ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12618001043224

Ethics application status

Approved

Date submitted

16/06/2018

Date registered

22/06/2018

Date last updated

28/11/2019

Date data sharing statement initially provided

28/11/2019

Type of registration

Prospectively registered

Titles & IDs

Public title

Trial to determine if the addition of a soft tissue tightening procedure to a particularly unstable knee following anterior cruciate ligament reconstruction, improves the outcome.

Scientific title

Augmentation of anterior cruciate ligament reconstruction with a modified ilio-tibial band tenodesis and patient scored outcomes: A randomised controlled trial

Secondary ID [1]

nil known

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

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

Anterior cruciate ligament rupture

Condition category

Condition code

Musculoskeletal

Other muscular and skeletal disorders

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

Patients undergoing an anterior cruciate ligament reconstruction routinely undergo an assessment of the stability of both knees using the pivot shift test before any surgery is performed. This test is graded 0-3 (where 0 is normal) and the goal of ligament reconstruction is to restore this test to a value similar to that the opposite side. All patients undergo an ACL reconstruction in the standard manner and then the pivot shift test is repeated. In patients in whom there is a difference of at least one grade between the operated knee and the un-operated un-injured contra-lateral knee, they are randomised to either undergo the augmentation procedure, that is a modified ilio-tibail band (ITB) tenodesis (MITBT), or no further surgery. Those who are radomized to arm 1 of the study have this procedure performed by the same orthopaedic surgeon, those in arm 2 do not have any further surgery performed.
The MITBT procedure is performed by taking a distally based 1cm strip of the ITB and passing it from superficial to deep, around the proximal end of the lateral collateral ligament and then securing it into a bone tunnel in the tibial at the attachment of the native ITB. The tension in the tenodesis is adjusted until it just corrects the pivot shift to a grade similar to that of the opposite side.
The MITBT adds approximately 20 minutes to the operating time.

Intervention code [1]

Treatment: Surgery

Comparator / control treatment

Those patients in arm 2 of the study, only have the ACL reconstruction performed. This is done using a quadrupled hamstring autograft, fixed both proximally and distally using interference screws.

Control group

Active

Outcomes

Primary outcome [1]

Knee function assessed using the International Knee Documentation Committee (IKDC) score

Timepoint [1]

2 years post surgery

Primary outcome [2]

Knee symptoms using the Knee Injury and Osteoarthritis Score (KOOS)

Timepoint [2]

2 years post surgery

Secondary outcome [1]

Knee function and activity levels using the Lysholm and Tegner score

Timepoint [1]

2 years post surgery

Eligibility

Key inclusion criteria

1) greater than one grade in the pivot shift score in the injured knee immediately following the ACL reconstruction
2) no previous knee surgery
3) no previous ligament ruptures
4) isolated ACL rupture diagnosed at the time of surgery
5) no osteochondral fracture
6) no meniscal repair performed
7) skeletally mature

Minimum age

18 Years

Maximum age

65 Years

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

1) history of rheumatological disorder (seronegative or seropositive)
2) not fit for surgery
3) not fit for general anaesthetic
4) skeletally immature

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)

Central randomisation by computer

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Simple randomisation using a randomisation table performed by computer software

Masking / blinding

Open (masking not used)

Who is / are masked / blinded?

Intervention assignment

Parallel

Other design features

Phase

Not Applicable

Type of endpoint/s

Efficacy

Statistical methods / analysis

The chi-squared test will be used to compare the outcomes of the IKDC and KOOS scores. The Wilcoxon test was used to compare the Lysholm and Tegner activity scores in the two groups.

Recruitment

Recruitment status

Recruiting

Date of first participant enrolment

Anticipated

1/07/2018

Actual

1/07/2018

Date of last participant enrolment

Anticipated

1/07/2025

Actual

Date of last data collection

Anticipated

Actual

Sample size

Target

100

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

ACT,NSW

Recruitment postcode(s) [1]

2600 - Barton

Funding & Sponsors

Funding source category [1]

Self funded/Unfunded

Name [1]

Mark Porter

Address [1]

Dr. Mark Porter, Suite 21, Calvary Clinic, 40 Mary Potter Circuit, Bruce, ACT 2617

Country [1]

Australia

Primary sponsor type

Individual

Name

Mark Porter

Address

Dr. Mark Porter, Suite 21 Calvary Clinic, 40 Mary Potter Circuit
Bruce, ACT 2617

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Barton Private Hospital Medical Advisory and Ethics Committee

Ethics committee address [1]

Barton Private Hospital, Sydney Avenue, 
Barton, ACT 2600

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

21/05/2018

Approval date [1]

30/05/2018

Ethics approval number [1]

BMAC #3

Summary

Brief summary

Following and ACL reconstruction, approximately one quarter of patients are not happy with the outcome and do not return to their previous level of activity. The most common cause of this persistent instability following the ACL reconstruction. The best available clinical test for anterolateral instability, is the pivot shift test. In some patients, even following an optimally performed ACL reconstruction, there may be some persistent instability, or anterolateral rotator instability (ALRI) as evidenced by a persistent pivot shift maneuver. This may be caused by damage to anterolateral extra-articular structures. Reconstruction of these anterolateral structures has been shown to be able to improve the stability of the knee, and outcome following revision ACL reconstruction. Dr. Mark Porter, has already demonstrated that the addition of the modified “iliotibial tenodesis” procedure, to those patients with a persistent pivot shift following revision ACL reconstruction improved the stability of the knee, and functional outcome (Porter et al Am J Sports Med 2018). However, it is not known if this is case when there is a persistent pivot shift, following primary ACL reconstruction. 
The goal of this study is to determine if the functional outcomes are improved when the ITBT procedure is added to the ACL reconstructions in patients with a positive pivot shift test, following primary ACL reconstruction. The study is a RCT in which patients who meet the study criteria (skeletally mature, physically active, medically fit, no previous knee surgery, isolated ACL rupture at the time of surgery, pivot shift test one grade or more in the reconstructed knee greater than that of the un-injured opposite knee, no previous ACL injury or surgery in either knee) are randomized to either have this procedure added to their ACL reconstruction (group 1) or not (group 2). The randomization is performed using a computer program, at the time of surgery. 
The ACL reconstruction is performed in a standard manner and as described in the literature (Porter et al. OJSM) using ipsilateral autologous hamstrings, with interference screw fixation in both the femur and the tibia. The modified ITB tenodesis procedure (ITBT) is performed using a 10cm long incision of the distal ITB and its insertion onto Gerdy’s tubercle. A 1cm distally based strip of the ITB is harvest. The free end is prepared with a locking whip-stitch and the passed from superficial to deep around the proximal lateral collateral ligament of  the knee, and secured into a bone tunnel at the posterior aspect of Gerdy’s tubercle. The ITBT is tensioned to correct the pivot shift to 0 before securing with an interference screw in the tunnel at Gerdy’s tubercle. All interference screws are made of biohydroxy-apatite and undergo osseous integration within 12 months of surgery. 
The outcome of interest is the following patient-reported outcomes, the IKDC (international knee documentation committee), the KOOS (knee osteoarthritis and injury outcome study), the Lysholm score, and Tegner activity score, all of which have been validated for this use and have been used before in similar research. The questionnaires take patients approximately 15 minutes to complete. 
The PROs are completed prior to surgery, and again at 1, 2, 5, 10 and 15 years post surgery. The data will be analyses using statistical analysis, with P<0.05 used to denote statistical significance. The occurrence of any complications and / or recurrence of ACL injury is also noted at each of these time intervals.

Trial website

Trial related presentations / publications

Public notes

Attachments [1]

/AnzctrAttachments/375314-Porter et al AmJSpMed 2018.pdf

Contacts

Principal investigator

Name

Dr Mark Porter

Address

Canberra Orthopaedics and Sports Medicine, Suite 21 Calvary Clinic, 40 Mary Potter Circuit, Bruce, ACT 2617

Country

Australia

Phone

+61, 02, 62016989

Fax

+61, 02, 62016902

mdporter@iinet.net.au

Contact person for public queries

Name

Mark Porter

Address

Canberra Orthopaedics and Sports Medicine, Suite 21 Calvary Clinic, 40 Mary Potter Circuit, Bruce, ACT 2617

Country

Australia

Phone

+61, 02, 62016989

Fax

+61, 02, 62016902

mdporter@iinet.net.au

Contact person for scientific queries

Name

Mark Porter

Address

Canberra Orthopaedics and Sports Medicine, Suite 21 Calvary Clinic,40 Mary Potter Circuit, Bruce, ACT 2617

Country

Australia

Phone

+61, 02, 62016989

Fax

+61, 02, 62016902

mdporter@iinet.net.au

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

No/undecided IPD sharing reason/comment

This will not be available by nature of the data storage

What supporting documents are/will be available?

Doc. No.	Type	Citation	Link	Email	Other Details	Attachment
5925	Ethical approval					375314-(Uploaded-23-11-2019-16-49-43)-Study-related document.pdf

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.

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