Medical and Economical Evaluation of Computer-assisted Reconstruction of the Anterior Cruciate Ligament (ACL)

Knee Injuries Clinical Trial

Official title:

Medical and Economical Evaluation of Computer-assisted Reconstruction of the ACL

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00492609
• Other study ID #: DCIC 05 47
• Secondary ID: PRAXIM SOCIETY
• Status: Completed
• Phase: N/A
• First received: June 26, 2007
• Last updated: November 10, 2009
• Start date: May 2006
• Est. completion date: April 2008

Study information

• Verified date: November 2009
• Source: University Hospital, Grenoble
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Observational

Clinical Trial 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).

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 285
• Est. completion date: April 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• First knee surgery

• Patients more than 18 years old

Exclusion Criteria:

• Knee surgery already done

• Patients unable to understand informed consent sheet

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Anterior Cruciate Ligament
• Arthroscopy
• Knee Injuries

Locations

Country	Name	City	State
France	University Hospital of Grenoble	Grenoble

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Grenoble	Netherlands: Ministry of Health, Welfare and Sports

Country where clinical trial is conducted

France, 

References & Publications (2)

Beaufils P, Lerat JL. [Navigation for knee surgery]. Rev Chir Orthop Reparatrice Appar Mot. 2006 Sep;92(5 Suppl):2S199-2S207. French. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	IKDC SCORE AT ONE YEAR		ONE YEAR	Yes
Secondary	COMPARISON IKDC SCORE BENEFIT AT ONE YEAR		one year	Yes
Secondary	functionnal regaining between two groups at one year		one year	Yes
Secondary	evaluate the surgeons' learning in the groups of patients with computer assisted		time of surgery, one year	Yes
Secondary	evaluate hospitals' parameters in two groups		time of surgery, time of hospitalization	Yes
Secondary	evaluate frequency of complication after surgery (infectious, thrombosis, scar)		6 months, one year	Yes