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

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...

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Vydáno v:The American journal of sports medicine Ročník 48; číslo 2; s. 285
Hlavní autoři: Getgood, Alan M J, Bryant, Dianne M, Litchfield, Robert, Heard, Mark, McCormack, Robert G, Rezansoff, Alex, Peterson, Devin, Bardana, Davide, MacDonald, Peter B, Verdonk, Peter C M, Spalding, Tim, Willits, Kevin, Birmingham, Trevor, Hewison, Chris, Wanlin, Stacey, Firth, Andrew, Pinto, Ryan, Martindale, Ashley, O'Neill, Lindsey, Jennings, Morgan, Daniluk, Michal, Boyer, Dory, Zomar, Mauri, Moon, Karyn, Pritchett, Raely, Payne, Krystan, Fan, Brenda, Mohan, Bindu, Buchko, Gregory M, Hiemstra, Laurie A, Kerslake, Sarah, Tynedal, Jeremy, Stranges, Greg, Mcrae, Sheila, Gullett, LeeAnne, Brown, Holly, Legary, Alexandra, Longo, Alison, Christian, Mat, Ferguson, Celeste, Mohtadi, Nick, Barber, Rhamona, Chan, Denise, Campbell, Caitlin, Garven, Alexandra, Pulsifer, Karen, Mayer, Michelle, Simunovic, Nicole, Duong, Andrew, Robinson, David, Levy, David, Skelly, Matt, Shanmugaraj, Ajaykumar, Howells, Fiona, Tough, Murray, Thompson, Pete, Metcalfe, Andrew, Asplin, Laura, Dube, Alisen, Clarkson, Louise, Brown, Jaclyn, Bolsover, Alison, Bradshaw, Carolyn, Belgrove, Larissa, Millan, Francis, Turner, Sylvia, Verdugo, Sarah, Lowe, Janet, Dunne, Debra, McGowan, Kerri, Suddens, Charlie-Marie, Declercq, Geert, Vuylsteke, Kristien, Van Haver, Mieke
Médium: Journal Article
Jazyk:angličtina
Vydáno: United States 01.02.2020
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ISSN:1552-3365, 1552-3365
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Abstract 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; < .0001). A total of 45 patients experienced graft rupture, 34/298 (11%) in the ACLR group compared with 11/291 (4%) in the ACL+LET group (RRR, 0.67; 95% CI, 0.36-0.83; < .001). The number needed to treat with LET to prevent 1 patient from graft rupture was 14.3 over the first 2 postoperative years. At 3 months, patients in the ACLR group had less pain as measured by the P4 ( = .003) and KOOS ( = .007), with KOOS pain persisting in favor of the ACLR group to 6 months ( = .02). No clinically important differences in patient-reported outcome measures were found between groups at other time points. The level of sports activity was similar between groups at 2 years after surgery, as measured by the Marx Activity Rating Scale ( = .11). 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).
AbstractList 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; < .0001). A total of 45 patients experienced graft rupture, 34/298 (11%) in the ACLR group compared with 11/291 (4%) in the ACL+LET group (RRR, 0.67; 95% CI, 0.36-0.83; < .001). The number needed to treat with LET to prevent 1 patient from graft rupture was 14.3 over the first 2 postoperative years. At 3 months, patients in the ACLR group had less pain as measured by the P4 ( = .003) and KOOS ( = .007), with KOOS pain persisting in favor of the ACLR group to 6 months ( = .02). No clinically important differences in patient-reported outcome measures were found between groups at other time points. The level of sports activity was similar between groups at 2 years after surgery, as measured by the Marx Activity Rating Scale ( = .11). 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).
Persistent anterolateral rotatory laxity after anterior cruciate ligament (ACL) reconstruction (ACLR) has been correlated with poor clinical outcomes and graft failure.BACKGROUNDPersistent 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.HYPOTHESISWe 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.STUDY DESIGNRandomized 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.METHODSThis 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; P < .0001). A total of 45 patients experienced graft rupture, 34/298 (11%) in the ACLR group compared with 11/291 (4%) in the ACL+LET group (RRR, 0.67; 95% CI, 0.36-0.83; P < .001). The number needed to treat with LET to prevent 1 patient from graft rupture was 14.3 over the first 2 postoperative years. At 3 months, patients in the ACLR group had less pain as measured by the P4 (P = .003) and KOOS (P = .007), with KOOS pain persisting in favor of the ACLR group to 6 months (P = .02). No clinically important differences in patient-reported outcome measures were found between groups at other time points. The level of sports activity was similar between groups at 2 years after surgery, as measured by the Marx Activity Rating Scale (P = .11).RESULTSA 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; P < .0001). A total of 45 patients experienced graft rupture, 34/298 (11%) in the ACLR group compared with 11/291 (4%) in the ACL+LET group (RRR, 0.67; 95% CI, 0.36-0.83; P < .001). The number needed to treat with LET to prevent 1 patient from graft rupture was 14.3 over the first 2 postoperative years. At 3 months, patients in the ACLR group had less pain as measured by the P4 (P = .003) and KOOS (P = .007), with KOOS pain persisting in favor of the ACLR group to 6 months (P = .02). No clinically important differences in patient-reported outcome measures were found between groups at other time points. The level of sports activity was similar between groups at 2 years after surgery, as measured by the Marx Activity Rating Scale (P = .11).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.CONCLUSIONThe 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).REGISTRATIONNCT02018354 ( ClinicalTrials.gov identifier).
Author Millan, Francis
Declercq, Geert
Van Haver, Mieke
Asplin, Laura
Wanlin, Stacey
Daniluk, Michal
Vuylsteke, Kristien
Zomar, Mauri
Simunovic, Nicole
Dunne, Debra
Moon, Karyn
Martindale, Ashley
Gullett, LeeAnne
Thompson, Pete
Dube, Alisen
Bryant, Dianne M
Firth, Andrew
Heard, Mark
MacDonald, Peter B
Metcalfe, Andrew
Rezansoff, Alex
Payne, Krystan
Pinto, Ryan
Campbell, Caitlin
Suddens, Charlie-Marie
Pritchett, Raely
Tynedal, Jeremy
Tough, Murray
O'Neill, Lindsey
Mayer, Michelle
Birmingham, Trevor
Levy, David
Buchko, Gregory M
McCormack, Robert G
Verdonk, Peter C M
Chan, Denise
Brown, Jaclyn
Skelly, Matt
Boyer, Dory
Spalding, Tim
Legary, Alexandra
Bolsover, Alison
Litchfield, Robert
Hewison, Chris
Brown, Holly
Mohan, Bindu
Turner, Sylvia
Garven, Alexandra
Bradshaw, Carolyn
Ferguson, Celeste
Robinson, David
Belgrove, Larissa
Mohtadi, Nick
Peterson, Devin
Clarkson, Louise
Willits, Kevin
Bardana, Davide
Stranges, Greg
Fan, Brenda
Longo, Alison
Getgood, Alan M J
Christian, Mat
Hiemstra, Laurie A
Mcrae, Sheila
Pulsifer, Karen
Lowe, Janet
Howells, Fiona
Shanmugara
AuthorAffiliation Investigation performed at The Fowler Kennedy Sport Medicine Clinic, Western University, London, Ontario, Canada
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  organization: Investigation performed at The Fowler Kennedy Sport Medicine Clinic, Western University, London, Ontario, Canada
– sequence: 70
  givenname: Kerri
  surname: McGowan
  fullname: McGowan, Kerri
  organization: Investigation performed at The Fowler Kennedy Sport Medicine Clinic, Western University, London, Ontario, Canada
– sequence: 71
  givenname: Charlie-Marie
  surname: Suddens
  fullname: Suddens, Charlie-Marie
  organization: Investigation performed at The Fowler Kennedy Sport Medicine Clinic, Western University, London, Ontario, Canada
– sequence: 72
  givenname: Geert
  surname: Declercq
  fullname: Declercq, Geert
  organization: Investigation performed at The Fowler Kennedy Sport Medicine Clinic, Western University, London, Ontario, Canada
– sequence: 73
  givenname: Kristien
  surname: Vuylsteke
  fullname: Vuylsteke, Kristien
  organization: Investigation performed at The Fowler Kennedy Sport Medicine Clinic, Western University, London, Ontario, Canada
– sequence: 74
  givenname: Mieke
  surname: Van Haver
  fullname: Van Haver, Mieke
  organization: Investigation performed at The Fowler Kennedy Sport Medicine Clinic, Western University, London, Ontario, Canada
BackLink https://www.ncbi.nlm.nih.gov/pubmed/31940222$$D View this record in MEDLINE/PubMed
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Keywords anterolateral complex
lateral extra-articular tenodesis
anterior cruciate ligament reconstruction
young patients
graft failure
Language English
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PublicationTitle The American journal of sports medicine
PublicationTitleAlternate Am J Sports Med
PublicationYear 2020
References 33208644 - J Bone Joint Surg Am. 2020 Nov 18;102(22):2009
32003642 - Am J Sports Med. 2020 Feb;48(2):281-284
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Snippet Persistent anterolateral rotatory laxity after anterior cruciate ligament (ACL) reconstruction (ACLR) has been correlated with poor clinical outcomes and graft...
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StartPage 285
SubjectTerms 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
Title Lateral Extra-articular Tenodesis Reduces Failure of Hamstring Tendon Autograft Anterior Cruciate Ligament Reconstruction: 2-Year Outcomes From the STABILITY Study Randomized Clinical Trial
URI https://www.ncbi.nlm.nih.gov/pubmed/31940222
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