Lateral Extra-Articular Tenodesis Reduces Failure of Hamstring Tendon Autograft ACL Reconstruction -Two Year Outcomes from the STABILITY Study Randomized Clinical Trial

Abstract

Objectives: Persistent anterolateral rotatory laxity following anterior cruciate ligament reconstruction (ACLR) has been correlated with poor outcome and graft failure. We hypothesized that anterolateral complex reconstruction by way of a 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. Methods: This is a pragmatic, multicenter, randomized clinical trial comparing standard hamstring tendon ACLR with combined ACLR and LET, utilizing a strip of iliotibial band (Modified Lemaire). Patients aged 25 years or less with an ACL deficient knee were included. They also had to have two of the following three criteria: 1) Grade 2 pivot shift or greater; 2) Returning to high risk/pivoting sports; 3) Generalized ligamentous laxity. The primary outcome was graft failure defined as either the need for revision ACLR or symptomatic instability associated with a positive asymmetric pivot shift, indicating persistent rotational laxity. Secondary outcome measures included the P4 pain scale, KOOS, IKDC. Patients were followed for two years with visits at 3, 6, 12 and 24 months postoperatively. A sample size of 300 per group was calculated based on a relative reduction in graft failure by 40%, with type 1 error of 5%, 80% power and 15% loss to follow-up rate. Results: 624 patients were randomized with a mean age of 18.9 (range: 14-25), 293 male. 436 (87.9%) patients presented pre-operatively with high-grade rotatory laxity (grade 2 pivot or greater) and 215 (42.1%) were diagnosed as having generalized ligamentous laxity (Beighton Score of 4 or greater). 523 of the 624 patients are at least 2 years postoperative; 29 lost to follow-up (˜5%). In the ACLR group 104/252 (41%) of patients suffered the primary outcome compared to 61/242 (25%) of the ACLR+LET patients (RR=0.61, 95%CI 0.47 to 0.79), p<0.0001. 39 patients suffered graft rupture, 28/252 (11%) in the ACLR group compared to 11/242 (4.5%) in the ACL+LET group (RR=0.41, 95%CI 0.21 to 0.80, p<0.001). At 3 months postoperative, patients in the ACLR group had less pain (p=0.004); at 3 and 6 months all KOOS subdomains, the IKDC favored the ACLR alone group (p=0.03). At 12 and 24 months, no important between-group differences were observed in any patient reported outcome. Conclusion: The addition of LET to a hamstring autograft ACLR in young active patients significantly reduces graft failure and persistent anterolateral rotatory laxity at 2 years post operatively.

Combined Anterior Cruciate Ligament Reconstruction and Lateral Extra-Articular Tenodesis in Skeletally Immature Patients: Surgical Technique

“…The addition of lateral extra-articular augmentation procedures in combination with ACL reconstructions have yielded encouraging early results in adults, including significantly lower graft failure rates without compromising subjective patient outcomes. 10 , 16 These procedures have garnered particular interest in high-risk patient populations, including pediatric patients, those with a high grade pivot shift, patients with soft-tissue grafts with open physes, generalized ligamentous laxity, those undergoing revision ACL reconstruction, and high-level athletes participating in a sport that requires pivoting. Recent studies have reported that isolated ACL reconstructions in pediatric athletes have a 10% to 25% graft re-rupture rate, with less than 70% of patients reported to return to sport.…”

“…4,9 Although the specific indications for the use of these procedures are controversial, recent literature has reported that this surgical augmentation significantly reduces the risk of ACL reconstruction failure. 10,11 In a randomized control trial, primary ACL reconstructions with a hamstring autograft had a 2-year failure rate of 11%, whereas ACL reconstructions with a combined LET (modified Lemaire technique) had a 4.5% failure rate without any difference in subjective patient-reported outcomes. 10 Biomechanical studies have shown that both of these anterolateral complex procedures significantly reduce internal tibial rotation and anterolateral rotary instability, and when combined with ACL reconstructions, are able to restore anterior tibial translation to comparable amounts seen in native, healthy knees.…”

“…10,11 In a randomized control trial, primary ACL reconstructions with a hamstring autograft had a 2-year failure rate of 11%, whereas ACL reconstructions with a combined LET (modified Lemaire technique) had a 4.5% failure rate without any difference in subjective patient-reported outcomes. 10 Biomechanical studies have shown that both of these anterolateral complex procedures significantly reduce internal tibial rotation and anterolateral rotary instability, and when combined with ACL reconstructions, are able to restore anterior tibial translation to comparable amounts seen in native, healthy knees. 1 Because of the anatomic location of the anterolateral ligament and its proximity to the epiphyseal growth plates, an ALL reconstruction, in particular with larger transosseous tunnel/interference screw fixation, is not recommended in the pediatric population.…”

“… 4 , 9 Although the specific indications for the use of these procedures are controversial, recent literature has reported that this surgical augmentation significantly reduces the risk of ACL reconstruction failure. 10 , 11 In a randomized control trial, primary ACL reconstructions with a hamstring autograft had a 2-year failure rate of 11%, whereas ACL reconstructions with a combined LET (modified Lemaire technique) had a 4.5% failure rate without any difference in subjective patient-reported outcomes. 10 …”

“… 10 , 11 In a randomized control trial, primary ACL reconstructions with a hamstring autograft had a 2-year failure rate of 11%, whereas ACL reconstructions with a combined LET (modified Lemaire technique) had a 4.5% failure rate without any difference in subjective patient-reported outcomes. 10 …”