Graft failure and revision rate after ACL repair with dynamic intraligamentary stabilization. One-year results of a prospective case series of 155 patients.

PURPOSE: The aim of this study was to assess graft failure, revision rate, and functional outcomes after treatment of acute ACL rupture with dynamic intraligamentary stabilization (DIS) Ligamys device one year post surgery. Additionally, differences in functional outcome between patients with and without anteroposterior laxity were assessed. It was hypothesized that the failure rate of DIS was non-inferior to that of previously reported ACL reconstruction (10%). METHODS: In this prospectively designed multicenter study, including patients with an acute ACL rupture, DIS was performed within 21 days after rupture. Primary outcome was failure of the graft at 1 year post surgery, defined as 1) re-rupture of the graft, 2) revision of DIS, or 3) a > 3 mm side-to-side difference in anterior tibial translation compared to the non-operated knee (∆ATT), measured by the KT1000 device. Additional analysis was performed using a 5 mm threshold. The subjective International Knee Documentation Committee Score (IKDC) and Numerical Rating Scales (NRS) for pain and confidence were used to evaluate functional outcome. RESULTS: A total of 155 patients were included with a mean age at surgery of 27.8 years (SD 9.4). The mean interval from rupture to DIS was 16.4 days (SD 5.2). At a median follow-up of 13 months (IQR 12-18) the failure rate of the graft was 30.2% (95%CI:22.0-39.4); 11 patients (7%) required secondary reconstructive surgery and of the 105 patients who attended ATT measurement, 24 patients (23%) had an ∆ATT > 3 mm. Secondary analysis, based on a 5 mm threshold, revealed a failure rate of 22.4% (95%CI: 15.2; 31.1). A total of 39 patients (25%) reported at least one complication, comprising mainly arthrofibrosis, traumatic re-rupture and pain. In these patients, removal of the monoblock was performed in 21 cases (13.5%). At follow-up no significant differences in functional outcomes between patients with ∆ATT > 3 mm and stable ATT were observed. CONCLUSION: This prospective multicenter study found a high failure rate at one year follow-up of 30% (7% revision surgery and 23% > 3 mm side-to-side difference in anterior tibial translation) in patients treated by primary repair of the ACL with DIS, and did therefore not demonstrate non-inferiority to ACL reconstruction. For patients who did not require secondary reconstructive surgery, this study found good functional outcomes, also in case of persistent anteroposterior knee laxity (∆ATT > 3 mm). LEVEL OF EVIDENCE: Level IV.

Collagen wrapping and local platelet-rich fibrin do not improve the survival rates of ACL repair with dynamic intraligamentary stabilization: a retrospective case series after ≥5 years postoperatively.

PURPOSE: Anterior cruciate ligament (ACL) repair has been recommended as a treatment principle for ACL tears. Several authors have advocated a potential role for primary repair techniques in the ACL decision tree. However, long-term results have been controversial. This study aims to determine the survival of the primarily repaired ACL after dynamic intraligamentary stabilization (DIS) with and without augmentation. METHODS: Between 2014 and 2019, 102 patients with isolated proximal ACL ruptures underwent DIS repair within 21 days from injury and were available for follow-up either clinically or telephonically after ≥5 years postoperatively. In 45 cases, DIS repair was augmented with collagen fleece wrapping, platelet-rich fibrin (PRF) or both. Failure was defined as traumatic re-rupture or conversion to ACL reconstruction. The patients being available for physical examination underwent a.-p. stability measurement with a KT-1000 device. Functional outcome was measured with the IKDC, Tegner and Lysholm scores. Kaplan-Meier survival analysis, Log-Rank Test and Binominal logistic regression were performed. RESULTS: After a minimum 5-year follow-up, 71/102 (69.6%) DIS repairs were not re-reptured and clinically and/or subjectively stable. Augmentation did not improve survival rates (p = 0.812). The identified factors influencing failure were a younger age and a pre-injury Tegner activity level of ≥7. 95.7% of those patients with an intact ACL repair had normal or near normal knee function based on the IKDC scoring system. CONCLUSIONS: The 5-year overall survival rate of DIS was 69.6%. Collagen fleece wrapping and local PRF application did not improve survival. Patients not suffering failure of repair demonstrated high satisfaction. Nevertheless, the results are inferior to those of established ACL reconstruction procedures. LEVEL OF EVIDENCE: Case series, Level IV.

Seventy percent long-term survival of the repaired ACL after dynamic intraligamentary stabilization.

PURPOSE: Primary repair of the anterior cruciate ligament (ACL) is regaining popularity. Long-term results are lacking. The purpose of the current study was to determine the survival of the primarily repaired ACL after dynamic intraligamentary stabilization. METHODS: Between 2011 and 2013, 57 patients with acute proximal ACL ruptures underwent DIS repair within 3 weeks from injury and were available for final follow-up at least 5 years postoperatively. Failure as an end point was defined as conversion to ACL reconstruction, failure to restore stability with persisting laxity side-to-side laxity of > 5 mm or a late-traumatic re-rupture or loss of stability. Kaplan-Meier survival analysis was performed. RESULTS: Kaplan-Meier survival analysis demonstrated an overall survival of 70.0% (standard error SE 6.6%) at 74 months follow-up. Patients performing competitive sports prior to injury demonstrated an inferior long-term ACL survival of 56.4% (SE 11.6%). Patients performing recreational sport activities demonstrated a survival rate of 79.2% (SE 7.7%). The one factor demonstrating a direct influence on failure after adjustment was a high-pre-injury level of physical (odds ratio 4.0 confidence interval 1.0-15.8, p = 0.04). CONCLUSION: The minimum 5 years survival rate after primary ACL repair using this technique was 70%. This value dropped to 56% in highly active patients performing competitive sports. Patients not suffering failure of repair demonstrated adequate restoration of knee laxity and high satisfaction. This study not only underlines the potential of ACL repair, but also highlights the danger of the procedure if strict patient selection is not appreciated. LEVEL OF EVIDENCE: Level IV.

Dynamic intraligamentary stabilization of anterior cruciate ligament repair: hardware removal has no effect on knee laxity at 2-year follow-up.

INTRODUCTION: Dynamic intraligamentary stabilization (DIS) stabilizes the knee joint during anterior cruciate ligament (ACL) healing. After 6 months, tibial hardware removal is offered to the patients if local discomfort at the implant site is present. AIM: This study compared knee laxity and functional scores 2 years after DIS between patients with and without hardware removal. It is hypothesized that it does not affect ACL healing. MATERIALS AND METHODS: The study retrospectively analyzed prospectively collected data from 173 patients with either hardware removal (n = 47) or no additional intervention (n = 126). Inverse probability of treatment weighting using the propensity score was applied to balance the groups for baseline characteristics. The primary outcome was the side-to-side difference in knee laxity measured with the rolimeter at manual maximum force (Δ-Lachman). Secondary outcomes were the pivot-shift test and subjective scores. RESULTS: Mean age was 34 years in both groups, and female gender was 47% (hardware removal group) and 50% (control group), respectively. No significant differences were found for Δ-Lachman (p = 0.09), pivot-shift test (p = 0.41), and subjective scores (p > 0.10) two years after DIS. CONCLUSION: Knee laxity 2 years after DIS in patients with tibial hardware removal and patients without hardware removal was not significantly different. The groups were also similar regarding all the assessed functional scores. This study confirms the hypothesis that the healing ACL resumes its stabilizing role, and the hardware can be removed beginning 6 months after surgery without adverse consequences for joint stability. LEVEL OF EVIDENCE: Case-control study, Level III.

Dynamic intraligamentary stabilization for ACL repair: a systematic review.

PURPOSE: It was the aim to assess all published original research dealing with dynamic repair of the anterior cruciate ligament (ACL) and to provide a semi-quantitative analysis of clinical outcome reports. METHODS: Both OVIS and MEDLINE databases were utilized for allocation of articles. All preclinical and clinical studies related to dynamic intraligamentary stabilization (DIS) were identified. Results were tabulated and semi-quantitative analysis performed. RESULTS: Twenty-three articles related to DIS were identified. The predominant level of evidence ranged between II and IV, with only one level I study. Reported failure rates ranged between 4% and 13.6%. Most clinical studies only reported revision rates without referring to failure of restoring stability. Highest success was achieved with proximal ACL ruptures. Both the level of physical activity and  patient age have been found to influence the risk of failure. CONCLUSION: There is sufficient evidence to support that DIS repair may be an effective modality for the treatment of acute proximal tears of the ACL. However, comparative studies are lacking. Upcoming studies should compare the technique to ACL reconstruction with failure as an endpoint. Comparison to rigid methods of proximal fixation is also necessary to justify the need for dynamic fixation. Overall, there is evidence to suggest the potential space for ACL repair in the decision tree for individualized treatment planning. The best outcome will be in the hands of the best patient selectors. LEVEL OF EVIDENCE: IV.

[Dynamic intraligamentary stabilization of acute anterior femoral cruciate ligament rupture : Preliminary and intermediate clinical results]. / Dynamische intraligamentäre Stabilisierung der akuten vorderen femoralen Kreuzbandruptur : Erste und mittelfristige klinische Ergebnisse.

BACKGROUND: The results of anterior cruciate ligament (ACL) reconstruction demonstrate excellent short and mid-term results; however, long-term follow-up results are compromized by high rates of osteoarthritis. Dynamic intraligamentary stabilization (DIS) focuses on preserving the cruciate ligament. The short and mid-term results of the dynamic ligamentary cruciate ligament suture from a nondevelopmental hospital are presented. MATERIAL AND METHODS: A total of 73 consecutive patients with an acute rupture of the ACL were included in this prospective study. Patients were surgically treated between July 2014 and October 2017 with DIS within 21 days after ACL rupture. All patients were reviewed before the operation, 60 patients reached a 3­month follow-up , 51 patients reached a 6­month follow-up and 38 patients a 12-month follow-up. The perioperative and postoperative complication spectrum was recorded. RESULTS: The positive results of the developmental clinics were confirmed. The Tegner, Lysholm and International knee documentation Committee (IKDC) scores showed very good results 12 months after surgery. The intraoperative and postoperative complication rates were low at 1.4% and 6.8%, respectively. Postoperative restrictions on movement required re-arthroscopy in 3 patients, 66% of the patients had concomitant damage to the knee joint, which could be treated simultaneously. CONCLUSION: The dynamic intraligamentary cruciate liament suture (Ligamys) is a successful additional option in the sugical treatment of acute femoral ACL rupture. A high proportion of collateral damage and injuries of the knee joint can be detected and simultaneously treated.

Improved results of ACL primary repair in one-part tears with intact synovial coverage.

PURPOSE: It was the aim to assess the influence of synovial sheath disruption on early failure of primary anterior cruciate ligament (ACL) repair. It was hypothesized that more-part ACL tears with disruption of the synovial sheath are associated with a higher risk of failure after primary ACL repair. METHODS: A cohort study was conducted comprising patients with primal ACL tears undergoing primary ACL repair and dynamic intraligamentary stabilization (DIS). The patients were stratified into three groups: A-one-part rupture with intact synovial membrane (n = 50), B-two-part ruptures resultant to separation of the ACL into two main bundles with synovial membrane tearing (n = 52) and C-more parts involving multilacerated ruptures with membrane disruption (n = 22). Failure was defined as a retear or residual laxity (anterior posterior translation > 5 mm compared to healthy knee). Adjustment for potential risk factors was performed using a multivariate logistic-regression model. RESULTS: The overall failure rate was 17.7% throughout the mean follow-up period of 2.3 ± 0.8 years. The failure rate in patients with one-part ACL tears with an intact synovial membrane was 4% (n = 2) (Group A), which was significantly lower than the failure rates in groups B and C, 26.9% (n = 14) (p = 0.001) and 27.3% (n = 6) (p = 0.003), respectively. Disruption of the synovial sheath in two- or more-part tears was identified as an independent factor influencing treatment failure in primary ACL repair (OR 8.9; 95% CI 2.0-40.0). CONCLUSION: The integrity of the ACL bundles and synovial sheath is a factor that influences the success of ACL repair. This needs to be considered intra-operatively when deciding about repair. LEVEL OF EVIDENCE: IV.

Surgeon experience with dynamic intraligamentary stabilization does not influence risk of failure.

PURPOSE: Studies on dynamic intraligamentary stabilization (DIS) of acute anterior cruciate ligament (ACL) ruptures reported failure rates similar to those of conventional ACL reconstruction. This study aimed to determine whether surgeon experience with DIS is associated with revision rates or patient-reported outcomes. The hypothesis was that more experienced surgeons achieved better outcomes following DIS due to substantial learning curve. METHODS: The authors prospectively enrolled 110 consecutive patients that underwent DIS and evaluated them at a minimum of 2 years. The effects of independent variables (surgeon experience, gender, age, adjuvant procedures, tear location, preinjury Tegner score, time from injury to surgery, and follow-up) on four principal outcomes (revision ACL surgery, any re-operation, IKDC and Lysholm score) were analyzed using univariable and multivariable regressions. RESULTS: From the 110 patients enrolled, 14 patients (13%) were lost to follow-up. Of the remaining 96 patients, 11 underwent revision ACL surgery, leaving 85 patients for clinical assessment at a mean of 2.2 ± 0.4 years (range 2.0-3.8). Arthroscopic reoperations were performed in 26 (27%) patients, including 11 (11%) revision ACL surgeries. Multivariable regressions revealed: (1) no associations between the reoperation rate and the independent variables, (2) better IKDC scores for 'designer surgeons' (b = 10.7; CI 4.9-16.5; p < 0.001), higher preinjury Tegner scores (b = 2.5, CI 0.8-4.2; p = 0.005), and younger patients (b = 0.3, CI 0.0-0.6; p = 0.039), and (3) better Lysholm scores for 'designer surgeons' (b = 7.8, CI 2.8-12.8; p = 0.005) and preinjury Tegner score (b = 1.9, CI 0.5-3.4; p = 0.010). CONCLUSION: Surgeon experience with DIS was not associated with rates of revision ACL surgery or general re-operations. Future, larger-scaled studies are needed to confirm these findings. Patients operated by 'designer surgeons' had slightly better IKDC and Lysholm scores, which could be due to better patient selection and/or positively biased attitudes of both surgeons and patients. LEVEL OF EVIDENCE: Level II, prospective comparative study.

Patient and surgical characteristics that affect revision risk in dynamic intraligamentary stabilization of the anterior cruciate ligament.

PURPOSE: Failure of dynamic intraligamentary stabilization (DIS) that requires revision surgery of the anterior cruciate ligament (ACL) has not been studied. The aim of this study was to investigate the incidence of revision ACL surgery, and the patient characteristics and surgery-related factors that are associated with an increased risk of ACL revision after DIS. METHODS: This study analysed a prospective, consecutively documented single-centre case series using standardized case report forms over a 2.5-year follow-up period. The primary endpoint was revision ACL surgery. We used Kaplan-Meier analysis to examine the revision-free survival time, and a multiple logistic regression model of potential risk factors including age, sex, BMI, smoking status, previous contralateral ACL injury, Tegner activity score, interval to surgery, rupture pattern, hardware removal, and postoperative side-to-side difference in knee laxity. Relative risk was calculated for subgroups of significant risk factors. RESULTS: In total, 381 patients (195 male) with a mean age of 33 ± 12 years were included in the analysis. The incidence of revision ACL surgery was 30/381 (7.9%). Younger age (p = 0.001), higher Tegner activity score (p = 0.003), and increased knee laxity (p = 0.015) were significantly associated with revision ACL surgery. The increased relative risk for patients who were less than 24 years old, participated in activities at a Tegner level >5 points, or had >2 mm of side-to-side difference in knee laxity was 1.6, 3.7, and 2.3, respectively. CONCLUSION: Young age, high level of sport activity, and high knee laxity observed in follow-up examinations increased the likelihood for revision surgery after DIS. Patients undergoing DIS should be informed of their potentially increased risk for therapy failure and carefully monitored during recovery. LEVEL OF EVIDENCE: Case series, Level IV.

Recovery of ACL function after dynamic intraligamentary stabilization is resultant to restoration of ACL integrity and scar tissue formation.

PURPOSE: Dynamic intraligamentary stabilization (DIS) is recognized as a ligament preserving technique for the treatment of acute anterior cruciate ligament (ACL) injuries. The aim of this study was to assess the integrity and morphology of the recovered ACL after DIS repair. METHODS: The cohort comprised 47 patients with an acute proximal ACL rupture undergoing DIS repair. All patients underwent diagnostic arthroscopy after a minimum postoperative interval of 6 months for semi-quantitative evaluation of ACL integrity, function and scar tissue formation. Tegner, Lysholm and International Knee Documentation Committee (IKDC) scores as well as objective anteroposterior (ap) translation were assessed at 6 weeks, 3-, 6-  and 12 months postoperatively. RESULTS: Full restoration of the ACL volume was affirmed in 30 (63.8%) patients and two-third restoration in 13 (27.7%). Hypertrophic scar formation was observed in 23 (48.9%) patients. Forty-four patients (93.6%) demonstrated sufficient ACL tensioning intraoperatively upon anterior stress. At final follow-up, the median Tegner activity level was 5.5 (3-10), Lysholm and IKDC scores were 100 (64-100) and 94 (55-100) points, respectively. The mean ap-translation differed from the normal knee by 2.1 ± 2.2 mm. Deficient ACL recovery was noted in four patients (8.5%), none of which required secondary reconstructive surgery. CONCLUSION: The results demonstrate that clinical recovery of ACL function after DIS repair is resultant to both restoration of ACL volume and scar tissue formation. Factors influencing the degree of scar tissue formation need further investigation to enable future attempts of guiding a balanced biological healing response. LEVEL OF EVIDENCE: IV.

Dynamic intraligamentary stabilization versus conventional ACL reconstruction: A matched study on return to work.

PURPOSE: The dynamic intraligamentary stabilization (DIS) technique is based on a different treatment approach than ACL reconstruction in that it intends to promote self-healing of the ligament. It is only recommended for acute injuries (<21days). The purpose of the present study was to compare DIS and ACLR with respect to the extent of work incapacity, revision rates, secondary arthroscopies, and treatment costs during recovery. METHODS: The study was a post-hoc analysis of prospectively collected data in the Swiss National Accident Insurance Fund (SUVA) database. All registered DIS cases treated until 31 December 2012 were included in the study. ACLR cases were matched to DIS cases using a propensity score approach and analysed in a follow-up period of 2 years after injury. Paired Student's T-test and the Chi-square test were used to compare the outcome measures. RESULTS: All 53 DIS patients were matched to an ACLR pair. The mean time period from injury to surgery was 14days for DIS and 50days for ACLR (p<0.001). Overall work incapacity was 13% for DIS and 17% for ACLR resulting in a difference of nearly 1 month of absence from work (p=0.03). The course of postoperative work incapacity was very similar between the groups, while the work incapacity prior to surgery lower in the DIS group. We found no difference in treatment costs, secondary arthroscopies and revision rates. CONCLUSION: DIS patients benefited from nearly one month shorter absence from work than ACLR patients. This difference is likely related to the early surgical timing that is recommended for DIS. Since no differences were found between DIS and ACLR in terms of treatment costs, secondary arthroscopies and revision rates, the study supports the choice of DIS as an additional treatment option for acute ACL injuries. Further comparative studies are proposed to improve the evidence about optimal timing and best practice in ACL treatment.

Collagen application reduces complication rates of mid-substance ACL tears treated with dynamic intraligamentary stabilization.

PURPOSE: Dynamic intraligamentary stabilization was recently proposed as an option for the treatment of acute ACL ruptures. The aim of this study was to investigate the feasibility of the procedure in mid-substance ACL ruptures and examine whether the additional application of a bilayer collagen I/III membrane would provide for a superior outcome. METHODS: The study group consisted of patients presenting with a mid-substance ACL rupture undergoing dynamic intraligamentary stabilization using the Ligamys™ device along with application of a collagen I/III membrane to the surface of the ACL (group A, n = 23). The control group comprised a matched series of patients presenting with a mid-substance ACL rupture also treated by dynamic intraligamentary stabilization Ligamys™ repair, however, without additional collagen application (group B, n = 33). Patients were evaluated preoperatively and at 24-month follow-up for stability as well as Tegner and Lysholm scores. Knee laxity was measured as a difference in anterior translation (ΔAP) and pivot shift. Any events occurring during the follow-up period of 24 months were documented. Logistic regression of complications was performed, and adjustment undertaken where necessary. RESULTS: A high total complication rate of 78.8 % was noted in group B, compared to group A (8.7 %) (p = 0.002). The addition of a collagen membrane was the only independent prognostic factor associated with reduced complications (OR 8.0, CI 2.0-32.2, p = 0.003, for collagen-free treatment). In group B, 6 patients suffered a re-rupture with subsequent instability requiring secondary hamstring reconstruction surgery, and 11 developed extension loss requiring arthroscopic debridement, whilst in group A, 2 patients required arthroscopic debridement for loss of exension, with no further encountered complication. Median Lysholm score was significantly higher in group A compared to group B (median 100 range 93-100 vs median 95 range 60-100, p = 0.03) at final follow-up. CONCLUSIONS: A high complication rate following ACL Ligamys™ repair of mid-substance ruptures was noted. Application of a collagen membrane to the surface of the ACL resulted in a reduced incidence of extension deficit and re-ruptures. The results indicate that solitary ACL Ligamys™ repair does not present an appropriate treatment modality for mid-substance ACL ruptures. Collage application proved to provide healing benefits with superior clinical outcome after ACL repair. LEVEL OF EVIDENCE: Case control study, Level III.

Dynamic intraligamentary stabilisation: initial experience with treatment of acute ACL ruptures.

AIMS: The purpose of this study was to report the experience of dynamic intraligamentary stabilisation (DIS) using the Ligamys device for the treatment of acute ruptures of the anterior cruciate ligament (ACL). PATIENTS AND METHODS: Between March 2011 and April 2012, 50 patients (34 men and 16 women) with an acute rupture of the ACL underwent primary repair using this device. The mean age of the patients was 30 years (18 to 50). Patients were evaluated for laxity, stability, range of movement (ROM), Tegner, Lysholm, International Knee Documentation Committee (IKDC) and visual analogue scale (VAS) scores over a follow-up period of two years. RESULTS: At final follow-up, anteroposterior translation differed from the normal knee by a mean of 0.96 mm (-2 mm to 6 mm). Median (interquartile range) IKDC, Tegner, Lysholm and VAS scores were 98 (95 to 100), 6 (5 to 7), 100 (98 to 100) and 10 (9 to 10), respectively. Pre-injury Tegner activity levels were reached one year post-operatively. A total of nine patients (18%) required a secondary intervention; five developed instability, of whom four underwent secondary hamstring reconstructive surgery, and five required arthroscopic treatment for intra-articular impingement due to scar tissue which caused a fixed flexion deformity. In addition, 30 patients (60%) required removal of the tibial screw. CONCLUSION: While there was a high rate of secondary interventions, 45 patients (90%) retained their repaired ACL two years post-operatively, with good clinical scores and stability of the knee. TAKE HOME MESSAGE: Dynamic intraligamentary stabilisation presents a promising treatment option for acute ACL ruptures, eliminating the need for ACL reconstruction. Cite this article: Bone Joint J 2016;98-B:793-8.