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Completed

NCT Number: NCT01439906

Surgical Treatment for Degenerative Scoliosis

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.

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Key information

Conditions

Scoliosis Bone Diseases Kyphoscoliosis Musculoskeletal Diseases Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms Spinal Curvatures Spinal Diseases

Age range

40 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Istituto Ortopedico Rizzoli

Bologna, 40136, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

  1. 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

    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.

  2. 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

    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

  3. 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

    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 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.

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

    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).

Sponsors and collaborators

Lead sponsor

Istituto Ortopedico Rizzoli

Other

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2013
Study completion
2014
First posted
Sep 23, 2011
Registry last updated
Apr 28, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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