ANZCTR - Registration

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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]

None

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Anterior cruciate ligament rupture

Condition category

Condition code

Surgery

Surgical techniques

Injuries and Accidents

Other injuries and accidents

Musculoskeletal

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]

Treatment: Surgery

Comparator / control treatment

Active control - isolated ACL reconstruction

Control group

Active

Outcomes

Primary outcome [1]

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]

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]

Patient satisfaction will be assessed using Global Rating of Change Score and ACL Recovery Score designed specifically for this study.

Timepoint [2]

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]

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]

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?

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

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

Recruitment hospital [1]

Sir Charles Gairdner Hospital - Nedlands

Recruitment postcode(s) [1]

6009 - Nedlands

Funding & Sponsors

Funding source category [1]

Hospital

Name [1]

Sir Charles Gairdner Hospital

Address [1]

Hospital Avenue
Nedlands
WA 6009

Country [1]

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]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Sir Charles Gairdner Group Human Research Ethics Committee

Ethics committee address [1]

Sir Charles Gairdner Hospital
Hospital Avenue
Nedlands
WA 6009

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

01/06/2016

Approval date [1]

01/11/2016

Ethics approval number [1]

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

Mr Toby Leys

Address

c/o Coastal Orthopaedics
Bethesda Hospital
25 Queenslea Drive
Claremont
WA 6010

Country

Australia

Phone

+61 411 411 359

Fax

+61 8 9230 6332

tobyleys@gmail.com

Contact person for public queries

Name

Toby Leys

Address

c/o Coastal Orthopaedics
Bethesda Hospital
25 Queenslea Drive
Claremont
WA 6010

Country

Australia

Phone

+61 411 411 359

Fax

+61 8 9230 6332

tobyleys@gmail.com

Contact person for scientific queries

Name

Toby Leys

Address

c/o Coastal Orthopaedics
Bethesda Hospital
25 Queenslea Drive
Claremont
WA 6010

Country

Australia

Phone

+61 8 9230 6333

Fax

+61 8 9230 6332

tobyleys@gmail.com

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

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

No additional documents have been identified.

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