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

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.

Study Overview

• Status: Completed
• Conditions: Scoliosis; Kyphoscoliosis
• Intervention / Treatment: Procedure: Surgical correction of the deformity

• Study Type: Observational
• Enrollment (Actual): 31

Contacts and Locations

Study Locations

• Italy
  • Bologna, Italy, 40136
    • Istituto Ortopedico Rizzoli

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Community sample

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Adult degenerative scoliosis; Patients aged 40-75 years affected by lumbar or thoraco-lumbar degenerative kyphoscoliosis presenting chronic low back pain from six months at least and/or neurological deficits who underwent a surgical correction of the deformity	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Istituto Ortopedico Rizzoli
• Investigators: Principal Investigator: Giovanni Barbanti Brodano, Dr, Istituto Ortopedico Rizzoli

Study record dates

Study Major Dates

• Study Start: January 1, 2010
• Primary Completion (Actual): December 1, 2013
• Study Completion (Actual): August 1, 2014

Study Registration Dates

• First Submitted: September 21, 2011
• First Submitted That Met QC Criteria: September 22, 2011
• First Posted (Estimate): September 23, 2011

Study Record Updates

• Last Update Posted (Estimate): April 28, 2015
• Last Update Submitted That Met QC Criteria: April 27, 2015
• Last Verified: September 1, 2014

More Information

Terms related to this study

• Keywords: Pain; Degenerative scoliosis; Deformity correction; Instrumented arthrodesis
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Spinal Diseases; Bone Diseases; Spinal Curvatures; Scoliosis
• Other Study ID Numbers: CVOD.SCOLIOSI DEGENERATIVA