| - candidate number | 2405 |
| - NTR Number | NTR870 |
| - ISRCTN | ISRCTN40231111 |
| - Date ISRCTN created | 8-feb-2007 |
| - date ISRCTN requested | 7-feb-2007 |
| - Date Registered NTR | 15-jan-2007 |
| - Secondary IDs | N/A |
| - Public Title | Computer Assisted Surgery versus conventional arthroscopic Anterior Cruciate Ligament reconstruction a prospective randomised clinical trial. |
| - Scientific Title | Computer Assisted Surgery versus conventional arthroscopic Anterior Cruciate Ligament reconstruction a prospective randomised clinical trial. |
| - ACRONYM | CAS versus conventional ACL reconstruction |
| - hypothesis | An ACL reconstruction can take place more accurate with Computer Assisted Surgery than a conventional arthroscopic reconstruction with regard to tunnel position |
| - Healt Condition(s) or Problem(s) studied | Anterior cruciate ligament, Rupture |
| - Inclusion criteria | 1. All patients with an ACL rupture who are indicated for a reconstruction; 2. Age >18 yrs. |
| - Exclusion criteria | 1. Patients who are unable to understand Dutch written language; 2. Patients who are unable to follow the regular postoperative controls. |
| - mec approval received | yes |
| - multicenter trial | no |
| - randomised | yes |
| - masking/blinding | Single |
| - control | Active |
| - group | Parallel |
| - Type | - |
| - Studytype | intervention |
| - planned startdate | 1-dec-2006 |
| - planned closingdate | 1-dec-2010 |
| - Target number of participants | 90 |
| - Interventions | Arthroscopic ACL reconstruction, randomised in 45 conventional (usual care), and 45 CAS. |
| - Primary outcome | Planned tunnel position versus actual achieved tunnel position of the ACL transplant (by CT) |
| - Secondary outcome | 1. difference in change in IKDC 2. difference in change in KOOS 3. difference in change in knee pain (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) 7. difference in change in objective muscle strenght (Biodex) 8. difference satisfaction of the treatment |
| - Timepoints | |
| - Trial web site | N/A |
| - status | open: patient inclusion |
| - CONTACT FOR PUBLIC QUERIES | D.E. Meuffels |
| - CONTACT for SCIENTIFIC QUERIES | M.M. Favejee |
| - Sponsor/Initiator | Erasmus Medical Center, Department of Orthopaedics |
| - Funding (Source(s) of Monetary or Material Support) | Erasmus Medical Center, Department of Orthopaedics |
| - Publications | N/A |
| - Brief summary | The most common reason for failure after an ACL reconstruction is a malposition of the new ACL transplant due to a malposition of the tibial tunnel and/ or femoral tunnel. Since one year in the Erasmus MC Computer-assisted surgery (CAS) has become established for total knee replacement. There are less malpositions following CAS than after implantation by the conventional technique. Nowadays its possible to use CAS for ACL reconstruction. The main aim of this study is to compare the results of the ACL reconstruction following CAS with a conventional ACL reconstruction. |
| - Main changes (audit trail) | |
| - RECORD | 15-jan-2007 - 9-feb-2007 |
- Indien u gegevens wilt toevoegen of veranderen, kunt u een mail sturen naar nederlands@trialregister.nl