Surgical Treatment for Degenerative Scoliosis

Scoliosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01439906
• Other study ID #: CVOD.SCOLIOSI DEGENERATIVA
• Status: Completed
• Phase: N/A
• First received: September 21, 2011
• Last updated: April 27, 2015
• Start date: January 2010
• Est. completion date: August 2014

Study information

• Verified date: September 2014
• Source: Istituto Ortopedico Rizzoli
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: August 2014
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 75 Years

Eligibility

Inclusion Criteria:

• Female or male

• Age 40-75 years

• Patients capable of understanding and willing

• Lumbar or thoraco-lumbar degenerative kyphoscoliosis

• Chronic low back pain from more than 6 months and/or presence of neurological deficits at lower limbs

• Failure to respond to conservative therapy

Exclusion Criteria:

• Infections in place

• Coagulation deficits

• Serious psychological comorbidity

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Kyphoscoliosis
• Scoliosis

Intervention

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

Locations

Country	Name	City	State
Italy	Istituto Ortopedico Rizzoli	Bologna

Sponsors (1)

Lead Sponsor	Collaborator
Istituto Ortopedico Rizzoli

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from the baseline clinical status at 1-3-6-12 months after the surgical treatment for degenerative scoliosis.	The clinical status of the patients will be evaluated before surgery and at 1-3-6-12 months of follow up (and then annually) by: 1. Visual Analog Scale (VAS); 2. Oswestry Disability Index (ODI); 3. Quality of life (EuroQoL 5D) test.	Before surgery, 1-3-6-12 months after surgery, then annually	No
Primary	Change from the baseline radiographic status at 1-3-6-12 months after the surgical treatment for degenerative scoliosis.	The correction of the deformity with respect to the pre-operative status will be assessed by anteroposterior, bending and lateral full standing radiographs at 1-3-6-12 months of follow up (and then annually). Flexion/extension radiographs will be taken at 1-3-6-12 months after surgery in order to evaluate fusion and proper positioning of hardware. Successful arthrodesis (fusion) will be also confirmed by CT scan at 1 year.; Criteria of fusion evaluation: Fusion certain; Fusion likely; Status uncertain; Pseudo arthrosis likely; Pseudo arthrosis certain	Before surgery, 1-3-6-12 months after surgery, then annually	No
Primary	Assessment of the psychological state of the patients before the surgical treatment and at 1-3-6-12 months of follow up.	The psychological state of the patients will be evaluate before the surgical treatment and at 1-3-6-12 months after surgery (then annually).; To evaluate the psychological state of the patients the following questionnaires will be used: STAI to evaluate the anxiety state; ZHUNG to evaluate the depressive state	Before surgery, 1-3-6-12 months after surgery, then annually	No
Secondary	Evaluation of possible surgical complications (hardware failure, neurological damages, re-intervention) during the perioperative period and at 1-3-6-12 months after surgery.	Major and minor surgical complications will be recorded and analysed during the perioperative period (early complications) and at 1-3-6-12 months after surgery (late complications).	Perioperative, 1-3-6-12 months after surgery, then annually	No