Comparative Risk-Benefit Profiles of Individual Devices for Graft Fixation in Anterior Cruciate Ligament Reconstruction: A Systematic Review and Network Meta-analysis

doi:10.1016/j.arthro.2020.04.023

Arthroscopy: The Journal of Arthroscopic & Related Surgery

Volume 36, Issue 7, July 2020, Pages 1953-1972

https://doi.org/10.1016/j.arthro.2020.04.023 Get rights and content

Purpose

To compare the efficacy and safety of individual devices for femoral and/or tibial graft fixation in anterior cruciate ligament (ACL) reconstruction.

Methods

The PubMed, Embase, Cochrane Library, and Web of Science databases were searched from inception to December 12, 2018. Randomized controlled trials comparing individual devices for ACL graft fixation were included. Bayesian network meta-analysis was performed to assess the efficacy profile using the following outcomes: Lysholm score, International Knee Documentation Committee (IKDC) category, laxity, range of motion, and Tegner score. The incidence of infection, effusion, and graft rupture for each device was reported.

Results

We included 57 randomized controlled trials involving 4,304 patients aged 23.8 to 40.9 years. The female proportion ranged from 0% to 100%. The length of follow-up ranged from 6 to 144 months. Of the 13 studied femoral fixation devices, none was significantly different from the others regarding the Lysholm score, IKDC category, range of motion, and Tegner score. Bioabsorbable interference screws (standardized mean difference, 1.3; 95% credible interval, 0.0-2.5) showed higher laxity than the EndoPearl at a borderline level of statistical significance, but the difference varied substantially within multiple sensitivity analyses. Infection (2.0%) was most commonly seen with the EndoPearl, whereas the bone mulch screw had the highest incidence of effusion (5.5%) and graft rupture (5.5%). For the 9 studied tibial fixation devices, no significant difference was observed in the aforementioned efficacy measurements. Bioabsorbable interference screws with staples had the highest incidence of infection (11.1%) and effusion (15.6%), whereas graft rupture was most commonly seen with the bone plug (4.0%).

Conclusions

Graft fixation devices in ACL reconstruction share a similar efficacy profile in terms of the Lysholm score, IKDC category, range of motion, and Tegner score but not laxity. On the other hand, safety profiles seem to vary among different devices. These findings can support surgeons, alongside their experience and preference, as well as the relative cost of each device, in delivering an individualized plan for an optimal operation.

Level of Evidence

Level II, meta-analysis of Level I and II studies.

Section snippets

Protocol

The Preferred Reporting Items for Systematic Reviews and Meta-analyses (PRISMA) statement for NMA³⁰ and our protocol, registered with PROSPERO, were followed when reporting this study.

Literature Search

Systematic literature searches were undertaken by 2 independent investigators (Y.W. and C.Z.) using the PubMed, Embase, Cochrane Library, and Web of Science databases. Search strategies with a series of keywords related to ACL, fixation devices, and study designs were used to identify relevant RCTs from database

Study Selection and Characteristics of Included Studies

A total of 4,066 records were initially selected from the database search. After removal of duplications, 2,480 records were identified. Of these records, 2,280 were excluded based on the title or abstract; thus, 200 full-text trials were evaluated for eligibility. Finally, 57 RCTs involving 4,304 participants who underwent primary ACLR were included (Fig 1). The trial size varied from 20 to 218 participants, the mean age ranged from 23.8 to 40.9 years, the proportion of women ranged from 0% to

Discussion

For femoral fixation, no device was significantly different from the others regarding the Lysholm score, IKDC category, ROM, and Tegner score. Bio-screws showed higher laxity than the EndoPearl at a borderline level of statistical significance, but the difference varied substantially within multiple sensitivity analyses. The EndoPearl had the highest incidence of infection, whereas effusion and graft rupture were most commonly seen with the bone mulch screw. For tibial fixation, no significant

Conclusions

Graft fixation devices in ACLR share a similar efficacy profile in terms of the Lysholm score, IKDC category, ROM, and Tegner score but not laxity. On the other hand, safety profiles seem to vary among different devices. These findings can support surgeons, alongside their experience and preference, as well as the relative cost of each device, in delivering an individualized plan for an optimal operation.

Acknowledgment

The authors thank Peter Mittwede, M.D., Ph.D., from Liwen Bianji, Edanz Editing China (www.liwenbianji.cn/ac), for editing the English text of a draft of this article.

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Cited by (9)

Anterior cruciate ligament reconstruction with a biocomposite interference screw maintains graft fixation survival and improves clinical outcomes at 1 year: A multicenter prospective case series
2023, Heliyon
A biocomposite interference screw with an open architecture was developed to provide a greater available surface area for bone ingrowth compared with conventional solid interference screws. We herein describe a prospective, single-cohort study conducted using this interference screw in anterior cruciate ligament (ACL) reconstruction. Sixty subjects (mean age, 34.9 years; standard deviation, 10.6) undergoing ACL repair using the biocomposite interference screw were enrolled at 3 sites in the United States. Subjects were followed preoperatively (baseline) and postoperatively at 6 months and 1 year. The primary endpoint was graft fixation survival rate at 6 months and 1 year. Secondary endpoints included graft survival (failure defined as that occurring for any reason); International Knee Documentation Committee (IKDC) score (exam and subjective forms); Tegner Activity form; Lysholm score; and EQ (EuroQuol)-5D-5L index score and visual analogue scale. There was a 100 % rate of graft fixation survival at 6 months (54/54; 95 % confidence interval [CI]: 100-100) and 1 year (50/50; 95 % CI: 100-100). One patient experienced a complete tear of the ACL 5 months following index surgery, resulting in graft survival rates of 98.1 % (53/54; 95 % CI: 94.6–100) at 6 months at 98.0 % (49/50; 95 % CI: 94.1–100) at 1 year. Significant improvements (p < .0001) were obtained between baseline and 6 months for the majority of patient-reported outcomes, and were maintained out to 1-year follow up. There was no significant difference over baseline in the IKDC sub-scale of symptoms. Nine patients (15.0 %) experienced serious adverse events during the course of the study; three of these patients’ adverse events were considered possibly or definitely related to the procedure device (ACL tear, pulmonary embolism/deep vein thrombosis, and a patellar fracture). In conclusion, this biocomposite interference screw has a favorable safety and efficacy profile at 1 year, with no failures of graft fixation, noted during that time.
Anteromedial Portal Technique, but Not Outside-in Technique, Is Superior to Standard Transtibial Technique in Knee Stability and Functional Recovery After Anterior Cruciate Ligament Reconstruction: A Network Meta-analysis
2023, Arthroscopy - Journal of Arthroscopic and Related Surgery
To compare the postoperative outcomes of 4 different femoral drilling techniques in anterior cruciate ligament reconstruction.
Three databases were searched for randomized controlled trials comparing any 2 or more of the following femoral drilling techniques in anterior cruciate ligament reconstruction: standard transtibial (sTT), anteromedial portal (AMP), outside-in (OI), or modified transtibial (mTT) technique. A Bayesian network meta-analysis was performed to assess postoperative stability and functional recovery in terms of the side-to-side difference (measured by arthrometry), Lachman test, pivot-shift test, International Knee Documentation Committee subjective and objective scores, Lysholm score, and Tegner score. The Fisher exact probability test and χ² test were used to compare the incidences of infection and graft rupture, respectively.
We included 20 randomized controlled trials involving 1,515 patients. The AMP technique showed a lower side-to-side difference (standardized mean difference, –0.33; 95% credible interval [CrI], –0.53 to –0.12), higher negative rate on the pivot-shift test (odds ratio, 2.19; 95% CrI, 1.38 to 3.44), and higher International Knee Documentation Committee objective score (odds ratio, 3.13; 95% CrI, 1.42 to 7.82) than the sTT technique. However, knee stability and functional outcomes did not differ significantly between the OI and sTT techniques. Safety outcomes of the mTT technique were unavailable. The incidence of graft rupture was 5.20% for the OI technique, 2.27% for the AMP technique, and 1.51% for the sTT technique. The OI technique had a significantly higher incidence of graft rupture than the sTT technique (χ² = 4.421, P = .035). No significant difference in the incidence of infection was found between the sTT, AMP, and OI techniques (P = .281).
The AMP technique, but not the OI technique, was superior to the sTT technique in knee stability and functional recovery. The OI technique had a higher incidence of graft rupture than the sTT technique. There was no significant difference between the AMP and OI techniques or between the mTT technique and any other femoral drilling technique.
Level II, meta-analysis of Level I and II studies.
A Simplified Double-Bundle Anterior Cruciate Ligament Reconstruction by the Three-Inside Technique With Two Suspension Buttons and One Interference Screw
2022, Arthroscopy Techniques
Citation Excerpt :
Along with a recent study, there is no difference in the range of motion, Lysholm, International Knee Documentation Committee category, and Tegner scores between graft fixation devices. Thus, this approach not only helps simplify the technique but also saves the surgery expenses.25 Fourth, we determine the position for hanging the PL bundle to reduce the complications.
In comparison with the single-bundle technique, double-bundle anterior cruciate ligament (ACL) reconstruction has proven its superiority regarding biomechanical studies and clinical outcomes in both rotational knee stability and anterior translation function. However, the complexity and risk of complications remain a great concern for the orthopaedic surgeon performing double-bundle ACL reconstruction. We present a simplified double-bundle ACL reconstruction by the 3-inside technique with 2 suspension buttons and 1 interference screw. The semitendinosus tendon is tripled to be the anteromedial (AM) bundle, whereas the gracilis is doubled for the posterolateral (PL) bundle. We perform a 3-socket approach with an inside-out femoral tunnel for the AM bundle, an outside-in femoral tunnel for the PL bundle, and a retrograde tibial socket for the tibial bundle. Thus, this technique is, simply, a combination of 2 procedures: one single all-inside method (for the AM bundle) and one outside-in method (for the PL bundle), with which most arthroscopic surgeons are familiar. The AM and PL bundles are fixed at 30° and 45°, respectively, using 2 suspension buttons and 1 interference screw. Our simplified technique could reduce surgical costs and minimize complications while maintaining isometric position and appropriate graft size for each patient.
The Graft Insertion Length in the Femoral Tunnel During Anterior Cruciate Ligament Reconstruction With Suspensory Fixation and Tibialis Anterior Allograft Does Not Affect Surgical Outcomes but Is Negatively Correlated With Tunnel Widening
2021, Arthroscopy - Journal of Arthroscopic and Related Surgery
To investigate the surgical outcomes of anterior cruciate ligament (ACL) reconstruction using a low-dose irradiated tibialis anterior allograft with a fixed-loop cortical suspension device for the femur based on the graft insertion length (GIL) in the femoral tunnel.
Between January 2010 and January 2018, the medical records of consecutive patients who underwent arthroscopic ACL reconstruction with a tibialis anterior allograft fixed with the EndoButton CL for the femur and who had at least 2 years of follow-up were retrospectively evaluated. Patients were classified into 3 groups based on the GIL in the femoral tunnel (group 1, GIL < 15 mm; group 2, GIL of 15-20 mm; and group 3, GIL > 20 mm), and their functional scores, knee laxity, and radiographic parameters were evaluated.
A total of 91 patients were analyzed. There were no statistically significant differences in the functional scores and knee laxity between the 3 groups at 2 years postoperatively. However, significant differences were observed in tunnel widening at 1 year postoperatively in the femur (P = .045 for absolute value and P = .004 for relative value) and the tibia (P = .014 for absolute value and P = .012 for relative value), revealing that both the femoral and tibial tunnels widened as the GIL decreased. Additional linear regression analyses were performed to identify whether the GIL independently affects tunnel widening. Consequently, the femoral tunnel depth, tunnel diameter, and GIL were found to independently influence femoral tunnel widening (P = .008, P = .019, and P < .001, respectively), whereas the tunnel diameter and GIL affected tibial tunnel widening (P < .001 and P = .004, respectively).
The GIL in the femoral tunnel during ACL reconstruction using a tibialis anterior allograft with a fixed-loop cortical suspension device for the femur has no significant association with the postoperative functional outcomes and knee laxity, but it has a negative correlation with tunnel widening in the femur and the tibia.
Level III, retrospective cohort study.
Understanding Network Meta-analysis (NMA) Conclusions Requires Scrutiny of Methods and Results: Introduction to NMA and the Geometry of Evidence
2021, Arthroscopy - Journal of Arthroscopic and Related Surgery
Synthesis of medical literature to determine the best treatment for a given problem is challenging, particularly when multiple options exist. Network meta-analysis (NMA) allows the comparison of different treatment approaches in a single, systematic review including treatments that have never been compared head-to-head. A key to understanding NMA is to focus on the network geometry showing the number of included studies and their relationships: different treatment options are illustrated as nodes. Lines between nodes represent direct comparisons. For nodes not directly compared, indirect effects may be determined by use of the property of transitivity. Limitations of NMA include heterogeneity, where variability among included studies biases pairwise comparisons, and consistency, if direct and indirect comparisons between treatments do not agree. In the end, NMA allows numeric ranking of the estimated effects of each treatment from most to least effective. A disadvantage of NMA ranking methods is that readers may focus overly on what treatment ranks best and focus insufficiently on the methods and results that determine the rankings. The reliability of the rankings requires consideration of the geometry and strength of the network, including evaluation of heterogeneity, consistency, and transitivity. The conclusion of an NMA requires scrutiny of the methods and results.
Surgical Timing Does Not Interfere on Clinical Outcomes in Combined Reconstruction of the Anterior Cruciate Ligament and Anterolateral Ligament: A Comparative Study With Minimum 2-Year Follow-Up
2021, Arthroscopy - Journal of Arthroscopic and Related Surgery
To compare the functional outcomes, knee stability, failure rate and complication rates of combined anterior cruciate ligament (ACL) and anterolateral ligament (ALL) reconstruction with hamstrings grafts between acute and chronic cases.
Consecutive patients who underwent combined ACL and ALL reconstruction with hamstrings grafts were evaluated. Patients operated on less than 8 weeks after injury were allocated to group 1, and the others were allocated to group 2. Demographic data, knee stability, and functional outcomes of the 2 groups were evaluated.
Thirty-four patients in the acute group and 96 in the chronic group were evaluated. The follow-up time was similar between the groups (28.7 ± 5.2 [24-43] months vs 29.4 ± 7.2 [24-58] months; P = 0.696). No differences were found between the groups in age, sex, trauma mechanism, presence of knee hyperextension, graft diameter, and meniscal injuries. There was no difference between the groups in the postoperative KT-1000 and in the pre- or postoperative pivot shift. The preoperative KT-1000 was higher in group 2 (7.9 ± 1.1 vs 7.4 ± 1.2; P = 0.031). There were no differences in the International Knee Documentation Committee or Lysholm. Three (2.3%) patients developed failure, 1 (2.9%) in group 1 and 2 (2.1%) in group 2. The total complication rate was 10% and did not differ between the groups.
Combined ACL and ALL reconstruction has similar outcomes in patients undergoing surgery in the acute and chronic phases. Patients with chronic injury have similar knee stability, functional scores, and failure rates as acute-injury patients, and patients with acute injury have no more complications than chronic patients.
Level III, retrospective comparative therapeutic trial.

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: The authors report the following potential conflicts of interest or sources of funding: This work was supported by the National Natural Science Foundation of China (81772413, 81672225, 81601941, 81702207, and 81702206); Scientific Research Project of Science and Technology Office of Hunan Province (2017TP1005); Key Research and Development Program of Hunan Province (2018SK2070); Postdoctoral Science Foundation of Central South University (182130); Natural Science Foundation of Hunan Province (2017JJ3491, 2017JJ3492, and 2018JJ3825); Innovation Foundation of the Central South University for Postgraduate (2018zzts045); and Postgraduate Independent Exploration and Innovation Project of Hunan Province (CX2017B065). Full ICMJE author disclosure forms are available for this article online, as supplementary material.

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Meta-analysisComparative Risk-Benefit Profiles of Individual Devices for Graft Fixation in Anterior Cruciate Ligament Reconstruction: A Systematic Review and Network Meta-analysis

Purpose

Methods

Results

Conclusions

Level of Evidence

Section snippets

Protocol

Literature Search

Study Selection and Characteristics of Included Studies

Discussion

Conclusions

Acknowledgment

Arthroscopy

Knee

Arthroscopy

Arthroscopy

Arthroscopy

Arthroscopy

Arthroscopy

Arthroscopy

Arthroscopy

Arthroscopy

Knee

Osteoarthritis Cartilage

Osteoarthritis Cartilage

J Clin Epidemiol

Arthroscopy

Arthroscopy

Arthroscopy

Surgeon

Arthroscopy

Clin Biomech (Bristol, Avon)

J Orthop Sci

J Orthop Sci

J Clin Orthop Trauma

Knee

Arthroscopy

Rev Bras Ortop

Arthroscopy

Arthroscopy

Arthroscopy

BMC Musculoskelet Disord

Arthroscopy

Arthroscopy

Arthroscopy

Knee

Graft fixation in cruciate ligament reconstruction

Am J Sports Med

Fixation of the graft in reconstruction of the anterior cruciate ligament

J Bone Joint Surg Br

A prospective evaluation of tunnel enlargement in anterior cruciate ligament reconstruction with hamstrings: Extracortical versus anatomical fixation

Knee Surg Sports Traumatol Arthrosc

Tunnel enlargement after anterior cruciate ligament surgery

Am J Sports Med

Bioabsorbable versus titanium screws in anterior cruciate ligament reconstruction using hamstring autograft: A prospective, blinded, randomized controlled trial with 5-year follow-up

Am J Sports Med

Femoral interference screw fixation of hamstring and quadriceps tendons for ACL reconstruction

Knee Surg Sports Traumatol Arthrosc

In vivo comparison of a fixed loop (EndoButton CL) with an adjustable loop (TightRope RT) device for femoral fixation of the graft in ACL reconstruction: A prospective randomized study and a literature review

J Orthop Surg (Hong Kong)

Anterior cruciate ligament reconstruction using autologous hamstring single-bundle Rigidfix technique compared with single-bundle Transfix technique

Adv Biomed Res

Comparative study after hamstring anterior cruciate ligament reconstruction with Endobutton and Rigidfix: A clinical trial study

Adv Biomed Res

Mechanical properties of soft tissue femoral fixation devices for anterior cruciate ligament reconstruction

Am J Sports Med

Suspensory versus aperture fixation of a quadrupled hamstring tendon autograft in anterior cruciate ligament reconstruction: A meta-analysis

Am J Sports Med

“Bungee cord” effect in hamstring tendon ACL reconstruction

Orthopedics

Stress fractures of the femur after ACL reconstruction with transfemoral fixation

Knee Surg Sports Traumatol Arthrosc

Complications following hamstring anterior cruciate ligament reconstruction with femoral cross-pin fixation

Arthroscopy

Bioabsorbable versus metallic interference screws for graft fixation in anterior cruciate ligament reconstruction

Cochrane Database Syst Rev

Cortical button versus cross-pin femoral fixation for hamstring anterior cruciate ligament reconstruction: A meta-analysis of randomized controlled trials

Am J Sports Med

Meta-analysis
Comparative Risk-Benefit Profiles of Individual Devices for Graft Fixation in Anterior Cruciate Ligament Reconstruction: A Systematic Review and Network Meta-analysis