Annular closure in lumbar microdiscectomy for prevention of reherniation: a randomized clinical trial

Background Context: Patients with large annular defects after lumbar discectomy for disc herniation are at high risk of symptomatic recurrence and reoperation. Purpose: The present study aimed to determine whether a bone-anchored annular closure device, in addition to lumbar microdiscectomy, resulted in lower reherniation and reoperation rates plus increased overall success compared with lumbar microdiscectomy alone. Design: This is a multicenter, randomized superiority study. Patient Sample: Patients with symptoms of lumbar disc herniation for at least 6 weeks with a large annular defect (6–10 mm width) after lumbar microdiscectomy were included in the study. Outcome Measures: The co-primary end points determined a priori were recurrent herniation and a composite end point consisting of patient-reported, radiographic, and clinical outcomes. Study success required superiority of annular closure on both end points at 2-year follow-up. Methods: Patients received lumbar microdiscectomy with additional bone-anchored annular closure device (n=276 participants) or lumbar microdiscectomy only (control; n=278 participants). This research was supported by Intrinsic Therapeutics. Two authors received study-specific support morethan $10,000 per year, 8 authors received study-specific support less than$10,000 per year, and 11 authors received no study-specific support. Results: Among 554 randomized participants, 550 (annular closure device: n=272; control: n=278) were included in the modified intent-to-treat efficacy analysis and 550 (annular closure device: n=267; control: n=283) were included in the as-treated safety analysis. Both co-primary end points of the study were met, with recurrent herniation (50% vs. 70%, P<.001) and composite end point success (27% vs. 18%, P=.02) favoring annular closure device. The frequency of symptomatic reherniation was lower with annular closure device (12% vs. 25%, P<.001). There were 29 reoperations in 24 patients in the annular closure device group and 61 reoperations in 45 control patients. The frequency of reoperations to address recurrent herniation was 5% with annular closure device and 13% in controls (P=.001). End plate changes were more prevalent in the annular closure device group (84% vs. 30%, P<.001). Scores for back pain, leg pain, Oswestry Disability Index, and health-related quality of life at regular visits were comparable between groups over 2-year follow-up. Conclusions: In patients at high risk of herniation recurrence after lumbar microdiscectomy, annular closure with a bone-anchored implant lowers the risk of symptomatic recurrence and reoperation. Additional study to determine outcomes beyond 2 years with a bone-anchored annular closure device is warranted

Clinical implications of vertebral endplate disruptions after lumbar discectomy: 3-year results from a randomized trial of a bone-anchored annular closure device

Objective: Vertebral endplate disruptions (VEPD) are common findings on imaging after lumbar surgery. The objective of this study was to explore the clinical implications of VEPD development following lumbar discectomy with or without implant with a bone-anchored annular closure device (ACD). Methods: This was a multicenter randomized controlled trial of patients with large post-surgical annular defects after limited lumbar discectomy who were randomized to addition-ally receive an ACD or no additional treatment. VEPD were identified on computed tomography and confirmed by an imaging core laboratory. Clinical outcomes included recurrent herniation, reoperation, Oswestry Disability Index, leg pain, and back pain. Patient follow-up in this study was 3 years. Results: In the ACD group (n=272), the risk of reoperation was lower in patients with vs without VEPD (8% vs 24%, p<0.01), but no other clinical outcomes differed when stratified by VEPD prevalence or size. In the Control group (n=278), the risk of symptomatic reherniation was higher in patients with VEPD (41% vs 23%, p<0.01) and patients with the largest VEPD had the highest reoperation rates. Patient-reported outcomes were not associated with VEPD prevalence or size in the Control group. Conclusion: VEPD had no significant influence on patient-reported outcomes at 3 years after lumbar discectomy. VEPD increased the risk of recurrence in patients treated with lumbar discectomy only, but had no negative influence in patients treated with the ACD

Clinical Implications of Vertebral Endplate Disruptions After Lumbar Discectomy: 3-Year Results from a Randomized Trial of a Bone-Anchored Annular Closure Device

Objective: Vertebral endplate disruptions (VEPD) are common findings on imaging after lumbar surgery. The objective of this study was to explore the clinical implications of VEPD development following lumbar discectomy with or without implant with a bone-anchored annular closure device (ACD). Methods: This was a multicenter randomized controlled trial of patients with large post-surgical annular defects after limited lumbar discectomy who were randomized to addition-ally receive an ACD or no additional treatment. VEPD were identified on computed tomography and confirmed by an imaging core laboratory. Clinical outcomes included recurrent herniation, reoperation, Oswestry Disability Index, leg pain, and back pain. Patient follow-up in this study was 3 years. Results: In the ACD group (n=272), the risk of reoperation was lower in patients with vs without VEPD (8% vs 24%, p<0.01), but no other clinical outcomes differed when stratified by VEPD prevalence or size. In the Control group (n=278), the risk of symptomatic reherniation was higher in patients with VEPD (41% vs 23%, p<0.01) and patients with the largest VEPD had the highest reoperation rates. Patient-reported outcomes were not associated with VEPD prevalence or size in the Control group. Conclusion: VEPD had no significant influence on patient-reported outcomes at 3 years after lumbar discectomy. VEPD increased the risk of recurrence in patients treated with lumbar discectomy only, but had no negative influence in patients treated with the ACD

BRAF V600E is associated with higher incidence of second cancers in adults with Langerhans cell histiocytosis

In this retrospective study, BRAF mutation status did not correlate with disease extent or (event-free) survival in 156 adults with Langerhans cell histiocytosis. BRAF V600E was associated with an increased incidence of second malignancies, often comprising hematological cancers, which may be clonally related.</p

BRAF^V600E is associated with higher incidence of second cancers in adults with Langerhans cell histiocytosis

In this retrospective study, BRAF mutation status did not correlate with disease extent or (event-free) survival in 156 adults with Langerhans cell histiocytosis. BRAFV600E was associated with an increased incidence of second malignancies, often comprising hematological cancers, which may be clonally related.</p

BRAF^V600E is associated with higher incidence of second cancers in adults with Langerhans cell histiocytosis

In this retrospective study, BRAF mutation status did not correlate with disease extent or (event-free) survival in 156 adults with Langerhans cell histiocytosis. BRAFV600E was associated with an increased incidence of second malignancies, often comprising hematological cancers, which may be clonally related.</p