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Trial registered on ANZCTR


Registration number
ACTRN12619001396112
Ethics application status
Approved
Date submitted
24/08/2019
Date registered
11/10/2019
Date last updated
11/10/2019
Date data sharing statement initially provided
11/10/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
A Comparison of the Outcomes of Quadriceps Autograft versus Hamstring Autograft For Use In Anterior Cruciate Ligament (ACL) Reconstruction
Scientific title
A Randomized Controlled Trial Comparing The Outcomes Of Quadriceps Autograft vs Hamstring Autograft In ACL Reconstruction
Secondary ID [1] 298840 0
none
Universal Trial Number (UTN)
U1111-1237-5472
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
ACL reconstruction 313791 0
Condition category
Condition code
Surgery 312206 312206 0 0
Other surgery
Musculoskeletal 312780 312780 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This is a randomised control trial comparing the outcomes of a quadriceps autograft versus a hamstring autograft for the treatment of ACL deficient knees in patients older than 15 years.

The Surgery will be performed by a Senior Consultant Orthopaedic Surgeon with at least 5 years experience. The patients will have an arthroscopic examination of the knee to ensure that they do not have any of the exclusion criteria. Then once they are determined to be eligible for the study an envelope will be opened which determines if a quadriceps or a hamstring tendon will be harvested. The ACL reconstruction will then be performed with the selected tendon. There is no significant difference in the time taken to harvest the quadriceps versus the hamstring tendon, with an approximate time of 45 minutes.

Hamstrings:
The Semitendinosus tendon is harvested from a 3 cm longitudinal incision over the pes anserine tendon origin utilizing an open tendon stripper. The Semi-tendinosis tendon is harvested and if a sufficient diameter and length was achieved, (length of at least 28cm and quadrupled diameter of at least 8 mm) the gracilis was left. However, if the length is not sufficient then the gracilis is harvested as well. The Semitendinosis is then prepared by incorporating the ABS tightrope. This is achieved by doubling up the tendon and whip stitching the ends together utilizing a fibre loop. The double loop is then quadrupled incorporating the RT tightrope. A 0 fibrewire suture is then placed 2cm from the end of the tendon at each end of the tendon. The suture goes through all the tendons and is then lopped around the graft. A so-called triple/double graft is prepared if both the gracilis and Semi-Tendinosus are prepared.

Quadriceps:
A full-thickness central slip of quadriceps tendon is harvested through a 3cm longitudinal incision over the proximal pole of the patella. A 10x7 mm Arthrex double blade is used to cut the central slip. The distal aspect is then released with a 15 Blade and the Cigar cutter utilized to strip proximally to a length of 7 cm and then cut. The proximal end is attached to an ABS tightrope using a fibrelink and the proximal aspect attached to a RT tightrope also utilizing a fibrelink.

Preparation and drilling of tunnels:
The ACL footprint in the notch is cleared with a shaver and electrocautery device to clearly see the back of the femoral condyle. The tibial stump of the ACL is removed.

For both techniques after graft harvest:
A 6/9 outside–in guide from Arthrex is utilized to place the femoral tunnel in the IDEAL position. The IDEAL femoral tunnel position aims to; replicate the most isometric fibres within the native ACL, be localized in the direct fibre subsection of the ACL origin base, be equidistant from the bottom and top of the notch with a tunnel back wall that is 1mm thick and eccentrically located high and deep within the footprint, be anatomic in position, and achieves a low tension-flexion pattern in the ACL graft, thus replicating the native tension-flexion behavior of the ACL. A flipcutter from Arthrex utilized to retrograde drill a tunnel of the measured diameter of the graft to a length of 25 mm. A fibrestick suture is passed and the loop is temporarily retrieved out of the lateral portal. An Arthrex tibial guide is used to drill an antegrade tunnel. The tibial guide angle is set at 55 degrees. A guide pin is inserted first and this is followed by a reamer diameter corresponding to the graft diameter plus 0.5mm, to help pull the graft through the tibia. The Femoral loop-passing suture is then retrieved through the tibial tunnel and the graft is delivered through the tibia into the femur. The RT button is flipped and pulled 1.5 cm into the femoral tunnel. The ABS button is then placed on the tibial side and tensioned ensuring 2 cm of length is in the tibial tunnel. Final tensioning of the RT button is then performed, pulling a further 5 mm into the femoral socket with the knee extended.

All surgeons will undergo cadaver training prior to the commencement of the study to ensure uniformity of surgical technique.

Post-operatively the patients will all undergo a standardised physiotherapy programme regardless of the tendon used for the reconstruction. Initially this consists of static quadriceps and hamstring exercises. Over the first 6 weeks gradual progression of range of motion, weight bearing progression and active assisted range quadriceps and hamstrings exercises. From 6 weeks onwards focus on strengthening and proprioceptive exercises. Physiotherapy will continue up to 6 months.

This will be a multi-centre randomised controlled trial with locations in Whangarei, Auckland and Christchurch.

The patients will have routine post-operative follow-ups at a prescribed time. There will be specific measurements of the stability of the reconstruction and strength testing of both the hamstrings and the quadriceps at the 1 year and 2 year mark
Intervention code [1] 315105 0
Treatment: Surgery
Comparator / control treatment
The control group is the group of patients who end up receiving a hamstring autograft as we are aiming to compare the outcome of the quadriceps autograft with respect to the hamstring autograft. Nil significant difference in the time for either procedure -similar duration of timing.

The same inclusion and exclusion criteria apply.
The same intervention as outlined above also applies
Control group
Active

Outcomes
Primary outcome [1] 320836 0
GNRB measurement of antero-posterior laxity of the knee
Timepoint [1] 320836 0
1 year post-surgery
Secondary outcome [1] 372997 0
Anterior knee pain Scale (AKPSA)
Timepoint [1] 372997 0
1 year post-surgery
Secondary outcome [2] 372998 0
MARX activity - this aims to find out the general level of activity of the patient
Timepoint [2] 372998 0
6 months, 1 year and 2 years post-surgery
Secondary outcome [3] 372999 0
Re-rupture rate based on reporting in the ACL registry
Timepoint [3] 372999 0
2 years post-surgery
Secondary outcome [4] 373000 0
Hamstring strength using a Biodex machine
Timepoint [4] 373000 0
1 year post-surgery
Secondary outcome [5] 373001 0
Presence of rotational laxity of the ACL as measured by Pivot shift test
Timepoint [5] 373001 0
1 year post surgery
Secondary outcome [6] 374874 0
KOOS score - five domains that looks at the outcomes following knee surgery with respect to pain, symptoms, activities of daily living, sporting and recreation function and knee related quality of life.
Timepoint [6] 374874 0
6 months, 1 year and 2 years post-surgery
Secondary outcome [7] 374875 0
KNEES-ACL score - patient outcome measure specific to the ACL function
Timepoint [7] 374875 0
6 months, 1 year and 2 years post-surgery
Secondary outcome [8] 374876 0
Quadriceps strength using a Biodex machine
Timepoint [8] 374876 0
1 year post-surgery
Secondary outcome [9] 375769 0
Hamstring strength as measured with a bode machine
Timepoint [9] 375769 0
1 year post-surgery

Eligibility
Key inclusion criteria
ACL deficiency with functional instability
Minimum age
15 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Concurrent other ligament injuries (PCL, Postero-lateral corner, Medial collateral ligament)
2. Contra-lateral knee ligament injury or previous surgery
3. Concurrent meniscal repair
4. Significant chondral damage (Outterbridge 2 or more)
5. Microfracture
6. Inability to understand/ read or answer the patient reported outcome forms
7. Peri-articular fractures (tibial plateau)
8. Neuro-vascular injuries
9. Revision ACL surgery
10. Patients requiring a lateral tenodesis or concurrent reconstruction of the anterolateral ligament (ie Grade 3 pivot shift and hyper-lax patients)
11. Previous hamstring/quadriceps injury or surgery
12. Concurrent injury preventing the ability to mobilise with crutches

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)
Sealed Opaque envelope
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Block randomization
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
The patients will be wearing an opaque stocking when they are assessed by the physiotherapist so the physiotherapist will be blinded to the graft choice.
The patients will not be told which graft was used in their situation.
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
An independent statistician performed a power analysis. A minimally important, clinically significant difference is determined to be >1.065mm between the two sides. However, a small number of patients (<20%) will have a difference of >3mm between sides. In order to not only account for the variability in the side-to-side difference, and power the study to 80% we require 15 patients per treatment arm at each centre, thus 90 patients total. We will add 10 extra patients per centre to account for any loss to follow-up. We will therefore recruit 120 patients in total.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
28/10/2019
Actual
Date of last participant enrolment
Anticipated
28/10/2020
Actual
Date of last data collection
Anticipated
22/08/2022
Actual
Sample size
Target
120
Accrual to date
Final
Recruitment outside Australia
Country [1] 21713 0
New Zealand
State/province [1] 21713 0
Whangarei
Country [2] 21861 0
New Zealand
State/province [2] 21861 0
Auckland
Country [3] 21862 0
New Zealand
State/province [3] 21862 0
Christchurch

Funding & Sponsors
Funding source category [1] 303389 0
Charities/Societies/Foundations
Name [1] 303389 0
Northland Orthopaedics Research Charitable Trust
Country [1] 303389 0
New Zealand
Primary sponsor type
Charities/Societies/Foundations
Name
Northland Orthopaedics Research Charitable Trust
Address
15 Kensington Ave, Kensington, Whangarei 0112
Country
New Zealand
Secondary sponsor category [1] 303426 0
None
Name [1] 303426 0
Address [1] 303426 0
Country [1] 303426 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 303918 0
Health and Disability Ethics Committee
Ethics committee address [1] 303918 0
Ethics committee country [1] 303918 0
New Zealand
Date submitted for ethics approval [1] 303918 0
25/07/2019
Approval date [1] 303918 0
27/08/2019
Ethics approval number [1] 303918 0
19/STH/139

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

Contacts
Principal investigator
Name 95246 0
Dr Jessica Mowbray
Address 95246 0
Orthopaedics Department
Whangarei Hospital, Maunu Rd, Private Bag 9742, Whangarei 0148
Country 95246 0
New Zealand
Phone 95246 0
+64 9 4304100
Fax 95246 0
Email 95246 0
jessica.mowbray@northlanddhb.govt.nz
Contact person for public queries
Name 95247 0
Jessica Mowbray
Address 95247 0
Orthopaedics Department
Whangarei Hospital, Maunu Rd, Private Bag 9742, Whangarei 0148
Country 95247 0
New Zealand
Phone 95247 0
+64 9 4304100
Fax 95247 0
Email 95247 0
jessica.mowbray@northlanddhb.govt.nz
Contact person for scientific queries
Name 95248 0
Jessica Mowbray
Address 95248 0
Orthopaedics Department
Whangarei Hospital, Maunu Rd, Private Bag 9742, Whangarei 0148
Country 95248 0
New Zealand
Phone 95248 0
+64 9 4304100
Fax 95248 0
Email 95248 0
jessica.mowbray@northlanddhb.govt.nz

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Participant data will be kept on an encrypted computer software system for the duration of the trial and for a 10 year period afterwards. Participants themselves will have access to the data upon request.


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.