ScoliosisNCT01439906
Surgical Treatment for Degenerative Scoliosis
An observational study of Scoliosis and Kyphoscoliosis, run by Istituto Ortopedico Rizzoli at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Scoliosis, Kyphoscoliosis
- What is being tested?
- Surgical correction of the deformity
- Type of treatment
- Surgery or procedure
- How many people
- 31 participants
- Where
- 1 siteItaly
- Study dates
- Jan 2010to Aug 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Community sample
Who may be able to join
- 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
Who cannot join
- Infections in place
- Coagulation deficits
- Serious psychological comorbidity
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Scoliosis, Kyphoscoliosis
- Being tested
- Surgical correction of the deformity
- Keywords
- Degenerative scoliosis, Pain, Deformity correction, Instrumented arthrodesis
- Medical subject headings
- Scoliosis, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surgical correction of the deformityProcedure or surgery
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Procedure: Surgical correction of the deformity |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from the baseline clinical status at 1-3-6-12 months after the surgical treatment for degenerative scoliosis.
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.
Measured: Before surgery, 1-3-6-12 months after surgery, then annually
Change from the baseline radiographic status at 1-3-6-12 months after the surgical treatment for degenerative scoliosis.
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
Measured: Before surgery, 1-3-6-12 months after surgery, then annually
Assessment of the psychological state of the patients before the surgical treatment and at 1-3-6-12 months of follow up.
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
Measured: Before surgery, 1-3-6-12 months after surgery, then annually
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.
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).
Measured: Perioperative, 1-3-6-12 months after surgery, then annually
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2011 (estimated)
- Study startJan 2010
- Primary completionDec 2013
- Study completionAug 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ScoliosisStudies of the same condition, open and under way.
- More trials run by Istituto Ortopedico RizzoliThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istituto Ortopedico Rizzoli
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Giovanni Barbanti Brodano, Dr, Principal investigator, Istituto Ortopedico Rizzoli
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01439906
- Sponsor's protocol ID
- CVOD.SCOLIOSI DEGENERATIVA
- Status last verified
- Sep 2014
- First submitted
- 21 Sep 2011
- Last updated
- 28 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Pain Relief and Functional Improvement After the Surgical Treatment for Low Back Pain Due to Degenerative Kyphoscoliosis - Pilot Study
- ClinicalTrials.gov ID
- NCT01439906
- Acronym / sponsor ID
- CVOD.SCOLIOSI DEGENERATIVA
- Conditions
- Scoliosis, Kyphoscoliosis
- Keywords
- Degenerative scoliosis, Pain, Deformity correction, Instrumented arthrodesis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Istituto Ortopedico RizzoliUniversity, hospital or other
- Study start
- Jan 2010
- Primary completion
- Dec 2013 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 23 Sep 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adult degenerative scoliosis | – | Procedure: Surgical correction of the deformityPatients 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 |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Community sample
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (3 listed)
- Infections in place
- Coagulation deficits
- Serious psychological comorbidity
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Surgical correction of the deformityThree 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 | Procedure or surgery | Adult degenerative scoliosis |
Primary outcome
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: 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
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
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Giovanni Barbanti Brodano, Dr principal investigator
Istituto Ortopedico Rizzoli
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Scoliosis and Kyphoscoliosis, run by Istituto Ortopedico Rizzoli at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the 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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2015.