STABILITY 2: Anterior Cruciate Ligament Reconstruction +/- Lateral Tenodesis With Patellar vs Quad Tendon

Condition(s) studied

Investigational drug(s) / intervention(s)

Anterior cruciate ligament reconstruction (ACLR): All participants will undergo an anatomic ACLR with either a BPTB or QT autograft, as randomized.

Lateral extra-articular tenodesis (LET): Participants randomized to the BPTB or QT arms will be randomized a second time to a LET procedure or no additional surgery.

Study summary

Anterior cruciate ligament (ACL) rupture is one of the most common musculoskeletal injuries in young individuals, particularly those that are active in sports. Up to 30% of individuals under the age of 20 years suffer a re-injury to the reconstructed ACL. Revision ACLR has been associated with degeneration of the articular cartilage and increased rates of meniscal tears, increasing the risk of post-traumatic osteoarthritis (PTOA), additional surgical procedures, reduced physical function and quality of life. As such, strategies to reduce ACLR failure, particularly in young active individuals, are critical to improving short and long-term outcomes after ACL rupture.

There is ongoing debate about the optimal graft choice and reconstructive technique. Three autograft options are commonly used, including the bone-patellar-tendon-bone (BPTB), quadriceps tendon (QT) and hamstring tendon (HT). Additionally, a lateral extra-articular tenodesis (LET) may provide greater stability to the ACLR; however, its effect on failure rate is unclear and surgery-induced lateral compartment OA is a concern.

To definitively inform the choice of autograft and the need for a LET, this multicenter, international randomized clinical trial will randomly assign 1292 young, active patients at high risk of re-injury to undergo ACLR using BPTB or QT autograft with our without LET.

Eligibility

Primary outcome measure(s)

• ACLR Clinical Failure — 24 months
  This is a composite endpoint defined as 1) graft rupture or, 2) persistent rotational laxity (asymmetrical positive pivot shift).

Trial sites (31)

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