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Trial registered on ANZCTR


Registration number
ACTRN12616000708459
Ethics application status
Approved
Date submitted
29/02/2016
Date registered
27/05/2016
Date last updated
20/03/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
Clinical Outcome of Anterior Cruciate Ligament Plus Lateral Extra-articular Tenodesis Compared to Isolated Anterior Cruciate Ligament Reconstruction: A Feasibility Study
Scientific title
Clinical Outcome of Anterior Cruciate Ligament Plus Lateral Extra-articular Stabilisation Compared to Isolated Anterior Cruciate Ligament Reconstruction in 18 to 40 year old patients to compare the return to function and re-rupture rates between the two treatment modalities
Secondary ID [1] 287688 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Anterior cruciate ligament rupture 296525 0
Condition category
Condition code
Surgery 296786 296786 0 0
Surgical techniques
Injuries and Accidents 298307 298307 0 0
Other injuries and accidents
Musculoskeletal 298308 298308 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will be randomly allocated to one of two treatment arms by opening a sealed envelope. They will then undergo either i) ACL reconstruction using a 4-strand hamstring ACL graft and iliotibial band (ITB) lateral extra-articular tenodesis, or ii) isolated intra-articular ACL reconstruction with a 4-strand hamstring graft. The duration of each procedure is approximately 45-60 minutes and will be performed by the consultant orthopaedic surgeon and his team. Post-operatively, participants will undertake a standard rehabilitation protocol for ACL reconstruction. Following surgery, clinical reviews will be conducted at 6 weeks, 3 months, 6 months, 12 months and 2 years post-operatively. Participants will no longer receive the yearly questionnaire, as stated previously.
Intervention code [1] 293084 0
Treatment: Surgery
Comparator / control treatment
Active control - isolated ACL reconstruction
Control group
Active

Outcomes
Primary outcome [1] 296391 0
Functional outcome following ACL reconstruction plus lateral extra-articular tenodesis will be measured using functional knee outcome tests including International Knee Documentation Committee (IKDC) score, Lysholm score, Tegner activity scale, Knee injury, Osteoarthritis Outcome Score (KOOS) and hop test. Knee laxity will be assessed using KT1000. The results of these tests will be included as a composite primary outcome.
Timepoint [1] 296391 0
Clinical reviews will be conducted at 6 weeks, 3 months, 6 months, 12 months and 2 years post-operatively. Participants will no longer receive a questionnaire, as stated previously.
Primary outcome [2] 298382 0
Patient satisfaction will be assessed using Global Rating of Change Score and ACL Recovery Score designed specifically for this study.
Timepoint [2] 298382 0
Clinical reviews will be conducted at 6 weeks, 3 months, 6 months, 12 months and 2 years post-operatively. Participants will no longer receive a questionnaire, as stated previously.
Secondary outcome [1] 318317 0
Lower re-rupture rate following ACL reconstruction plus lateral extra-articular tenodesis. The integrity of the graft will be assessed through clinical examination of the participant's knee during each of the post-operative follow-up appointments. If there are any concerns, further radiological investigations will be organised, including an X-ray and/or an MRI scan.
Timepoint [1] 318317 0
Clinical reviews will be conducted at 6 weeks, 3 months, 6 months, 12 months and 2 years post-operatively.

Eligibility
Key inclusion criteria
For inclusion in the study patients must be aged between 18 and 40 years, have Grade 2 or 3 knee instability on pivot shift test and have a confirmed ACL tear on MRI scan. They must also be medically able to undergo a general or regional anaesthetic.
Minimum age
18 Years
Maximum age
40 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients with multi-ligament knee injury or any other ligaments requiring surgery will be excluded, along with people from non-English speaking backgrounds, those residing interstate or overseas and those who are unable to provide their own consent for any reason.

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)
Randomisation by sealed envelope
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using sealed envelopes
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
20/02/2017
Actual
7/03/2017
Date of last participant enrolment
Anticipated
31/10/2022
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 7551 0
Sir Charles Gairdner Hospital - Nedlands
Recruitment postcode(s) [1] 15442 0
6009 - Nedlands

Funding & Sponsors
Funding source category [1] 292244 0
Hospital
Name [1] 292244 0
Sir Charles Gairdner Hospital
Country [1] 292244 0
Australia
Primary sponsor type
Individual
Name
Toby Leys
Address
c/o Coastal Orthopaedics
Bethesda Hospital
25 Queenslea Drive
Claremont
WA 6010
Country
Australia
Secondary sponsor category [1] 291176 0
None
Name [1] 291176 0
Address [1] 291176 0
Country [1] 291176 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293708 0
Sir Charles Gairdner Group Human Research Ethics Committee
Ethics committee address [1] 293708 0
Sir Charles Gairdner Hospital
Hospital Avenue
Nedlands
WA 6009
Ethics committee country [1] 293708 0
Australia
Date submitted for ethics approval [1] 293708 0
01/06/2016
Approval date [1] 293708 0
01/11/2016
Ethics approval number [1] 293708 0
HREC No: 2015-144

Summary
Brief summary
The anterior cruciate ligament (ACL) is an important stabilizing ligament of the knee. It is also the most common knee ligament injury requiring surgery, with an annual incidence of approximately 1 in 3500 in the general population. Numerous technological advances have been made in recent times in the surgical techniques for ACL reconstruction but, in spite of this, the failure rate remains approximately 7-15% and many people do not return to full function in their knee after ACL reconstruction.

The anterolateral ligament (ALL), a structure located in the anterolateral part of the knee, has recently been identified as an important contributor to rotational stability of the knee in addition to the ACL. Loss of ALL integrity may be responsible for some cases of failure post-operatively. Although intra-articular ACL reconstruction remains the current gold standard for operative management, it does not address the extra-articular ALL deficiency and therefore does not restore normal knee kinematics.

The aim of this study is to compare the return to function and re-rupture rates following combined ACL reconstruction with lateral extra-articular tenodesis versus an isolated intra-articular ACL reconstruction.

Participants will be randomly allocated to one of two treatment arms by opening a sealed envelope. They will then undergo either i) ACL reconstruction using a 4-strand hamstring ACL graft and iliotibial band (ITB) lateral extra-articular tenodesis, or ii) isolated intra-articular ACL reconstruction with a 4-strand hamstring graft.

Following surgery, clinical reviews will be conducted at 6 weeks, 3 months, 6 months, 12 months and 2 years post-operatively during which the physiotherapist will make an assessment using a variety of objective knee scoring systems and a patient satisfaction survey. Any post-operative complications will also be recorded. Comparison will then be made to determine which technique has better functional outcome and lower re-rupture rate.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 61042 0
Mr Toby Leys
Address 61042 0
c/o Coastal Orthopaedics
Bethesda Hospital
25 Queenslea Drive
Claremont
WA 6010
Country 61042 0
Australia
Phone 61042 0
+61 411 411 359
Fax 61042 0
+61 8 9230 6332
Email 61042 0
[email protected]
Contact person for public queries
Name 61043 0
Toby Leys
Address 61043 0
c/o Coastal Orthopaedics
Bethesda Hospital
25 Queenslea Drive
Claremont
WA 6010
Country 61043 0
Australia
Phone 61043 0
+61 411 411 359
Fax 61043 0
+61 8 9230 6332
Email 61043 0
[email protected]
Contact person for scientific queries
Name 61044 0
Toby Leys
Address 61044 0
c/o Coastal Orthopaedics
Bethesda Hospital
25 Queenslea Drive
Claremont
WA 6010
Country 61044 0
Australia
Phone 61044 0
+61 8 9230 6333
Fax 61044 0
+61 8 9230 6332
Email 61044 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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