Quality of Life and Functional Status in Adults with Spinal Deformity

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study follows 320 adults with spinal deformity to see which factors are linked with quality of life. Participants are grouped by the type of care they receive: non-operative management, initial corrective surgery, or revision surgery. Data collected include imaging findings from routine care, patient-reported outcomes on quality of life and symptoms, and assessments of psychosocial well-being and frailty. Follow-up extends up to two years with assessments scheduled around key clinical milestones for surgical and non-surgical groups. No experimental treatments are used; standard clinical care is followed throughout.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Voluntary written informed consent of the participant or their legally authorized representative has been obtained prior to any screening procedures
2. Age at inclusion 18 years or older.
3. Diagnosed with Adult spinal deformity
4. Planned routine management through one of the following pathways:

   1. Conservative/non-operative management;
   2. Primary ASD surgery;
   3. Revision ASD surgery.
5. Ability to complete the Dutch-language questionnaire package.

Exclusion Criteria:

1. No valid informed consent.
2. 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.
3. Inability to complete the Dutch-language questionnaire package.
4. 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.
5. 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.

Where it's running

• UZ Leuven
  Leuven, Belgium Recruiting

Study contacts

• Study coordinator: Lieven Moke, prof. dr.
• Email: lieven.moke@uzleuven.be
• Phone: 016338827

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.