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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified February 2013 by University Hospital, Ghent
Sponsor:
Collaborators:
Universitaire Ziekenhuizen Leuven
GZA Ziekenhuizen Campus 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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 Ziekenhuizen Campus Sint-Augustinus
Investigators
Principal Investigator: Peter Verdonk, MD, Phd University Hospital, Ghent
  More Information

Additional Information:
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 August 28, 2014