# STABILITY 2: ACL Reconstruction +/- Lateral Tenodesis with Patellar vs. Quad Tendon

> **NIH NIH U01** · UNIVERSITY OF PITTSBURGH AT PITTSBURGH · 2020 · $648,412

## Abstract

Project Summary/Abstract
Rationale: Anterior cruciate ligament reconstruction (ACLR) is complicated by high failure rates in young
active individuals. Failure of ACLR is associated with limited activity, reduced quality of life, increased
socioeconomic costs and higher rates of osteoarthritis (OA). A lateral extra-articular tenodesis (LET) may
provide greater stability to the ACLR; but, its effect on failure rate is unclear and surgery-induced lateral
compartment OA is a concern. A meta-analysis suggests that bone-patellar-tendon-bone (BPTB) grafts
provide better stability compared to a hamstring tendon (HT) grafts, albeit with greater donor site
morbidity. Recently, the quadriceps tendon (QT) has become a popular graft choice claiming stability
equivocal to BPTB but without donor site morbidity. By evaluating whether one graft is superior at
reducing failure rates and minimizing donor site morbidity and by determining whether the addition of an
LET contributes to reduced failure, this study (STABILITY 2) addresses NIAMS’ mission to contribute to
knowledge related to the treatment and prevention of arthritis and NIH’s mission to enhance health and
reduce disability.
Specific Aims:
1. To determine if graft type (QT, BPTB or HT) with or without a LET affects the rate of graft failure 2 years
 after ACLR.
2. To determine if graft type (QT, BPTB or HT) with or without a LET affects patient-reported symptoms,
 function & QOL, performance-based measures of function and return-to-sports 2 years after ACLR.
3. To determine if graft type (QT, BPTB or HT) with or without LET affects rates of intervention-related
 donor site morbidity, complications and adverse outcomes 2 years after ACLR.
4. To determine if the addition of a particular graft type (QT, BPTB or HT) with or without a LET is a more
 cost-effective approach to ACLR.
Methods: This study will include 21 sites across the USA, Canada, and Europe and will randomly assign
1200 patients to either QT (+/- LET) or BPTB (+/- LET). Randomization will be stratified by surgeon, sex
and the status of the meniscus. Patients will follow a standardized rehabilitation protocol. Outcomes will be
assessed over two years postoperative by a blinded evaluator and include failure status, functional
performance, patient-reported function, quality of life and return-to-sport; presence of donor site morbidity,
lateral joint space narrowing; and costs associated with failure. Data from a previously performed HT+/-
LET RCT (STABILITY 1) will be combined with STABILITY 2 data. Analyses will follow intention-to-treat
and primarily consist of mixed effects modeling.

## Key facts

- **NIH application ID:** 10020168
- **Project number:** 5U01AR076144-02
- **Recipient organization:** UNIVERSITY OF PITTSBURGH AT PITTSBURGH
- **Principal Investigator:** JAMES JOHN IRRGANG
- **Activity code:** U01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $648,412
- **Award type:** 5
- **Project period:** 2019-09-17 → 2025-08-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10020168

## Citation

> US National Institutes of Health, RePORTER application 10020168, STABILITY 2: ACL Reconstruction +/- Lateral Tenodesis with Patellar vs. Quad Tendon (5U01AR076144-02). Retrieved via AI Analytics 2026-05-22 from https://api.ai-analytics.org/grant/nih/10020168. Licensed CC0.

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