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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
first corrective surgery
Procedure/Surgerypatients undergoing a first corrective surgery or reoperation for ASD
Reoperation
Procedure/Surgerypatients undergoing a reoperation
Treatment groups
320 Participants
are divided into 3 treatment groupsGroup A: Fist corrective surgeryExperimental treatment 1 intervention
Group B: ReoperationExperimental treatment 1 intervention
Group C: treated conservativelyNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Cross-sectional associations in QoL between conservative, primary surgery, and revision surgery study groups.
QoL is measured using the SRS-22r questionnaire during screening visit, at 6-weeks, 4 months, 1 year and 2 year.For Scoliosis Research Society 22 Revised (SRS-22r) questionaire a patient reported measure of health related quality of life in individuals with scoliosis. PROM assessing five domains: Function/Activity, Pain, Self image/Appearance, Mental Health, Satisfaction with Management. The mean score is located between 5 (Best) and 1 (Worst).
Time frame
within a period of 2 year2
Cross sectional associations in QoL between conservative, primary surgery, and revision surgery study groups.
QoL is measured using EQ-5D-5L questionnaire questionnaire during screening visit, at 6-weeks, 4 months, 1 year and 2 year The EuroQol 5 Dimension 5 Level(EQ-5D-5L) include 5-digit health profile: Mobility, Self Care, Usual Activities, Pain/Discomfort, Anxiety/Depression converting it to an index value using the country-specific value set (range -0.59 to 1.0). EQ-5D-5L score expresses health status as a utility value ranging from \<0 (worse than death) to 1 (full health). Higher values indicate better overall health.
Time frame
Withing 2 years3
Cross sectional associations in QoL between conservative, primary surgery, and revision surgery study groups.
QoL is measured using VAS questionnaire during screening visit, at 6-weeks, 4 months, 1 year and 2 year The Visual Anlog Score (VAS) - ranges from 0 to 100, where 0 means "worst imaginable health" and 100 means "best imaginable health." A higher VAS score reflects better self perceived health.
Time frame
Withing 2 years4
Cross sectional associations in QoL between conservative, primary surgery, and revision surgery study groups.
QoL in non-revision ASD patients, adjusted for structural deformity severity, demographic characteristics, treatment pathway, and frailty-related health status. Structural covariates include Sagittal Vertical Axis(SVA), Pelvic tilt(PT), Pelvic incidence-lumbar lordosis mismatch (PI-LL) mismatch, and coronal Cobb angle. Frailty-related health status will be measured using the mFI-5. The modified 5-item frailty index (mFI-5) which assesses five clinical deficits: diabetes, hypertension, congestive heart failure, chronic obstructive pulmonary disease, and functional dependence. Each deficit is scored as 0 (absent) or 1 (present). The unit of measure is the total frailty score ranging from 0 to 5, where higher scores indicate greater frailty.
Time frame
Withing 2 yearsSecondary outcomes
1
Cross-sectional differences between conservative, primary surgery, and revision surgery groups.
Cross-sectional differences between conservative, primary surgery, and revision surgery groups in QoL, psychosocial burden, functional impairment, structural deformity severity, spine-specific symptom burden, and frailty-related health status. Longitudinal within-patient changes across repeated routine-care follow-up timepoints in SRS-22r, EQ-5D-5L, HADS, FABQ-DV, FES-I, IPA, FASD, ODI, COMI, SVA, PT, PI-LL mismatch, coronal Cobb angle, and mFI-5. The use of these scales is already described in the primary outcomes.
Time frame
within a period of 2 yearSponsors and contacts
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Source ClinicalTrials.gov