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Recruiting NCT07749534

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

Conditions: ASD, Scoliosis Idiopathic Adolescent, Scoliosis Idiopathic Adolescent Treatment

Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 320
Sponsor: Universitaire Ziekenhuizen KU Leuven

Location: UZ Leuven Leuven

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.

Eligibility Criteria

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.

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07749534). StuddyBuddy aggregates publicly available trial information.