Trial Review

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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] 295164 0
nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Anterior cruciate ligament rupture 308283 0
Condition category
Condition code
Musculoskeletal 307294 307294 0 0
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] 301501 0
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] 306250 0
Knee function assessed using the International Knee Documentation Committee (IKDC) score
Timepoint [1] 306250 0
2 years post surgery
Primary outcome [2] 306251 0
Knee symptoms using the Knee Injury and Osteoarthritis Score (KOOS)
Timepoint [2] 306251 0
2 years post surgery
Secondary outcome [1] 347992 0
Knee function and activity levels using the Lysholm and Tegner score
Timepoint [1] 347992 0
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?
No
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
53
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW
Recruitment postcode(s) [1] 22995 0
2600 - Barton

Funding & Sponsors
Funding source category [1] 299752 0
Self funded/Unfunded
Name [1] 299752 0
Mark Porter
Country [1] 299752 0
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] 299164 0
None
Name [1] 299164 0
Address [1] 299164 0
Country [1] 299164 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 300642 0
Barton Private Hospital Medical Advisory and Ethics Committee
Ethics committee address [1] 300642 0
Barton Private Hospital, Sydney Avenue,
Barton, ACT 2600
Ethics committee country [1] 300642 0
Australia
Date submitted for ethics approval [1] 300642 0
21/05/2018
Approval date [1] 300642 0
30/05/2018
Ethics approval number [1] 300642 0
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] 2776 2776 0 0
/AnzctrAttachments/375314-Porter et al AmJSpMed 2018.pdf

Contacts
Principal investigator
Name 84314 0
Dr Mark Porter
Address 84314 0
Canberra Orthopaedics and Sports Medicine, Suite 21 Calvary Clinic, 40 Mary Potter Circuit, Bruce, ACT 2617
Country 84314 0
Australia
Phone 84314 0
+61, 02, 62016989
Fax 84314 0
+61, 02, 62016902
Email 84314 0
mdporter@iinet.net.au
Contact person for public queries
Name 84315 0
Dr Mark Porter
Address 84315 0
Canberra Orthopaedics and Sports Medicine, Suite 21 Calvary Clinic, 40 Mary Potter Circuit, Bruce, ACT 2617
Country 84315 0
Australia
Phone 84315 0
+61, 02, 62016989
Fax 84315 0
+61, 02, 62016902
Email 84315 0
mdporter@iinet.net.au
Contact person for scientific queries
Name 84316 0
Dr Mark Porter
Address 84316 0
Canberra Orthopaedics and Sports Medicine, Suite 21 Calvary Clinic,40 Mary Potter Circuit, Bruce, ACT 2617
Country 84316 0
Australia
Phone 84316 0
+61, 02, 62016989
Fax 84316 0
+61, 02, 62016902
Email 84316 0
mdporter@iinet.net.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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.TypeCitationLinkEmailOther DetailsAttachment
5925Ethical 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.