Risk Factors for Proximal Junctional Kyphosis Assessment After Spinal Instrumentation

NCT02881580 | Completed DMC

• 1 other identifier: CYPHORACHI
• Study Type: observational
• Target: 314
• Locations: 1 country
• Sites: 1

Brief Summary

The surgical management of spinal deformities especially in adults is complex. The conventional surgical treatment of these deformations is a scope arthrodesis of the spine. The quality of the result depends on many variables such as the choice of the vertebrae to fuse, location and the number of implants, the type of material used or the type of correction maneuver used. All these variables affect the surgical outcome and may be involved as a modifiable risk factor for possible postoperative complications. The study proposes to focus on the junctional kyphosis postoperative proximal (CJP or Proximal Junctional Kyphosis: PJK). Their prevalence in adults ranges from 20% to 43% depending on the series. The radiographic definition of CJP's kyphosis with an angle\> 10 ° measured from the lower plate of the proximal instrumented vertebra to the upper plate of the adjacent vertebra proximal not instrumented; this measure is being compared to the pre operative data. Either the CJP are asymptomatic and do not require revision surgery either they are and thereby generate a revision surgery. Several factors may potentially influence the development of the CJP. Among them, age, preoperative comorbidities, obesity, osteoporosis, lesions of the posterior elements, hybrid instrumentation, correction forces applied during surgery, sagittal balance pre and post operative degeneration joint capsules, etc. There are few studies on the identification and analysis of these risk factors; literature gives only single-center studies on small samples with a single surgical procedure. Review articles describe the incidence and risk factors of the CJP. However, the pathophysiological mechanisms of the CJP are still controversial to this day. The aim of this study is to determine the incidence of occurrence of postoperative kyphosis proximal junctional and identify risk factors for developing this major complication of a multicenter population of scoliosis operated an extensive fusion.

Conditions

Spinal Deformity

Outcome Measures

Primary Outcomes (1)

• Number of proximal junctional kyphosis

  Day 1

Secondary Outcomes (1)

• Number of proximal junctional kyphosis leading to revision surgery and the surgical recovery factors.

  Day 1

Interventions

No intervention : descriptive study OTHER

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients admitted to Saint Joseph Hospital

You may qualify if:

• age over 40 years
• Decline minimum 6 months
• Scoliosis degenerative etiology, neurological and idiopathic.
• segmental instrumentation over 3 levels (4 vertebrae) in the lumbar area.
• Patients operated on for the 1st time.

You may not qualify if:

• Lumbar spinal surgery or history of chest instrumented
• Etiology post traumatic tumor
• non-segmental instrumentation (Harrington type)
• segmental instrumentation on less than 3 levels.
• Pre and unreadable or missing postoperative radiograph
• Decline \<6 months

Sponsors & Collaborators

• Fondation Hôpital Saint-Joseph: lead

Study Sites (1)

Groupe Hospitalier Paris Saint Joseph

Paris, Île-de-France Region, 75014, France

Location

Study Officials

• Guillaume P RIOUALLON, MD

  Fondation Hôpital Saint-Joseph

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 24, 2016
• First Posted: August 29, 2016
• Study Start: June 1, 2015
• Primary Completion: November 1, 2015
• Study Completion: November 1, 2015
• Last Updated: August 10, 2018

Record last verified: 2016-08

Locations

FR (1)