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

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

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12625000668404
Acronym
ACL STARR Aus
Enrollment
214
Registered
2025-06-25
Start date
2025-12-15
Completion date
2026-09-30
Last updated
2025-12-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

Interventions

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.

Sponsors

University of Sydney
Lead SponsorUniversity

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment

Eligibility

Sex/Gender
All
Age
14 Years to No maximum
Healthy volunteers
No

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).

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)

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026