ANZCTR - Registration

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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]

Nil

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Anterior cruciate ligament rupture

Anterolateral ligament rupture

Condition category

Condition code

Musculoskeletal

Other muscular and skeletal disorders

Physical Medicine / Rehabilitation

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]

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]

Knee function - IKDC and KOOS scores

Timepoint [1]

2 weeks,
6 weeks
3 months
12 months

Primary outcome [2]

Rotational instability on Pivot Shift assessed post operatively by an orthopaedic surgeon

Timepoint [2]

at surgery
12 months

Primary outcome [3]

Patient self reports - Return to sports

Timepoint [3]

12 months

Secondary outcome [1]

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]

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?

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

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

QLD

Recruitment hospital [1]

Mater Hospital Pimlico - Pimlico

Recruitment postcode(s) [1]

4812 - Pimlico

Funding & Sponsors

Funding source category [1]

Other

Name [1]

ORIQL - Orthopaedic Research Institute of Queensland

Address [1]

ORIQL
Suite 3 level 2
Mater Medical Centre
21-29 Fulham Rd. Pimlico QLD 4812

Country [1]

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]

Individual

Name [1]

Peter McEwen

Address [1]

North Queensland Orthopaedics
Suite 3 level 2
Mater Medical Centre
21-29 Fulham Rd. Pimlico QLD 4812

Country [1]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Mater Hospital Human Research Ethics Committee Pimlico

Ethics committee address [1]

Human Research Ethics Committee 
Locked bag 1000 Aitken ValeQLD 4814

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

01/04/2015

Approval date [1]

01/06/2015

Ethics approval number [1]

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

Dr Peter McEwen

Address

Orthopaedic Research Institute of Queensland
Suite 3 Level 2 Mater Medical Centre/21-29 Fulham Rd, Pimlico QLD 4812

Country

Australia

Phone

+61 7 47550564

Fax

research_coordinator@oriql.com.au

Contact person for public queries

Name

Andrea Grant

Address

Orthopaedic Research Institute of Queensland
Suite 3 Level 2 Mater Medical Centre/21-29 Fulham Rd, Pimlico QLD 4812

Country

Australia

Phone

+617 47550564

Fax

research_coordinator@oriql.com.au

Contact person for scientific queries

Name

Andrea Grant

Address

Orthopaedic Research Institute of Queensland
Suite 3 Level 2 Mater Medical Centre/21-29 Fulham Rd, Pimlico QLD 4812

Country

Australia

Phone

+617 47550564

Fax

research_coordinator@oriql.com.au

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

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Documents added automatically

No additional documents have been identified.

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