Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified December 2014 by University Hospital, Ghent.
Recruitment status was:  Recruiting
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: December 4, 2014
Last verified: December 2014
  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

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 2015 (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   (Adult)
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

Locations
Belgium
GZA Sint-Augustinus
Antwerp, Belgium
University Hospital
Ghent, Belgium, 9000
University Hospital
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:
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: December 4, 2014
Health Authority: Belgium: Ethics Committee

ClinicalTrials.gov processed this record on December 02, 2016