery. Of the utmost importance for the final outcome is a
reproducible tunnel position of the transplanted ligament. A new development
has been computer assisted surgery, which uses a virtual reality image as an
additional reference during surgery.
Study objective
To compare the results of a traditional placement of reconstruction of an
anterior cruciate ligament versus computer assisted surgery.
Study design
This study is set up as a prospective randomized study, in which conventional
arthroscopic anterior cruciate ligament reconstruction is compared to a
computer assisted technique.
Intervention
conventional arthroscopic anterior cruciate ligament reconstruction versus
computer assisted technique.
Study burden and risks
Because of the use of usual methods there are no additional risks
Postbus 2040
3000 CA Rotterdam
NL
Postbus 2040
3000 CA Rotterdam
NL
Listed location countries
Age
Inclusion criteria
Patients with a rupture of the anterior cruciate ligament indicated for reconstructive surgery,
Age of 18 year and above.
Exclusion criteria
Insufficient command of the Dutch language, spoken and/or written;
Patients from which it is not sure that they will be able to attend the follow-up measurements.
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 | NL13096.078.06 |