Mid- to Long-term Results of Single-Bundle Versus Double-Bundle Anterior Cruciate Ligament Reconstruction: Randomized Controlled Trial

doi:10.1016/j.arthro.2014.07.020

Arthroscopy: The Journal of Arthroscopic & Related Surgery

Volume 31, Issue 1, January 2015, Pages 69-76

https://doi.org/10.1016/j.arthro.2014.07.020 Get rights and content

Purpose

To evaluate the mid-to long-term results of a randomized controlled trial of single-bundle (SB) versus double-bundle (DB) anterior cruciate ligament (ACL) reconstruction using a semitendinosus tendon.

Methods

Seventy-eight patients who underwent primary ACL reconstruction with an autologous semitendinosus tendon were prospectively randomized into 2 groups: SB reconstruction (n = 39) and DB reconstruction (n = 39). In both groups, grafts were fixed at 30° of flexion with a total tension of 80 N. The following evaluation methods were used: clinical examination, KT-1000 arthrometer (MEDmetric, San Diego, CA) measurement, muscle strength, Tegner activity score, Lysholm score, subjective rating scale regarding patient satisfaction and sports performance level, graft retear, contralateral ACL tear, and additional meniscus surgery.

Results

Fifty-three patients (25 in SB group and 28 in DB group) who were followed up for a minimum of 3 years (mean, 69 months; range, 36 to 140 months) were evaluated. Preoperatively, there were no differences between the groups. Postoperatively, the Lachman and pivot-shift test results were better in the DB group (P = .024 and P < .0001, respectively). KT measurements were better in the DB group (mean, 1.4 mm v 2.7 mm; P = .0023). The Tegner score was also better in the DB group (P = .033). There were no significant differences in range of motion, muscle strength, Lysholm score, subjective rating scale, graft retear, and secondary meniscal tear.

Conclusions

In ACL reconstruction using the transtibial approach, DB reconstruction was significantly better than SB reconstruction regarding anterior and rotational stability during the 3- to 12-year follow-up. The results of KT measurements and the Lachman and pivot-shift tests were significantly better in the DB group, whereas there was no difference in the anterior drawer test results. The Tegner score was also better in the DB group; however, there were no differences in the other subjective findings.

Level of Evidence

Level II, lesser-quality prospective randomized trial.

Section snippets

Patients

We performed collection of the baseline data at our institution between July 2002 and March 2004. The inclusion criteria were primary ACL reconstruction with an autologous semitendinosus tendon. The exclusion criteria included a history of injury to the ipsilateral knee and a history of ligamentous injury to the contralateral knee. The patients were then randomized by their birth dates by a senior attending surgeon (T. Muneta) who performed the surgical procedure; therefore the surgeon was not

Results

Eighty-four patients met the inclusion criteria, and 6 patients were excluded according to the exclusion criteria. Seventy-eight patients were randomized by their birth dates. SB reconstruction was selected in patients with odd-numbered birth dates (SB group, n = 39), and DB reconstruction was selected in those with even-numbered birth dates (DB group, n = 39). Among these patients, 10 were lost to follow-up within 1 year (5 in the SB group and 5 in the DB group), and finally, there were 25

Discussion

The most important finding of this study was that DB ACL reconstruction was significantly better than SB reconstruction regarding anterior and rotational stability during the 3- to 12-year follow-up. In this study the mid-to long-term results of a randomized controlled trial of SB versus DB ACL reconstruction using a semitendinosus tendon were evaluated. Our primary hypothesis was validated because negative Lachman and pivot-shift test results were found in more patients in the DB group than in

Conclusions

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Cited by (48)

The Patient Acceptable Symptomatic State in Primary Anterior Cruciate Ligament Reconstruction: Predictors of Achievement
2021, Arthroscopy - Journal of Arthroscopic and Related Surgery
Citation Excerpt :
Recent literature suggests that the location of the intra-articular tunnel aperture may be more consequential than the technique used.50 Studies examining outcomes after ACLR have generally demonstrated significant improvements across legacy PROMs at various follow-up time points,51-53 although a recent review has suggested no statistically significant improvements beyond the 1-year follow-up.54 In addition, previous studies have examined patient satisfaction in ACLR,50,55 reporting rates exceeding 80% at the 2-year follow-up.56,57
To identify thresholds for patient acceptable symptomatic state (PASS) achievement in a cohort of primary anterior cruciate ligament reconstruction (ACLR) recipients, and to identify factors predictive of PASS achievement.
A prospective clinical registry was queried for primary ACLR patients from January 2014 to April 2017 with serial patient-reported outcome measure (PROM) completion at 6, 12, and 24 months. Exclusion criteria included significant concomitant procedures. Knee-based PROMs included the International Knee Documentation Committee (IKDC) score and Knee Injury and Osteoarthritis Outcome Score (KOOS) subscores. PASS threshold values were calculated using receiver operating characteristic (ROC) curves with area under the curve (AUC) analysis. A stepwise multivariate regression identified preoperative and operative predictors of PASS achievement.
A total of 144 primary ACLR patients (30.86 ± 12.78 years, body mass index 25.51 ± 4.64, 41.0% male) were included in the analysis. PASS threshold values were established using ROC curve analysis, all of which exceeded 0.7 on AUC analysis (0.742 to 0.911). Factors impacting odds of PASS achievement in the ACLR cohort included preoperative exercises (odds ratio [OR] 2.95 to 4.74, P = .003 to .038), worker’s compensation status (OR 0.25 to 0.28, P = .014 to .033), preoperative scores (OR 1.03 to 1.07, P = .005 to <.001), iliotibial band tenodesis (OR 11.08, P = .010), and anteromedial approach (OR 18.03 to 37.05, P < .001).
Factors predictive of PASS achievement in recipients of primary ACLR include functional status (e.g., preoperative exercise, preoperative KOOS Sport/Recreation score), worker’s compensation status, technique (e.g., anteromedial) and preoperative PROMs. The results of our study are important in better informing shared decision-making models and improving evidence-based guidelines to optimize patient outcomes.
Risk factors for postoperative graft laxity without re-injury after double-bundle anterior cruciate ligament reconstruction in recreational athletes
2021, Knee
Citation Excerpt :
The number of ACL reconstructions has increased in patients younger than 20 years and in those 40 years or older [1], implying that not only younger athletes but also older, recreational athletes have recently been undergoing more ACL reconstructions. Although some biomechanical studies show that double-bundle (DB) ACL reconstruction yields more normal knee kinematics with respect to rotational stability than single-bundle (SB) reconstruction [2–4], the clinical superiority of DB reconstruction remains controversial [5–11]. Nevertheless, current treatment strategies cannot completely prevent graft failure and subsequent revision surgery.
Although high activity is a risk factor for graft failure after anterior cruciate ligament (ACL) reconstruction, the risk factors for postoperative laxity after ACL reconstruction in recreational athletes are unknown.
We enrolled 91 patients (40 males, 51 females; mean age 29.2 years; mean follow-up 4.3 years) who scored ≤ 6 on the Tegner activity scale, underwent double-bundle ACL reconstruction between 2010 and 2018, and did not experience re-injury. In the stable group (75 patients, <3.0 mm side-to-side difference (SSD) in anterior translation, grade 0 or 1 pivot shift 1 year after surgery) and unstable group (16 patients, ≥3.0 mm SSD, ≥grade 2 pivot shift), multivariate logistic regression analyses adjusted for factors showing P ≤ 0.3 on univariate analysis assessed risk factors for graft laxity. Lysholm score and graft intensity on MRI (Howell grade) were compared at final follow-up.
Mean SSD in anterior translation was 0.7 mm (stable group) and 3.3 mm (unstable group). Pivot shift grades were 0 (88%) and 1 (12%) in the stable group, and 0 (12.5%), 1 (50%), and 2 (37.5%) in the unstable group. Multivariate regression analyses showed that younger age and knee hyperextension were significant risk factors for graft laxity (P = 0.018 and 0.0016; cutoffs 18 years old and 8°, respectively). Lysholm scores in both groups were comparable, but graft intensity on MRI demonstrated significantly worse Howell grade in the unstable group (P = 0.002).
Younger age and knee hyperextension were risk factors for postoperative graft laxity without re-injury in recreational athletes.
The long-term outcomes of different grafts in anterior cruciate ligament reconstruction: a network meta-analysis
2021, Journal of Orthopaedic Translation
Citation Excerpt :
We further screened these studies and excluded unmatched group dividing studies, studies with no available or relative data, studies with incomplete data, studies with short-term follow-up and other studies needed to be excluded according to the search strategy. Finally, 30 studies were included [12,60–73,75–79,81–89,92]. A total of five different graft types were included in the included studies, and the corresponding letters used in this study are shown in Table 2.
To compare the long-term prognosis of patients with different types of grafts used in anterior cruciate ligament reconstruction (ACLR).
PubMed, Ovid (MEDLINE and Embase) and the Cochrane library were searched up to Feb 2020. Eligible studies about different grafts in ACLR were searched for identifying the evidence comparing the long-term (mean or median follow-up time or the general description of the follow-up time≥2 years) knee outcomes of different grafts for ACLR. The final included articles and evaluation criteria were confirmed by the authors and senior clinicians to ensure the validity of the included articles. Lysholm score, the results of pivot shift test, Lachman test and International Knee Documentation Committee (IKDC) evaluation were selected as prognostic indicators. A Bayesian network meta-analysis was conducted.
A total of 30 articles were included in our network meta-analysis. Finally, we found that artificial graft or augmentation can provide the not bad Lysholm score but the worse result of IKDC evaluation for patients with ACLR compared with other types of grafts. Double-bundle hamstring autograft can provide a good Lysholm score as well as lower positive rate of pivot shift test and Lachman test. Patellar tendon autograft can provide the better result of IKDC evaluation. The patients with allogeneic tendon graft may get the higher positive rate of pivot shift test and Lachman test. Patients with single-bundle hamstring autograft may get the ordinary result of IKDC evaluation and Lysholm score.
Double-bundle hamstring autograft may be a better choice because of more items of good prognosis for the patients with ACLR. Patellar tendon autograft is a right choice which only shows the disadvantage on the Lysholm score. The prognosis of patients with single-bundle hamstring autograft is ordinary. The effect of artificial graft or augmentation needs more evidence to prove. Allogeneic tendon graft is not a better choice when compared with other grafts referred in our network meta-analysis.
In this study, we made a comprehensive comparison of the grafts commonly used in anterior cruciate ligament reconstruction. The evidence presented in this study provides a reference for clinicians to select a suitable anterior cruciate ligament graft.
Single-Bundle Versus Double-Bundle Anterior Cruciate Ligament Reconstruction—5-Year Results
2018, Arthroscopy - Journal of Arthroscopic and Related Surgery
To compare anatomic single-bundle (SB) with double-bundle (DB) anterior cruciate ligament reconstruction (ACL-R) and to evaluate the respective clinical outcome results.
In a prospective randomized study, 64 patients were included and separated into 2 groups. Anatomic SB and DB ACL-Rs were performed with hamstring tendons. Five years after surgery, the follow-up (FU) examination comprised International Knee Documentation Committee (IKDC) 2000, Laxitester (ORTEMA Sport Protection, Markgroeningen, Germany) measurement, and radiograph evaluation. Power calculation was performed to achieve a 95% confidence interval and 80% power on the base of 7-point IKDC subjective difference between the groups.
A total of 53 patients (83% FU) were examined at 63.2 ± 4.7 months after surgery: 28 patients in the DB group and 25 patients in the SB group. IKDC subjective (SB: 92.8 ± 6.2, DB: 91.6 ± 7.1; P = .55) and objective scores (grade A SB/DB 20%/25%, B SB/DB 72%/57%, C SB/DB 8%/18%, D SB/DB 4%/0%; P = .45) showed no differences comparing both groups. The Laxitester measurements showed no significant difference in regard to anterior-posterior translation in neutral, internal, and external rotation or to rotation angles (P = .79). No difference was seen between the groups regarding osteoarthritic changes and tunnel widening.
At the 5-year FU, no advantage for either the DB or SB technique in ACL-R can be seen with regard to patient-related and objective outcome measures.
Level I, prospective randomized controlled clinical trial.
A Systematic Review of Single-Versus Double-Bundle Results
2018, The Anterior Cruciate Ligament: Reconstruction and Basic Science: Second Edition
This chapter summarizes the most important results of studies comparing single- and double-bundle reconstruction.
Both in terms of rotatory laxity and AP laxity all significant objective findings except two are in favor of double-bundle reconstruction. Thus, there is a trend toward less knee laxity after double-bundle reconstruction.
Few significant results are found in terms of PROMs, however the significant outcome differences found are all in favor of double-bundle reconstruction.
Little differences are found comparing ROM, strength and OA. However, double-bundle reconstruction appears to result in faster resumption to sport.
Outcomes After Double-Bundle Anterior Cruciate Ligament Reconstruction
2018, Arthroscopy - Journal of Arthroscopic and Related Surgery
To identify the risk factors predicting unsatisfactory postoperative clinical outcomes after double-bundle (DB) anterior cruciate ligament (ACL) reconstruction using multivariate logistic regression.
Inclusion criteria were consecutive DB ACL reconstructions from January 2006 to September 2012 with a minimum 3-year follow-up. Exclusion criteria included (1) a delay to surgery from initial injury of more than 4 years (210 weeks); (2) contralateral knee pathology; (3) the lack of postoperative 3-dimensional computed tomography; (4) single-bundle ACL reconstruction; (5) revision ACL reconstruction; (6) meniscus allograft transplantation after total or subtotal meniscectomy; (7) multiple ligament surgeries. According to the overall International Knee Documentation Committee (IKDC) rating at the last follow-up, we sorted all enrolled subjects into superior (IKDC grade A or B) and inferior outcome groups (IKDC grade C or D). Multivariate logistic regression was used to analyze risk factors, including age, gender, body mass index, time from injury to surgery, posterior tibial slope, notch width index, cartilage injury, meniscus injury, and femoral and tibial tunnel positions.
In comparison between the superior outcome group (n = 240) and inferior outcome group (n = 50), anterior (adjusted odds ratio [OR]: 0.902, 95% confidence interval [CI]: 0.846-0.962) or distal (adjusted OR: 1.025, 95% CI: 1.006-1.060) femoral anteromedial tunnel position was a significant risk factor for the inferior outcomes. Partial meniscectomy of medial (adjusted OR: 49.002, 95% CI: 7.047-340.717) or lateral (adjusted OR: 14.974, 95% CI: 2.181-102.790) meniscus and delayed time from injury to surgery (adjusted OR: 1.062, 95% CI: 1.023-1.102) were also a significant predictor.
Anterior or distal anteromedial femoral tunnel position, partial meniscectomy of medial or lateral meniscus, and prolonged surgical delay of more than 11.5 weeks from injury were significant risk factors for the inferior clinical outcomes after DB ACL reconstruction.
Level III, retrospective therapeutic case series.

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: The authors report that they have no conflicts of interest in the authorship and publication of this article.

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Original ArticleMid- to Long-term Results of Single-Bundle Versus Double-Bundle Anterior Cruciate Ligament Reconstruction: Randomized Controlled Trial

Purpose

Methods

Results

Conclusions

Level of Evidence

Section snippets

Patients

Results

Discussion

Conclusions

Knee

Arthroscopy

Arthroscopy

Arthroscopy

Injury

Arthroscopy

Arthroscopy

The effect of graft fixation angles on anteroposterior and rotational knee laxity in double-bundle anterior cruciate ligament reconstruction: Evaluation using computerized navigation

Am J Sports Med

Biomechanical analysis of an anatomic anterior cruciate ligament reconstruction

Am J Sports Med

The effectiveness of reconstruction of the anterior cruciate ligament with hamstrings and patellar tendon. A cadaveric study comparing anterior tibial and rotational loads

J Bone Joint Surg Am

Reconstruction of the anterior cruciate ligament. Single- versus double-bundle multistranded hamstring tendons

J Bone Joint Surg Br

Comparison between single-and double-bundle anterior cruciate ligament reconstruction: A prospective, randomized, single-blinded clinical trial

Am J Sports Med

A prospective randomised study of anatomical single-bundle versus double-bundle anterior cruciate ligament reconstruction: Quantitative evaluation using an electromagnetic measurement system

Int Orthop

Anterior cruciate ligament reconstruction using autologous hamstring double bundle graft compared with single bundle procedures

J Bone Joint Surg Br

Double-bundle versus single-bundle ACL reconstruction using the horizontal femoral position: A prospective, randomized study

Knee Surg Sports Traumatol Arthrosc

Prospective comparative study of anterior cruciate ligament reconstruction using the double-bundle and single-bundle techniques

Am J Sports Med

Reconstruction of the ACL with a semitendinosus tendon graft: A prospective randomized single blinded comparison of double-bundle versus single-bundle technique in male athletes

Knee Surg Sports Traumatol Arthrosc

Original Article
Mid- to Long-term Results of Single-Bundle Versus Double-Bundle Anterior Cruciate Ligament Reconstruction: Randomized Controlled Trial