Eike K Hoff1, Patrick Strube2, Matthias Pumberger1, Robert K Zahn1, Michael Putzier3. 1. Klinik für Orthopädie, Centrum für Muskuloskeletale Chirurgie, Charité, Universitätsmedizin Berlin, Charitéplatz 1, 10117, Berlin, Germany. 2. Klinik für Orthopädie am Walkrankenhaus "Rudolph Elle" GmbH Eisenberg, Friedrich-Schiller-Universität Jena, Eisenberg, Germany. 3. Klinik für Orthopädie, Centrum für Muskuloskeletale Chirurgie, Charité, Universitätsmedizin Berlin, Charitéplatz 1, 10117, Berlin, Germany. michael.putzier@charite.de.
Abstract
STUDY DESIGN: Prospective, randomized trial. PURPOSE: The treatment of degenerative disc disease (DDD) with two-level fusion has been associated with a reasonable rate of complications. The aim of the present study was to compare (Hybrid) stand-alone anterior lumbar interbody fusion (ALIF) at L5/S1 with total disc replacement at L4/5 (TDR) as an alternative surgical strategy to (Fusion) 2-level circumferential fusion employing transforaminal lumbar interbody fusion (TLIF) with transpedicular stabilization at L4-S1. METHODS: A total of 62 patients with symptomatic DDD of segments L5/S1 (Modic ≥2°) and L4/5 (Modic ≤2°; positive discography) were enrolled; 31 were treated with Hybrid and 31 with Fusion. Preoperatively, at 0, 12, and a mean follow-up of 37 months, clinical (ODI, VAS) and radiological evaluations (plain/extension-flexion radiographs evaluated for implant failure, fusion, global and segmental lordosis, and ROM) were performed. RESULTS: In 26 of 31 Hybrid and 24 of 31 Fusion patients available at the final follow-up, we found a significant clinical improvement compared to preoperatively. Hybrid patients had significantly lower VAS scores immediately postoperatively and at follow-up compared to Fusion patients. The complication rates were low and similar between the groups. Lumbar lordosis increased in both groups. The increase was mainly located at L4-S1 in the Hybrid group and at L1-L4 in the Fusion group. Hybrid patients presented with increased ROM at L4/5 and L3/4, and Fusion patients presented with increased ROM at L3/4, with significantly greater ROM at L3/4 compared to Hybrid patients at follow-up. CONCLUSIONS:Hybrid surgery is a viable surgical alternative for the presented indication. Approach-related inferior trauma and the balanced restoration of lumbar lordosis resulted in superior clinical outcomes compared to two-level circumferential fusion with TLIF.
RCT Entities:
STUDY DESIGN: Prospective, randomized trial. PURPOSE: The treatment of degenerative disc disease (DDD) with two-level fusion has been associated with a reasonable rate of complications. The aim of the present study was to compare (Hybrid) stand-alone anterior lumbar interbody fusion (ALIF) at L5/S1 with total disc replacement at L4/5 (TDR) as an alternative surgical strategy to (Fusion) 2-level circumferential fusion employing transforaminal lumbar interbody fusion (TLIF) with transpedicular stabilization at L4-S1. METHODS: A total of 62 patients with symptomatic DDD of segments L5/S1 (Modic ≥2°) and L4/5 (Modic ≤2°; positive discography) were enrolled; 31 were treated with Hybrid and 31 with Fusion. Preoperatively, at 0, 12, and a mean follow-up of 37 months, clinical (ODI, VAS) and radiological evaluations (plain/extension-flexion radiographs evaluated for implant failure, fusion, global and segmental lordosis, and ROM) were performed. RESULTS: In 26 of 31 Hybrid and 24 of 31 Fusion patients available at the final follow-up, we found a significant clinical improvement compared to preoperatively. Hybrid patients had significantly lower VAS scores immediately postoperatively and at follow-up compared to Fusion patients. The complication rates were low and similar between the groups. Lumbar lordosis increased in both groups. The increase was mainly located at L4-S1 in the Hybrid group and at L1-L4 in the Fusion group. Hybrid patients presented with increased ROM at L4/5 and L3/4, and Fusion patients presented with increased ROM at L3/4, with significantly greater ROM at L3/4 compared to Hybrid patients at follow-up. CONCLUSIONS: Hybrid surgery is a viable surgical alternative for the presented indication. Approach-related inferior trauma and the balanced restoration of lumbar lordosis resulted in superior clinical outcomes compared to two-level circumferential fusion with TLIF.
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