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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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Netherlands Trial Register |
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Last refreshed on:
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28 April 2013 |
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Main ID: |
NTR870 |
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Date of registration:
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15/01/2007 |
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Primary sponsor: |
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Public title:
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Computer Assisted Surgery versus conventional arthroscopic Anterior Cruciate Ligament reconstruction ? a prospective randomised clinical trial.
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Scientific title:
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Computer Assisted Surgery versus conventional arthroscopic Anterior Cruciate Ligament reconstruction ? a prospective randomised clinical trial. - CAS versus conventional ACL reconstruction |
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Date of first enrolment:
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1/12/2006 |
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Target sample size:
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90 |
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Recruitment status: |
recruiting |
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URL:
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http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=870 |
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Study type:
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intervention |
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Study design:
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Randomised: Yes; Masking: Single; Control: Active; Group: Parallel; Type: -
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Countries of recruitment
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The Netherlands
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Contacts
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Name:
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M.M.
Favejee |
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Address:
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PO Box 2040, Erasmus MC, Department of Orthopaedics
3000 CA
Rotterdam
The Netherlands |
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Telephone:
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0031-10-4635088 |
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Email:
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d.meuffels@erasmusmc.nl |
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Affiliation:
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Name:
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D.E.
Meuffels |
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Address:
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PO Box 2040, Erasmus MC, Department of Orthopaedics
3000 CA
Rotterdam
The Netherlands |
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Telephone:
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0031-10-4635088 |
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Email:
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d.meuffels@erasmusmc.nl |
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Affiliation:
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Key inclusion & exclusion criteria
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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.
Age minimum:
Age maximum:
Gender:
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Health Condition(s) or Problem(s) studied
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Anterior cruciate ligament, Rupture
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Intervention(s)
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Arthroscopic ACL reconstruction, randomised in 45 conventional (usual care), and 45 CAS.
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Primary Outcome(s)
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Planned tunnel position versus actual achieved tunnel position of the ACL transplant (by CT)
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Secondary Outcome(s)
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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
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Secondary ID(s)
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ISRCTN40231111
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N/A
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Source(s) of Monetary Support
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Erasmus Medical Center, Department of Orthopaedics
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