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

NCT07749534 | Recruiting

• 2 other identifiers: S72384Research chair IORT
• Study Type: interventional
• Target: 320
• Locations: 1 country
• Sites: 1

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; Scoliosis Idiopathic Adolescent Treatment

Keywords

scoliosis; asd; QOL; quality of life

Outcome Measures

Primary Outcomes (10)

• 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).

  within a period of 2 year

• 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.

  Withing 2 years

• 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.

  Withing 2 years

• 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.

  Withing 2 years

• Cross-sectional associations in psychosocial burden between conservative, primary surgery, and revision surgery study groups.

  Measures include HADS during screening visit, at 6-weeks, 4 months, 1 year and 2 year. Hospital Anxiety and Depression Scale (HADS) a validated 14 item self report questionnaire assessing symptoms of anxiety and depression. Each item is scored on a 0-3 Likert scale, and the unit of measure is the subscale total score for Anxiety (HADS A, range 0-21) and Depression (HADS D, range 0-21). Higher scores indicate more severe symptoms.

  within a period of 2 year

• Cross sectional associations in psychosocial burden between conservative, primary surgery, and revision surgery study groups.

  Measures include FABQ-DV during screening visit, at 6-weeks, 4 months, 1 year and 2 year. Fear Avoidance Beliefs Questionnaire - Dutch Version( FABQ-DV) validated self report instrument assessing fear avoidance beliefs related to physical activity and work. The questionnaire contains items scored on a Likert scale from 0 to 6, where higher scores indicate stronger fear avoidance beliefs. The unit of measure is the total score per subscale (Physical Activity and Work), each expressed as the sum of item scores, with higher totals reflecting greater fear avoidance.

  Withing 2 years

• Cross sectional associations in psychosocial burden between conservative, primary surgery, and revision surgery study groups.

  Measures include FES-I during screening visit, at 6-weeks, 4 months, 1 year and 2 year. Falls Efficacy Scale - International (FES-I) a validated self report questionnaire assessing fear of falling during everyday activities. The instrument contains 16 items, each scored on a 4 point Likert scale (1-4). The unit of measure is the total score ranging from 16 to 64, where higher scores indicate greater fear of falling.

  Withing 2 years

• Cross sectional associations in psychosocial burden between conservative, primary surgery, and revision surgery study groups.

  Measures include IPA during screening visit, at 6-weeks, 4 months, 1 year and 2 year. Impact on Participation and Autonomy Questionnaire (IPA) a validated self report instrument assessing perceived participation restrictions and autonomy in daily life. The questionnaire contains multiple domains (e.g., Autonomy Indoors, Autonomy Outdoors, Social Life, Family Role, Work/Education), with items scored on a Likert scale from 0 to 4. The unit of measure is the domain score, expressed as the mean or sum of item scores, where higher scores indicate greater perceived limitations in participation and autonomy.

  Withing 2 years

• Cross-sectional associations in functional impairment between conservative, primary surgery, and revision surgery study groups.

  Measures include FASD. Function Assessment scale for Spinal Deformity (FASD) contains 14 items across three subscales: spinal balance/mobility, stability limits/sensory integration, and ADL/gait. Each is graded on an ordinal 3- or 4-point scale. The maximum total score is 56; higher numbers represent better functional performance.

  within a period of 2 year

• Cross sectional associations in functional impairment between conservative, primary surgery, and revision surgery study groups.

  Measures include ODI. Oswestry Disability Index (ODI) summerise the points from all 10 completed sections like pain intensity, lifting, and walking (each scored from 0 (least disability) to 5 (severe disability). Score is reported as a percentage from 0% to 100% that measures functional impairment from low back pain, divided into five standard ranges: minimal disability (0-20%), moderate disability (21-40%), severe disability (41-60%), crippled (61-80%), and bed-bound or exaggerating symptoms (81-100%)

  Withing 2 years

Secondary Outcomes (1)

• Cross-sectional differences between conservative, primary surgery, and revision surgery groups.

  within a period of 2 year

Study Arms (3)

Fist corrective surgery

EXPERIMENTAL

patients undergoing a first corrective surgery

Procedure: first corrective surgery

Reoperation

EXPERIMENTAL

patients undergoing a reoperation

Procedure: Reoperation

treated conservatively

NO INTERVENTION

patients who are treated conservatively

Interventions

first corrective surgery PROCEDURE

patients undergoing a first corrective surgery or reoperation for ASD

Fist corrective surgery

Reoperation PROCEDURE

patients undergoing a reoperation

Reoperation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universitaire Ziekenhuizen KU Leuven: lead

Study Sites (1)

UZ Leuven

Leuven, 3200, Belgium

RECRUITING

MeSH Terms

Conditions

Scoliosis; Child Development Disorders, Pervasive

Interventions

Reoperation

Condition Hierarchy (Ancestors)

Spinal Curvatures; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Neurodevelopmental Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Surgical Procedures, Operative

Central Study Contacts

Lieven Moke, prof. dr.

CONTACT

016338827; lieven.moke@uzleuven.be

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 14, 2026
• First Posted: August 6, 2026
• Study Start: August 1, 2026
• Primary Completion (Estimated): July 1, 2029
• Study Completion (Estimated): July 1, 2029
• Last Updated: August 6, 2026

Record last verified: 2026-07

Locations

BE (1)