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

Overview

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.

Detailed description

This study investigates which factors are associated with quality of life in adults with a spinal deformity. Among patients with a comparable spinal alignment, pain, daily functioning, and quality of life can vary greatly. Therefore, the study examines not only the structural abnormality on medical imaging, but also pain, limitations in daily functioning, anxiety and low mood, fear of movement, concern about falling, participation in daily life, and overall frailty. The results may contribute to a more person-centred assessment and treatment of adults with a spinal deformity.

A total of 320 adults with a spinal deformity will be included. The study compares three groups: patients treated conservatively, patients undergoing a first corrective surgery, and patients undergoing a reoperation. Treatment is entirely determined by the regular care team; the study does not add any experimental intervention. Participants complete questionnaires on quality of life, back symptoms, functioning, and psychosocial well-being. Where applicable, the Function Assessment Scale for Spinal Deformity (FASD) is administered, a functional movement test that is part of standard care. Available EOS or X-ray images from routine care are used; no additional images are taken solely for the study.

Follow-up lasts up to 2 years. For surgically treated participants, assessments may take place at surgery and around 6 weeks, 4 months, 1 year, and 2 years post-operatively. Conservatively treated participants are assessed at baseline and, where appropriate within routine care, around 1 and 2 years.

Interventions

• Procedure first corrective surgery
  patients undergoing a first corrective surgery or reoperation for ASD
• Procedure Reoperation
  patients undergoing a reoperation

Primary outcome measures

• Cross-sectional associations in QoL between conservative, primary surgery, and revision surgery study groups. [Time frame: within a period of 2 year]
• Cross sectional associations in QoL between conservative, primary surgery, and revision surgery study groups. [Time frame: Withing 2 years]
• Cross sectional associations in QoL between conservative, primary surgery, and revision surgery study groups. [Time frame: Withing 2 years]
• Cross sectional associations in QoL between conservative, primary surgery, and revision surgery study groups. [Time frame: Withing 2 years]
• Cross-sectional associations in psychosocial burden between conservative, primary surgery, and revision surgery study groups. [Time frame: within a period of 2 year]
• Cross sectional associations in psychosocial burden between conservative, primary surgery, and revision surgery study groups. [Time frame: Withing 2 years]
• Cross sectional associations in psychosocial burden between conservative, primary surgery, and revision surgery study groups. [Time frame: Withing 2 years]
• Cross sectional associations in psychosocial burden between conservative, primary surgery, and revision surgery study groups. [Time frame: Withing 2 years]
• Cross-sectional associations in functional impairment between conservative, primary surgery, and revision surgery study groups. [Time frame: within a period of 2 year]
• Cross sectional associations in functional impairment between conservative, primary surgery, and revision surgery study groups. [Time frame: Withing 2 years]

Secondary outcome measures (1)

• Cross-sectional differences between conservative, primary surgery, and revision surgery groups. [Time frame: within a period of 2 year]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Non-randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Other

Study locations

Belgium · 1 center

• UZ Leuven — Leuven

Identifiers

NCT: NCT07749534 · S72384 · Research chair IORT

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗