NCT01598636

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Feb 2013

Geographic Reach
1 country

3 active sites

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 9, 2012

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 15, 2012

Completed
9 months until next milestone

Study Start

First participant enrolled

February 1, 2013

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2014

Completed
Last Updated

December 15, 2022

Status Verified

December 1, 2022

Enrollment Period

1.3 years

First QC Date

May 9, 2012

Last Update Submit

December 14, 2022

Conditions

Outcome Measures

Primary Outcomes (7)

  • Evaluation of clinical scores pre-operative

    pre-operative

  • evaluation of clinical scores at 3 months

    3 months post operative

  • Evaluation of clinical scores at 6 months

    6 months post operative

  • Evaluations of clinical scores at 1 year

    1 year post operative

  • Evaluation of CT scan and X-ray pre-operative

    pre-operative

  • Evaluation of CT scan and X-ray post-operative

    post-operative

  • Evaluation of CT scan and X-ray 1 year post-operative

    1 year post-operative

Study Arms (1)

Lateral Tibial Tunnel technique

EXPERIMENTAL
Procedure: Lateral tibial tunnel

Interventions

To reduce the rehabilitation time after ACL revision surgery due to a better surgical technique

Lateral Tibial Tunnel technique

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • patients requiring ACL revision surgery
  • patients requiring ACL surgery who have bone stock problems at the medial side of the proximal tibia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

GZA Sint-Augustinus

Antwerp, Belgium

Location

University Hospital

Ghent, 9000, Belgium

Location

University Hospital

Leuven, Belgium

Location

Related Links

Study Officials

  • Peter Verdonk, MD, Phd

    University Hospital, Ghent

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 9, 2012

First Posted

May 15, 2012

Study Start

February 1, 2013

Primary Completion

June 1, 2014

Study Completion

June 1, 2014

Last Updated

December 15, 2022

Record last verified: 2022-12

Locations