Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000858099
Ethics application status
Not yet submitted
Date submitted
7/10/2010
Date registered
14/10/2010
Date last updated
14/10/2010
Type of registration
Prospectively registered

Titles & IDs
Public title
Femoral tunnel placement in Anterior cruciate ligament (ACL)reconstruction
Scientific title
Anterior Cruciate Ligament Reconstruction: Clinical and Radiological outcomes for three techniques for femoral tunnel placement
Secondary ID [1] 252863 0
none
Universal Trial Number (UTN)
U1111-1117-4175
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Anterior Cruciate ligamanet rupture 258345 0
Condition category
Condition code
Musculoskeletal 258529 258529 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The correct position of the tibial and femoral tunnels for Anterior Cruciate Ligamanet (ACL) reconstruction are generally agreed. However it can be very difficult to acurately reproduce these ideal positions intraoperatively. The correct position of the tibial tunnel is commonly achieved by an outside in aiming device allowing a guide wire to be passed from the proximal tibial cortex into the ACL tibial footprint at the correct trajectory and then the Tibial tunnel drilled with a cannulated drill. The correct placement of the femoral tunnel is more difficult and has been shown to have a larger variability. The current method of femoral tunnel placement is achieved by passing a guide wire either through the tibial tunnel (transtibial technique) already created or through an anteromedial porthole in an inside out manner. Alternatives to these methods are being developed to improve the reproducibility of correct femoral tunnel placement.
A new technique where by an outside in method for placement of the femoral tunnel has been developed to circumvent some of the problems seen with the inside out method. This involves using a tibial aiming device and then passing a specially engineered guide wire called a Flip Cutter (trademark) which when in the correct position can deploy a cutting edge to drill the femoral tunnel in a retrograde fashion. It is thought that this technique will allow more consistent, accurate placement of the femoral tunnel which will correspond in a better functioning graft and more stable knee. The exposure will occour only once during the operation.
Intervention code [1] 257358 0
Treatment: Surgery
Comparator / control treatment
The trans tibial group will be the controll group
Control group
Active

Outcomes
Primary outcome [1] 259370 0
Position of the femoral tunnel as measured by Computer Assisted Tomography (CAT) scanning
Timepoint [1] 259370 0
post operatively
Primary outcome [2] 259371 0
KT1000 'knee ligament arthrometer'
Timepoint [2] 259371 0
pre operatively, postoperatively at 12, 24 and 36 months
Primary outcome [3] 259405 0
Knee injury and osteoarthritis outcome score
Timepoint [3] 259405 0
pre operatively, postoperatively at 12, 24 and 36 months
Secondary outcome [1] 265888 0
Torniquet time
Timepoint [1] 265888 0
intraoperatively
Secondary outcome [2] 265939 0
pivot shift test
Timepoint [2] 265939 0
post operatively, 12, 24 and 36 months
clinical diagnosis
Secondary outcome [3] 265940 0
anterior draw test
Timepoint [3] 265940 0
post operatively, 12, 24 and 36 months
clinical diagnosis
Secondary outcome [4] 265941 0
infection
clinical diagnosis
Timepoint [4] 265941 0
any stage
Secondary outcome [5] 265942 0
implant faiulure
clinical diagnosis
Timepoint [5] 265942 0
At any stage
Secondary outcome [6] 265943 0
ligament rupture
Timepoint [6] 265943 0
post operatively, 12, 24 and 36 months
clinical diagnosis

Eligibility
Key inclusion criteria
Anterior Cruciate Ligamantdeficient knees,
Normal Contralateral knee
Skeletally Mature
Ability to provide informed consent
Four stranded hamstring autograft with retrobutton and interference screw fixation
Minimum age
16 Years
Maximum age
100 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Associated ligament injury
Previous Anterior Cruciate Ligamant reconstruction

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Consecutive patients receiving a primary ACL reconstruction by the senior author at Ascott private hospital, Auckland, New Zealand. The Senior author will determine if the patient is suitable for inclusion for the trial. The senior auther will not know what intervention the patient will recieve untill opening a sealed opaque envelope
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomization is via computer-generated random number list, blocked into groups to ensure equal numbers.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/02/2011
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
90
Accrual to date
Final
Recruitment outside Australia
Country [1] 2957 0
New Zealand
State/province [1] 2957 0

Funding & Sponsors
Funding source category [1] 257808 0
Self funded/Unfunded
Name [1] 257808 0
Mark Clatworthy
Country [1] 257808 0
New Zealand
Primary sponsor type
Individual
Name
Mark Clatworthy
Address
Auckland Bone and Joint Surgery,
Private Bag 28912,
Remuera,
Auckland, 1541.
Country
New Zealand
Secondary sponsor category [1] 257013 0
None
Name [1] 257013 0
Address [1] 257013 0
Country [1] 257013 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 259831 0
Northern X Regional Ethics Committee
Ethics committee address [1] 259831 0
Ministry of Health,
3rd Floor, Unisys Building,
Great South Road, Penrose,
Private Bag 92 522
Wellesly Street, Auckland 1141
Ethics committee country [1] 259831 0
New Zealand
Date submitted for ethics approval [1] 259831 0
17/08/2010
Approval date [1] 259831 0
Ethics approval number [1] 259831 0

Summary
Brief summary
The anterior cruciate ligament (ACL) is a major ligament in the knee which is commonly ruptured in active individuals. Following an ACL rupture the knee can feel unstable, predisposing to further injuries and eventually premature arthritis. ACL reconstruction is an operation where the ACL ligament is recreated with a tendon graft taken from another area of the body and fixed between the femur and the tibia with the aim of stabilising the knee. It is clear that accurate placements of both the femoral and tibial tunnel are crucial to the long term success of the operation.

The correct placement of the graft in the femur can be difficult using the current methods. A new technique for placement of the femoral tunnel has been developed to allow consistent, accurate placement of the femoral tunnel which could correspond in a better functioning graft and more stable knee

This is a study to compare the accuracy of the currently used femoral tunnel techniques with the new technique and determine if this correlates with the patient’s clinical outcome. It is a prospective, randomized, single centre study of three standardized surgical techniques.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 31747 0
Address 31747 0
Country 31747 0
Phone 31747 0
Fax 31747 0
Email 31747 0
Contact person for public queries
Name 14994 0
Mark Clatworthy
Address 14994 0
Auckland Bone and Joint Surgery,
Private Bag 28912,
Remuera,
Auckland,
1541.
Country 14994 0
New Zealand
Phone 14994 0
+64 9 520 9632
Fax 14994 0
+64 9 520 9636
Email 14994 0
[email protected]
Contact person for scientific queries
Name 5922 0
Mark Clatworthy
Address 5922 0
Auckland Bone and Joint Surgery,
Private Bag 28912,
Remuera,
Auckland,
1541.
Country 5922 0
New Zealand
Phone 5922 0
+64 9 520 9632
Fax 5922 0
+64 9 520 9636
Email 5922 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.