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Predicting the Risk of Mechanical Complications after Adult Scoliosis Surgery by GAPB and SAAS Methods: A Prospective Observational Controlled Study

Predicting the Risk of Mechanical Complications after Adult Scoliosis Surgery by GAPB and SAAS Methods: A Prospective Observational Controlled Study

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2400087814
Enrollment
Unknown
Registered
2024-08-05
Start date
2024-05-01
Completion date
Unknown
Last updated
2024-08-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Adult scoliosis

Interventions

GAPB group:Utilize the GAPB method to predict the occurrence of postoperative complications and the quality of life after surgery for patients
SAAS group:Utilize the SAAS method to predict the occurrence of postoperative complications and the quality of life after surgery for patients

Sponsors

Shanghai Changzheng Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
45 Years to 70 Years

Inclusion criteria

Inclusion criteria: ?Age between 45 and 70 at the time of surgery; ?Adult scoliosis; ?Indication for surgery and failure of regular conservative treatment for 3 months; ?Consent to undergo three-dimensional corrective osteotomy, fusion, and internal fixation surgery for scoliosis; ?Fusion segments = 5; ?Patients who have signed the informed consent form and can follow the research schedule for follow-up as instructed by the doctor.

Exclusion criteria

Exclusion criteria: ?History of previous spinal fusion surgery; ?Scoliosis secondary to syndromes, autoimmune diseases, infections, tuberculosis, tumors, or other pathological curvatures such as neuromuscular, Scheuermann's disease, or chondrodysplasia; ?Presence of systemic or local infection, or severe infectious diseases such as HIV; ?Patients who cannot tolerate prolonged prone positioning; ?Poor general health, unable to withstand surgery, or with significant surgical risks; ?Concurrent diseases affecting bone healing, such as Parkinson's disease or severe osteoporosis; ?Conditions judged by the investigator to be life-threatening, medical conditions, or organ system dysfunctions that may endanger the patient's safety, increase surgical risks, or place the study results at undue risk.

Design outcomes

Primary

MeasureTime frame
Whether patients develop mechanical complications within 2 years after adult scoliosis corrective surgery;

Secondary

MeasureTime frame
Visual Analogue Scale (VAS);Oswestry Disability Index (ODI);36-item Short-Form, SF-36;Modified Global Alignment and Proportion Scoring With Body Mass Index and Bone Mineral Density (GAPB);Sagittal age adjusted score (SAAS) ;

Countries

China

Contacts

Public ContactYe Tianwen

Shanghai Changzheng Hospital

yetianwenvip@126.com+86 136 6145 9167

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026