Quality of Life, Psychosocial Burden, and Structural-functional Status in Adults With Spinal Deformity.
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversitaire Ziekenhuizen KU Leuven
About this trial
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.
Eligibility criteria
Qualifiers
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
Conservative/non-operative management;
Disqualifiers
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.
Trial design
Treatments tested in this trial
- first corrective surgery
- Reoperation
Treatment groups
320 Participants
are divided into 3 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov