Computer assisted surgery versus conventional arthroscopic anterior cruciate ligament reconstruction: a prospective randomised clinical trial

ISRCTN ISRCTN40231111
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

P.O. Box 2040
Rotterdam
3000 CA
Netherlands

Phone +31 (0)10 463 5088
Email d.meuffels@erasmusmc.nl

Study information

Study designRandomised, active-controlled, parallel group, single blinded trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Scientific titleComputer assisted surgery versus conventional arthroscopic anterior cruciate ligament reconstruction: a prospective randomised clinical trial
Study objectivesAn 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) studiedRupture, anterior cruciate ligament
InterventionArthroscopic ACL reconstruction, randomised in 45 conventional (usual care), and 45 CAS patients.
Intervention typeOther
Primary outcome measurePlanned tunnel position versus actual achieved tunnel position of the ACL transplant (by Computed Tomography [CT]).
Secondary outcome measures1. 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 date01/12/2006
Completion date01/12/2010

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexNot Specified
Target number of participants90
Total final enrolment100
Key inclusion criteria1. All patients with an ACL rupture who are indicated for a reconstruction
2. Aged more than 18 years
Key exclusion criteria1. Patients who are unable to understand Dutch written language
2. Patients who are unable to follow the regular postoperative controls
Date of first enrolment01/12/2006
Date of final enrolment01/12/2010

Locations

Countries of recruitment

  • Netherlands

Study participating centre

P.O. Box 2040
Rotterdam
3000 CA
Netherlands

Sponsor information

Erasmus Medical Centre (The Netherlands)
Hospital/treatment centre

Department of Orthopaedics
P.O. Box 2040
Rotterdam
3000 CA
Netherlands

Phone +31 (0)10 463 5088
Email d.meuffels@erasmusmc.nl
Website http://www.erasmusmc.nl/
ROR logo "ROR" 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
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot 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.