Lateral Extra-articular Tenodesis Reduces Failure of Hamstring Tendon Autograft Anterior Cruciate Ligament Reconstruction: 2-Year Outcomes From the STABILITY Study Randomized Clinical Trial.

Adolescent Adult Anterior Cruciate Ligament Reconstruction Female Hamstring Tendons / transplantation Humans Joint Instability / surgery Knee Joint / surgery Male Prospective Studies Quality of Life Tenodesis Treatment Failure Young Adult
anterior cruciate ligament reconstruction anterolateral complex graft failure lateral extra-articular tenodesis young patients

Journal

The American journal of sports medicine
ISSN: 1552-3365
Titre abrégé: Am J Sports Med
Pays: United States
ID NLM: 7609541

Informations de publication

Date de publication:
02 2020
Historique:
pubmed: 16 1 2020
medline: 12 9 2020
entrez: 16 1 2020
Statut: ppublish

Résumé

Persistent anterolateral rotatory laxity after anterior cruciate ligament (ACL) reconstruction (ACLR) has been correlated with poor clinical outcomes and graft failure. We hypothesized that a single-bundle, hamstring ACLR in combination with a lateral extra-articular tenodesis (LET) would reduce the risk of ACLR failure in young, active individuals. Randomized controlled trial; Level of evidence, 1. This is a multicenter, prospective, randomized clinical trial comparing a single-bundle, hamstring tendon ACLR with or without LET performed using a strip of iliotibial band. Patients 25 years or younger with an ACL-deficient knee were included and also had to meet at least 2 of the following 3 criteria: (1) grade 2 pivot shift or greater, (2) a desire to return to high-risk/pivoting sports, (3) and generalized ligamentous laxity (GLL). The primary outcome was ACLR clinical failure, a composite measure of rotatory laxity or a graft rupture. Secondary outcome measures included the P4 pain scale, Marx Activity Rating Scale, Knee injury Osteoarthritis and Outcome Score (KOOS), International Knee Documentation Committee score, and ACL Quality of Life Questionnaire. Patients were reviewed at 3, 6, 12, and 24 months postoperatively. A total of 618 patients (297 males; 48%) with a mean age of 18.9 years (range, 14-25 years) were randomized. A total of 436 (87.9%) patients presented preoperatively with high-grade rotatory laxity (grade 2 pivot shift or greater), and 215 (42.1%) were diagnosed as having GLL. There were 18 patients lost to follow-up and 11 who withdrew (~5%). In the ACLR group, 120/298 (40%) patients sustained the primary outcome of clinical failure, compared with 72/291 (25%) in the ACLR+LET group (relative risk reduction [RRR], 0.38; 95% CI, 0.21-0.52; The addition of LET to a single-bundle hamstring tendon autograft ACLR in young patients at high risk of failure results in a statistically significant, clinically relevant reduction in graft rupture and persistent rotatory laxity at 2 years after surgery. NCT02018354 ( ClinicalTrials.gov identifier).

Sections du résumé

BACKGROUND
Persistent anterolateral rotatory laxity after anterior cruciate ligament (ACL) reconstruction (ACLR) has been correlated with poor clinical outcomes and graft failure.
HYPOTHESIS
We hypothesized that a single-bundle, hamstring ACLR in combination with a lateral extra-articular tenodesis (LET) would reduce the risk of ACLR failure in young, active individuals.
STUDY DESIGN
Randomized controlled trial; Level of evidence, 1.
METHODS
This is a multicenter, prospective, randomized clinical trial comparing a single-bundle, hamstring tendon ACLR with or without LET performed using a strip of iliotibial band. Patients 25 years or younger with an ACL-deficient knee were included and also had to meet at least 2 of the following 3 criteria: (1) grade 2 pivot shift or greater, (2) a desire to return to high-risk/pivoting sports, (3) and generalized ligamentous laxity (GLL). The primary outcome was ACLR clinical failure, a composite measure of rotatory laxity or a graft rupture. Secondary outcome measures included the P4 pain scale, Marx Activity Rating Scale, Knee injury Osteoarthritis and Outcome Score (KOOS), International Knee Documentation Committee score, and ACL Quality of Life Questionnaire. Patients were reviewed at 3, 6, 12, and 24 months postoperatively.
RESULTS
A total of 618 patients (297 males; 48%) with a mean age of 18.9 years (range, 14-25 years) were randomized. A total of 436 (87.9%) patients presented preoperatively with high-grade rotatory laxity (grade 2 pivot shift or greater), and 215 (42.1%) were diagnosed as having GLL. There were 18 patients lost to follow-up and 11 who withdrew (~5%). In the ACLR group, 120/298 (40%) patients sustained the primary outcome of clinical failure, compared with 72/291 (25%) in the ACLR+LET group (relative risk reduction [RRR], 0.38; 95% CI, 0.21-0.52;
CONCLUSION
The addition of LET to a single-bundle hamstring tendon autograft ACLR in young patients at high risk of failure results in a statistically significant, clinically relevant reduction in graft rupture and persistent rotatory laxity at 2 years after surgery.
REGISTRATION
NCT02018354 ( ClinicalTrials.gov identifier).

Identifiants

DOI: 10.1177/0363546519896333 PMID: 31940222
pubmed: 31940222
doi: 10.1177/0363546519896333
doi:

Banques de données

ClinicalTrials.gov
['NCT02018354']

Types de publication

Journal Article Multicenter Study Randomized Controlled Trial Research Support, Non-U.S. Gov't

Langues

eng

Sous-ensembles de citation

IM

Pagination

285-297

Commentaires et corrections

Type : CommentIn
Type : CommentIn

Auteurs

Alan M J Getgood (AMJ)

Investigation performed at The Fowler Kennedy Sport Medicine Clinic, Western University, London, Ontario, Canada.

Dianne M Bryant (DM)

Investigation performed at The Fowler Kennedy Sport Medicine Clinic, Western University, London, Ontario, Canada.

Robert Litchfield (R)

Investigation performed at The Fowler Kennedy Sport Medicine Clinic, Western University, London, Ontario, Canada.

Mark Heard (M)

Investigation performed at The Fowler Kennedy Sport Medicine Clinic, Western University, London, Ontario, Canada.

Robert G McCormack (RG)

Investigation performed at The Fowler Kennedy Sport Medicine Clinic, Western University, London, Ontario, Canada.

Alex Rezansoff (A)

Investigation performed at The Fowler Kennedy Sport Medicine Clinic, Western University, London, Ontario, Canada.

Devin Peterson (D)

Investigation performed at The Fowler Kennedy Sport Medicine Clinic, Western University, London, Ontario, Canada.

Davide Bardana (D)

Investigation performed at The Fowler Kennedy Sport Medicine Clinic, Western University, London, Ontario, Canada.

Peter B MacDonald (PB)

Investigation performed at The Fowler Kennedy Sport Medicine Clinic, Western University, London, Ontario, Canada.

Peter C M Verdonk (PCM)

Investigation performed at The Fowler Kennedy Sport Medicine Clinic, Western University, London, Ontario, Canada.

Tim Spalding (T)

Investigation performed at The Fowler Kennedy Sport Medicine Clinic, Western University, London, Ontario, Canada.
Investigation performed at The Fowler Kennedy Sport Medicine Clinic, Western University, London, Ontario, Canada.

Kevin Willits (K)

Investigation performed at The Fowler Kennedy Sport Medicine Clinic, Western University, London, Ontario, Canada.

Trevor Birmingham (T)

Investigation performed at The Fowler Kennedy Sport Medicine Clinic, Western University, London, Ontario, Canada.

Chris Hewison (C)

Investigation performed at The Fowler Kennedy Sport Medicine Clinic, Western University, London, Ontario, Canada.

Stacey Wanlin (S)

Investigation performed at The Fowler Kennedy Sport Medicine Clinic, Western University, London, Ontario, Canada.

Andrew Firth (A)

Investigation performed at The Fowler Kennedy Sport Medicine Clinic, Western University, London, Ontario, Canada.

Ryan Pinto (R)

Investigation performed at The Fowler Kennedy Sport Medicine Clinic, Western University, London, Ontario, Canada.

Ashley Martindale (A)

Investigation performed at The Fowler Kennedy Sport Medicine Clinic, Western University, London, Ontario, Canada.

Lindsey O'Neill (L)

Investigation performed at The Fowler Kennedy Sport Medicine Clinic, Western University, London, Ontario, Canada.

Morgan Jennings (M)

Investigation performed at The Fowler Kennedy Sport Medicine Clinic, Western University, London, Ontario, Canada.

Michal Daniluk (M)

Investigation performed at The Fowler Kennedy Sport Medicine Clinic, Western University, London, Ontario, Canada.

Dory Boyer (D)

Investigation performed at The Fowler Kennedy Sport Medicine Clinic, Western University, London, Ontario, Canada.

Mauri Zomar (M)

Investigation performed at The Fowler Kennedy Sport Medicine Clinic, Western University, London, Ontario, Canada.

Karyn Moon (K)

Investigation performed at The Fowler Kennedy Sport Medicine Clinic, Western University, London, Ontario, Canada.

Raely Pritchett (R)

Investigation performed at The Fowler Kennedy Sport Medicine Clinic, Western University, London, Ontario, Canada.

Krystan Payne (K)

Investigation performed at The Fowler Kennedy Sport Medicine Clinic, Western University, London, Ontario, Canada.

Brenda Fan (B)

Investigation performed at The Fowler Kennedy Sport Medicine Clinic, Western University, London, Ontario, Canada.

Bindu Mohan (B)

Investigation performed at The Fowler Kennedy Sport Medicine Clinic, Western University, London, Ontario, Canada.

Gregory M Buchko (GM)

Investigation performed at The Fowler Kennedy Sport Medicine Clinic, Western University, London, Ontario, Canada.

Laurie A Hiemstra (LA)

Investigation performed at The Fowler Kennedy Sport Medicine Clinic, Western University, London, Ontario, Canada.

Sarah Kerslake (S)

Investigation performed at The Fowler Kennedy Sport Medicine Clinic, Western University, London, Ontario, Canada.

Jeremy Tynedal (J)

Investigation performed at The Fowler Kennedy Sport Medicine Clinic, Western University, London, Ontario, Canada.

Greg Stranges (G)

Investigation performed at The Fowler Kennedy Sport Medicine Clinic, Western University, London, Ontario, Canada.

Sheila Mcrae (S)

Investigation performed at The Fowler Kennedy Sport Medicine Clinic, Western University, London, Ontario, Canada.

LeeAnne Gullett (L)

Investigation performed at The Fowler Kennedy Sport Medicine Clinic, Western University, London, Ontario, Canada.

Holly Brown (H)

Investigation performed at The Fowler Kennedy Sport Medicine Clinic, Western University, London, Ontario, Canada.

Alexandra Legary (A)

Investigation performed at The Fowler Kennedy Sport Medicine Clinic, Western University, London, Ontario, Canada.

Alison Longo (A)

Investigation performed at The Fowler Kennedy Sport Medicine Clinic, Western University, London, Ontario, Canada.

Mat Christian (M)

Investigation performed at The Fowler Kennedy Sport Medicine Clinic, Western University, London, Ontario, Canada.

Celeste Ferguson (C)

Investigation performed at The Fowler Kennedy Sport Medicine Clinic, Western University, London, Ontario, Canada.

Nick Mohtadi (N)

Investigation performed at The Fowler Kennedy Sport Medicine Clinic, Western University, London, Ontario, Canada.

Rhamona Barber (R)

Investigation performed at The Fowler Kennedy Sport Medicine Clinic, Western University, London, Ontario, Canada.

Denise Chan (D)

Investigation performed at The Fowler Kennedy Sport Medicine Clinic, Western University, London, Ontario, Canada.

Caitlin Campbell (C)

Investigation performed at The Fowler Kennedy Sport Medicine Clinic, Western University, London, Ontario, Canada.

Alexandra Garven (A)

Investigation performed at The Fowler Kennedy Sport Medicine Clinic, Western University, London, Ontario, Canada.

Karen Pulsifer (K)

Investigation performed at The Fowler Kennedy Sport Medicine Clinic, Western University, London, Ontario, Canada.

Michelle Mayer (M)

Investigation performed at The Fowler Kennedy Sport Medicine Clinic, Western University, London, Ontario, Canada.

Nicole Simunovic (N)

Investigation performed at The Fowler Kennedy Sport Medicine Clinic, Western University, London, Ontario, Canada.

Andrew Duong (A)

Investigation performed at The Fowler Kennedy Sport Medicine Clinic, Western University, London, Ontario, Canada.

David Robinson (D)

Investigation performed at The Fowler Kennedy Sport Medicine Clinic, Western University, London, Ontario, Canada.

David Levy (D)

Investigation performed at The Fowler Kennedy Sport Medicine Clinic, Western University, London, Ontario, Canada.

Matt Skelly (M)

Investigation performed at The Fowler Kennedy Sport Medicine Clinic, Western University, London, Ontario, Canada.

Ajaykumar Shanmugaraj (A)

Investigation performed at The Fowler Kennedy Sport Medicine Clinic, Western University, London, Ontario, Canada.

Fiona Howells (F)

Investigation performed at The Fowler Kennedy Sport Medicine Clinic, Western University, London, Ontario, Canada.

Murray Tough (M)

Investigation performed at The Fowler Kennedy Sport Medicine Clinic, Western University, London, Ontario, Canada.

Tim Spalding (T)

Investigation performed at The Fowler Kennedy Sport Medicine Clinic, Western University, London, Ontario, Canada.

Pete Thompson (P)

Investigation performed at The Fowler Kennedy Sport Medicine Clinic, Western University, London, Ontario, Canada.

Andrew Metcalfe (A)

Investigation performed at The Fowler Kennedy Sport Medicine Clinic, Western University, London, Ontario, Canada.

Laura Asplin (L)

Investigation performed at The Fowler Kennedy Sport Medicine Clinic, Western University, London, Ontario, Canada.

Alisen Dube (A)

Investigation performed at The Fowler Kennedy Sport Medicine Clinic, Western University, London, Ontario, Canada.

Louise Clarkson (L)

Investigation performed at The Fowler Kennedy Sport Medicine Clinic, Western University, London, Ontario, Canada.

Jaclyn Brown (J)

Investigation performed at The Fowler Kennedy Sport Medicine Clinic, Western University, London, Ontario, Canada.

Alison Bolsover (A)

Investigation performed at The Fowler Kennedy Sport Medicine Clinic, Western University, London, Ontario, Canada.

Carolyn Bradshaw (C)

Investigation performed at The Fowler Kennedy Sport Medicine Clinic, Western University, London, Ontario, Canada.

Larissa Belgrove (L)

Investigation performed at The Fowler Kennedy Sport Medicine Clinic, Western University, London, Ontario, Canada.

Francis Millan (F)

Investigation performed at The Fowler Kennedy Sport Medicine Clinic, Western University, London, Ontario, Canada.

Sylvia Turner (S)

Investigation performed at The Fowler Kennedy Sport Medicine Clinic, Western University, London, Ontario, Canada.

Sarah Verdugo (S)

Investigation performed at The Fowler Kennedy Sport Medicine Clinic, Western University, London, Ontario, Canada.

Janet Lowe (J)

Investigation performed at The Fowler Kennedy Sport Medicine Clinic, Western University, London, Ontario, Canada.

Debra Dunne (D)

Investigation performed at The Fowler Kennedy Sport Medicine Clinic, Western University, London, Ontario, Canada.

Kerri McGowan (K)

Investigation performed at The Fowler Kennedy Sport Medicine Clinic, Western University, London, Ontario, Canada.

Charlie-Marie Suddens (CM)

Investigation performed at The Fowler Kennedy Sport Medicine Clinic, Western University, London, Ontario, Canada.

Geert Declercq (G)

Investigation performed at The Fowler Kennedy Sport Medicine Clinic, Western University, London, Ontario, Canada.

Kristien Vuylsteke (K)

Investigation performed at The Fowler Kennedy Sport Medicine Clinic, Western University, London, Ontario, Canada.

Mieke Van Haver (M)

Investigation performed at The Fowler Kennedy Sport Medicine Clinic, Western University, London, Ontario, Canada.

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Classifications MeSH

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