Study protocol: a single-blind, multi-center, randomized controlled trial comparing dynamic intraligamentary stabilization, internal brace ligament augmentation and reconstruction in individuals with an acute anterior cruciate ligament rupture: LIBRƎ study
Abstract:Background: The current gold standard for the treatment of an anterior cruciate ligament (ACL) rupture is reconstruction with tendon graft. Recently, two surgical ACL repair techniques have been developed for treating an acute ACL rupture: Dynamic Intraligamentary Stabilization (DIS, Ligamys®) and Internal Brace Ligament Augmentation (IBLA, InternalBrace™). We will conduct a single-blind, multi-center, randomized controlled trial which compares DIS, IBLA and reconstruction for relative clinical efficacy and ec… Show more
“… 12 An ongoing prospective randomized clinical trial comparing BEAR, DIS, internal brace augmentation, and ACL reconstruction will help clarify the relative merit of each approach. 10 Supplemental Material for this article is available at https://journals.sagepub.com/doi/full/10.1177/23259671221132564#supplementary-materials . …”
Background: Bibliometrics is a methodology that measures the scientific output of an author, institution, or country. Visualized analysis is the transformation of data into visible form by software, highlighting important features, including commonalities and anomalies, allowing users to easily and quickly perceive significant aspects of their data. Purpose: To conduct a bibliometric analysis of the literature on anterior cruciate ligament (ACL) repair, with visualization of trends, in order to identify the areas of interest and the primary researchers involved in ACL repair. Study Design: Cross-sectional study. Methods: The PubMed database was queried on April 14, 2022, for publications that reported on ACL repair from 1960 onward. The initial search resulted in 1392 publications. Filter settings were applied to remove publications with weak correlation, such as those on meniscal repair and ACL reconstruction. Publication information, citations, authors, commonly used terms, and affiliated institutions and countries were analyzed by VOSviewer and Python. Results: A total of 553 articles were included for analysis. Three techniques were visualized: bridge-enhanced ACL repair, internal brace, and dynamic intraligamentary stabilization. The most published authors were Martha Murray (51 articles), Gregory Difelice (35 articles), and Braden Fleming (31 articles). The most cited article was “Collagen–Platelet Rich Plasma Hydrogel Enhances Primary Repair of the Porcine Anterior Cruciate Ligament” by Murray et al. The journals with the most publications on ACL repair were the American Journal of Sports Medicine (n = 49); Knee Surgery, Sports Traumatology, Arthroscopy (n = 49); and Arthroscopy (n = 48). The top 3 institutions by publication number were the Hospital for Special Surgery (n = 51), Boston Children’s Hospital (n = 49), and Brown University (n = 31), with the most publications coming from the United States (n = 242), Germany (n = 83), and the United Kingdom (n = 47). Conclusion: The results demonstrate that the research on ACL repair comes from a small number of authors and corresponding institutions; the top sports medicine journals and the developed countries have an interest in this topic.
“… 12 An ongoing prospective randomized clinical trial comparing BEAR, DIS, internal brace augmentation, and ACL reconstruction will help clarify the relative merit of each approach. 10 Supplemental Material for this article is available at https://journals.sagepub.com/doi/full/10.1177/23259671221132564#supplementary-materials . …”
Background: Bibliometrics is a methodology that measures the scientific output of an author, institution, or country. Visualized analysis is the transformation of data into visible form by software, highlighting important features, including commonalities and anomalies, allowing users to easily and quickly perceive significant aspects of their data. Purpose: To conduct a bibliometric analysis of the literature on anterior cruciate ligament (ACL) repair, with visualization of trends, in order to identify the areas of interest and the primary researchers involved in ACL repair. Study Design: Cross-sectional study. Methods: The PubMed database was queried on April 14, 2022, for publications that reported on ACL repair from 1960 onward. The initial search resulted in 1392 publications. Filter settings were applied to remove publications with weak correlation, such as those on meniscal repair and ACL reconstruction. Publication information, citations, authors, commonly used terms, and affiliated institutions and countries were analyzed by VOSviewer and Python. Results: A total of 553 articles were included for analysis. Three techniques were visualized: bridge-enhanced ACL repair, internal brace, and dynamic intraligamentary stabilization. The most published authors were Martha Murray (51 articles), Gregory Difelice (35 articles), and Braden Fleming (31 articles). The most cited article was “Collagen–Platelet Rich Plasma Hydrogel Enhances Primary Repair of the Porcine Anterior Cruciate Ligament” by Murray et al. The journals with the most publications on ACL repair were the American Journal of Sports Medicine (n = 49); Knee Surgery, Sports Traumatology, Arthroscopy (n = 49); and Arthroscopy (n = 48). The top 3 institutions by publication number were the Hospital for Special Surgery (n = 51), Boston Children’s Hospital (n = 49), and Brown University (n = 31), with the most publications coming from the United States (n = 242), Germany (n = 83), and the United Kingdom (n = 47). Conclusion: The results demonstrate that the research on ACL repair comes from a small number of authors and corresponding institutions; the top sports medicine journals and the developed countries have an interest in this topic.
“…There are several issues that should be addressed in future ACL repair research. As mentioned in the ACL repair reviews, high-quality large RCTs between ACL recon and ACL repair, as well as between the different ACL repair techniques, are needed [ 73 , 74 ]. PROMs, return to work and sports, instrumented knee laxity, magnetic resonance imaging outcome, cost/utility analysis, reintervention for another reason than rerupture, and rerupture and failure rates and their risk factors should be addressed in these studies.…”
Until the past decade the common thought was that the anterior cruciate ligament (ACL) was not able to heal and restore knee stability. In this manuscript a brief review of studies of the developers and the early adaptors of four different modern ACL repair techniques are presented. The present status and considerations for the future of ACL repair and its research are shared. After promising short- to midterm ACL healing results by the developers, the results of the early adaptors show more variety in terms of rerupture and reintervention for other reasons. Risk factors for failure are a young age, high preinjury sports activity level, midsubstance ruptures and impaired integrity of the ACL bundles and the synovial sheath. There is a call for more clinical data and randomized clinical trials. Conclusion: an important finding of the past decade is that the ACL is able to heal and subsequently restabilize the knee. Patient selection is emphasized: the ideal patient is a non-high athlete older than 25 and has an acute proximal one bundle ACL rupture. Further research will have to show if ACL repair could be a game changer or if history will repeat itself.
“…A single-blind multi-center randomized study "LIBRE" is currently underway to compare outcomes at 2-year follow-up between standard anterior cruciate ligament reconstruction, Internal Bracing, and Dynamic Intraligamentary Stabilization [33].…”
Anterior cruciate ligament injuries are one of the most frequent knee joint injuries, leading to instability which limits return to sport activity, and is one of osteoarthritis risk factors. Treatment issues are present since 1895, when Mayo Robertson performed first documented open ACL repair. Positive short-term results of open suturing led to rising popularity of this method, which in 70’s and 80’s became golden standard of ACL injury treatment. Feagin in his longterm observations noticed that nearly half of patients after open ACL repair, during first 5 years suffered from reappearing ACL tear. Since then, for many years reconstruction techniques with graft use became most popular technique. Increasing knowledge of ligament healing biology, creation of Sherman’s ACL injury location classification, development of arthroscopic techniques, connected with growing tendency for biological treatment caused increase in repair techniques interest. Most important potential benefits of this techniques are: limitation of perioperative trauma – no need to harvest graft, drill large tunnels, possible retention of additional ACL proprioceptive feeling, easier eventual reoperation. Effort to save patient’s ACL is especially indicated in case of acute trauma (depending on source up to 3-14 weeks from injury), with proximal tear (type I in Sherman classification) with good remnant quality. Most popular techniques of ACL repair are: proximal ACL attachment reinsertion, IBLA – Internal Bracing Ligament Augmentation and DIS – Dynamic Intraligamentary Stabilization. The aim of this study was to present actual state of knowledge concerning options of primary ACL repair, it’s results, indications, and sharing authors own experiences in this treatment methods. Preliminary, available in literature, results of studies concerning methods mentioned above are good and very good, comparable, and sometimes even superior to results of classical ACL reconstruction. However, there is lack of long-term studies, that might confirm increase in survivorship rate of repaired ACLs comparing to previous open suturing technique.
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