Clinical trial NCT00492609: Medical and Economical Evaluation of Computer-assisted Reconstruction of the Anterior Cruciate Ligament (ACL)
Official title: Medical and Economical Evaluation of Computer-assisted Reconstruction of the ACL
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Knee Injuries
Anterior Cruciate Ligament
Arthroscopy
Keywords: Surgery
Navigation
ACL
IKDC
comparative study
Lead sponsor: University Hospital, Grenoble
Sponsor class: OTHER
Collaborators: name: Netherlands: Ministry of Health, Welfare and Sports
First posted: 2007-06-27
Enrollment: 285
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with first knee surgery, available to control's visits at 6 months and one year

Brief summary: A poor outcome in anterior cruciate ligament (ACL) reconstruction is often related to tunnel position. The researchers believe that improving the accuracy of tunnel position will lead to an improved outcome in ACL surgery. The researchers' purpose is to perform a controlled study on a series of 500 patients in two groups: group I (250 cases) using conventional instrumentation and group II (250 cases) using navigation (Surgetics ACL Julliard protocol).

Detailed description: This study compares the percentage of patients in 2 groups (full success) at 1 year of follow up. The results were evaluated on clinical outcome based on the IKDC (International Knee Documented Committee, subjective evaluation) form between one group using conventional instrumentation and another group using navigation.

Secondary Aims:

* To compare in 2 groups:

  * Gain of IKDC score at one year (based on pre-operative IKDC score)
  * Evolution of IKDC subjective (pre-operative, at 12 months)
* To compare performances at one year (% class A or B) in terms of initial instability measured with laximetry score
* Study of the learning curve
* Evaluate: lasting quality, complication rate, extra-operative time
* Evaluate frequency of thrombovenous complications
* Evaluate delay to return to sport

Eligibility criteria: Inclusion Criteria:

* First knee surgery
* Patients more than 18 years old

Exclusion Criteria:

* Knee surgery already done
* Patients unable to understand informed consent sheet

Primary outcomes:
measure: IKDC SCORE AT ONE YEAR
timeFrame: ONE YEAR
Secondary outcomes:
measure: COMPARISON IKDC SCORE BENEFIT AT ONE YEAR
timeFrame: one year
measure: functionnal regaining between two groups at one year
timeFrame: one year
measure: evaluate the surgeons' learning in the groups of patients with computer assisted
timeFrame: time of surgery, one year
measure: evaluate hospitals' parameters in two groups
timeFrame: time of surgery, time of hospitalization
measure: evaluate frequency of complication after surgery (infectious, thrombosis, scar)
timeFrame: 6 months, one year
Other outcomes:
Locations:
city: Grenoble
country: France
facility: University Hospital of Grenoble
Study officials:
affiliation: University Hospital, Grenoble
name: Plaweski AP Stephane, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Beaufils P, Lerat JL. [Navigation for knee surgery]. Rev Chir Orthop Reparatrice Appar Mot. 2006 Sep;92(5 Suppl):2S199-2S207. No abstract available. French.
citation: Plaweski S, Cazal J, Rosell P, Merloz P. Anterior cruciate ligament reconstruction using navigation: a comparative study on 60 patients. Am J Sports Med. 2006 Apr;34(4):542-52. doi: 10.1177/0363546505281799.