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

ISRCTN	ISRCTN40231111
DOI	https://doi.org/10.1186/ISRCTN40231111
Protocol serial number	NL856 (NTR870)
Sponsor	Erasmus Medical Centre (The Netherlands)
Funder	Erasmus Medical Centre (The Netherlands)

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

Primary study design	Interventional
Study design	Randomised, active-controlled, parallel group, single blinded trial
Secondary study design	Randomised controlled trial
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(s)	Planned tunnel position versus actual achieved tunnel position of the ACL transplant (by Computed Tomography [CT]).
Key secondary outcome measure(s)	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
Completion date	01/12/2010

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Not Specified
Target sample size at registration	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

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	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.