NCT00492609

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
285

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2006

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2006

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

June 26, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 27, 2007

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2008

Completed
Last Updated

November 11, 2009

Status Verified

November 1, 2009

First QC Date

June 26, 2007

Last Update Submit

November 10, 2009

Conditions

Knee InjuriesAnterior Cruciate LigamentArthroscopy

Keywords

SurgeryNavigationACLIKDCcomparative study

Outcome Measures

Primary Outcomes (1)

  • IKDC SCORE AT ONE YEAR

    ONE YEAR

Secondary Outcomes (5)

  • COMPARISON IKDC SCORE BENEFIT AT ONE YEAR

    one year

  • functionnal regaining between two groups at one year

    one year

  • evaluate the surgeons' learning in the groups of patients with computer assisted

    time of surgery, one year

  • evaluate hospitals' parameters in two groups

    time of surgery, time of hospitalization

  • evaluate frequency of complication after surgery (infectious, thrombosis, scar)

    6 months, one year

Study Arms (2)

1

PATIENTS WITH COMPUTER-ASSISTED

2

PATIENTS WITHOUT COMPUTER-ASSISTED

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with first knee surgery, available to control's visits at 6 months and one year

You may qualify if:

  • First knee surgery
  • Patients more than 18 years old

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital of Grenoble

Grenoble, 38043, France

Location

Related Publications (2)

  • 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.

    PMID: 17088785BACKGROUND

  • 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.

    PMID: 16556753BACKGROUND

MeSH Terms

Conditions

Knee Injuries

Condition Hierarchy (Ancestors)

Leg InjuriesWounds and Injuries

Study Officials

  • Plaweski AP Stephane, PhD

    University Hospital, Grenoble

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 26, 2007

First Posted

June 27, 2007

Study Start

May 1, 2006

Study Completion

April 1, 2008

Last Updated

November 11, 2009

Record last verified: 2009-11

Locations

FR(1)