Surgical Treatment for Degenerative Scoliosis
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|ClinicalTrials.gov Identifier: NCT01439906|
Recruitment Status : Completed
First Posted : September 23, 2011
Last Update Posted : April 28, 2015
|Condition or disease||Intervention/treatment|
|Scoliosis Kyphoscoliosis||Procedure: Surgical correction of the deformity|
|Study Type :||Observational|
|Actual Enrollment :||31 participants|
|Official Title:||Evaluation of Pain Relief and Functional Improvement After the Surgical Treatment for Low Back Pain Due to Degenerative Kyphoscoliosis - Pilot Study|
|Study Start Date :||January 2010|
|Actual Primary Completion Date :||December 2013|
|Actual Study Completion Date :||August 2014|
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:
- 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.
- 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
- 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
- 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).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01439906
|Istituto Ortopedico Rizzoli|
|Bologna, Italy, 40136|
|Principal Investigator:||Giovanni Barbanti Brodano, Dr||Istituto Ortopedico Rizzoli|