Condition category
Musculoskeletal Diseases
Date applied
08/02/2007
Date assigned
08/02/2007
Last edited
21/02/2007
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr D E Meuffels

ORCID ID

Contact details

P.O. Box 2040
Rotterdam
3000 CA
Netherlands
+31 (0)10 463 5088
d.meuffels@erasmusmc.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Acronym

Study hypothesis

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

Approval received from the local medical ethics committee on the 12th September 2006 (ref: MEC-2006-223).

Study design

Randomised, active-controlled, parallel group, single blinded trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Rupture, anterior cruciate ligament

Intervention

Arthroscopic ACL reconstruction, randomised in 45 conventional (usual care), and 45 CAS patients.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

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 trial start date

01/12/2006

Overall trial end date

01/12/2010

Reason abandoned

Eligibility

Participant inclusion criteria

1. All patients with an ACL rupture who are indicated for a reconstruction
2. Aged more than 18 years

Participant type

Patient

Age group

Adult

Gender

Not Specified

Target number of participants

90

Participant exclusion criteria

1. Patients who are unable to understand Dutch written language
2. Patients who are unable to follow the regular postoperative controls

Recruitment start date

01/12/2006

Recruitment end date

01/12/2010

Locations

Countries of recruitment

Netherlands

Trial participating centre

P.O. Box 2040
Rotterdam
3000 CA
Netherlands

Sponsor information

Organisation

Erasmus Medical Centre (The Netherlands)

Sponsor details

Department of Orthopaedics
P.O. Box 2040
Rotterdam
3000 CA
Netherlands
+31 (0)10 463 5088
d.meuffels@erasmusmc.nl

Sponsor type

Hospital/treatment centre

Website

http://www.erasmusmc.nl/

Funders

Funder type

Hospital/treatment centre

Funder name

Erasmus Medical Centre (The Netherlands)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes