Surgical Treatment for Degenerative Scoliosis

NCT01439906 | Completed

• 1 other identifier: CVOD.SCOLIOSI DEGENERATIVA
• Study Type: observational
• Target: 31
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Degenerative scoliosis; Pain; Deformity correction; Instrumented arthrodesis

Outcome Measures

Primary Outcomes (3)

• 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: 1. Fusion certain 2. Fusion likely 3. Status uncertain 4. Pseudo arthrosis likely 5. 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 Outcomes (1)

• Evaluation of possible surgical complications (hardware failure, neurological damages, re-intervention) during the perioperative period and at 1-3-6-12 months after surgery.

  Perioperative, 1-3-6-12 months after surgery, then annually

Study Arms (1)

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

Interventions

Surgical correction of the deformity PROCEDURE

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

Adult degenerative scoliosis

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Community sample

You may qualify if:

• 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

You may not qualify if:

• Infections in place
• Coagulation deficits
• Serious psychological comorbidity

Sponsors & Collaborators

• Istituto Ortopedico Rizzoli: lead

Study Sites (1)

Istituto Ortopedico Rizzoli

Bologna, 40136, Italy

Location

MeSH Terms

Conditions

Scoliosis; Pain

Condition Hierarchy (Ancestors)

Spinal Curvatures; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Giovanni Barbanti Brodano, Dr

  Istituto Ortopedico Rizzoli

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: September 21, 2011
• First Posted: September 23, 2011
• Study Start: January 1, 2010
• Primary Completion: December 1, 2013
• Study Completion: August 1, 2014
• Last Updated: April 28, 2015

Record last verified: 2014-09

Locations

IT (1)