Neurologic Complications in Spinal Deformity Surgery

NCT01305343 | Completed DMC

• 1 other identifier: Scoli-Risk-1
• Study Type: observational
• Target: 273
• Locations: 7 countries
• Sites: 15

Brief Summary

240 subjects with "high risk" adult spinal deformity requiring surgical correction will be enrolled in a prospective multi-center international study. "High risk" patients are defined by either their diagnoses and/or the type of surgical intervention as listed in the inclusion criteria. Neurologic complications in the form of new motor and sensory deficits will be monitored prospectively in all patients at hospital discharge, and at 6 weeks (± 2 weeks) six months (± 2 months) and 24 months(± 2 months) after the surgery. All new deficits will be adjudicated for relationship to the surgical intervention. Regression analyses will be used to evaluate the association between patient demographics, co morbidities, treatment history, spinal deformity characteristics, surgical characteristics, non-neurologic complications and pre-surgical status to occurrence of a neurologic deficit after surgery.

Conditions

Adult Spinal Deformity

Keywords

Spinal Deformity; Scoliosis; Neurologic complications

Outcome Measures

Primary Outcomes (1)

• Rate of treatment-related neurologic complication

  * Spinal Cord Deficit * Cauda Equina Deficit * Nerve Root Deficit * Motor Deficit * Sensory Deficit * Radiculopathy

  6 months

Secondary Outcomes (1)

• • Sensory status as measured by the ASIA Sensory Score

  6 months

Study Arms (1)

Surgical treatment

This observational study is examining the outcomes of standard surgical treatments for adult spinal deformity.

Procedure: Routinely performed surgical correction of spinal deformity

Interventions

Routinely performed surgical correction of spinal deformity PROCEDURE

Routinely performed surgical correction of spinal deformity

Surgical treatment

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients receiving care at the investigative sites will be pre-screened as potential subjects for this observational study study.

You may qualify if:

• Signed informed consent
• Age 18 to 80 years old inclusive
• Diagnosis of adult spinal deformity with an apex of the major deformity in the cervico-thoracic or thoraco-lumbar region (Apex between C7 and L2 inclusive) with any of the following deformity characteristics
• Primary Scoliosis, Kyphosis or Kyphoscoliosis with major Cobb ≥ 80° in the coronal or sagittal plane
• Congenital Spinal Deformity undergoing corrective spinal osteotomy
• Revision Spinal Deformity undergoing corrective spinal osteotomy
• Any patient undergoing a 3-column spinal osteotomy (i.e. Pedicle Subtraction Osteotomy, Vertebral Column Resection) from C7 to L5 inclusive
• Any patient with preoperative myelopathy due to their spinal deformity
• Any patient with ossification of the Ligamentum Flavum or Posterior Longitudinal Ligament and a deformity that needs concomitant reconstruction along with decompression of the spinal cord

You may not qualify if:

• Unlikely to comply with follow-up
• Recent history ≤ 3 months of substance dependency or psychosocial disturbance
• Presence of active malignancy
• Has active, overt bacterial infection, systemic or local
• Recent (≤3 months) history of significant spinal trauma/injury/ fracture/malignancy in the spinal region
• Patients with complete, long term paraplegia
• Pregnant or nursing women, unable to agree not to become pregnant for a period of 6 months after surgery
• Prisoners
• Institutionalized individuals

Sponsors & Collaborators

• AO Foundation, AO Spine: lead
• Scoliosis Research Society: collaborator

Study Sites (15)

University of California

San Francisco, California, 94118, United States

Location

Norton Leatherman Spine Center

Louisville, Kentucky, 40202, United States

Location

Johns Hopkins University

Baltimore, Maryland, 21205, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Department of Orthopaedic Surgery, Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Hospital for Special Surgery

New York, New York, 10021, United States

Location

NYU School of Medicine

Yew York, New York, 10023, United States

Location

University of Virginia

Charlottesville, Virginia, 22903, United States

Location

University of Toronto

Toronto, M5T 2S8, Canada

Location

University of Hong Kong

Hong Kong, 102, China

Location

Nanjing Drum Tower Hospital

Nanjing, 210008, China

Location

Rigshospitalet

Copenhagen, 2100, Denmark

Location

University School of Medicine

Hamamatsu, 3192, Japan

Location

Hospital Universitari Vall D'Hebron

Barcelona, 08035, Spain

Location

University Hospital Nottingham, NHS Trust

Nottingham, NG7 2UH, United Kingdom

Location

Related Publications (1)

• Kwan KYH, Lenke LG, Shaffrey CI, Carreon LY, Dahl BT, Fehlings MG, Ames CP, Boachie-Adjei O, Dekutoski MB, Kebaish KM, Lewis SJ, Matsuyama Y, Mehdian H, Qiu Y, Schwab FJ, Cheung KMC; AO Spine Knowledge Forum Deformity. Are Higher Global Alignment and Proportion Scores Associated With Increased Risks of Mechanical Complications After Adult Spinal Deformity Surgery? An External Validation. Clin Orthop Relat Res. 2021 Feb 1;479(2):312-320. doi: 10.1097/CORR.0000000000001521.

  PMID: 33079774 DERIVED

Related Links

• Related Info
• Related Info

MeSH Terms

Conditions

Scoliosis

Condition Hierarchy (Ancestors)

Spinal Curvatures; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases

Study Officials

• Lawrence Lenke, MD

  Scoliosis Research Society

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 25, 2011
• First Posted: February 28, 2011
• Study Start: August 1, 2011
• Primary Completion: November 1, 2014
• Study Completion: March 1, 2015
• Last Updated: December 24, 2015

Record last verified: 2015-12

Locations

US (8); DK (1); ES (1); GB (1); CA (1); CN (2); JP (1)