The Stability study: a protocol for a multicenter randomized clinical trial comparing anterior cruciate ligament reconstruction with and without Lateral Extra-articular Tenodesis in individuals who are at high risk of graft failure

被引：42

作者：

Getgood, Alan ^{[1
,4
]}

Bryant, Dianne ^{[2
,4
]}

Firth, Andrew ^{[3
,4
]}

Litchfield, Robert ^{[4
]}

Willits, Kevin ^{[4
]}

Hewison, Chris ^{[4
]}

Kaniki, Nicole ^{[4
]}

Remtulla, Alliya ^{[4
]}

Wanlin, Stacey ^{[4
]}

Pinto, Ryan ^{[4
]}

Martindale, Ashley ^{[4
]}

O'Neill, Lindsey ^{[4
]}

Jennings, Morgan ^{[4
]}

Daniluk, Michal ^{[4
]}

Birmingham, Trevor ^{[4
]}

Boyer, Dory ^{[5
]}

McCormack, Bob ^{[5
]}

Zomar, Mauri ^{[5
]}

Moon, Karyn ^{[5
]}

Moon, Raely ^{[5
]}

Fan, Brenda ^{[5
]}

Mohan, Bindu ^{[5
]}

Heard, Mark ^{[6
]}

Buchko, Greg ^{[6
]}

Hiemstra, Laurie ^{[6
]}

Kerslake, Sarah ^{[6
]}

Heard, Meagan ^{[6
]}

MacDonald, Peter ^{[7
]}

Stranges, Greg ^{[7
]}

Mcrae, Sheila ^{[7
]}

Gullett, LeeAnne ^{[7
]}

Brown, Holly ^{[7
]}

Legary, Alexandra ^{[7
]}

Longo, Alison ^{[7
]}

Christian, Mat ^{[7
]}

Ferguson, Celeste ^{[7
]}

Rezansoff, Alex ^{[8
]}

Mohtadi, Nick ^{[8
]}

Barber, Rhamona ^{[8
]}

Chan, Denise ^{[8
]}

Campbell, Caitlin ^{[8
]}

Garven, Alexandra ^{[8
]}

Pulsifer, Karen ^{[8
]}

Mayer, Michelle ^{[8
]}

Peterson, Devin ^{[9
]}

Simunovic, Nicole ^{[9
]}

Duong, Andrew ^{[9
]}

Islam, Zakia ^{[9
]}

Bardana, Davide ^{[10
]}

Howells, Fiona ^{[10
]}

机构：

[1] Univ Western Ontario, Fowler Kennedy Sport Med Clin, 3M Ctr, 1151 Richmond St, London, ON N6A 3K7, Canada

[2] Univ Western Ontario, Elborn Coll, Fac Hlth Sci, Room 1438,1201 Western Rd, London, ON N6C 1H1, Canada

[3] Univ Western Ontario, 3M Ctr, Fowler Kennedy Sport Med Clin, 1151 Richmond St, London, ON N6A 3K7, Canada

[4] Western Univ, Fowler Kennedy Sport Med Clin, London Hlth Sci Ctr, London, ON, Canada

[5] Fraser Orthopaed Inst, New Westminster, BC, Canada

[6] Banff Sport Med, Banff, AB, Canada

[7] Pan Clin, Winnipeg, MB, Canada

[8] Univ Calgary, Sport Med Ctr, Calgary, AB, Canada

[9] McMaster Univ, Hamilton, ON, Canada

[10] Queens Univ, Kingston, ON, Canada

[11] Univ Hosp Coventry Warwickshire NHS Trust, Coventry, W Midlands, England

[12] Antwerp Orthopaed Ctr, Ghent, Belgium

来源：

BMC MUSCULOSKELETAL DISORDERS | 2019年 / 20卷 / 1期

关键词：

Orthopaedics; Anterior cruciate ligament (ACL) repair; Anterolateral ligament; Tenodesis; QUALITY-OF-LIFE; ACL RECONSTRUCTION; PATELLAR TENDON; OUTCOME MEASURE; YOUNGER PATIENTS; TIBIAL ROTATION; KNEE; INJURY; OSTEOARTHRITIS; METAANALYSIS;

D O I：

10.1186/s12891-019-2589-x

中图分类号：

R826.8 [整形外科学]; R782.2 [口腔颌面部整形外科学]; R726.2 [小儿整形外科学]; R62 [整形外科学（修复外科学）];

学科分类号：

摘要：

BackgroundThe purpose of anterior cruciate ligament reconstruction (ACLR) is to restore stability to the knee. Persistent rotational laxity following ACLR has been correlated with poor outcome and graft failure. We hypothesize that anterolateral complex reconstruction by way of a Modified Lemaire Lateral Extra-articular Tenodesis (LET) in combination with single bundle ACLR would reduce the risk of persistent rotatory laxity in young individuals who are deemed as being at high risk of failure. We will conduct a pragmatic, multicenter, randomized clinical trial comparing standard single bundle hamstring ACLR with combined ACLR and LET.MethodsSix-hundred patients (300 per group) aged 25years or less with an ACL deficient knee that meet two of the following three criteria will be included: 1) Grade 2 pivot shift or greater; 2) Returning to high risk cutting or pivoting sports; 3) Generalized ligamentous laxity. Participants will be seen at 3-months, 6-months, 12-months and 24-months post-operatively. The primary outcome measure is graft failure requiring revision ACLR or symptomatic instability associated with a positive asymmetric pivot shift indicating persistent rotational laxity. Patients will complete secondary outcome measures at each follow-up visit including patient-reported outcome measures, functional and biomechanical testing, and magnetic resonance imaging.DiscussionThis protocol is the first adequately powered randomized clinical trial investigating the effects of augmenting ACLR with an LET in patients at high-risk of graft failure. The successful completion of this trial has the potential to change surgical practice and provide evidence for the role of the LET in ACLR.Trial registrationThe trial is registered at ClinicalTrials.gov: NCT02018354, 23-12-2013.

引用

页数：11

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