Quality of Life, Psychosocial Burden, and Structural-functional Status in Adults With Spinal Deformity. | NCT07749534

NCT07749534

Overview

NCT ID: NCT07749534
Lead Sponsor: Universitaire Ziekenhuizen KU LeuvenOTHER
Official Title: Quality of Life, Psychosocial Burden, and Structural-functional Status in Adults With Spinal Deformity.
Brief Summary: This study examines which factors influence quality of life in adults with a spinal deformity. It looks at imaging findings together with pain, daily functioning, psychosocial factors, and frailty to support more person-centred care.

A total of 320 adults will participate in three groups: conservative treatment, first corrective surgery, or reoperation. All care follows standard practice; no experimental treatments are added. Participants complete questionnaires, and routine FASD tests and existing EOS/X-ray images may be used.

Follow-up lasts up to 2 years, with scheduled assessments depending on whether treatment is surgical or conservative.
Conditions: ASD
Scoliosis Idiopathic Adolescent

Status and Timeline

Status: Recruiting
Last Update Posted: Aug 6, 2026Actual
Start Date: Aug 2026Estimated
Primary Completion Date: Jul 2029Estimated
Completion Date

Participation Criteria

Ages Eligible for Study: Adult (18-64)Older Adult (65+)
Sexes Eligible for Study: All
Accepts Healthy Volunteers?: No
Eligibility Criteria: Inclusion Criteria:

Voluntary written informed consent of the participant or their legally authorized representative has been obtained prior to any screening procedures

Age at inclusion 18 years or older.

Diagnosed with Adult spinal deformity

Planned routine management through one of the following pathways:

Conservative/non-operative management;

Primary ASD surgery;

Revision ASD surgery.

Ability to complete the Dutch-language questionnaire package.

Exclusion Criteria:

No valid informed consent.

Missing baseline structural imaging required for endpoint determination. We allow images to be older than 2 years if no new radiographs are obtained, in accordance with the ALARA principle.

Inability to complete the Dutch-language questionnaire package.

Known cognitive impairment, severe psychiatric condition, or other condition that, in the Investigator's judgement, precludes valid informed consent or reliable completion of study assessments.

Primary spinal condition other than adult spinal deformity that is expected to invalidate endpoint assessment, including acute traumatic, infectious, tumour-related, or inflammatory spinal pathology as the main reason for presentation.

Study Plan

Study Type: Interventional
Phase: Not Applicable
Enrollment: 320Estimated
Primary Purpose: Other
Allocation: Non-Randomized
Interventional Model: Parallel Assignment
Masking

Contacts and Locations

Central Contacts: Lieven Moke, prof. dr.Contact
lieven.moke@uzleuven.be

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