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  • 1
    In: Cancer Control, SAGE Publications, Vol. 9, No. 1 ( 2002-01), p. 9-15
    Type of Medium: Online Resource
    ISSN: 1073-2748 , 1073-2748
    Language: English
    Publisher: SAGE Publications
    Publication Date: 2002
    detail.hit.zdb_id: 2004182-2
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  • 2
    In: The American Journal of Sports Medicine, SAGE Publications, Vol. 51, No. 1 ( 2023-01), p. 49-57
    Abstract: Anterior cruciate ligament (ACL) revision surgery is challenging for both patients and surgeons. Understanding the risk factors for failure after bridge-enhanced ACL restoration (BEAR) may help with patient selection for ACL restoration versus ACL reconstruction. Purpose: To identify the preoperative risk factors for ACL revision surgery within the first 2 years after BEAR. Study Design: Case-control study; Level of evidence, 3. Methods: Data from the prospective BEAR I, II, and III trials were used to determine the preoperative risk factors for ACL revision surgery. All patients with a complete ACL tear (aged 13-47 years, depending on the trial), who met all other inclusion/exclusion criteria and underwent a primary BEAR procedure within 30 to 50 days from the injury (dependent on the trial), were included. Demographic data (age, sex, body mass index), baseline patient-reported outcomes (International Knee Documentation Committee [IKDC] subj ective score, Marx activity score), preoperative imaging results (ACL stump length, notch size, tibial slope), and intraoperative findings (knee hyperextension, meniscal status) were evaluated to determine their contribution to the risk of ipsilateral ACL revision surgery. Results: A total of 123 patients, with a median age of 17.6 years (interquartile range, 16-23 years), including 67 (54%) female patients, met study criteria. Overall, 18 (15%) patients required ACL revision surgery in the first 2 years after the BEAR procedure. On bivariate analyses, younger age ( P = .011), having a contact injury at the time of the initial tear ( P = .048), and increased medial tibial slope (MTS; P = .029) were associated with a higher risk of ipsilateral revision surgery. Multivariable logistic regression analyses identified 2 independent predictors of revision: patient age and MTS. The odds of ipsilateral revision surgery were decreased by 32% for each 1-year increase in age (odds ratio, 0.684 [95% CI, 0.517-0.905]; P = .008) and increased by 28% for each 1° increase in MTS (odds ratio, 1.280 [95% CI, 1.024-1.601] ; P = .030). Sex, baseline IKDC or Marx score, knee hyperextension, and meniscal status were not significant predictors of revision. Conclusion: Younger age and higher MTS were predictors of ipsilateral ACL revision surgery after the BEAR procedure. Younger patients with higher tibial slopes should be aware of the increased risk for revision surgery when deciding to undergo ACL restoration.
    Type of Medium: Online Resource
    ISSN: 0363-5465 , 1552-3365
    Language: English
    Publisher: SAGE Publications
    Publication Date: 2023
    detail.hit.zdb_id: 2063945-4
    SSG: 31
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  • 3
    In: The American Journal of Sports Medicine, SAGE Publications, Vol. 48, No. 6 ( 2020-05), p. 1305-1315
    Abstract: Preclinical studies suggest that for complete midsubstance anterior cruciate ligament (ACL) injuries, a suture repair of the ACL augmented with a protein implant placed in the gap between the torn ends (bridge-enhanced ACL repair [BEAR]) may be a viable alternative to ACL reconstruction (ACLR). Hypothesis: We hypothesized that patients treated with BEAR would have a noninferior patient-reported outcomes (International Knee Documentation Committee [IKDC] Subjective Score; prespecified noninferiority margin, –11.5 points) and instrumented anteroposterior (AP) knee laxity (prespecified noninferiority margin, +2-mm side-to-side difference) and superior muscle strength at 2 years after surgery when compared with patients who underwent ACLR with autograft. Study Design: Randomized controlled trial; Level of evidence, 1. Methods: One hundred patients (median age, 17 years; median preoperative Marx activity score, 16) with complete midsubstance ACL injuries were enrolled and underwent surgery within 45 days of injury. Patients were randomly assigned to receive either BEAR (n = 65) or autograft ACLR (n = 35 [33 with quadrupled semitendinosus-gracilis and 2 with bone–patellar tendon–bone]). Outcomes—including the IKDC Subjective Score, the side-to-side difference in instrumented AP knee laxity, and muscle strength—were assessed at 2 years by an independent examiner blinded to the procedure. Patients were unblinded after their 2-year visit. Results: In total, 96% of the patients returned for 2-year follow-up. Noninferiority criteria were met for both the IKDC Subjective Score (BEAR, 88.9 points; ACLR, 84.8 points; mean difference, 4.1 points [95% CI, –1.5 to 9.7]) and the side-to-side difference in AP knee laxity (BEAR, 1.61 mm; ACLR, 1.77 mm; mean difference, –0.15 mm [95% CI, –1.48 to 1.17] ). The BEAR group had a significantly higher mean hamstring muscle strength index than the ACLR group at 2 years (98.2% vs 63.2%; P 〈 .001). In addition, 14% of the BEAR group and 6% of the ACLR group had a reinjury that required a second ipsilateral ACL surgical procedure ( P = .32). Furthermore, the 8 patients who converted from BEAR to ACLR in the study period and returned for the 2-year postoperative visit had similar primary outcomes to patients who had a single ipsilateral ACL procedure. Conclusion: BEAR resulted in noninferior patient-reported outcomes and AP knee laxity and superior hamstring muscle strength when compared with autograft ACLR at 2-year follow-up in a young and active cohort. These promising results suggest that longer-term studies of this technique are justified. Registration: NCT02664545 (ClinicalTrials.gov identifier)
    Type of Medium: Online Resource
    ISSN: 0363-5465 , 1552-3365
    Language: English
    Publisher: SAGE Publications
    Publication Date: 2020
    detail.hit.zdb_id: 2063945-4
    SSG: 31
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  • 4
    In: Orthopaedic Journal of Sports Medicine, SAGE Publications, Vol. 8, No. 7 ( 2020-07-01), p. 232596712092765-
    Abstract: A bridge-enhanced anterior cruciate ligament (ACL) repair (BEAR) procedure places an extracellular matrix implant, combined with autologous whole blood, in the gap between the torn ends of the ligament at the time of suture repair to stimulate healing. Prior studies have suggested that white blood cell (WBC) and platelet concentrations significantly affect the healing of other musculoskeletal tissues. Purpose/Hypothesis: The purpose of this study was to determine whether concentrations of various blood cell types placed into a bridging extracellular matrix implant at the time of ACL repair would have a significant effect on the healing ligament cross-sectional area or tissue organization (as measured by signal intensity). We hypothesized that patients with higher physiologic platelet and lower WBC counts would have improved healing of the ACL on magnetic resonance imaging (MRI) (higher cross-sectional area and/or lower signal intensity) 6 months after surgery. Study Design: Cohort study; Level of evidence, 2. Methods: A total of 61 patients underwent MRI at 6 months after bridge-enhanced ACL repair as part of the BEAR II trial. The normalized signal intensity and average cross-sectional area of the healing ligament were measured from a magnetic resonance stack obtained using a gradient echo sequence. The results were stratified by sex, and univariate and multivariate regression analyses determined significant correlations between blood cell concentrations on these 2 magnetic resonance parameters. Results: In unadjusted analyses, older age and male sex were associated with greater healing ligament cross-sectional area ( P 〈 .04) but not signal intensity ( P 〉 .15). Adjusted multivariable analyses indicated that in female patients, a higher monocyte concentration correlated with a higher ACL cross-sectional area (β = 1.01; P = .049). All other factors measured, including the physiologic concentration of platelets, neutrophils, lymphocytes, basophils, and immunoglobulin against bovine gelatin, were not significantly associated with either magnetic resonance parameter in either sex ( P 〉 .05 for all). Conclusion: Although older age, male sex, and monocyte concentration in female patients were associated with greater healing ligament cross-sectional area, signal intensity of the healing ligament was independent of these factors. Physiologic platelet concentration did not have any significant effect on cross-sectional area or signal intensity of the healing ACL at 6 months after bridge-enhanced ACL repair in this cohort. Given these findings, factors other than the physiologic platelet concentration and total WBC concentration may be more important in the rate and amount of ACL healing after bridge-enhanced ACL repair.
    Type of Medium: Online Resource
    ISSN: 2325-9671 , 2325-9671
    Language: English
    Publisher: SAGE Publications
    Publication Date: 2020
    detail.hit.zdb_id: 2706251-X
    SSG: 31
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  • 5
    In: The American Journal of Sports Medicine, SAGE Publications, Vol. 49, No. 14 ( 2021-12), p. 3833-3841
    Abstract: Magnetic resonance–based measurements of signal intensity have been used to track healing of surgically treated anterior cruciate ligaments (ACLs). However, it is unknown how the signal intensity values in different regions of the ligament or graft change during healing. Hypotheses: (1) Normalized signal intensity of the healing graft or repaired ACL is heterogeneous; (2) temporal changes in normalized signal intensity values differ among the tibial, middle, and femoral regions; and (3) there are no differences in regional normalized signal intensity values 2 years postoperatively among grafts, repaired ACLs, and contralateral native ACLs. Study Design: Cohort study; Level of evidence, 2. Methods: Magnetic resonance imaging scans were analyzed from patients in a trial comparing ACL reconstruction (n = 35) with bridge-enhanced ACL repair (n = 65). The ACLs were segmented from images acquired at 6, 12, and 24 months postoperatively and were partitioned into 3 sections along the longitudinal axis (femoral, middle, and tibial). Linear mixed modeling was used to compare location-specific differences in normalized ligament signal intensity among time points (6, 12, and 24 months) and groups (ACL reconstruction, repair, and contralateral native ACL). Results: For grafts, the middle region had a higher mean normalized signal intensity when compared with the femoral region at all time points ( P 〈 .01) but compared with the tibial region only at 6 months ( P 〈 .01). For repaired ACLs, the middle region had a higher mean normalized signal intensity versus the femoral region at all time points ( P 〈 .01) but versus the tibial region only at 6 and 12 months ( P 〈 .04). From 6 to 24 months, the grafts showed the greatest reduction in normalized signal intensity in the femoral and middle regions (vs tibial regions; P 〈 .01), while there were no regional differences in repaired ACLs. At 2 years after surgery, repaired ACLs had a lower normalized signal intensity in the tibial region as compared with reconstructed grafts and contralateral native ACLs ( P 〈 .01). Conclusion: The results suggest that graft remodeling is location specific. Repaired ACLs were more homogeneous, with lower or comparable normalized signal intensity values at 2 years as compared with the contralateral native ACL and reconstructed grafts.
    Type of Medium: Online Resource
    ISSN: 0363-5465 , 1552-3365
    Language: English
    Publisher: SAGE Publications
    Publication Date: 2021
    detail.hit.zdb_id: 2063945-4
    SSG: 31
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  • 6
    In: Orthopaedic Journal of Sports Medicine, SAGE Publications, Vol. 7, No. 3 ( 2019-03), p. 232596711882435-
    Type of Medium: Online Resource
    ISSN: 2325-9671 , 2325-9671
    Language: English
    Publisher: SAGE Publications
    Publication Date: 2019
    detail.hit.zdb_id: 2706251-X
    SSG: 31
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  • 7
    In: Orthopaedic Journal of Sports Medicine, SAGE Publications, Vol. 7, No. 3_suppl2 ( 2019-03-01), p. 2325967119S0019-
    Abstract: 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.
    Type of Medium: Online Resource
    ISSN: 2325-9671 , 2325-9671
    Language: English
    Publisher: SAGE Publications
    Publication Date: 2019
    detail.hit.zdb_id: 2706251-X
    SSG: 31
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  • 8
    In: Orthopaedic Journal of Sports Medicine, SAGE Publications, Vol. 10, No. 10 ( 2022-10-01), p. 232596712211273-
    Abstract: The cross-sectional area (CSA) of the anterior cruciate ligament (ACL) and reconstructed graft has direct implications on its strength and knee function. Little is known regarding how the CSA changes along the ligament length and how those changes vary between treated and native ligaments over time. Hypothesis: It was hypothesized that (1) the CSA of reconstructed ACLs and restored ACLs via bridge-enhanced ACL restoration (BEAR) is heterogeneous along the length. (2) Differences in CSA between treated and native ACLs decrease over time. (3) CSA of the surgically treated ACLs is correlated significantly with body size (ie, height, weight, body mass index) and knee size (ie, bicondylar and notch width). Study Design: Cohort study; Level of evidence, 2. Methods: Magnetic resonance imaging scans of treated and contralateral knees of 98 patients (n = 33 ACL reconstruction, 65 BEAR) at 6, 12, and 24 months post-operation were used to measure the ligament CSA at 1% increments along the ACL length (tibial insertion, 0%; femoral insertion, 100%). Statistical parametric mapping was used to evaluate the differences in CSA between 6 and 24 months. Correlations between body and knee size and treated ligament CSA along its length were also assessed. Results: Hamstring autografts had larger CSAs than native ACLs at all time points ( P 〈 .001), with region of difference decreasing from proximal 95% of length (6 months) to proximal 77% of length (24 months). Restored ACLs had larger CSAs than native ACLs at 6 and 12 months, with larger than native CSA only along a small midsubstance region at 24 months ( P 〈 .001). Graft CSA was correlated significantly with weight (6 and 12 months), bicondylar width (all time points), and notch width (24 months). Restored ACL CSA was significantly correlated with bicondylar width (6 months) and notch width (6 and 12 months). Conclusion: Surgically treated ACLs remodel continuously within the first 2 years after surgery, leading to ligaments/grafts with heterogeneous CSAs along the length, similar to the native ACL. While reconstructed ACLs remained significantly larger, the restored ACL had a CSA profile comparable with that of the contralateral native ACL. In addition to size and morphology differences, there were fundamental differences in factors contributing to CSA profile between the ACL reconstruction and BEAR procedures. Registration: NCT 02664545 ( ClinicalTrials.gov identifier).
    Type of Medium: Online Resource
    ISSN: 2325-9671 , 2325-9671
    Language: English
    Publisher: SAGE Publications
    Publication Date: 2022
    detail.hit.zdb_id: 2706251-X
    SSG: 31
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