Subchondral Microfracture of Tibia After Arthroscopic Anterior Cruciate Ligament Surgery Reconstruction
This study is currently recruiting participants.
Verified April 2012 by Hôpital Ambroise Paré
Sponsor:
Hôpital Ambroise Paré
Information provided by (Responsible Party):
Shahnaz Klouche, MD, Hôpital Ambroise Paré
ClinicalTrials.gov Identifier:
NCT01588977
First received: April 27, 2012
Last updated: April 30, 2012
Last verified: April 2012
| Tracking Information | |||||
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| First Received Date ICMJE | April 27, 2012 | ||||
| Last Updated Date | April 30, 2012 | ||||
| Start Date ICMJE | April 2012 | ||||
| Estimated Primary Completion Date | July 2012 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Subchondral microfracture of tibia on MRI [ Time Frame: 2 days after surgery ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT01588977 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
Pain on Visual Analogue Scale [ Time Frame: During two days after surgery, twice a day ] [ Designated as safety issue: No ] | ||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Subchondral Microfracture of Tibia After Arthroscopic Anterior Cruciate Ligament Surgery Reconstruction | ||||
| Official Title ICMJE | Subchondral Microfracture of Tibia After Arthroscopic Anterior Cruciate Ligament Surgery Reconstruction With Two Different Drilling Techniques. Correlation With Postoperative Pain | ||||
| Brief Summary | The arthroscopic anterior cruciate (ACL) ligament reconstruction surgery is widespread. The creation of the tibial tunnel, retrograde or antegrade, is not consensual. A cadaveric study demonstrated tibial subchondral microfractures in the group "antegrade tibial tunnel" unlike group "retrograde tibial tunnel." To our knowledge, no clinical evaluation was performed. The investigators hypothesize that retrograde drilling will cause less local bone injury than antegrade drilling in creation of the tibial tunnel for ACL reconstruction. |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Case Control Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Non-Probability Sample | ||||
| Study Population | Primary arthroscopic reconstruction surgery of an Anterior Cruciate Ligament tear |
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| Condition ICMJE |
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| Intervention ICMJE | Not Provided | ||||
| Study Group/Cohort (s) |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Recruiting | ||||
| Estimated Enrollment ICMJE | 60 | ||||
| Estimated Completion Date | August 2012 | ||||
| Estimated Primary Completion Date | July 2012 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE |
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| Location Countries ICMJE | France | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01588977 | ||||
| Other Study ID Numbers ICMJE | APR042012 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Shahnaz Klouche, MD, Hôpital Ambroise Paré | ||||
| Study Sponsor ICMJE | Hôpital Ambroise Paré | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE | Not Provided | ||||
| Information Provided By | Hôpital Ambroise Paré | ||||
| Verification Date | April 2012 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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