NCT01439906

Surgical Treatment for Degenerative Scoliosis

Evaluation of Pain Relief and Functional Improvement After the Surgical Treatment for Low Back Pain Due to Degenerative Kyphoscoliosis - Pilot Study

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 31 (actual)
• Sponsor: Istituto Ortopedico Rizzoli · Academic / Other
• Sex: All
• Age: 40 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The study aims to analyze the surgical treatment of low back pain due to degenerative kyphoscoliosis, already routinely performed on patients treated in Istituto Ortopedico Rizzoli, in terms of reduction of the pain and functional improvement. The comparison of back pain and functional ability before and after the surgical treatment will be performed by administering to the patients specific questionnaires (Visual Analog Score VAS, Oswestry Disability Index ODI, Quality of Life EuroQoL 5D). Questionnaires administration will be matched to a purely objective and radiological assessment according to international guidelines. A psychological analysis will be also performed in order to evaluate co-morbidity from this field, considering that the concept of "shared decision-making" for the therapeutic approach to low back pain requires the evaluation of all these parameters.

Conditions

• Scoliosis
• Kyphoscoliosis

Interventions

Type	Name	Description
PROCEDURE	Surgical correction of the deformity	Three different surgical techniques are used: * lumbar fusion vs thoraco-lumbar fusion * iliac fixation vs fixation to the sacrum * posterior + interbody fusion vs posterior interbody fusion

Timeline

• Start date: 2010-01-01
• Primary completion: 2013-12-01
• Completion: 2014-08-01
• First posted: 2011-09-23
• Last updated: 2015-04-28

Locations

1 site across 1 country: Italy