Surgical Treatment for Degenerative Scoliosis

NCT ID: NCT01439906

Last Updated: 2015-04-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

31 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-01-31

Study Completion Date

2014-08-31

Brief Summary

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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.

Detailed Description

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Conditions

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Scoliosis Kyphoscoliosis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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

Surgical correction of the deformity

Intervention Type 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

Interventions

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Surgical 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

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

40 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Istituto Ortopedico Rizzoli

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Giovanni Barbanti Brodano, Dr

Role: PRINCIPAL_INVESTIGATOR

Istituto Ortopedico Rizzoli

Locations

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Istituto Ortopedico Rizzoli

Bologna, , Italy

Site Status

Countries

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Italy

Other Identifiers

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CVOD.SCOLIOSI DEGENERATIVA

Identifier Type: -

Identifier Source: org_study_id

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