Computer assisted surgery versus conventional arthroscopic anterior cruciate ligament reconstruction: a prospective randomised clinical trial
ISRCTN | ISRCTN40231111 |
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DOI | https://doi.org/10.1186/ISRCTN40231111 |
Secondary identifying numbers | NL856 (NTR870) |
- Submission date
- 08/02/2007
- Registration date
- 08/02/2007
- Last edited
- 26/03/2021
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Musculoskeletal Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr D E Meuffels
Scientific
Scientific
P.O. Box 2040
Rotterdam
3000 CA
Netherlands
Phone | +31 (0)10 463 5088 |
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d.meuffels@erasmusmc.nl |
Study information
Study design | Randomised, active-controlled, parallel group, single blinded trial |
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Primary study design | Interventional |
Secondary study design | Randomised controlled trial |
Study setting(s) | Hospital |
Study type | Treatment |
Scientific title | Computer assisted surgery versus conventional arthroscopic anterior cruciate ligament reconstruction: a prospective randomised clinical trial |
Study objectives | 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(s) | Approval received from the local medical ethics committee on the 12th September 2006 (ref: MEC-2006-223). |
Health condition(s) or problem(s) studied | Rupture, anterior cruciate ligament |
Intervention | Arthroscopic ACL reconstruction, randomised in 45 conventional (usual care), and 45 CAS patients. |
Intervention type | Other |
Primary outcome measure | 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 study start date | 01/12/2006 |
Completion date | 01/12/2010 |
Eligibility
Participant type(s) | Patient |
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Age group | Adult |
Lower age limit | 18 Years |
Sex | Not Specified |
Target number of participants | 90 |
Total final enrolment | 100 |
Key inclusion criteria | 1. All patients with an ACL rupture who are indicated for a reconstruction 2. Aged more than 18 years |
Key exclusion criteria | 1. Patients who are unable to understand Dutch written language 2. Patients who are unable to follow the regular postoperative controls |
Date of first enrolment | 01/12/2006 |
Date of final enrolment | 01/12/2010 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
P.O. Box 2040
Rotterdam
3000 CA
Netherlands
3000 CA
Netherlands
Sponsor information
Erasmus Medical Centre (The Netherlands)
Hospital/treatment centre
Hospital/treatment centre
Department of Orthopaedics
P.O. Box 2040
Rotterdam
3000 CA
Netherlands
Phone | +31 (0)10 463 5088 |
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d.meuffels@erasmusmc.nl | |
Website | http://www.erasmusmc.nl/ |
https://ror.org/018906e22 |
Funders
Funder type
Hospital/treatment centre
Erasmus Medical Centre (The Netherlands)
No information available
Results and Publications
Intention to publish date | |
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Individual participant data (IPD) Intention to share | No |
IPD sharing plan summary | Not provided at time of registration |
Publication and dissemination plan | Not provided at time of registration |
IPD sharing plan |
Study outputs
Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
---|---|---|---|---|---|
Results article | 05/09/2012 | 26/03/2021 | Yes | No |
Editorial Notes
26/03/2021: The following changes were made to the trial record:
1. Publication reference added.
2. The total final enrolment was added.