Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615000378527
Ethics application status
Approved
Date submitted
30/03/2015
Date registered
23/04/2015
Date last updated
14/06/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Anterolateral ligament reconstruction in addition to Anterior Cruciate Ligament reconstruction ; Does it improve stability ?
Scientific title
In patients undergoing anterior cruciate reconstruction does the addition of a anterolateral ligament reconstruction improve stability lead to better functional outcomes and higher rates of return to sports. A randomized controlled trial.
Secondary ID [1] 286448 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Anterior cruciate ligament rupture
 294619 0
Anterolateral ligament rupture 294620 0
Condition category
Condition code
Musculoskeletal 294923 294923 0 0
Other muscular and skeletal disorders
Physical Medicine / Rehabilitation 294998 294998 0 0
Other physical medicine / rehabilitation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Patients undergoing anterior cruciate ligament reconstruction will be examined on the operating table by an under anaesthetic by a orthopaedic surgeon, if they have a grade 3 pivot shift, they will be recruited and randomized to Anterior Cruciate Ligament (ACL) reconstruction or ACL reconstruction with anterolateral ligament reconstruction (ALL).

The ACL reconstruction will be performed using a 4 strand anatomically placed semitendinosis graft, with proximal and distal suspensory fixation. The ALL will be reconstructed using a gracilis tendon harvested from the ipsilateral side and secured with anchors.

The Patients will complete subjective knee function scores post operatively. Orthopaedic Surgeons will assess the patients post op range of motion and pivot shift.
Intervention code [1] 291525 0
Treatment: Surgery
Comparator / control treatment
ACL group alone is the comparator group

ACL and ALL reconstruction are the intervention group
Control group
Active

Outcomes
Primary outcome [1] 294673 0
Knee function - IKDC and KOOS scores
Timepoint [1] 294673 0
2 weeks,
6 weeks
3 months
12 months
Primary outcome [2] 294675 0
Rotational instability on Pivot Shift assessed post operatively by an orthopaedic surgeon
Timepoint [2] 294675 0
at surgery
12 months
Primary outcome [3] 294750 0
Patient self reports - Return to sports
Timepoint [3] 294750 0
12 months
Secondary outcome [1] 313852 0
Pre operative Magnetic Resonance Imaging (MRI) findings of anterolateral lateral ligament integrity compared to clinical pivot shift findings at time of surgery and examination under a general anaesthetic
Timepoint [1] 313852 0
at inital MRI
at surgery

Eligibility
Key inclusion criteria
ACL rupture.
Consented for ACL reconstruction
Grade 3 pivot shift.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Previous ACL recontruction
Age less than 18yrs
Unable to consent, high dependency, cognitive impairment

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)
Patients undergoing ACL reconstruction are invited to participate. At the time of surgery under general anesthesia they are examined and if they have a grade 3 pivot shift then they are randomized to ACL or ACL with ALL reconstruction, via a sealed envelope system.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The Principle Investigator coin uses simple randomization by randomly allocating the treatment group based on coin toss to either ALL or no ALL. These are recorded on a randomization table and allocated on a sequential basis by the principle investigator.

Participating clinicians are given the randomly generated treatment allocations within sealed opaque envelopes. Once a patient has consented to enter a trial an envelope is opened and the patient is then allocated treatment regimen.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
No data analysis planned
Reason for early stopping/withdrawal
Participant recruitment difficulties
Date of first participant enrolment
Anticipated
18/09/2015
Actual
18/09/2015
Date of last participant enrolment
Anticipated
Actual
1/02/2017
Date of last data collection
Anticipated
28/04/2017
Actual
28/04/2017
Sample size
Target
40
Accrual to date
Final
12
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 3620 0
Mater Hospital Pimlico - Pimlico
Recruitment postcode(s) [1] 9403 0
4812 - Pimlico

Funding & Sponsors
Funding source category [1] 291014 0
Other
Name [1] 291014 0
ORIQL - Orthopaedic Research Institute of Queensland
Country [1] 291014 0
Australia
Primary sponsor type
Other
Name
Orthopaedic Research Institute of Queensland (ORIQL)
Address
ORIQL
7 Turner Street
Pimlico, Townsville, QLD 4812
Country
Australia
Secondary sponsor category [1] 289690 0
Individual
Name [1] 289690 0
Peter McEwen
Address [1] 289690 0
North Queensland Orthopaedics
Suite 3 level 2
Mater Medical Centre
21-29 Fulham Rd. Pimlico QLD 4812
Country [1] 289690 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292598 0
Mater Hospital Human Research Ethics Committee Pimlico
Ethics committee address [1] 292598 0
Human Research Ethics Committee
Locked bag 1000 Aitken ValeQLD 4814
Ethics committee country [1] 292598 0
Australia
Date submitted for ethics approval [1] 292598 0
01/04/2015
Approval date [1] 292598 0
01/06/2015
Ethics approval number [1] 292598 0
MHS20150512-03

Summary
Brief summary
A functioning intact anterior cruciate ligament (ACL) is important as it stabilizes movement of the tibia in relation to the femur, providing the stability required to participate in sporting activities.

It is often injured leading to rupture resulting in knee instability and primary repair of the ligament is usually unsuccessful. Surgeons have be reconstructing the ACL since 1930 and technique has been continuously refined. Even after surgical reconstruction, a small percentage of patients continue to experience knee instability, especially rotatory instability.

Recently a scientific paper identified an additional ligament called the anterolateral ligament (ALL). The ALL has been bio-mechanically examined and plays an important role in stabilizing the knee in the rotational axis.

Patients will be invited to participate in the study if they are undergoing ACL reconstruction surgery. Prior to the surgery commencing, after they have had a general anesthetic, they will have their pivot shift assessed on the operating table.

If the pivot shift is grade 3 (as described by Macintosh - tibia persistently subluxing anteriorly on the femur even with external rotation) then they will be randomised to ACL only or ACL and ALL reconstruction.

In this study patients will undergo standard arthroscopic ACL reconstruction using a hamstring graft and be randomized to have their ALL reconstructed using a hamstring graft.

The group that the patients are allocated to will be concealed from them, the additional ALL reconstruction requires only one, very small additional incision. Those not undergoing ALL reconstruction will not undergo any form of sham ALL reconstruction.

The patients knee function will be assessed pre-operatively and post-operatively, using subjective patient reported scores and objectively assessed using range of motion. They will be followed up at two weeks, six weeks, three months, six months and 12 months.

A secondary objective of the study will be correlating the findings of the Antero-lateral ligament on MRI with the pivot shift findings under anesthetic.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 56162 0
Dr Peter McEwen
Address 56162 0
Orthopaedic Research Institute of Queensland
Suite 3 Level 2 Mater Medical Centre/21-29 Fulham Rd, Pimlico QLD 4812
Country 56162 0
Australia
Phone 56162 0
+61 7 47550564
Fax 56162 0
Email 56162 0
[email protected]
Contact person for public queries
Name 56163 0
Mrs Andrea Grant
Address 56163 0
Orthopaedic Research Institute of Queensland
Suite 3 Level 2 Mater Medical Centre/21-29 Fulham Rd, Pimlico QLD 4812
Country 56163 0
Australia
Phone 56163 0
+617 47550564
Fax 56163 0
Email 56163 0
[email protected]
Contact person for scientific queries
Name 56164 0
Mrs Andrea Grant
Address 56164 0
Orthopaedic Research Institute of Queensland
Suite 3 Level 2 Mater Medical Centre/21-29 Fulham Rd, Pimlico QLD 4812
Country 56164 0
Australia
Phone 56164 0
+617 47550564
Fax 56164 0
Email 56164 0
[email protected]

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No Supporting Document Provided



Results publications and other study-related documents

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