Knee InjuriesNCT00492609
Medical and Economical Evaluation of Computer-assisted Reconstruction of the Anterior Cruciate Ligament (ACL)
An observational study of Knee Injuries and Anterior Cruciate Ligament, run by University Hospital, Grenoble at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Knee Injuries, Anterior Cruciate Ligament, Arthroscopy
- How many people
- 285 participants
- Where
- 1 siteFrance
- Study dates
- May 2006to Apr 2008
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with first knee surgery, available to control's visits at 6 months and one year
Who may be able to join
- First knee surgery
- Patients more than 18 years old
Who cannot join
- Knee surgery already done
- Patients unable to understand informed consent sheet
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Medical and Economical Evaluation of Computer-assisted Reconstruction of the ACL
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).
Read the 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
- Conditions
- Knee Injuries, Anterior Cruciate Ligament, Arthroscopy
- Keywords
- Surgery, Navigation, ACL, IKDC, comparative study
- Medical subject headings
- Knee Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1 | PATIENTS WITH COMPUTER-ASSISTED | |
| 2 | PATIENTS WITHOUT COMPUTER-ASSISTED |
What is being measured
The primary outcome is the main question the study is designed to answer.
IKDC SCORE AT ONE YEAR
Measured: ONE YEAR
Secondary outcomes (5)
COMPARISON IKDC SCORE BENEFIT AT ONE YEAR
Measured: one year
functionnal regaining between two groups at one year
Measured: one year
evaluate the surgeons' learning in the groups of patients with computer assisted
Measured: time of surgery, one year
evaluate hospitals' parameters in two groups
Measured: time of surgery, time of hospitalization
evaluate frequency of complication after surgery (infectious, thrombosis, scar)
Measured: 6 months, one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2007 (estimated)
- Study startMay 2006
- Study completionApr 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Knee InjuriesStudies of the same condition, open and under way.
- More trials run by University Hospital, GrenobleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 285 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Collaborators
- Netherlands: Ministry of Health, Welfare and Sports
- Investigators
- Plaweski AP Stephane, PhD, Principal investigator, University Hospital, Grenoble
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00492609
- Sponsor's protocol ID
- DCIC 05 47
- Other IDs
- PRAXIM SOCIETY
- Status last verified
- Nov 2009
- First submitted
- 26 Jun 2007
- Last updated
- 11 Nov 2009
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 17088785Plaweski 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.
PubMed 16556753
Study at a glance
From the registry record, last updated by the sponsor on 11 Nov 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Medical and Economical Evaluation of Computer-assisted Reconstruction of the ACL
- ClinicalTrials.gov ID
- NCT00492609
- Acronym / sponsor ID
- DCIC 05 47
- Conditions
- Knee Injuries, Anterior Cruciate Ligament, Arthroscopy
- Keywords
- Surgery, Navigation, ACL, IKDC, comparative study
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 285 participants (actual)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Collaborators
- Netherlands: Ministry of Health, Welfare and Sports
- Study start
- May 2006
- Study completion
- Apr 2008 (actual)
- First posted
- 27 Jun 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –PATIENTS WITH COMPUTER-ASSISTED |
| 2 | – | –PATIENTS WITHOUT COMPUTER-ASSISTED |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with first knee surgery, available to control's visits at 6 months and one year
Key inclusion criteria (2 listed)
- First knee surgery
- Patients more than 18 years old
Key exclusion criteria (2 listed)
- Knee surgery already done
- Patients unable to understand informed consent sheet
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
IKDC SCORE AT ONE YEAR
Time frame: ONE YEAR
5 secondary outcomes
COMPARISON IKDC SCORE BENEFIT AT ONE YEAR
Time frame: one year
functionnal regaining between two groups at one year
Time frame: one year
evaluate the surgeons' learning in the groups of patients with computer assisted
Time frame: time of surgery, one year
evaluate hospitals' parameters in two groups
Time frame: time of surgery, time of hospitalization
evaluate frequency of complication after surgery (infectious, thrombosis, scar)
Time frame: 6 months, one year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Nov 2009.
- Background: PubMed 17088785Beaufils P, Lerat JL. [Navigation for knee surgery]. Rev Chir Orthop Reparatrice Appar Mot. 2006 Sep;92(5 Suppl):2S199-2S207. No abstract available. French.
- Background: PubMed 16556753Plaweski 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Plaweski AP Stephane, PhD principal investigator
University Hospital, Grenoble
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Knee Injuries and Anterior Cruciate Ligament, run by University Hospital, Grenoble at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Nov 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
IKDC SCORE AT ONE YEAR (time frame: ONE YEAR). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00492609, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Nov 2009.