Kyphoscoliosis, Scoliosis
Conditions
Keywords
Degenerative scoliosis, Pain, Deformity correction, Instrumented arthrodesis
Brief summary
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.
Interventions
PROCEDURESurgical 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
Sponsors
Istituto Ortopedico Rizzoli
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
40 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from the baseline clinical status at 1-3-6-12 months after the surgical treatment for degenerative scoliosis. | 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. | 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: 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. | 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
| Measure | Time frame | Description |
|---|---|---|
| Evaluation of possible surgical complications (hardware failure, neurological damages, re-intervention) during the perioperative period and at 1-3-6-12 months after surgery. | 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). |
Countries
Italy
Outcome results
None listed