ANZCTR - Registration

Reset your password and enable multi-factor authentication (MFA)

For ANZCTR account holders: to help ensure the cyber safety of your account, you’ll need to reset your password and set-up multi-factor authentication (MFA) as per the instructions below.

Go to the Login page, click ‘reset password’ and follow the instructions.
Check your email for the link to set a new password.
Create a new password that meets requirements.
Return to the Login page and enter your new password. A verification code will be sent to your email.
Check your email for the code and enter it on the Login page. If the code is entered incorrectly, you can re-enter the correct one or request a new one.

Learn more about MFA and its importance on the Australian Signals Directorate website.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers

Trial registered on ANZCTR

Registration number

ACTRN12625000668404p

Ethics application status

Submitted, not yet approved

Date submitted

6/06/2025

Date registered

25/06/2025

Date last updated

25/06/2025

Date data sharing statement initially provided

25/06/2025

Type of registration

Prospectively registered

Titles & IDs

Public title

Anterior Cruciate Ligament Stratified Accelerated Repair or Reconstruction (ACL STARR Aus)

Scientific title

Anterior Cruciate Ligament Stratified Accelerated Repair or Reconstruction (ACL STARR-AUS): Single-blind randomised controlled trial for patients with proximal ACL injuries treatment with ACL Repair v ACL Reconstruction

Secondary ID [1]

None

Universal Trial Number (UTN)

Trial acronym

ACL STARR Aus

Linked study record

The mirror UK ACL STARR trial is registered under ISRCTN24078391.

Health condition

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

Anterior cruciate ligament injuries

Condition category

Condition code

Surgery

Surgical techniques

Musculoskeletal

Other muscular and skeletal disorders

Injuries and Accidents

Other injuries and accidents

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

ACL Repair - is conducted with the ligament being stitched back onto the bone.
An orthopaedic surgeon will do this procedure, with surgery time anticipated to be ~1-2 hours.
Investigators will complete study-specific report forms related to the surgery which can be verified against operative reports.

Intervention code [1]

Treatment: Surgery

Comparator / control treatment

ACL Reconstruction - is conducted by replacing the torn ACL with other tissue (e.g. hamstring graft), to act as a replacement.
An orthopaedic surgeon will do this procedure, with surgery time anticipated to be ~1-2 hours.
Investigators will complete study-specific report forms related to the surgery which can be verified against operative reports.

Control group

Active

Outcomes

Primary outcome [1]

Knee functional outcome (self-reported)

Timepoint [1]

24 months post-surgery

Secondary outcome [1]

Determine the cost-effectiveness of ACL Repair compared with ACL Reconstruction from a health system perspective, in patients with recent proximal ACL ruptures

Timepoint [1]

baseline (pre-surgery), 6, 12 & 24 months post-surgery.

Secondary outcome [2]

Knee related emotional functioning following ACL Repair or Reconstruction surgery

Timepoint [2]

baseline (pre-surgery), 6, 12 & 24 months post-surgery.

Secondary outcome [3]

Surgeon confidence in the ACL surgery performed

Timepoint [3]

day of surgery

Secondary outcome [4]

Post-operative pain following ACL Repair and Reconstruction

Timepoint [4]

3 and 6 weeks post-surgery

Secondary outcome [5]

Return to activity / level of sports following ACL Repair or Reconstruction surgery and time to return to sport

Timepoint [5]

baseline (pre-surgery), 6, 12 & 24 months post-surgery.

Secondary outcome [6]

Patient satisfaction with the outcome of treatment following ACL Repair or Reconstruction surgery

Timepoint [6]

12 & 24 months post-surgery

Secondary outcome [7]

Complication profile and rate for ACL Repair and Reconstruction in the management of recent proximal ACL tears.

Timepoint [7]

day of surgery, 6, 12, 24 months post-surgery

Secondary outcome [8]

Evaluate outcomes related to the knee and changes to scores over time

Timepoint [8]

6, 12 & 24 months post-surgery

Secondary outcome [9]

Surgical complications

Timepoint [9]

day of surgery, 6, 12, 24 months post-surgery

Secondary outcome [10]

Return to sport

Timepoint [10]

12 & 24 months post-surgery

Eligibility

Key inclusion criteria

1. Patients aged 14 years and above
2. Willing & able to provide informed consent and comply with study procedures
3. Proximal ACL tear pattern diagnosed by MRI suitable for both repair or reconstruction*
4. Willing to accept either study arm allocation
*A proximal tear will be diagnosed on review of the MRI scan, and eligibility will be confirmed intra-operatively on arthroscopic inspection, to confirm a Sherman Type 1 or Type 2 tear and acceptable tissue quality for repair (i.e. an intact synovial sheath surrounding the torn ACL as a single unit).

Minimum age

14 Years

Maximum age

No limit

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

A patient with not be eligible for the study if ANY of the following apply:
1. History of knee major soft tissue surgery
a. Have had previous knee surgery (other than diagnostic arthroscopy or partial meniscectomy) to the index knee,
2. Concomitant severe injury to the contra-lateral knee
3. High grade multi ligament injury
a. High grade injuries to other ligaments (i.e. medial collateral, lateral collateral, posterior cruciate) in the knee (Grade >2).
4. Surgeon decision – patient not considered clinically appropriate for ACL Repair (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)

central randomisation by computer

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Permuted block randomisation

Masking / blinding

Who is / are masked / blinded?

Intervention assignment

Parallel

Other design features

Phase

Not Applicable

Type of endpoint/s

Statistical methods / analysis

Recruitment

Recruitment status

Not yet recruiting

Date of first participant enrolment

Anticipated

4/08/2025

Actual

Date of last participant enrolment

Anticipated

30/09/2026

Actual

Date of last data collection

Anticipated

30/09/2028

Actual

Sample size

Target

214

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

ACT,NSW,QLD,SA,WA,VIC

Funding & Sponsors

Funding source category [1]

Government body

Name [1]

NHMRC

Address [1]

Country [1]

Australia

Primary sponsor type

University

Name

University of Sydney

Address

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Submitted, not yet approved

Ethics committee name [1]

Sydney Local Health District Ethics Review Committee (RPAH Zone)

Ethics committee address [1]

https://www.slhd.nsw.gov.au/rpa/research/

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

23/06/2025

Approval date [1]

Ethics approval number [1]

Summary

Brief summary

There are different surgical options for people with an ACL injury. The most common is reconstruction, which uses tissue from other parts of the body, such as the hamstrings, to act as a replacement. This is a successful operation but does involve damage to bones from drilling holes, removal of tissue from elsewhere in the body, and does not keep any of the torn ligament which has potentially useful nerve endings. 
Modern ACL repair (stitching) is relatively new and, despite clear potential, has not been fully evaluated. It remains unknown whether it confers any of the theoretical benefits. We aim to conduct a comparative study to find out which is the best technique, reconstructing the ligament or repairing it. The research question is: For patients with recent proximal ACL ruptures (where the ligament has pulled directly off the bone), is ACL repair superior to ACL reconstruction at 24 months post-surgery? This will be measured by a questionnaire relating to the knee called KOOS-4.

Trial website

Trial related presentations / publications

Public notes

This study is a mirror study to the UK-based ACL Repair vs Reconstruction Study (ACL STARR). The current study will be undertaken as funded by the NHMRC (conducted to the same core protocol) in Australia, coordinated within the NHMRC Clinical Trials Centre (CTC), Sydney. This study will be conducted and reported separately from ACL STARR (UK), with a view to combining de-identified data for a meta-analysis.

Contacts

Principal investigator

Name

Prof David Beard

Address

NHMRC Clinical Trials Centre (CTC), Level 6, Lifehouse, 119-143 Missenden Rd, Camperdown NSW 2050

Country

Australia

Phone

+61 2 9562 5000

Fax

[email protected]

Contact person for public queries

Name

Ms Clare Toms

Address

NHMRC Clinical Trials Centre (CTC), Level 6, Lifehouse, 119-143 Missenden Rd, Camperdown NSW 2050

Country

Australia

Phone

+61 2 9562 5000

Fax

[email protected]

Contact person for scientific queries

Name

David Beard

Address

NHMRC Clinical Trials Centre (CTC), Level 6, Lifehouse, 119-143 Missenden Rd, Camperdown NSW 2050

Country

Australia

Phone

+61 2 9562 5000

Fax

[email protected]

Data sharing statement

Will the study consider sharing individual participant data?

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.

Trial Review

Documents added manually

Documents added automatically