Surgical Treatment for Degenerative Scoliosis
Recruitment status was Recruiting
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.
|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|
- 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:
- 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 ] [ 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
- 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).
|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)|
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:
Please refer to this study by its ClinicalTrials.gov identifier: NCT01439906
|Istituto Ortopedico Rizzoli||Recruiting|
|Bologna, Italy, 40136|
|Contact: Cristiana Griffoni, Dr 051-6366971 firstname.lastname@example.org|
|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|
|Principal Investigator:||Giovanni Barbanti Brodano, Dr||Istituto Ortopedico Rizzoli|