Clinical Trials in the Spotlight Main Page.

Study Description

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. Recently, the quadriceps tendon (QT) has become a popular graft choice claiming stability equivocal to BPTB but without donor site morbidity. This study evaluates 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.

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.

ELIGIBILITY CRITERIA:

Ages Eligible for Study: up to 25 Years (Child, Adult)

Sexes Eligible for Study: All

Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• An ACL-deficient knee,
• Skeletal maturity (i.e. closed epiphyseal growth plates on standard knee radiographs) but no older than 25 years of age,
• At least two of the following: participate in a competitive pivoting sport; have a pivot shift of grade 2 or greater; have generalized ligamentous laxity (Beighton score of ≥4) and/or genu recurvatum >10 degrees.

Exclusion Criteria:

• Previous ACLR on either knee,
• Multiple ligament injury (two or more ligaments requiring surgery),
• Symptomatic articular cartilage defect requiring treatment other than debridement,
• >3 degrees of asymmetric varus,
• Inability to provide consent.

Study Design:

Allocation: Randomized

Intervention Model: Parallel Assignment

Masking: Single (Outcomes Assessor)

Primary Purpose: Treatment

Study Location(s):

University of Minnesota, Minneapolis, Minnesota, United States, 55455

Mayo Clinic, Rochester, Minnesota, United States, 55905

Missouri Orthopaedic Institute, Columbia, Missouri, United States, 65201

Wake Forest University School of Medicine, Winston-Salem, North Carolina, United States, 27101

University of Pittsburgh, Pittsburgh, Pennsylvania, United States, 15260

The Rector and Visitors of the University of Virginia, Charlottesville, Virginia, United States, 22903

Antwerp Orthopedic Center, Antwerp, Belgium, 2018

Banff Sport Medicine Clinic, Banff, Alberta, Canada, T1L 1B3

University of Calgary Sport Medicine Centre, Calgary, Alberta, Canada, T2N 1N4

Fraser Health Authority, New Westminster, British Columbia, Canada, V3L 5P5

Pan Am Clinic, Winnipeg, Manitoba, Canada, R3M 3E4

McMaster University, Hamilton, Ontario, Canada, L8N 3Z5

Queen's University, Kingston, Ontario, Canada, K7L 2V7

Fowler Kennedy Sport Medicine Clinic, London, Ontario, Canada, N6A 3K7

University of Ottawa, Ottawa, Ontario, Canada, K1N 6N5

St. Michael's Hospital, Toronto, Ontario, Canada, M5B 1W8

University Klinik Münster, Münster, Germany, 48149

Oslo University Hospital, Oslo, Norway, 0372

Sahlgrenska Institute, Gothenburg, Sweden, MXP4+W7

Stockholm South Hospital, Karolinska Institutet, Stockholm, Sweden, 922M+CC

University Hospitals Coventry and Warwickshire NHS Trust, Coventry, United Kingdom, CV2 2DX

Study Website:

https://clinicaltrials.gov/ct2/show/NCT03935750?term=NCT03935750&draw=2&rank=1