STUDY DESIGN: A randomized prospective study. OBJECTIVE: To compare safety, efficacy, and cost between 1-stage and 2-stage anterior and posterior spinal fusion in treating rigid thoracic adolescent idiopathic scoliosis (AIS). SUMMARY OF BACKGROUND DATA: Retrospective study issued different outcomes comparing 1-stage with 2-stage surgical procedures in treating neuromuscular and congenital scoliosis. A randomized prospective study in AIS has rarely been reported. METHODS.: Twenty-four patients were randomly divided into 2 groups. Group A underwent a 2-stage procedure, group B a 1-stage procedure. Inclusion criteria were: (1) AIS; (2) rigid single thoracic curve, > or =90 degrees on anteroposterior and > or =60 degrees on side bending view; and (3) pulmonary function tests, vital capacity > or =500 mL or FEV1 > or =50%. Exclusion criteria were: (1) curves either <90 degrees on anteroposterior or <60 degrees on bending view; and (2) pulmonary function tests, both vital capacity <500 mL and FEV1 <50%. The mean follow up was 3.3 years (range 2-5.1). Clinical outcomes between the 2 groups were analyzed. RESULTS: A statistical t test demonstrated no significant difference in age (P = 0.299), curves on anteroposterior (P = 0.908), on bending (P = 0.905), after surgery (P = 0.699), and at last follow-up (P = 0.946). No significant difference in blood loss (P = 0.089), transfusion (P = 0.334), operation time (P = 0.172), fusion segments anterior (P = 0.161), posterior (P = 0.546), wound drainage (P = 0.557), thoraco drainage (P = 0.948), and loss of correction at follow-up (P = 0.596). However, significant differences were found in length of stay (P < 0.001), patient cost of hospitalization (P < 0.001) between 2 groups, and curve correction (P < 0.001) in each group. Perioperative complications included 1 patient each with pneumonia, pneumothorax (group A), and ileus (group B). Screw nut loosing was found in 1 patient in group B, but no curve deteriorated. No neurologic deficit occurred in either group. CONCLUSION: A comparison of 1-stage versus 2-stage fusion in treating rigid thoracic curves in AIS did not show significant differences in safety or efficacy but did demonstrate significant difference in length of stay and patient cost.
RCT Entities:
STUDY DESIGN: A randomized prospective study. OBJECTIVE: To compare safety, efficacy, and cost between 1-stage and 2-stage anterior and posterior spinal fusion in treating rigid thoracic adolescent idiopathic scoliosis (AIS). SUMMARY OF BACKGROUND DATA: Retrospective study issued different outcomes comparing 1-stage with 2-stage surgical procedures in treating neuromuscular and congenital scoliosis. A randomized prospective study in AIS has rarely been reported. METHODS.: Twenty-four patients were randomly divided into 2 groups. Group A underwent a 2-stage procedure, group B a 1-stage procedure. Inclusion criteria were: (1) AIS; (2) rigid single thoracic curve, > or =90 degrees on anteroposterior and > or =60 degrees on side bending view; and (3) pulmonary function tests, vital capacity > or =500 mL or FEV1 > or =50%. Exclusion criteria were: (1) curves either <90 degrees on anteroposterior or <60 degrees on bending view; and (2) pulmonary function tests, both vital capacity <500 mL and FEV1 <50%. The mean follow up was 3.3 years (range 2-5.1). Clinical outcomes between the 2 groups were analyzed. RESULTS: A statistical t test demonstrated no significant difference in age (P = 0.299), curves on anteroposterior (P = 0.908), on bending (P = 0.905), after surgery (P = 0.699), and at last follow-up (P = 0.946). No significant difference in blood loss (P = 0.089), transfusion (P = 0.334), operation time (P = 0.172), fusion segments anterior (P = 0.161), posterior (P = 0.546), wound drainage (P = 0.557), thoraco drainage (P = 0.948), and loss of correction at follow-up (P = 0.596). However, significant differences were found in length of stay (P < 0.001), patient cost of hospitalization (P < 0.001) between 2 groups, and curve correction (P < 0.001) in each group. Perioperative complications included 1 patient each with pneumonia, pneumothorax (group A), and ileus (group B). Screw nut loosing was found in 1 patient in group B, but no curve deteriorated. No neurologic deficit occurred in either group. CONCLUSION: A comparison of 1-stage versus 2-stage fusion in treating rigid thoracic curves in AIS did not show significant differences in safety or efficacy but did demonstrate significant difference in length of stay and patient cost.