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

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 1236 young, active patients at high risk of re-injury to undergo ACLR using BPTB or QT autograft with our without LET.

Conditions

• Anterior Cruciate Ligament Injury
• Anterior Cruciate Ligament Reconstruction
• Joint Instability

Interventions

PROCEDURE

Anterior cruciate ligament reconstruction (ACLR)

All participants will undergo an anatomic ACLR with either a BPTB or QT autograft, as randomized.

PROCEDURE

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.

Sponsors & Collaborators

• University of Western Ontario, Canada

  collaborator OTHER

• National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

  collaborator NIH

• Canadian Institutes of Health Research (CIHR)

  collaborator OTHER_GOV

• University of Pittsburgh

  lead OTHER

Principal Investigators

• James J Irrgang, PT PhD FAPTA · University of Pittsburgh

• Alan Getgood, MD FRCS · Fowler Kennedy Sport Medicine Clinic, Western University, Department of Surgery

• Volker Musahl, MD · University of Pittsburgh

• Dianne M Bryant, PhD · Western University, School of Physical Therapy & Department of Surgery

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

14 Years

Max Age

25 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2020-07-28

Primary Completion

2027-06-30

Completion

2028-06-30

Countries

• United States
• Canada
• Denmark
• Germany
• Ireland
• Norway
• Sweden
• United Kingdom

Study Locations