Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618001520224
Ethics application status
Approved
Date submitted
1/09/2018
Date registered
11/09/2018
Date last updated
14/08/2019
Date data sharing statement initially provided
14/08/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Hamstring Tendon Autograft versus Quadriceps Tendon Autograft for Anterior Cruciate Ligament Reconstruction: A Randomised Controlled Trial
Scientific title
Evaluation of post-operative graft laxity following Hamstring Tendon Autograft versus Quadriceps Tendon Autograft for Anterior Cruciate Ligament Reconstruction: A Randomised Controlled Trial
Secondary ID [1] 295968 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Anterior Cruciate Ligament Rupture 309479 0
Condition category
Condition code
Musculoskeletal 308313 308313 0 0
Other muscular and skeletal disorders
Injuries and Accidents 308385 308385 0 0
Other injuries and accidents
Surgery 308386 308386 0 0
Surgical techniques

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This is a prospective randomized controlled trial (RCT) comparing the outcome of patients undergoing primary anterior cruciate ligament reconstruction (ACLR) with either a hamstring tendon (HT) or a quadriceps tendon (QT) autograft. Patient outcomes will be collected and compared between the two surgical cohorts over a 24 month post-operative period, and will include a range of subjective and functional outcomes, knee movement and laxity measures, patient satisfaction, and kneeling tolerance.

This trial has been designed as a randomised, controlled, multicentre trial with two parallel groups. Block randomisation will be performed with a 1:1 allocation.

All patients who are undergoing primary ACLR with the primary surgeon will be invited to participate in this trial. Participants will be invited to be part of the study after consultation with their surgeon, having confirmed ACL rupture by clinical examination and magnetic resonance imaging (MRI), and being scheduled for surgery. Initial contact and recruitment will be conducted by a member of the research team.

Patients will undergo ACLR, under general anaesthetic. Surgery will take between 45-90 minutes. Patients will have a standardised anaesthetic regime, consisting of a single-shot adductor canal regional block using 0.375% ropivacaine plus 8mg dexamethasone, placed with ultrasound guidance once the patient is under general anaesthetic.

If randomised to the HT graft, HT graft harvest will be obtained via a transverse incision over the pes anserinus. Semitendinosus will be harvested using a closed tendon harvester, quadrupled and prepared. The investigator's preference is to use the Arthrex graftlink system, enabling single HT harvest for the majority of cases. In the case of a small diameter graft, gracilis will be harvested and used in combination.

If randomised to the QT graft, QT harvest will be obtained via a longitudinal incision over the distal portion of the quadriceps tendon and proximal pole of patella. A soft-tissue graft will be obtained using a 9, 10 or 11mm graft harvester depending on the size of the patient. Approximately 70mm of graft will be harvested, and then prepared as per guidelines for use with the Arthrex graftlink system, enabling the same graft fixation techniques to be employed for both graft types.

Knee arthroscopy will then be performed, with treatment of any chondral or meniscus injury as dictated by the intra-operative findings. Femoral and tibial tunnels will be prepared to allow for passage of the graft in an anterograde manner, using adjustable loop fixation for both the femoral and tibial fixation. Graft tensioning will be performed in full knee extension in line with the manufacturers recommendations, with cycling of the graft prior to final fixation. The wounds will be closed in layers, haemostasis ensured and absorbable subcuticular wound closure employed. Dressings will be applied, followed by wool and crepe bandages. A straight splint will be applied whilst the patient is under general anaesthetic, which is used for pain relief in the early post-operative phase only.
Intervention code [1] 312298 0
Treatment: Surgery
Comparator / control treatment
If randomised to the HT graft, HT graft harvest will be obtained via a transverse incision over the pes anserinus. Semitendinosus will be harvested using a closed tendon harvester, quadrupled and prepared. The investigator's preference is to use the Arthrex graftlink system, enabling single HT harvest for the majority of cases. In the case of a small diameter graft, gracilis will be harvested and used in combination.
Control group
Active

Outcomes
Primary outcome [1] 307290 0
Post-operative graft laxity as measured by KT-1000 arthrometer.
Timepoint [1] 307290 0
6, 12 (primary endpoint), 24 months
Secondary outcome [1] 351392 0
Visual Analogue Pain Scale (VAS)
Timepoint [1] 351392 0
3, 6, 12, 24 months
Secondary outcome [2] 351393 0
International Knee Documentation Committee (IKDC) Subjective Knee Form
Timepoint [2] 351393 0
Baseline, 3, 6, 12, 24 months
Secondary outcome [3] 351600 0
Knee Outcome Survey - Activities of Daily Living (KOS – ADL)
Timepoint [3] 351600 0
Baseline, 3, 6, 12, 24 months
Secondary outcome [4] 351601 0
Knee Injury and Osteoarthritis Outcome Score (KOOS)
Timepoint [4] 351601 0
Baseline, 3, 6, 12, 24 months
Secondary outcome [5] 351602 0
Modified Cincinnati Knee Rating System Questionnaire
Timepoint [5] 351602 0
Baseline, 3, 6, 12, 24 months
Secondary outcome [6] 351603 0
Lysholm Knee Score (LKS)
Timepoint [6] 351603 0
Baseline, 3, 6, 12, 24 months
Secondary outcome [7] 351604 0
Tegner Activity Scale (TAS)
Timepoint [7] 351604 0
Baseline, 3, 6, 12, 24 months
Secondary outcome [8] 351605 0
Anterior Cruciate Ligament Return to Sport after Injury (ACL-RSI) score
Timepoint [8] 351605 0
Baseline, 3, 6, 12, 24 months
Secondary outcome [9] 351606 0
Perth kneeling tolerance test
Timepoint [9] 351606 0
Baseline, 3, 6, 12, 24 months

Eligibility
Key inclusion criteria
• The individual is between the ages of 16 and 50 years.
• The individual clinically qualifies for ACLR surgery based on clinical examination and MRI.
• The individual has sustained the ACL tear within the last 12 months.
• The individual is not currently being treated for a psychiatric disorder, senile dementia, Alzheimer’s disease, presence of alcohol/substance abuse.
Minimum age
16 Years
Maximum age
50 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• The individual is unable or unwilling to sign the Patient Informed Consent, specific to this study, and approved by the Institutional Ethics Review Board.
• The individual is unable or unwilling to follow the designated rehabilitation protocol.
• The individual is classified as morbidly obese (>40 BMI).
• The individual is skeletally immature.
• The ACLR is combined with another ligament reconstruction or repair in the knee (multi- ligament knee reconstruction).
• Revision ACLR procedures.

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 is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created 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
A priori sample size has been calculated using the G*Power application. Alpha error was set at 0.05 and power was set at 0.80. Size was calculated based on a two-tailed difference of means. KT-1000 measured laxity was chosen as the primary end-point with a minimum clinically important difference of 1mm, and standard deviation of 2. To achieve the pre-set power the sample size required was found to be 51 per group. Assuming 10% lost to follow-up the total sample size to be recruited is n=112 (56 per surgical group).

Linear mixed models (with baseline value as a covariate and graft type as a fixed factor) will be used to evaluate the difference and 95% CI in the outcomes over the post-operative time periods. Bootstrapped standard errors will be used in case of skewed distributions.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
8/10/2018
Actual
16/04/2019
Date of last participant enrolment
Anticipated
30/12/2019
Actual
Date of last data collection
Anticipated
31/12/2021
Actual
Sample size
Target
112
Accrual to date
15
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 11757 0
Royal Perth Hospital - Perth
Recruitment hospital [2] 11758 0
Hollywood Private Hospital - Nedlands
Recruitment hospital [3] 11759 0
Bethesda Hospital - Claremont
Recruitment postcode(s) [1] 23850 0
6000 - Perth
Recruitment postcode(s) [2] 23851 0
6009 - Nedlands
Recruitment postcode(s) [3] 23852 0
6010 - Claremont

Funding & Sponsors
Funding source category [1] 300564 0
Commercial sector/Industry
Name [1] 300564 0
Perth Orthopaedic & Sports Medicine Centre
Country [1] 300564 0
Australia
Primary sponsor type
Individual
Name
Mr Ross Radic
Address
Perth Orthopaedic and Sports Medicine Centre
31 Outram St
West Perth, WA, 6005
Country
Australia
Secondary sponsor category [1] 300049 0
None
Name [1] 300049 0
Address [1] 300049 0
Country [1] 300049 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 301356 0
Royal Perth Hospital Human Research Ethics Committee
Ethics committee address [1] 301356 0
Ethics committee country [1] 301356 0
Australia
Date submitted for ethics approval [1] 301356 0
01/10/2018
Approval date [1] 301356 0
24/01/2019
Ethics approval number [1] 301356 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 86726 0
Mr Ross Radic
Address 86726 0
Perth Orthopaedic and Sports Medicine Centre
31 Outram St
West Perth, WA, 6005
Country 86726 0
Australia
Phone 86726 0
+61892124200
Fax 86726 0
Email 86726 0
[email protected]
Contact person for public queries
Name 86727 0
Ross Radic
Address 86727 0
Perth Orthopaedic and Sports Medicine Centre
31 Outram St
West Perth, WA, 6005
Country 86727 0
Australia
Phone 86727 0
+61892124200
Fax 86727 0
Email 86727 0
[email protected]
Contact person for scientific queries
Name 86728 0
Ross Radic
Address 86728 0
Perth Orthopaedic and Sports Medicine Centre
31 Outram St
West Perth, WA, 6005
Country 86728 0
Australia
Phone 86728 0
+61892124200
Fax 86728 0
Email 86728 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Individual participant data underlying published results only
When will data be available (start and end dates)?
From time of publication and ending 5 years following publication
Available to whom?
Researchers who provide a methodologically sound proposal
Available for what types of analyses?
Any purpose
How or where can data be obtained?
Access subject to approval of written request to Principal Investigator


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.