LTT-HVDB: The Lateral Tibial Tunnel in ACL Surgery

• Sponsor: University Hospital, Ghent (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT01598636
• Collaborator: Universitaire Ziekenhuizen Leuven (Other), GZA Ziekenhuizen Campus Sint-Augustinus (Other)
• Enrollment: 50
• Locations: 3
• Arm: 1
• Duration (Months): 27.9
• Patients Per Site: 16.7
• Patients Per Site Per Month: 0.6

Study Details

Study Description

Brief Summary

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 or Disease	Intervention/Treatment	Phase
Anterior Cruciate Ligament Revision Surgery	Procedure: Lateral tibial tunnel	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 50 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (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
• Study Start Date: Feb 1, 2013
• Anticipated Primary Completion Date: Jun 1, 2015
• Anticipated Study Completion Date: Jun 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Lateral Tibial Tunnel technique	Procedure: Lateral tibial tunnel; To reduce the rehabilitation time after ACL revision surgery due to a better surgical technique

Outcome Measures

Primary Outcome Measures

1. Evaluation of clinical scores pre-operative [pre-operative]

2. evaluation of clinical scores at 3 months [3 months post operative]

3. Evaluation of clinical scores at 6 months [6 months post operative]

4. Evaluations of clinical scores at 1 year [1 year post operative]

5. Evaluation of CT scan and X-ray pre-operative [pre-operative]

6. Evaluation of CT scan and X-ray post-operative [post-operative]

7. Evaluation of CT scan and X-ray 1 year post-operative [1 year post-operative]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	GZA Sint-Augustinus	Antwerp		Belgium
2	University Hospital	Ghent		Belgium	9000
3	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

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Related Info

Publications

None provided.

• Responsible Party: University Hospital, Ghent
• ClinicalTrials.gov Identifier: NCT01598636
• Other Study ID Numbers: 2012/324
• First Posted: May 15, 2012
• Last Update Posted: Dec 5, 2014
• Last Verified: Dec 1, 2014

Study Results

No Results Posted as of Dec 5, 2014