Surgical Treatment for Degenerative Scoliosis

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2012 by Istituto Ortopedico Rizzoli
Sponsor:
Information provided by (Responsible Party):
Istituto Ortopedico Rizzoli
ClinicalTrials.gov Identifier:
NCT01439906
First received: September 21, 2011
Last updated: December 5, 2012
Last verified: December 2012
  Purpose

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.


Condition Intervention
Scoliosis
Kyphoscoliosis
Procedure: Surgical correction of the deformity

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Evaluation of Pain Relief and Functional Improvement After the Surgical Treatment for Low Back Pain Due to Degenerative Kyphoscoliosis - Pilot Study

Resource links provided by NLM:


Further study details as provided by Istituto Ortopedico Rizzoli:

Primary Outcome Measures:
  • Change from the baseline clinical status at 1-3-6-12 months after the surgical treatment for degenerative scoliosis. [ Time Frame: Before surgery, 1-3-6-12 months after surgery, then annually ] [ Designated as safety issue: No ]
    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.

  • Change from the baseline radiographic status at 1-3-6-12 months after the surgical treatment for degenerative scoliosis. [ Time Frame: Before surgery, 1-3-6-12 months after surgery, then annually ] [ Designated as safety issue: No ]

    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

  • Assessment of the psychological state of the patients before the surgical treatment and at 1-3-6-12 months of follow up. [ Time Frame: Before surgery, 1-3-6-12 months after surgery, then annually ] [ Designated as safety issue: No ]

    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


Secondary Outcome Measures:
  • Evaluation of possible surgical complications (hardware failure, neurological damages, re-intervention) during the perioperative period and at 1-3-6-12 months after surgery. [ Time Frame: Perioperative, 1-3-6-12 months after surgery, then annually ] [ Designated as safety issue: No ]
    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).


Estimated Enrollment: 60
Study Start Date: January 2010
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   40 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Community sample

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01439906

Locations
Italy
Istituto Ortopedico Rizzoli Recruiting
Bologna, Italy, 40136
Contact: Cristiana Griffoni, Dr    051-6366971    cgriffoni@hotmail.com   
Principal Investigator: Giovanni Barbanti Brodano, Dr         
Sub-Investigator: Bandiera Stefano, Dr         
Sub-Investigator: Gasbarrini Alessandro, Dr         
Sub-Investigator: Terzi Silvia, Dr         
Sub-Investigator: Boriani Stefano, Dr         
Sponsors and Collaborators
Istituto Ortopedico Rizzoli
Investigators
Principal Investigator: Giovanni Barbanti Brodano, Dr Istituto Ortopedico Rizzoli
  More Information

No publications provided

Responsible Party: Istituto Ortopedico Rizzoli
ClinicalTrials.gov Identifier: NCT01439906     History of Changes
Other Study ID Numbers: CVOD.SCOLIOSI DEGENERATIVA
Study First Received: September 21, 2011
Last Updated: December 5, 2012
Health Authority: Italy: Ethics Committee

Keywords provided by Istituto Ortopedico Rizzoli:
Degenerative scoliosis
Pain
Deformity correction
Instrumented arthrodesis

Additional relevant MeSH terms:
Scoliosis
Spinal Curvatures
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases

ClinicalTrials.gov processed this record on August 28, 2014