Anterior Cruciate Ligament Revision Surgery Clinical Trial
— LTT-HVDBOfficial title:
The Lateral Tibial Tunnel in Anterior Cruciate Ligament Surgery. A Clinical and Ct-graphic Study.to Evaluate the Concept
| NCT number | NCT01598636 |
| Other study ID # | 2012/324 |
| Secondary ID | |
| Status | Withdrawn |
| Phase | N/A |
| First received | |
| Last updated | |
| Start date | February 2013 |
| Est. completion date | June 2014 |
| Verified date | December 2022 |
| Source | University Hospital, Ghent |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Withdrawn |
| Enrollment | 0 |
| Est. completion date | June 2014 |
| Est. primary completion date | June 2014 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 65 Years |
| Eligibility | Inclusion Criteria: - patients requiring ACL revision surgery - patients requiring ACL surgery who have bone stock problems at the medial side of the proximal tibia |
| Country | Name | City | State |
|---|---|---|---|
| Belgium | GZA Sint-Augustinus | Antwerp | |
| Belgium | University Hospital | Ghent | |
| Belgium | University Hospital | Leuven |
| Lead Sponsor | Collaborator |
|---|---|
| University Hospital, Ghent | GZA Ziekenhuizen Campus Sint-Augustinus, Universitaire Ziekenhuizen KU Leuven |
Belgium,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Evaluation of clinical scores pre-operative | pre-operative | ||
| Primary | evaluation of clinical scores at 3 months | 3 months post operative | ||
| Primary | Evaluation of clinical scores at 6 months | 6 months post operative | ||
| Primary | Evaluations of clinical scores at 1 year | 1 year post operative | ||
| Primary | Evaluation of CT scan and X-ray pre-operative | pre-operative | ||
| Primary | Evaluation of CT scan and X-ray post-operative | post-operative | ||
| Primary | Evaluation of CT scan and X-ray 1 year post-operative | 1 year post-operative |