Occurrence of inadequate ACL healing after Dynamic Intraligamentary Stabilization and functional outcome—a multicentre case series

Introduction Dynamic Intraligamentary Stabilization (DIS) is a technique for preservation, anatomical repair and stabilization of a freshly injured anterior cruciate ligament (ACL). The main purpose of this study was to evaluate the short-term re-operation rate when compared to traditional autograft reconstruction. Methods Four, from the developer independent, centres enrolled patients that underwent ACL repair by DIS, according to the specific indications given by MRI imaging at a minimum follow-up of 12 months. The re-operation rate was recorded as primary outcome. Secondary outcome measures were the postoperative antero-posterior knee laxity (using a portable Rolimeter®), as well as the Tegner, Lysholm and IKDC Scores. Results A total of 105 patients were investigated with a median follow-up of 21 months. Thirteen patients were lost to follow-up. Of the remaining 92 patients 15 (16.3%) had insufficient functional stability and required subsequent ACL reconstruction. These patients were excluded from further analysis, leaving 77 consecutive patients for a 12 months follow-up. The median age at time of surgery was 30 years for that group. At time of follow-up a median antero-posterior translation difference of 2 mm was measured. None of these patients reported subjective insufficiency (giving way), but in 14 patients (18.2%), the difference of antero-posterior translation was more than 3 mm. We found a median Tegner Score of 5.5, a median Lysholm Score of 95.0 and a median IKDC Score of 89.4. Conclusion The main finding of this multicentre study is a relevant re-operation rate of 16.3%. Another 18.2% showed objective antero-posterior laxity (≥ 3 mm) during testing raising the suspicion of postoperative non-healing. The failure rate of DIS in this study is higher than for reconstruction with an autologous tendon graft. However, our successfully treated patients had a good clinical and functional outcome based on antero-posterior knee laxity and clinical scores, comparable to patients treated by autograft reconstruction.

Primary stability of single-stage revision reconstruction of the anterior cruciate ligament in case of failure of dynamic intraligamentary stabilization depends on implant position during ACL repair

Introduction The object of this study was to evaluate the primary stability of tibial interference screw (IFS) fixation in single-stage revision surgery of the anterior cruciate ligament (ACL) in the case of recurrent instability after ACL repair with dynamic intraligamentary stabilization (DIS), dependent on the implant position during DIS. Materials and methods Tibial aperture fixation in ACL reconstruction (ACL-R) was performed in a porcine knee model using an IFS. Native ACL-R was performed in the control group (n = 15). In the intervention groups DIS and subsequent implant removal were performed prior to single-stage revision ACL-R. A distance of 20 mm in group R-DIS1 (n = 15) and 5 mm in group R-DIS2 (n = 15) was left between the joint line and the implant during DIS. Specimens were mounted in a material-testing machine and load-to-failure was applied in a worst-case-scenario. Results Load to failure was 454 ± 111 N in the R-DIS1 group, 154 ± 71 N in the R-DIS2 group and 405 ± 105 N in the primary ACL-R group. Load-to-failure, stiffness and elongation of the group R-DIS2 were significantly inferior in comparison to R-DIS1 and ACL-R respectively (p < 0.001). No significant difference was found between load-to-failure, stiffness and elongation of R-DIS1 and the control group. Conclusion Primary stability of tibial aperture fixation in single-stage revision ACL-R in case of recurrent instability after DIS depends on monobloc position during ACL repair. Primary stability is comparable to aperture fixation in primary ACL-R, if a bone stock of 20 mm is left between the monobloc and the tibial joint line during the initial procedure.

Repair With Dynamic Intraligamentary Stabilization Versus Primary Reconstruction of Acute Anterior Cruciate Ligament Tears: 2-Year Results From a Prospective Randomized Study

Background: Anterior cruciate ligament (ACL) repair has once again become a focus of research because of the development of new techniques. Purpose/Hypothesis: The purpose was to compare the functional results and recurrent instability rates in patients undergoing ACL repair with dynamic intraligamentary stabilization (DIS) versus primary ACL reconstruction (ACLR) for acute isolated ACL tears. The hypothesis was that functional results and knee joint stability after ACL repair with DIS would be comparable with that after ACLR. Study Design: Randomized clinical trial; Level of evidence, 1. Methods: A total of 85 patients with acute ACL tears were randomized to undergo either ACL repair with DIS or primary ACLR. The preinjury activity level and function were recorded. Follow-up examinations were performed at 6 weeks and 6, 12, and 24 months postoperatively. Anterior tibial translation (ATT) was evaluated using Rolimeter testing. The Tegner activity scale, International Knee Documentation Committee (IKDC) subjective form, and Lysholm knee scoring scale scores were obtained. Clinical failure was defined as ΔATT >3 mm in combination with subjective instability. Recurrent instability and other complications were recorded. Results: There were 83 patients (97.6%) who were successfully followed until 2 years. ATT was significantly increased in the DIS group compared with the ACLR group (ΔATT, 1.9 vs 0.9 mm, respectively; P = .0086). A total of 7 patients (16.3%) in the DIS group had clinical failure and underwent single-stage revision. In the ACLR group, 5 patients (12.5%) had failure of the reconstruction procedure; 4 of these patients required 2-stage revision. The difference in the failure rate was not significant ( P = .432). There were 4 patients (3 in the DIS group and 1 in the ACLR group) who showed increased laxity (ΔATT >3 mm) without subjective instability and did not require revision. Recurrent instability was associated with young age (<25 years) and high Tegner scores (>6) in both groups. No significant differences between ACL repair with DIS and ACLR were found for the Tegner, IKDC, and Lysholm scores at any time. Conclusion: Whereas ATT measured by Rolimeter testing was significantly increased after ACL repair with DIS, clinical failure was similar to that after ACLR. In addition, functional results after ACL repair with DIS for acute tears were comparable with those after ACLR. The current study supports the use of ACL repair with DIS as an option to treat acute ACL tears. Registration: DRKS00015466 (German Clinical Trials Register)

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

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.