scholarly journals Bridge-Enhanced ACL Repair: Two Year Results of the First In Human Study

2019 ◽  
Vol 7 (3_suppl2) ◽  
pp. 2325967119S0019
Author(s):  
Martha M. Murray ◽  
Leslie Kalish ◽  
Braden C. Fleming ◽  
Brett Flutie ◽  
Laura Thurber ◽  
...  

Objectives: The Bridge-Enhanced ACL Repair (BEAR) procedure is an alternate form of anterior cruciate ligament (ACL) surgery that involves suture repair of the ligament combined with a scaffold to bridge the gap between the torn ligament ends. In this paper, we report outcomes of this procedure and a non-randomized concurrent control group receiving ACL reconstruction with quadrupled hamstring tendon autograft. We hypothesized that patients treated with Bridge-Enhanced ACL Repair would have physical exam findings, patient reported outcomes and adverse events at one and two years that were similar to patients treated with ACL reconstruction. Methods: This was an observational cohort study. Twenty patients were enrolled. Ten patients received a Bridge-Enhanced ACL Repair (BEAR®) and 10 received a hamstring autograft ACL reconstruction. Outcomes were assessed at time points up to 2 years post-operatively, including the International Knee Documentation Committee (IKDC) Subjective Score, the IKDC Objective score, KT-1000 testing for AP laxity and functional testing. Results: There were no graft or repair failures in the first two years after surgery. The IKDC Subjective Scores in both groups improved significantly from baseline (p< 0.0001) but were similar in BEAR and ACL reconstruction groups at 12 and 24 months. An IKDC Objective score of A (normal) was found in 44% of the patients in the BEAR group and 29% of the patients in the ACL reconstruction group at two years; no patients in either group had a grade of C (abnormal) or D (severely abnormal). KT-1000 testing demonstrated a side to side difference that was similar in the two groups at 2 years (mean(±SD) 1.9(± 2.1) mm in the BEAR group, 3.1(± 2.7) mm in the ACLR group). Functional hop testing results were similar in the two groups at 1 and 2 years after surgery. Hamstring strength indices measured by dynamometer were significantly higher at all time points in the BEAR group than in the hamstring autograft group (mean percentages relative to contralateral side at two years, 98.6%(±10.5%) vs 56.3%(±19.0%), p=0.0001). Conclusion: In a small first-in-human study, Bridge-Enhanced ACL Repair produced similar outcomes to ACL reconstruction with autograft quadruple bundle hamstring tendon.

2018 ◽  
Vol 20 (4) ◽  
pp. 285-291 ◽  
Author(s):  
Serkan Sözkesen ◽  
Huseyin Gokhan Karahan ◽  
Ahmet Kurtulmus ◽  
Cemil Kayali ◽  
Taskin Altay

Background. The purpose of this study is to describe the role of Platelet Rich Plasma in preventing tunnel enlargement in anterior cruciate ligament reconstruction with a hamstring autograft Material and methods. Forty-four patients who underwent transtibial reconstructive surgery with a hamstring tendon autograft between March 2014 and July 2015 were included in this study. This study involved two groups. Group A consisted of 18 patients who underwent PRPadministration into the femoral and tibial tunnel. Group B was a control group that included 26 patients who underwent ACL reconstruction surgery with a hamstring autograft without PRP. The patients were evaluated preoperatively and postoperatively with the IKDC score, Lysholm score, Tegner activity scale and a KT-1000 arthrometer device. The diameter of the tibial and femoral tunnels of the operated knees was measured on the first day and at three months postoperatively using CT. Measurements carried out for tomography standardization of the patients were evaluated on coronal, sagittal and axial images from 64-slice MSCT scans. Results. On comparison of radiological data between both groups, there was less tunnel enlargement in PRP-administered group for the femoral tunnel, but the result was not statistically significant. No difference was seen between clinical examination results and the grading scales used. Conclusions. 1. The radiological findings of our study indicated that while there was less tunnel enlargement in the PRP group, there was no statistically significant difference between the groups. 2. Similarly, clinical exa­mination results and scoring scales used did not de­monstrate any intergroup difference. 3. As a result, we donot recommend routine use of PRP for the prevention of tunnel enlargement after ACL reconstruction.


2020 ◽  
Vol 8 (7_suppl6) ◽  
pp. 2325967120S0035
Author(s):  
Braden Fleming ◽  
Gary Badger ◽  
Dennis Kramer ◽  
Lyle Micheli ◽  
Yi-Meng YenMD ◽  
...  

Objectives: Preclinical studies and an early clinical cohort study have suggested that for complete midsubstance ACL injuries, the technique of suture repair of the anterior cruciate ligament (ACL) augmented with a protein implant placed in the gap between the torn ends (bridge-enhanced ACL repair) may be a viable alternative to ACL reconstruction. We hypothesized that patients treated with bridge-enhanced ACL repair would have non-inferior patient reported outcomes and anteroposterior (AP) laxity, and superior hamstring strength at 2 years after surgery when compared with subjects who had ACL reconstruction with autograft. Study Design: Prospective Randomized Control Trial (NCT02664545). Methods: One hundred patients, ages 13 to 35, with complete mid-substance ACL injuries, were enrolled and underwent surgery within 45 days of injury. Sixty-five patients were randomized to receive a bridge-enhanced ACL repair (BEAR group) and 35 were randomized to receive autograft ACL reconstruction (ACLR group). Outcomes, including the International Knee Documentation Committee (IKDC) Subjective score, instrumented AP laxity and muscle strength were assessed at 2 years post-operatively. Both patients and assessors were blinded as to surgical assignment until after the 2-year assessment. Results: Ninety-six percent of the subjects returned for follow-up at 2 years. The median age of the subjects in both groups at enrollment was 17 years and the median pre-operative Marx score in both groups was 16 points. Non-inferiority criteria were met for both the IKDC subjective score and AP laxity. The BEAR group had significantly better recovery of hamstring strength than the ACLR group (p<0.001). The number of subjects who were reinjured and required a second ACL surgery was not statistically different between the two groups. Subjects who converted from BEAR to ACLR in the study period had outcomes at the 2-year point that were similar to those for subjects who had only a single ipsiateral ACL procedure (BEAR or ACLR). Conclusion: Bridge-enhanced ACL repair using a specific protein-based implant led to non-inferior outcomes to that of ACL reconstruction for patient reported and instrumented knee laxity measures at 2 years after surgery in a young and active cohort of patients with acute mid-substance ACL tears.


2017 ◽  
Vol 5 (5_suppl5) ◽  
pp. 2325967117S0017
Author(s):  
Ritwik Kejriwal ◽  
Jens Buelow

Objectives: Revision anterior cruciate ligament (ACL) reconstruction is associated with poorer outcomes and higher rerupture rates when compared to primary ACL reconstruction. There is also a significant heterogeneity in surgical technique, number of stages, and graft options. We report a large single surgeon case series with hamstring autograft as a graft option. Methods: Observational series of revision ACL reconstructions performed by the senior author between 2005 and 2015 was carried out. Chart reviews and clinic follow-ups were performed with the following recorded – re-rupture rate, radiographic grading of osteoarthritis, KT-1000 arthrometer test, IKDC outcome scores and knee range of motion. All patients underwent single bundle four-strand hamstring autograft performed in one stage with use of new tunnels in majority of the cases. Results: 66 patients underwent hamstring autograft one-stage revision ACL reconstruction by Dr Jens Buelow. Chart review was carried out on all patients, and 26 (39%) were followed up in clinic and/or by phone with a mean follow up of 4.7 years. Outcomes included re-rupture rate of 4.5%, reoperation rate of 12%, mean visual analogue scale score of 7.6, mean side-to-side difference of 2.6 mm for KT-1000 arthrometer test, and mean IKDC score of 79. Of the 17 patients with radiographs, 40% had moderate osteoarthritis (grade 2 or 3) at follow-up. Conclusion: Revision ACL reconstruction can result in a satisfactory outcome when performed with a hamstring autograft in one stage.


2019 ◽  
Vol 7 (7_suppl5) ◽  
pp. 2325967119S0035
Author(s):  
Drew A. Lansdown ◽  
Weiyuan Xiao ◽  
Alan L. Zhang ◽  
Christina R. Allen ◽  
Brian T. Feeley ◽  
...  

Objectives: Following surgical reconstruction of the anterior cruciate ligament (ACL), the tendon graft undergoes a remodeling process of ligamentization. Collagen within the ACL graft becomes organized along the long-axis of the ligament and the proteoglycan content increases. Quantitative imaging sequences, specifically T2 and T1rho, allow for a non-invasive assessment of collagen orientation and proteoglycan content, respectively. The purpose of this study was to investigate the longitudinal progression of T2 and T1rho relaxation times of the graft after ACL reconstruction and the relationship between these quantitative imaging markers and patient-reported outcome measures. We hypothesized that T2 and T1rho would decrease significantly over time, reflecting improved collagen organization and ncreased proteoglycan content, and that T2 and T1rho relaxation times would be inversely correlated with Knee Osteoarthritis Outcome Scores (KOOS). Methods: Thirty-two patients (mean age 29.4±8.2 years, 12 females) were followed prospectively after arthroscopic ACL reconstruction with hamstring autograft. Patients provided informed consent and all procedures were IRB-approved. Exclusion criteria included allograft reconstruction, other ligamentous injury, meniscal tear requiring repair, prior knee surgery, or history of arthritis. Post-operative MR imaging was obtained for 31 patients at 6 months, 30 patients at 12 months, 26 patients at 24 months, and 23 patients at 36 months after surgery. T2 and T1rho relaxation times were simultaneously acquired with a combined 3D sagittal sequence using a 3 T MR system (GE Healthcare) with a 1Tx/8Rx knee coil. The intra-articular ACL graft was identified on a fat-suppressed sagittal high-resolution 3D fast spin echo images and manually segmented. The T2 and T1rho relaxation times for the graft were recorded. Patients completed the KOOS at each imaging time point. Repeated measures analysis of variance (ANOVA) tests with Tukey corrections were used to compare T2 and T1rho relaxation times between time points. The relationship between KOOS and T2 and T1rho values at 2 years post-operative was investigated with Spearman’s rank correlation. Significance was defined as p<0.05. Results: The T2 relaxation times of the ACL graft were significantly higher at 6 months relative to 12 months (p<0.001), 24 months (p<0.001,) and 36 months (p<0.001) after ACL reconstruction, as well as significantly higher at 12 months relative to 36 months (p<0.001) (Figure 1A). The T1rho relaxation times of the ACL graft were significantly higher at 6 months relative to 12 months (p<0.001), 24 months (p<0.001), and 36 months (p<0.001) (Figure 1B). The two-year T2 relaxation times and T1rho relaxation times were significantly correlated with the KOOS Sports, Pain, Symptoms, and Activities of Daily Living sub-scores. Conclusion: We observed significant changes in the tendon graft over time following ACL reconstruction with hamstring autograft, reflecting a higher concentration of proteoglycan and more longitudinally-organized collagen structure over time. Improved collagen organization (lower T2 values) and increased proteoglycan content (lower T1rho values) were correlated with better outcomes based on KOOS scores. Quantitative T2 and T1rho relaxation times of ACL graft may offer a non-invasive method for monitoring graft maturation that correlates with patient-reported knee function after ACL reconstruction. [Figure: see text][Table: see text]


2020 ◽  
Vol 48 (12) ◽  
pp. 2962-2969
Author(s):  
Frans J.A. Hagemans ◽  
Freerk J. Jonkers ◽  
Matthijs J.J. van Dam ◽  
Amber L. von Gerhardt ◽  
Jelle P. van der List

Background: The short-term outcomes of anterior cruciate ligament (ACL) reconstruction with bone–patellar tendon–bone or hamstring tendon (HT) graft are excellent with good clinical stability and patient-reported outcomes. Although some studies have reported the long-term outcomes of bone–patellar tendon–bone graft ACL reconstruction, few have reported the outcomes of HT graft ACL reconstruction. Purpose: To assess clinical and radiographic outcomes of HT graft ACL reconstruction with femoral cortical button fixation at a minimum 20-year follow-up. Study Design: Case series; Level of evidence, 4. Methods: A prospective study was performed in which all patients undergoing isolated transtibial primary ACL reconstruction between 1994 and 1996 with HT graft and femoral cortical button fixation were assessed clinically and radiographically. Follow-up was obtained in 48 of 94 patients (51%). Median (interquartile range) age at operation was 31 years (26-39 years); median follow-up was 21 years (20-22 years); 65% were male; and 48% had meniscal injury at surgery and underwent partial meniscectomy. Graft rupture, reoperation, and contralateral injury rates were assessed; clinical stability was measured using the KT-1000 arthrometer; patient-reported outcomes were assessed (International Knee Documentation Committee [IKDC], Lysholm, Forgotten Joint Score, Tegner activity, Knee injury and Osteoarthritis Outcome Score [KOOS], Anterior Cruciate Ligament Quality of Life [ACL-QOL], EuroQol 5-Dimension 5-Level [EQ-5D-5L]); and radiographic osteoarthritis (defined as Kellgren-Lawrence grade ≥2) was assessed for the ipsilateral and the contralateral knee. Results: Graft rupture occurred in 4 patients (8%), contralateral injury in 4 patients (8%), and reoperation in 15 patients (31%), which consisted mainly of meniscal tears or hardware removal. In patients with an intact graft, excellent patient-reported outcome measures (PROMs) were noted, with a median Lysholm of 90 (78-100), subjective IKDC of 86 (72-95), and KOOS–Sports of 86 (58-100). There was low awareness of the operated knee (Forgotten Joint Score, 81 [60-96]) and good quality of life (ACL-QOL, 85 [75-94]; EQ-5D-5L, 0.87 [0.83-1.00]). Median side-to-side difference, as measured with the KT-1000 arthrometer, was 1 mm (-1 to 3 mm). Radiographic osteoarthritis was evident in 49% of ipsilateral and 10% of contralateral knees and was associated with meniscectomy at index surgery and decreased PROMs at follow-up. Conclusion: Long-term outcomes of transtibial HT graft ACL reconstruction with femoral cortical button fixation are generally good with a low failure rate, low awareness of the operated knee, and good clinical stability. Radiographic osteoarthritis was evident in approximately half of the patients at 20-year follow-up and was associated with meniscectomy at index surgery and decreased PROMs at follow-up.


2019 ◽  
Vol 7 (10) ◽  
pp. 232596711987907
Author(s):  
Jay R. Ebert ◽  
Peter T. Annear

Background: There are a number of surgical methods for undertaking anterior cruciate ligament (ACL) reconstruction (ACLR), although relatively high rates of ipsilateral retears and contralateral tears exist, with only 65% of patients returning to their preinjury level of sport. ACLR techniques adopting synthetic augmentation have been proposed in an attempt to improve clinical outcomes and reduce reinjury rates. Purpose: To determine the efficacy of ACLR using autologous hamstrings augmented with the Ligament Augmentation and Reconstruction System (LARS). Study Design: Case series; Level of evidence, 4. Methods: A total of 65 patients were prospectively treated with arthroscopically assisted single-bundle ACLR using hamstrings augmented with the LARS, of whom 50 were available for 1- and 2-year reviews. Patient-reported outcome measures (PROMs), KT-1000 arthrometer testing, knee range of motion, peak isokinetic knee strength testing, and a battery of 4 hop tests were employed. Limb symmetry indices (LSIs) were calculated. Analysis of variance was used to evaluate differences over time and between limbs. Data on return to the preinjury level of sport, retears, and reoperations were collected. Results: High PROM scores were demonstrated at 1 and 2 years. Before the injury, 47 patients (94%) were actively participating in level 1 or 2 sports, with 38 (76%) and 43 (86%) patients having returned at 1 and 2 years, respectively. Normal (<3 mm; 90%) or nearly normal (3-5 mm; 10%) KT-1000 arthrometer side-to-side differences were observed at 2 years. Apart from knee flexion ( P < .0001), extension ( P = .001), and the 6-m timed hop ( P = .039), there were no between-limb differences at 1 year, and there were no differences on any objective measures at 2 years (all P > .05). Mean LSIs across all measures were ≥90%. At 2 years, 84% to 90% of patients were ≥90% on the hop tests, with 72% and 76% of patients having ≥90% for extension and flexion strength, respectively. Two reoperations were undertaken for meniscal tears (7 and 8.5 months), 1 patient (2%) suffered a retear at 7 months, and 2 patients (3%) suffered a contralateral tear (8 and 12 months). Conclusion: This augmented ACLR technique demonstrated good clinical scores, a high rate of return to sport, and low rates of secondary ruptures and contralateral ACL tears at 2 years. Some caution should be noted in interpreting these results, as 15 of 65 patients (23%) were not included in the 2-year follow-up.


Author(s):  
Xiaozuo Zheng ◽  
Yang Hu ◽  
Peng Xie ◽  
Tong Li ◽  
Yu-e Feng ◽  
...  

Abstract Background There is no consensus as to the choice of grafts for primary anterior cruciate ligament (ACL) reconstruction. The purpose of this study was to compare the clinical and second-look arthroscopic outcomes after ACL reconstruction by use of autograft, hybrid graft, and γ-irradiated allograft. Methods Ninety-seven patients who underwent second-look arthroscopy after ACL reconstruction with autografts (28 patients, hamstring autograft), hybrid grafts (32 patients, hamstring autograft augmented with γ-irradiated tibialis anterior tendon allograft), or γ-irradiated allografts (37 patients, tibialis anterior tendons) were included in this study. The clinical outcomes were compared by using Lysholm score, International Knee Documentation Committee (IKDC) score, and Tegner activity score, and the side-to-side differences of KT-1000 measurement. Second-look arthroscopic findings were compared in terms of synovial coverage and graft tension. Results There were no statistical significances among the three groups in Lysholm score, IKDC score, or Tegner activity score (P > 0.05). The KT-1000 examination showed more anterior laxity in the γ-irradiated allograft group than in the autograft or hybrid graft groups (P = 0.006, and P = 0.013, respectively). Two patients in the autograft group, 2 patients in the hybrid graft group and 4 patients in the allograft group were evaluated as graft failure on second-look arthroscopy. The synovial coverage was superior in the autograft group than that in the hybrid graft group or the allograft group (P = 0.013 and P = 0.010, respectively), and was comparable between the hybrid graft group and allograft group (P = 0.876). With regard to graft tension, the autograft group and hybrid group were comparable (P = 0.883) but showed better results than the allograft group (P = 0.011 and P = 0.007, respectively). Conclusion The hamstring autografts and hybrid grafts used for ACL reconstruction produced equal efficacy but provided better knee stability than allografts. In addition, the hamstring autografts showed better synovial coverage than the other two graft types.


2014 ◽  
Vol 2 (11_suppl3) ◽  
pp. 2325967114S0021
Author(s):  
Çetin Işık ◽  
Nurdan Çay ◽  
Osman Tecimel ◽  
Ahmet Fırat ◽  
Mustafa Akkaya ◽  
...  

Objectives: The purpose of this study is to determine the average thickness of 4 folded hamstring tendons (autograft) which we used on our patients who had tendon reconstruction because of ACB rapture diagnostic. Methods: Between the dates of January 2009 and December 2013, patients who had tendon reconstruction with hamstring autograft because of ACB rapture diagnostic were evaluated retrospectively in Yıldırım Beyazıt University Ankara Atatürk Training And Research Hospital – Orthopaedics and Trauma Clinic. 258 patients who had 4 folded hamstring tendon which was prefered usually, were included into the study but 26 patients were not included into the study who had different autograft applications and direct allografts usages. Results: 242 of the 258 patiens who were included into the study were males and remaining 16 were females. Average age was 28.7 (14-52). The average thickness of the 4 folded hamstring tendons (semitendinosus and gracilis tendons) of the patients was observed as 7.9mm (6-10mm). The tendon thickness of 47 patients were measured below 7mm. For those patients, the tendon thickness was increased by combining allografts with autografts. Conclusion: The average thickness of the 4 folded hamstring tendons what we have used was 7.9mm. By considering the average graft thickness, it may be beneficial to make the planing by thinking about different configurations or keeping allografts ready for the cases which may require thicker grafts.


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