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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

September 21, 2011
December 5, 2012
January 2010
December 2013   (final data collection date for primary outcome measure)
  • 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
Same as current
Complete list of historical versions of study NCT01439906 on ClinicalTrials.gov Archive Site
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).
Same as current
Not Provided
Not Provided
 
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.

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Probability Sample

Community sample

  • Scoliosis
  • Kyphoscoliosis
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
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
Intervention: Procedure: Surgical correction of the deformity
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
60
December 2013
December 2013   (final data collection date for primary outcome measure)

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
Both
40 Years to 75 Years
No
Italy
 
NCT01439906
CVOD.SCOLIOSI DEGENERATIVA
No
Istituto Ortopedico Rizzoli
Istituto Ortopedico Rizzoli
Not Provided
Principal Investigator: Giovanni Barbanti Brodano, Dr Istituto Ortopedico Rizzoli
Istituto Ortopedico Rizzoli
December 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP