Panagiotis Korovessis1, Thomas Repantis2, Andreas Baikousis3, Panagiotis Iliopoulos4. 1. Orthopaedic Department, General Hospital 'Agios Andreas', 1 Tsertidou str, 26224, Patras, Greece. korovess@otenet.gr. 2. Orthopaedic Department, General Hospital 'Agios Andreas', 1 Tsertidou str, 26224, Patras, Greece. 3. Orthopaedic Department, General Hospital of Messolonghi, Messolonghi, Greece. 4. Radiology Department, General Hospital 'Agios Andreas' Patras, Patras, Greece.
Abstract
BACKGROUND: Theoretically, 360° instrumented fusion has been considered to offer better radiological correction than PLF. Despite numerous publications, this correlation is still weak with several controversies in the relative literature. PURPOSE: This prospective randomized study was designed to compare the radiological segmental results, complications and outcome of 360° instrumented fusion with the use of a single diagonal expandable PLIF device versus posterolateral pedicle screw fixation in monosegmental lumbar DDD and to show that the use of an novel expandable cage is associated with low PLIF-related complication rate compared to conventional cages reported previously. STUDY DESIGN: Prospective randomized controlled clinical and radiological study. PATIENT SAMPLE: Adults who suffered from monosegmental DDD were eligible for enrolment in this trial. We randomly assigned 150 patients to receive either 360° instrumented fusion (group A) with expandable cage or PLF (group B). OUTCOME MEASURES: Differences between the two groups regarding clinical parameters and radiographic sagittal measurements after 36 months of follow-up. METHODS: The record included global [T12-S1 lordosis, sagittal global spinal balance (SB) (C7-mid-femoral axis)] and segmental [segmental disc wedging (SDW), anterior (ADHr) and posterior (PDHr) disc height ratio] radiological measurements at the instrumented segment. Additionally, clinical outcome was evaluated with VAS, SF-36 (Physical function and Bodily Pain) and ODI questionnaires. Fusion was evaluated with the use of Christiansen method. RESULTS: In 73 and 72 participants of group A and B, respectively, who completed follow-up to 36 months, there were no differences with respect to the rate of improvement in SF-36, ODI and VAS scores. However, in the spines of group A, there was a significant increase in anterior disc height ratio (P = 0.0057), posterior disc height (P = 0.016) and segmental disc wedging (P = 0.00021) without subsequent loss of correction. Fusion rate was radiologically shown in 94.5% and 87% spines of group A and B, respectively (P > 0.2). Four and 9 spines in group A and B, respectively, showed non-union at the final observation. CONCLUSIONS: Our findings suggest that 360° fusion offers better sagittal radiological restoration associated with circumferential fusion. However, this difference seemed not to have any medium-term clinical impact. The use of expandable cage was associated with low PLIF-related complications compared to conventional cages.
RCT Entities:
BACKGROUND: Theoretically, 360° instrumented fusion has been considered to offer better radiological correction than PLF. Despite numerous publications, this correlation is still weak with several controversies in the relative literature. PURPOSE: This prospective randomized study was designed to compare the radiological segmental results, complications and outcome of 360° instrumented fusion with the use of a single diagonal expandable PLIF device versus posterolateral pedicle screw fixation in monosegmental lumbar DDD and to show that the use of an novel expandable cage is associated with low PLIF-related complication rate compared to conventional cages reported previously. STUDY DESIGN: Prospective randomized controlled clinical and radiological study. PATIENT SAMPLE: Adults who suffered from monosegmental DDD were eligible for enrolment in this trial. We randomly assigned 150 patients to receive either 360° instrumented fusion (group A) with expandable cage or PLF (group B). OUTCOME MEASURES: Differences between the two groups regarding clinical parameters and radiographic sagittal measurements after 36 months of follow-up. METHODS: The record included global [T12-S1 lordosis, sagittal global spinal balance (SB) (C7-mid-femoral axis)] and segmental [segmental disc wedging (SDW), anterior (ADHr) and posterior (PDHr) disc height ratio] radiological measurements at the instrumented segment. Additionally, clinical outcome was evaluated with VAS, SF-36 (Physical function and Bodily Pain) and ODI questionnaires. Fusion was evaluated with the use of Christiansen method. RESULTS: In 73 and 72 participants of group A and B, respectively, who completed follow-up to 36 months, there were no differences with respect to the rate of improvement in SF-36, ODI and VAS scores. However, in the spines of group A, there was a significant increase in anterior disc height ratio (P = 0.0057), posterior disc height (P = 0.016) and segmental disc wedging (P = 0.00021) without subsequent loss of correction. Fusion rate was radiologically shown in 94.5% and 87% spines of group A and B, respectively (P > 0.2). Four and 9 spines in group A and B, respectively, showed non-union at the final observation. CONCLUSIONS: Our findings suggest that 360° fusion offers better sagittal radiological restoration associated with circumferential fusion. However, this difference seemed not to have any medium-term clinical impact. The use of expandable cage was associated with low PLIF-related complications compared to conventional cages.