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Trial registered on ANZCTR


Registration number
ACTRN12621000782831
Ethics application status
Approved
Date submitted
26/04/2021
Date registered
22/06/2021
Date last updated
22/06/2021
Date data sharing statement initially provided
22/06/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Comparison of the ability of two different techniques used to augment anterior cruciate cruciate ligament reconstruction, to improve the stability of the knee and reduce the risk of re-tearing the reconstructed ligament, in patients taking part in pivoting sports.
Scientific title
Randomized controlled trial of lateral extra-caspular tenodesis versus a modified ilio-tibial band tenodesis (MITBT) used to augment anterior cruciate ligament reconstruction, comparing patient scored outcomes, risks of recurrence and meniscal tears.
Secondary ID [1] 303987 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 321599 0
Condition category
Condition code
Surgery 319339 319339 0 0
Surgical techniques

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The LET procedure involves taking a 1cm strip of the ITB, 15cm long, left attached distally, and then re-routed deep to the proximal lateral collateral ligament (LCL) of the knee and attached to the periosteum posterior and superior to the LCL where it is secured under hand tension using a titanium bone staple.
The surgery is performed by a consultant orthopaedic surgeon and takes approximately 30 mins to perform. The surgeon is one of the researchers so adherence to the intervention is not indicated and the operative notes document the procedure performed. The study is on-going and may last for 20 years.
Intervention code [1] 320381 0
Treatment: Surgery
Comparator / control treatment
This groups will have the same ACL reconstruction performed, but the MITB performed rather than the LET.
This procedure involves taking a similar distally attached 1cm strip of the ITB, but this time is is passed superficial to deep, around the LCL and then back into a tunnel in the proximal tibial at Gerdy's tubercle, and the re-routed tissue is tensioned until the pivot shift is corrected before fixation with a screw. The surgeon is one of the researchers so adherence to the intervention is not indicated and the operative notes document the procedure performed. The study is on-going and may last for 20 years.
The operation is performed by a consultant surgeon and the surgery recorded in the notes. The MITB takes approximately 30 minutes to perform.
Control group
Active

Outcomes
Primary outcome [1] 327311 0
Recurrent ACL rupture diagnosed with recurrence of the pivot shift on clinical assessment and MRI.
Timepoint [1] 327311 0
2 years
Primary outcome [2] 327312 0
Meniscal tear diagnosed at second look arthroscopy
Timepoint [2] 327312 0
2 years
Secondary outcome [1] 394577 0
Knee injury Osteoarthritis and Outcome Score (KOOS)
Timepoint [1] 394577 0
2 years
Secondary outcome [2] 396096 0
Knee function measured with International Knee Documentation Committee (IKDC)
Timepoint [2] 396096 0
2 years
Secondary outcome [3] 396097 0
ACL Quality of Life Questionnaire (QOL)
Timepoint [3] 396097 0
2 years
Secondary outcome [4] 396098 0
Tegner activity scores (TAS)
Timepoint [4] 396098 0
2 years

Eligibility
Key inclusion criteria
ACL rupture confirmed on MRI and at time of surgery, the presence of clinical signs of instability immediate following the performance of the ACL reconstruction when the patients re-assessed after the ACL reconstruction (the presence of a pivot shift test despite the ACL reconstruction) involved in sports that require twisting / pivoting, desirous to return to this sport, patient willing to be randomly allocated to either treatment group, Tegner activity score of at least 7
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Unwilling to take part, presence of other ligament damage in the injured knee, previous contra-lateral ACL rupture, injury associated with an unstable fracture, not fit for a general anaesthetic,

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 by computer soft ware
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
Statistical analysis will be performed using SPSS computer
software (version 22; IBM). The baseline characteristics
of the 2 groups will be compared using the chi-square test
for sex and grade of pivot shift in both the injured and contralateral
knees, and analysis of variance will be used for age,
body mass index, posterior tibial slopeI, time before surgery, IKDC score, KOOS Sport/
Rec score, KOOS QoL score, LKS score, and graft size. For
the Tegner activity scores, nonparametric analysis using the Wilcoxon
test was performed. Follow-up data will be analyzed to compare
the 2 groups with respect to changes in scores within
groups and between groups using analysis of variance for
IKDC, KOOS Sport/Rec, KOOS QoL, and LKS scores and
the chi-square test for recurrence of ACL ruptures, contralateral
ACL ruptures, and further surgery on the injured
knee. The Wilcoxon test will used to compare the changes
in TAS scores.
A power analysis determined that the study
would be sufficiently powered to detect a significant difference in
KOOS Sport/Rec scores, KOOS QoL scores, LKS scores,
TAS scores, and recurrence of ACL ruptures, if the study size was 42 and this would result in power of 80% and a 5% risk of a type I error.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/07/2021
Actual
Date of last participant enrolment
Anticipated
31/05/2023
Actual
Date of last data collection
Anticipated
31/05/2025
Actual
Sample size
Target
140
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,VIC
Recruitment postcode(s) [1] 33765 0
2600 - Barton
Recruitment postcode(s) [2] 33766 0
2617 - Bruce

Funding & Sponsors
Funding source category [1] 308447 0
Self funded/Unfunded
Name [1] 308447 0
Country [1] 308447 0
Primary sponsor type
Individual
Name
Mark Porter
Address
Canberra Orthopaedics and Sports Medicine, Suite 21, 40 Mary Potter Circuit, Bruce, ACT 2617
Country
Australia
Secondary sponsor category [1] 309280 0
None
Name [1] 309280 0
Address [1] 309280 0
Country [1] 309280 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 308335 0
Barton Private Hospital Medical Advisory and Ethics Committee
Ethics committee address [1] 308335 0
Barton Private Hospital,
Sydney Avenue,
Barton, ACT 2600
Ethics committee country [1] 308335 0
Australia
Date submitted for ethics approval [1] 308335 0
30/03/2021
Approval date [1] 308335 0
10/04/2021
Ethics approval number [1] 308335 0
BPH MAC 4

Summary
Brief summary
Augmentation of anterior cruciate ligament reconstruction using autologous hamstring graft, with a modified iliotibial band tenodesis or lateral extracapsular tenodesis, for patients with a residual pivot shift: A 2 year prospective randomised controlled trial comparing recurrence rate and clinical outcome.
Background:
Approximately 10% of ACLs injuries are associated with damage to the anterolateral complex (ALC) of the knee, manifest as greater anterolateral rotatory instability (ALRI). The pivot shift test is the best available clinical test for ALRI. Addition of an ALC reconstructive procedure can improve stability of the knee and clinical outcome in these patients following ACL reconstruction. There is little data comparing the efficacy of the various ALC procedures.
Hypothesis:
We hypothesized that the clinical outcome would be similar when either a modified ilio-tibial band tenodesis (MITBT) or lateral extracapsular tenodesis (LET) was added to ACL reconstruction.
Study Design:
Randomized controlled trial; Level of evidence, 1.
Methods:
The inclusion criteria were a residual pivot shift following ACL reconstruction, in a skeletally mature patient, pre-injury Tegner Activity Score of at least 7, desirous to return to a similar level of activity, an intact contra-lateral ACL ligament and consenting to be randomly allocated to either treatment group. Patients in group A underwent MITBT, those in group B, LET, in addition to their ACL reconstruction. The primary outcome was recurrent ACL rupture and / or meniscal tears. Secondary outcomes were the Knee injury Osteoarthritis and Outcome Score (KOOS), International Knee Documentation Committee (IKDC) score, ACL Quality of Life Questionnaire (QOL) and Tegner activity scores (TAS). Patients were reviewed at 12, and 24 months postoperatively. Statistical comparison of the groups was performed, P<0.05 denoting significance. A power analysis determined that 140 patients were required to achieve a power of 80% and 5% risk of a type 1 error.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 110346 0
Dr Mark Porter
Address 110346 0
Canberra Orthopaedics and Sports Medicine, Suite 21 , 4o Mary Potter Circuit, Bruce, ACT 2617
Country 110346 0
Australia
Phone 110346 0
+61 02 62535404
Fax 110346 0
+61 02 62016802
Email 110346 0
[email protected]
Contact person for public queries
Name 110347 0
Mark Porter
Address 110347 0
Canberra Orthopaedics and Sports Medicine, Suite 21 ,4o Mary Potter Circuit, Bruce, ACT 2617
Country 110347 0
Australia
Phone 110347 0
+61 02 62535404
Fax 110347 0
+61 02 62016802
Email 110347 0
[email protected]
Contact person for scientific queries
Name 110348 0
Mark Porter
Address 110348 0
Canberra Orthopaedics and Sports Medicine, Suite 21 Calvary Clinic, 40 Mary Potter Circuit, Bruce, ACT 2617
Country 110348 0
Australia
Phone 110348 0
+61 02 62535404
Fax 110348 0
+61 02 62016802
Email 110348 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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.