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LONG-TERM EFFECT OF SELECTIVE THORACIC FUSION ON LUMBAR DEGENERATIVE DISC DISEASE IN IDIOPATHIC SCOLIOSIS

LONG-TERM EFFECT OF SELECTIVE THORACIC FUSION ON LUMBAR DEGENERATIVE DISC DISEASE IN IDIOPATHIC SCOLIOSIS - DISCUS study

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON54795
Enrollment
60
Registered
2017-10-03
Start date
2021-12-03
Completion date
Unknown
Last updated
2024-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

curved spine scoliosis

Interventions

None listed

Sponsors

Orthopedie
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: For all patients • Patients with adolescent idiopathic scoliosis • Lenke type 1 scoliosis • at least 25 years skeletal matureGroup 1 • Not treated surgicallyGroup 3 • Curve size matching curve size of group 1 before operation • Not treated surgically

Exclusion criteria

Exclusion criteria: • Inadequate knowledge of Dutch language • Other forms of scoliosis (e.g. neuromuscular or congenital scoliosis) • Inability to undergo an MRI scan (claustrophobia, pacemaker, etc)

Design outcomes

Primary

MeasureTime frame
Signs of osteoarthritis can be quantified by radiography in 2 directions (Posterior-Anterior and lateral) . Signs of osteoarthritis will be classified by Pathria, Kellgren-Lawrence and Weishaupt classification. Signs of DDD will quantified by the total number of degenerated disc per subject and the proportion of degenerated discs. In addition, proportion of discs with Schmorl*s nodes, discs herniation and discs with inflammatory end plate changes will be determined.

Secondary

MeasureTime frame
The radiological results may be correlated to patients demographics, curve types (e.g. Lenke classification) , size of the remaining curve, parameters of spinal balance or clinical outcomes of our BASIS study (a previous study of ours which evaluated long-term clinical self-reported outcomes with the following questionnaires: Health related quality of life: SF-36, EQ-5D, SRS-22& and low back pain: Oswestry Disability Index and visual analogue scale) The spirometry will be compared to the one performed during childhood to examine the difference in pulmonary functioning over the years. The DISCUS study protocol describes the inclusion of three patient groups: group 1 is operated on and had a curvature of 45-55 degrees before surgery (after correction, their curvature measures 20-25 degrees), group 2 is non-operated and has a curvature of approximately 20-25 degrees at the end of growth, and group 3 is non-operated with a curvature of 45-55 degrees at the end of growth (similar to group 1 before surgery). Groups 1 and 3 have already completed all examinations, and interim results show minimal disc degeneration in group 3 on the MRI scan. Therefore, we expect that MRI scans of group 2 (with less scoliosis than group 3) will not provide additional value, and we intend to refrain from including this patient group to avoid subjecting them to unnecessary research. However, we observe significant scoliosis progression in group 3 (classified as severe scoliosis with a Cobb angle of 45 degrees) based on the new X-rays. We would like to expand this research group by obtaining X-rays of more patients with non-operated scoliosis and a curvature of 45 degrees. This population has previously participated in the study on Health Related Quality of Life (BASIS WO15.017) and has already provided consent to be approached for follow-up research. This group consists of 22 patients. Expanding the sample size of scoliosis patients from "Group 3" aims to provide

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)