scholarly journals 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

2019 ◽  
Vol 20 (1) ◽  
Author(s):  
Christiaan H. W. Heusdens ◽  
Katja Zazulia ◽  
Ella Roelant ◽  
Lieven Dossche ◽  
Damien van Tiggelen ◽  
...  
Keyword(s):  
Economic Benefit ◽  
Controlled Trial ◽  
Cruciate Ligament ◽  
Acl Rupture ◽  
Dynamic Intraligamentary Stabilization ◽  
Randomized Controlled ◽  
Ligament Augmentation ◽  
Internal Brace ◽  
Anterior Cruciate ◽  
Single Blind

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 economic benefit. Methods Subjects, aged 18–50 years, with a proximal, primary and repairable ACL rupture will be included. DIS is preferably performed within 4 weeks post-rupture, IBLA within 12 weeks and reconstruction after 4 weeks post-rupture. Patients are included in study 1 if they present within 0–4 weeks post-rupture and surgery is feasible within 4 weeks post-rupture. Patients of study 1 will be randomized to either DIS or IBLA. Patients are included in study 2 if they present after 4 weeks post-rupture and surgery is feasible between 5 and 12 weeks post-rupture. Patients of study 2 will be randomized to either IBLA or reconstruction. A total of 96 patients will be included, with 48 patients per study and 24 patients per study arm. Patients will be followed-up for 2 years. The primary outcome is change from baseline (pre-rupture) in International Knee Documentation Committee score to 6 months post-operatively. The main secondary outcomes are the EQ-5D-5 L, Tegner score, Lysholm score, Lachman test, isokinetic and proprioceptive measurements, magnetic resonance imaging outcome, return to work and sports, and re-rupture/failure rates. The statistical analysis will be based on the intention-to-treat principle. The economic impact of the surgery techniques will be evaluated by the cost-utility analysis. The LIBRƎ study is to be conducted between 2018 and 2022. Discussion This LIBRƎ study protocol is the first study to compare DIS, IBLA and ACL reconstruction for relative clinical efficacy and economic benefit. The outcomes of this study will provide data which could aid orthopaedic surgeons to choose between the different treatment options for the surgical treatment of an acute ACL rupture. Trial registration This study is registered at ClinicalTrials.gov; NCT03441295. Date registered 13.02.2018.

scholarly journals Anterior Cruciate Ligament Reconstruction Using a Bone–Patellar Tendon–Bone Graft With and Without a Ligament Augmentation Device: A 25-Year Follow-up of a Prospective Randomized Controlled Trial

2018 ◽  
Vol 6 (11) ◽  
pp. 232596711880877 ◽  
Author(s):  
Marlene Mauseth Elveos ◽  
Jon Olav Drogset ◽  
Lars Engebretsen ◽  
Raymond Brønn ◽  
Trond Olav Lundemo ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Knee Arthroplasty ◽  
Controlled Trial ◽  
Cruciate Ligament ◽  
Randomized Controlled ◽  
Bptb Graft ◽  
Ligament Augmentation ◽  
Anterior Cruciate ◽  
Bone Patellar Tendon

Background: Various grafts and ligament augmentation devices (LADs) have been used in the search for optimal reconstruction of the anterior cruciate ligament (ACL). Purpose: To compare 25-year follow-up results after ACL reconstruction using a bone–patellar tendon–bone (BPTB) graft with or without the Kennedy LAD. Study Design: Randomized controlled trial; Level of evidence, 1. Methods: One hundred patients undergoing ACL reconstruction between 1991 and 1993 were randomized into 2 groups: reconstruction using a BPTB graft alone (BPTB group, 51 patients) or a BPTB graft with the Kennedy LAD (LAD group, 49 patients). The 25-year follow-up evaluation included a clinical knee examination, patient-reported outcome measures, and an assessment of radiological osteoarthritis (OA) according to the Ahlbäck classification. Additional outcomes were reruptures and knee arthroplasty. Results: Ninety-three patients (93%) were available for the follow-up evaluation: 48 patients in the BPTB group and 45 in the LAD group. Through telephone calls, 26 patients were excluded from further investigation because of reruptures and arthroplasty in the knee of interest; 67 patients were further investigated. A total of 43 of 44 (98%) and 42 of 44 (95%) patients had negative or 1+ Lachman and pivot-shift test results, respectively. The mean Lysholm score was 85 for the BPTB group and 83 for the LAD group. All mean Knee injury and Osteoarthritis Outcome Score (KOOS) subscale values were ≥73. There were no statistically significant differences between groups in any of these outcomes or regarding the Tegner score, radiological classification of OA, or number of ACL reruptures. Signs of radiological OA were detected in all patients, and severe radiological OA (Ahlbäck grade III, IV, or V) was detected in 32% of patients in the BPTB group and 21% of patients in the LAD group ( P = .37). There were 12 patients in the BPTB group and 7 in the LAD group who had documented reruptures ( P = .40). One patient in the BPTB group and 6 in the LAD group underwent knee arthroplasty ( P = .054). Conclusion: In the present study, there were no statistically significant differences between groups in any of the outcomes. After 25 years, 19% of patients had reruptures, 27% had severe radiological OA, and 7% underwent knee arthroplasty.

RegentK and Physiotherapy Support Knee Function after Anterior Cruciate Ligament Rupture without Surgery after 1 Year: A Randomized Controlled Trial

2017 ◽  
Vol 25 (1) ◽  
pp. 30-37 ◽  
Author(s):  
Michael Ofner ◽  
Andreas Kastner ◽  
Gerhard Schwarzl ◽  
Hermann Schwameder ◽  
Nathalie Alexander ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Anterior Cruciate Ligament ◽  
Conservative Treatment ◽  
Repeated Measures ◽  
Controlled Trial ◽  
Cruciate Ligament ◽  
Acl Rupture ◽  
Randomized Controlled ◽  
Alternative Treatment Option ◽  
Anterior Cruciate

Background: Recent data have opened the debate on whether conservative treatment of anterior cruciate ligament (ACL) rupture might be an alternative treatment option to surgery. In a previous study, such a conservative treatment, i.e. ‘Regenerative Therapy According to Mohammed Khalifa' (RegentK), had shown good effects over physiotherapy. Methods: This was a randomized controlled trial assessing the efficacy of 1 session of RegentK compared to the myofascial mobilization technique (MMT), another type of intensive physiotherapy, in 20 patients with fresh ACL rupture during the previous 4 weeks. The International Knee Documentation Committee (IKDC) 2000 score was measured before, immediately after, and 3 months after treatment, and 1 year later; magnetic resonance imaging (MRI) data were taken before treatment and 1 year after treatment. Results: Both groups were comparable at baseline. A repeated measures analysis of variance showed a strong effect of time (p < 0.0001; partial η2 = 0.81) and no significant interaction or group effect. Both groups reached near full function after 1 year. The IKDC score was 90.9 (standard deviation (SD) 6.7; 95% confidence interval (CI) 86.2-95.6) for the RegentK group and 93.3 (SD 3.1; 95% CI 91.1-95.5) for the MMT group. Conclusion: One treatment session of enhanced MMT physiotherapy or RegentK can lead to nearly full function and thus recovery of a ruptured ACL after 1 year.

scholarly journals Nonsurgical Management of an Anterior Cruciate Ligament-Deficient Knee in a Women's Soccer Player: A Validation Clinical Case Report

2017 ◽  
Vol 52 (11) ◽  
pp. 1079-1083
Author(s):  
Courtney E. Gray ◽  
Chris Hummel ◽  
Todd Lazenby
Keyword(s):  
Randomized Controlled Trial ◽  
Anterior Cruciate Ligament ◽  
Case Report ◽  
Soccer Player ◽  
Controlled Trial ◽  
Cruciate Ligament ◽  
Meniscal Tear ◽  
Randomized Controlled ◽  
Anterior Cruciate ◽  
Acl Deficient

Background:  A collegiate women's soccer player sustained an isolated anterior cruciate ligament (ACL) tear and expressed a desire to continue her season without surgical intervention. Design:  Case report. Intervention(s):  Using the results of a randomized controlled trial and published clinical guidelines, the clinicians classified the patient as an ACL-deficient coper. The patient completed her soccer season without incident, consistent with the findings of the established clinical guidelines. However, 6 months later, she sustained a meniscal tear, which was not unexpected given that 22% of ACL-deficient copers in the randomized controlled trial incurred a meniscal tear within 24 months of ACL injury. Conclusion:  The external evidence was helpful in making informed clinical decisions regarding patient care.

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