Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621001162808
Ethics application status
Approved
Date submitted
23/07/2021
Date registered
27/08/2021
Date last updated
31/10/2022
Date data sharing statement initially provided
27/08/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Suture-tape augmentation of anterior cruciate ligament reconstruction: a randomised controlled trial
Scientific title
Suture-tape augmentation of anterior cruciate ligament reconstruction: a randomised controlled trial (STACLR) comparing residual knee laxity, patient reported outcomes and complications in adults
Secondary ID [1] 304019 0
Nil known.
Universal Trial Number (UTN)
U1111-1268-1487
Trial acronym
STACLR
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Anterior cruciate ligament rupture 321645 0
Condition category
Condition code
Surgery 319386 319386 0 0
Surgical techniques
Musculoskeletal 319387 319387 0 0
Other muscular and skeletal disorders
Injuries and Accidents 320715 320715 0 0
Other injuries and accidents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This study will assess the intervention of additional suture-tape augmentation of anterior cruciate ligament (ACL) grafts during ACL reconstruction. The intervention will be delivered by by Australian AOA (Australian Orthopaedic Association) certified, fellowship trained sports knee surgeons familiar with the technique or by trainees directly supervised by the above surgeons. Patients randomized to the suture tape augmentation (SA) arm will have a single strand of Fibertape looped through the proximal Tightrope construct prior to graft implantation to serve as a suture augment. The femoral button and graft will then be shuttled through the proximal bone tunnel and docked into place. The tibial end of the graft will then be pulled through the tibial tunnel, along with the free ends of the suture tape. The suture tape will be tensioned independently of the graft according to previously described techniques. A guide pin is drilled 1.5 cm distal to the ABS tibial fixation to a depth of 20mm, and subsequently reamed to a 4.5mm diameter. Ensuring the free ends of the Fibertape are separate from the tibial sided graft sutures, a haemostat or artery forceps is then placed underneath the FiberTape limbs to ensure it is not tighter than the graft. The suture tape is then fixed with a 19mm knotless Swivelock anchor, always in full extension to avoid limiting extension of the joint. The knee is then taken through range of motion to ensure full range is present. The tibial side of the graft is then fixed with an interference screw (BioComposite; Arthrex Inc.) at 0 degrees of knee flexion in standard fashion. The knee is then cycled through range of motion to ensure full range. Closure is performed in a standardised method. It is anticipated that the incorporation of suture tape will add no more than 5 minutes to the surgical time. The surgery itself will take between 60-120 minutes depending on concomitant procedures undertaken. All participants are expected to be discharged the following day. Adherence to the intervention will be monitored by documentation by the surgeon in a study specific form at the end of each surgery.
Intervention code [1] 320331 0
Treatment: Surgery
Comparator / control treatment
All included participants will undergo standard arthroscopic single bundle anterior cruciate ligament reconstruction using a femoral socket with adjustable cortical fixation and a full tibial tunnel with interference screw fixation of the graft. Patients randomized to the SA arm will receive an additional procedure as described above. All patients will receive standard management of concomitant meniscal, and chondral pathology based on surgeon intra-operative discretion. All surgical details of such management will be recorded for analysis.
Surgery will be performed by by Australian AOA (Australian Orthopaedic Association) certified, fellowship trained sports knee surgeons familiar with the technique or by trainees directly supervised by the above surgeons.
The semitendinosus and gracilis tendons will be harvested from the ipsilateral knee via a tendon harvester. Each tendon will be doubled and sutured together at both ends with 2-Fibreloop suture (Arthrex, Naples, FL, USA) to create a 4-strand graft 7 to 10 mm in diameter. If the graft diameter is less than 7mm in females or 7.5 mm in males both tendons will be tripled to create a 6-strand construct. Fixation will be performed with an adjustable suspensory ACL TightRope® RT device (Arthrex, Naples, FL, USA) on the femoral side and an interference screw (Arthrex, Naples, FL, USA) on the tibial sides. The ACL footprint on the femoral side will be identified and the tibial stump debrided. An appropriately sized bone socket, which will be drilled via an inside-out technique, and a full thickness tibial tunnel will be created with a drill guide. The femoral button and graft will then be shuttled through the bone tunnels and docked into the femur. The tibial side of the graft is then tensioned using a proprietary tensioning device at 80N and fixed with an interference screw (PEEK; Arthrex Inc.) at 0 degrees of knee flexion. The knee is then cycled through range of motion to ensure full range and the graft re-tensioned. Closure is performed in a standardised method.

The surgery itself will take between 60-120 minutes depending on concomitant procedures undertaken. All participants are expected to be discharged the following day. Adherence to the surgical plan above will be monitored by documentation by the surgeon in a study specific form at the end of each surgery.
Control group
Active

Outcomes
Primary outcome [1] 328292 0
Residual knee laxity: As assessed by the GNRB arthrometer, the primary outcome will be the mean difference between operative and non-operative limbs (side-to-side).
Timepoint [1] 328292 0
2 years post operative
Secondary outcome [1] 398381 0
Residual knee laxity: As assessed by the GNRB arthrometer, the primary outcome will be the mean difference between operative and non-operative limbs (side-to-side).
Timepoint [1] 398381 0
Assessed preoperatively, and at 3 months and 12 months post operative.
Secondary outcome [2] 398764 0
Return to physical acitivity as assessed by the Marx Activity Scale
Timepoint [2] 398764 0
Assessed preoperatively, and at 6 weeks, 3 months, 12 months and 2 years postoperative.
Secondary outcome [3] 398765 0
Overall quality of life as assessed by the EQ5D-5L subscale
Timepoint [3] 398765 0
Assessed preoperatively, and at 6 weeks, 3 months, 12 months and 2 years postoperative.
Secondary outcome [4] 398766 0
Return to sport as assessed by the The Anterior Cruciate Ligament Return to Sport Index (ACL RSI)
Timepoint [4] 398766 0
Assessed preoperatively, and at 6 weeks, 3 months, 12 months and 2 years postoperative.
Secondary outcome [5] 398767 0
the Knee Injury and Osteoarthritis Outcome Score Quality of Life scale (KOOS QOL)
Timepoint [5] 398767 0
Assessed preoperatively, and at 6 weeks, 3 months, 12 months and 2 years postoperative.
Secondary outcome [6] 398768 0
Knee specific quality of life as assessed by the The international knee documentation committee subscale (IKDC)
Timepoint [6] 398768 0
Assessed preoperatively, and at 6 weeks, 3 months, 12 months and 2 years postoperative.
Secondary outcome [7] 398769 0
Complications including; pain levels, graft failure rates, contralateral ACL rupture, timing of graft failure, return to theatre, second look arthroscopy rates and findings assessed by regular review of the medical record
Timepoint [7] 398769 0
Assessed at 6 weeks, 3 months, 12 months and 24 months post operatively.
Secondary outcome [8] 399349 0
The presence of knee effusion on examination (patellar tap test and medial swipe test) as assessed by the associate investigators
Timepoint [8] 399349 0
Assessed preoperatively, and at 6 weeks, 3 months and 12 months post operatively.
Secondary outcome [9] 399350 0
Knee range of motion as assessed by the associate investigators (estimated visually)
Timepoint [9] 399350 0
Assessed preoperatively, and at 6 weeks, 3 months and 12 months post operatively.
Secondary outcome [10] 399351 0
The presence (and grade) of a positive Lachmans test as assessed by the associate investigators. This is a subjective knee examination which assesses the degree of anterior tibial translation relative to the femur at 30 degrees of knee flexion (which would usually be limited by an intact anterior cruciate ligament). Grading will be as follows; grade 1: 5 mm; grade 11: 5-10 mm; grade Ill: more than 10 mm, A: Firm end point, B: Soft end point.
Timepoint [10] 399351 0
Assessed preoperatively, and at 6 weeks, 3 months and 12 months post operatively.
Secondary outcome [11] 399352 0
The presence (and grade) of a positive anterior draw test as assessed by the associate investigators. This is a subjective knee examination which assesses the degree of anterior tibial translation relative to the femur at 90 degrees of knee flexion (which would usually be limited by an intact anterior cruciate ligament). Grading will be as follows; grade 1: 5 mm; grade 11: 5-10 mm; grade Ill: more than 10 mm, A: Firm end point, B: Soft end point.
Timepoint [11] 399352 0
Assessed preoperatively, and at 6 weeks, 3 months and 12 months post operatively.
Secondary outcome [12] 399353 0
The presence of a positive (and grade) pivot shift test as assessed by the associate investigators. This is a subjective test of anterolateral knee stability whereby the examiner aims to sublux the lateral tibial plateau in extension by applying a valgus force to the knee and internally rotating the tibia, before flexing the knee to observe a reducing motion at increasing degrees of knee flexion. This motion would usually be limited by an intact anterior cruciate ligament. Grading will be 0; no pivot I: glide, II: clunk, III: gross clunk.
Timepoint [12] 399353 0
Assessed preoperatively, and at 6 weeks, 3 months and 12 months post operatively.
Secondary outcome [13] 399354 0
Absolute return to sport rates collected via patient reported online questionnaires custom designed for this study
Timepoint [13] 399354 0
Assessed at 6 weeks, 3 months, 12 months and 24 months post operatively.
Secondary outcome [14] 399355 0
Time to return to sport collected by patient reported online questionnaires (number of days between operation and return to full engagement in sport e.g. games) custom designed for this study.
Timepoint [14] 399355 0
Assessed at 6 weeks, 3 months, 12 months and 24 months post operatively.
Secondary outcome [15] 399356 0
Time to return to performance as assessed by participants (time to return to previous level of sporting performance as appraised by participants) collected by patient reported online questionnaires custom designed for this study.
Timepoint [15] 399356 0
Assessed at 6 weeks, 3 months, 12 months and 24 months post operatively.

Eligibility
Key inclusion criteria
Participants will be included if they are; waitlisted for ACLR with either of the associated investigators (S.T or L.B). Waitlisting is based on MRI imaging, clinical examination in keeping with a ruptured anterior cruciate ligament and the appropriate lifestyle indication for surgical reconstruction of the ligament, are able to give informed consent and to participate fully in the interventions and follow-up procedures. Adult patients aged 18 and over where ACLR technique will not be modified due to the presence of open physes. Patients with concomitant meniscal and/or osteochondral pathology can be included.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Participants will be excluded on the basis of the following; The participant has had a previous ACL reconstruction on the ipsilateral knee, participant has had a previous ACL injury on the non operative knee, is of an developmental age where the presence of open physes would otherwise alter the surgical technique utilised, has grade 2 or 3 medial collateral ligament (MCL)/lateral collateral ligament (LCL) injury, associated posterior cruciate ligament (PCL)/ posterolateral corner (PLC) injury that requires surgical intervention, has inflammatory arthritis, is pregnant, has an articular cartilage defect requiring treatment that would alter the post-operative rehabilitation protocol and timelines, has a meniscal injury requiring treatment that would alter the post-operative rehabilitation protocol and timelines (i.e meniscal root or bucket handle tear repair), has an ACL re-rupture risk significant enough to warrant the addition of an osteotomising procedure or lateral extraarticular tenodesis.

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)
Allocation concealment will be performed by central randomisation via computer on REDCAP software.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block randomisation generated by an independent statistician in a blinded fashion.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
Intervention assignment
Parallel
Other design features
This study is a randomised controlled single-blind interventional 2-arm parallel group superiority trial utilising 1:1 allocation ratio comparing ACL reconstruction with suture tape augmentation to standard ACL reconstruction technique with femoral adjustable cortical fixation and tibial interference screw. All patients will undergo preoperative GNRB and PROM assessments. All surgical interventions will be delivered by one of two lead surgeons. Final determination of inclusion and exclusion criteria will be performed after diagnostic arthroscopy, before on table randomisation and allocation in the operating room.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
All principal analyses will be based on the intention-to-treat principle, analysing participants in the groups to which they are randomised. Side-to-side difference in anteroposterior laxity, overall ACL-RSI, EQ5D-5L, Marx activity scales, IKDC and KOOS-QOL will be calculated as means, with measures of dispersion reported as standard deviation. Differences between groups will be reported as mean differences, with dispersion reported with confidence intervals. Data normality will be assessed with the Shapiro-Wilk test for continuous parametric assessment. Between group comparisons, such as the primary outcome of mean difference in GNRB anteroposterior laxity at two years, will be assessed with independent samples t-tests. If data is found to be non-parametric in distribution, the Wilcoxon Rank Sum Test will be utilized. Comparison of two dichotomous variables, such as return to sport rates & complication rates will be performed with Fischer’s exact test. Repeated measures such as GNRB measures and mean PROMs will be assessed using mixed effects linear analysis. Missing data will be quantified and if possible multiple imputation will be used, otherwise simple imputation will be used. A p value of <0.05 will be considered the cut off for statistical significance.

Power analysis was performed with G*power 3.1 Software. To achieve a minimum 80% statistical power with an alpha value of 0.05, power analysis based on a hypothesised mean residual side-to-side difference of 2 mm of anteroposterior tibial translation yielded a sample size of n=48 (24 per group) utilizing an expected independent t-test. A total of 66 patients will be randomised on the basis of an expected 30% loss to follow up rate at two years post operative based on institutional caseloads.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/01/2022
Actual
3/03/2022
Date of last participant enrolment
Anticipated
30/06/2024
Actual
Date of last data collection
Anticipated
30/06/2026
Actual
Sample size
Target
66
Accrual to date
9
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 19678 0
Western Hospital - Footscray - Footscray
Recruitment hospital [2] 19679 0
Sunshine Hospital - St Albans
Recruitment hospital [3] 19680 0
Williamstown Hospital - Williamstown
Recruitment postcode(s) [1] 34310 0
3011 - Footscray
Recruitment postcode(s) [2] 34311 0
3021 - St Albans
Recruitment postcode(s) [3] 34312 0
3016 - Williamstown

Funding & Sponsors
Funding source category [1] 307703 0
Hospital
Name [1] 307703 0
Western Health (Footscray Hospital) Orthopaedic Department Special Purpose Fund
Country [1] 307703 0
Australia
Primary sponsor type
Hospital
Name
Western Health - Sunshine Hospital
Address
Mr Bill Karanatsisios, Research Program Director, Western Health Office for Research Level 3 Office for Research, Western
Centre for Health & Research Education (WCHRE), Sunshine Hospital, 176
Furlong Road, St Albans, Vic 3021
Country
Australia
Secondary sponsor category [1] 310200 0
None
Name [1] 310200 0
Address [1] 310200 0
Country [1] 310200 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 307732 0
Melbourne Health Human Research Ethics Committee
Ethics committee address [1] 307732 0
Office for Research
The Royal Melbourne Hospital Level 2 South West
300 Grattan Street
Parkville VIC 3050
Australia
Ethics committee country [1] 307732 0
Australia
Date submitted for ethics approval [1] 307732 0
01/04/2021
Approval date [1] 307732 0
06/04/2021
Ethics approval number [1] 307732 0
HREC/73668/MH-2021

Summary
Brief summary
This is a parallel arm, 1:1 allocated randomised controlled trial comparing anterior cruciate ligament (ACL) reconstruction with suture tape augmentation of the graft to standard ACL reconstructive technique. Whilst many ACL reconstruction patients return to sport, a significant minority suffer complications of graft rupture, particularly during the early return to sport and rehabilitative period. Inherent weakness of the graft in withstanding the loads applied during these periods has been attributed to graft failure risk, as well as residual laxity (looseness) of the knee. Recently, the use of suture-tape to run alongside the graft (or augment) has emerged to increase the strength of the new ACL, however, there is little comparative evidence available regarding this technique, particularly in its capacity to reduce residual knee laxity, or improve patient outcomes after ACLR.

We aim to investigate the use of this technique by randomly allocating ACL reconstructive patient to receive it, or standard technique (the same surgery without the additional suture). We will compare the outcomes following this by testing the looseness of the knee at standard time points (3 months, 12 months and 2 years) compared with the patients other 'normal' knee. We will also compare patient reported outcomes (via patient delivered surveys), findings on examination of the knee, return to sport times and rates and complications such as the need for return to surgery, and failure of the ACL reconstruction.

We will perform this study with an aim to improve our understandings about the potential benefit or harms associated with tape augmentation, with the hope that it will inform the use of this technique in future patients needing to undergo ACL reconstruction to return to sport.

We hypothesise that patients whose knees are reconstructed with suture-tape augmented grafts will have a smaller difference between operative and non operative sides at two years after surgery, compared with patients who undergo standard ACL reconstruction. Secondly, we hypothesise that patients with tape augmented ACL grafts will return to sport sooner, and have improved patient reported outcome measures during the follow up period (2 years).

Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 108314 0
A/Prof Phong Tran
Address 108314 0
Head of Unit, Department of Orthopaedics, Level 1, Footscray Hospital, 160 Gordon St, Footscray, VIC 3011
Country 108314 0
Australia
Phone 108314 0
+61 03 8345 5757
Fax 108314 0
Email 108314 0
[email protected]
Contact person for public queries
Name 108315 0
Ms Libby Spiers
Address 108315 0
Department of Orthopaedics, Western Health
Western Hospital
Level 1 South, 160 Gordon St
Footscray, VIC 3011
Country 108315 0
Australia
Phone 108315 0
+61 03 8345 5757
Fax 108315 0
Email 108315 0
[email protected]
Contact person for scientific queries
Name 108316 0
Dr Lachlan Huntington
Address 108316 0
ATTN: Lidia Carbone (orthopaedic Secretary)
Department of Orthopaedics, Western Health
Western Hospital
Level 1 South, 160 Gordon St
Footscray, VIC 3011
Country 108316 0
Australia
Phone 108316 0
+61 03 8345 5757
Fax 108316 0
Email 108316 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
SourceTitleYear of PublicationDOI
EmbaseSuture-tape augmentation of anterior cruciate ligament reconstruction: a prospective, randomised controlled trial (STACLR).2023https://dx.doi.org/10.1186/s13063-023-07127-0
N.B. These documents automatically identified may not have been verified by the study sponsor.