- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01598636
The Lateral Tibial Tunnel in ACL Surgery (LTT-HVDB)
December 14, 2022 updated by: University Hospital, Ghent
The Lateral Tibial Tunnel in Anterior Cruciate Ligament Surgery. A Clinical and Ct-graphic Study.to Evaluate the Concept
The Lateral Tibial Tunnel technique is a new concept in Anterior Cruciate Ligament (ACL) surgery.
In this technique a tibial tunnel is drilled from the antero-lateral side of the tibia towards the ACL footprint.
This technique allows the surgeon to deal with bone stock problems in the antero-medial part of the tibia as often encountered in ACL revision surgery.
In ACL revision surgery it is often impossible to perform a one-stage revision surgery procedure due to bone stock deficiency in the antero-medial side of the tibia.
It is hypothesized that the Lateral tibial tunnel technique allows the surgeon to perform a one-stage procedure instead of a two stage procedure.
Furthermore the lateral tibial tunnel technique allows better graft fixation in two-stage ACL revision surgery.
Several biomechanical studies proved biomechanical superiority of the new technique compared to the classical technique.
Study Overview
Status
Withdrawn
Conditions
Intervention / Treatment
Study Type
Interventional
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Antwerp, Belgium
- GZA Sint-Augustinus
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Ghent, Belgium, 9000
- University Hospital
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Leuven, Belgium
- University Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years to 63 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- patients requiring ACL revision surgery
- patients requiring ACL surgery who have bone stock problems at the medial side of the proximal tibia
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Lateral Tibial Tunnel technique
|
To reduce the rehabilitation time after ACL revision surgery due to a better surgical technique
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Evaluation of clinical scores pre-operative
Time Frame: pre-operative
|
pre-operative
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evaluation of clinical scores at 3 months
Time Frame: 3 months post operative
|
3 months post operative
|
Evaluation of clinical scores at 6 months
Time Frame: 6 months post operative
|
6 months post operative
|
Evaluations of clinical scores at 1 year
Time Frame: 1 year post operative
|
1 year post operative
|
Evaluation of CT scan and X-ray pre-operative
Time Frame: pre-operative
|
pre-operative
|
Evaluation of CT scan and X-ray post-operative
Time Frame: post-operative
|
post-operative
|
Evaluation of CT scan and X-ray 1 year post-operative
Time Frame: 1 year post-operative
|
1 year post-operative
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Peter Verdonk, MD, Phd, University Hospital, Ghent
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 1, 2013
Primary Completion (Actual)
June 1, 2014
Study Completion (Actual)
June 1, 2014
Study Registration Dates
First Submitted
May 9, 2012
First Submitted That Met QC Criteria
May 10, 2012
First Posted (Estimate)
May 15, 2012
Study Record Updates
Last Update Posted (Estimate)
December 15, 2022
Last Update Submitted That Met QC Criteria
December 14, 2022
Last Verified
December 1, 2022
More Information
Terms related to this study
Other Study ID Numbers
- 2012/324
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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Clinical Trials on Lateral tibial tunnel
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Hamilton Health Sciences CorporationUnknownBacteremia | InfectionCanada
-
University of LouisvilleCompletedGingival Recession
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University of LouisvilleWithdrawn
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Penn State UniversityCompletedCarpal Tunnel SyndromeUnited States
-
Vanderbilt UniversityTerminated