Contact information
Type
Scientific
Primary contact
Dr D E Meuffels
ORCID ID
Contact details
P.O. Box 2040
Rotterdam
3000 CA
Netherlands
+31 (0)10 463 5088
d.meuffels@erasmusmc.nl
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Acronym
Study hypothesis
An Anterior Cruciate Ligament (ACL) reconstruction can take place more accurately with Computer Assisted Surgery (CAS) than a conventional arthroscopic reconstruction with regard to tunnel position.
Ethics approval
Approval received from the local medical ethics committee on the 12th September 2006 (ref: MEC-2006-223).
Study design
Randomised, active-controlled, parallel group, single blinded trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Rupture, anterior cruciate ligament
Intervention
Arthroscopic ACL reconstruction, randomised in 45 conventional (usual care), and 45 CAS patients.
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
Planned tunnel position versus actual achieved tunnel position of the ACL transplant (by Computed Tomography [CT]).
Secondary outcome measures
1. Difference in change in International Knee Documentation Committee (IKDC) subjective knee score
2. Difference in change in Knee injury and Osteoarthritis Outcome Score (KOOS)
3. Difference in change in knee pain (Visual Analogue Scale [VAS] for pain)
4. Difference in change in knee complaints (Lysholm score)
5. Difference in change in sport activity (Tegner score)
6. Difference in change in objective instability of the knee (KT1000 arthrometer)
7. Difference in change in objective muscle strength (Biodex)
8. Difference in satisfaction of the treatment
Overall trial start date
01/12/2006
Overall trial end date
01/12/2010
Reason abandoned
Eligibility
Participant inclusion criteria
1. All patients with an ACL rupture who are indicated for a reconstruction
2. Aged more than 18 years
Participant type
Patient
Age group
Adult
Gender
Not Specified
Target number of participants
90
Participant exclusion criteria
1. Patients who are unable to understand Dutch written language
2. Patients who are unable to follow the regular postoperative controls
Recruitment start date
01/12/2006
Recruitment end date
01/12/2010
Locations
Countries of recruitment
Netherlands
Trial participating centre
P.O. Box 2040
Rotterdam
3000 CA
Netherlands
Sponsor information
Organisation
Erasmus Medical Centre (The Netherlands)
Sponsor details
Department of Orthopaedics
P.O. Box 2040
Rotterdam
3000 CA
Netherlands
+31 (0)10 463 5088
d.meuffels@erasmusmc.nl
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Hospital/treatment centre
Funder name
Erasmus Medical Centre (The Netherlands)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary