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The Lateral Tibial Tunnel in ACL Surgery (LTT-HVDB)

This study is not yet open for participant recruitment.
Verified February 2013 by University Hospital, Ghent
Sponsor:
Collaborators:
Universitaire Ziekenhuizen Leuven
GZA Sint-Augustinus
Information provided by (Responsible Party):
University Hospital, Ghent
ClinicalTrials.gov Identifier:
NCT01598636
First received: May 9, 2012
Last updated: February 1, 2013
Last verified: February 2013
History of Changes
  Purpose

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.


Condition Intervention
Anterior Cruciate Ligament Revision Surgery
 Procedure: Lateral tibial tunnel

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Lateral Tibial Tunnel in Anterior Cruciate Ligament Surgery. A Clinical and Ct-graphic Study.to Evaluate the Concept

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University Hospital, Ghent:

Primary Outcome Measures:
  • Evaluation of clinical scores pre-operative [ Time Frame: pre-operative ] [ Designated as safety issue: Yes ]
  • evaluation of clinical scores at 3 months [ Time Frame: 3 months post operative ] [ Designated as safety issue: Yes ]
  • Evaluation of clinical scores at 6 months [ Time Frame: 6 months post operative ] [ Designated as safety issue: Yes ]
  • Evaluations of clinical scores at 1 year [ Time Frame: 1 year post operative ] [ Designated as safety issue: Yes ]
  • Evaluation of CT scan and X-ray pre-operative [ Time Frame: pre-operative ] [ Designated as safety issue: Yes ]
  • Evaluation of CT scan and X-ray post-operative [ Time Frame: post-operative ] [ Designated as safety issue: Yes ]
  • Evaluation of CT scan and X-ray 1 year post-operative [ Time Frame: 1 year post-operative ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 50
Study Start Date: February 2013
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Lateral Tibial Tunnel technique Procedure: Lateral tibial tunnel
To reduce the rehabilitation time after ACL revision surgery due to a better surgical technique

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • patients requiring ACL revision surgery
  • patients requiring ACL surgery who have bone stock problems at the medial side of the proximal tibia
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01598636

Contacts
Contact: Hans Van der Bracht, MD 00324434812 info@vanderbracht.com

Locations
Belgium
GZA Sint-Augustinus Not yet recruiting
Antwerp, Belgium
Contact: Hans Van der Bracht, MD            
Sub-Investigator: Hans Van der Bracht, MD            
University Hospital Not yet recruiting
Ghent, Belgium, 9000
Contact: Peter Verdonk, MD, Phd            
Principal Investigator: Peter Verdonk, MD, Phd            
University Hospital Not yet recruiting
Leuven, Belgium
Sponsors and Collaborators
University Hospital, Ghent
Universitaire Ziekenhuizen Leuven
GZA Sint-Augustinus
Investigators
Principal Investigator: Peter Verdonk, MD, Phd University Hospital, Ghent
  More Information

Additional Information:
Related Info  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: University Hospital, Ghent
ClinicalTrials.gov Identifier: NCT01598636     History of Changes
Other Study ID Numbers: 2012/324
Study First Received: May 9, 2012
Last Updated: February 1, 2013
Health Authority: Belgium: Ethics Committee

ClinicalTrials.gov processed this record on May 22, 2013