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

NCT ID: NCT00492609

Last Updated: 2009-11-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

285 participants

Study Classification

OBSERVATIONAL

Study Start Date

2006-05-31

Study Completion Date

2008-04-30

Brief Summary

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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

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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

Conditions

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Knee Injuries Anterior Cruciate Ligament Arthroscopy

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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1

PATIENTS WITH COMPUTER-ASSISTED

No interventions assigned to this group

2

PATIENTS WITHOUT COMPUTER-ASSISTED

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* First knee surgery
* Patients more than 18 years old

Exclusion Criteria

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

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Netherlands: Ministry of Health, Welfare and Sports

OTHER_GOV

Sponsor Role collaborator

University Hospital, Grenoble

OTHER

Sponsor Role lead

Responsible Party

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Grenoble University Hospital

Principal Investigators

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Plaweski AP Stephane, PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Grenoble

Locations

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University Hospital of Grenoble

Grenoble, , France

Site Status

Countries

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France

References

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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.

Reference Type BACKGROUND
PMID: 17088785 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16556753 (View on PubMed)

Other Identifiers

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PRAXIM SOCIETY

Identifier Type: -

Identifier Source: secondary_id

DCIC 05 47

Identifier Type: -

Identifier Source: org_study_id

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