Development and Prospective Internal-Validation Protocol of the SpinePROTECT Score: A Digital Biopsychosocial Risk...

Background and Objectives: Postoperative recovery after spine surgery remains heterogeneous, and conventional perioperative risk assessment insufficiently represents psychosocial determinants. We developed the preliminary SpinePROTECT Score within a digital biopsychosocial framework intended to support structured preoperative risk stratification. Materials and Methods: Framework development integrated a structured narrative evidence review, evidence from three complementary institutional research programs, predefined candidate-predictor criteria, expert-informed preliminary weighting, and translation into a modular digital platform. The protocol defines a prospective model-development and internal-validation cohort of 300 adults undergoing elective primary or revision surgery for spinal disorders, with follow-up at 6 weeks, 3 months, and 12 months. The study was prospectively registered in the German Clinical Trials Register on 8 September 2026 (DRKS00041544) following ethics approval on 28 August 2026 (protocol code 151/26). At prospective registration, recruitment was scheduled to begin on 10 September 2026; the present protocol article reports no prospective outcome data. Results: The development process yielded three complementary domains: psychological vulnerability, clinical burden, and procedural invasiveness. The preliminary framework includes Type-D personality, depression, anxiety, pain catastrophizing, fear-avoidance beliefs, baseline disability, symptom duration, opioid use, revision status, and surgical trauma. Digital implementation enables electronic questionnaire acquisition, automated calculation of the preliminary SpinePROTECT Score, standardized reports, longitudinal follow-up, and structured research-data capture. Predictive performance is not reported in this protocol article. Conclusions: The SpinePROTECT framework provides a transparent methodological and digital foundation for biopsychosocial risk stratification in spine surgery. The planned prospective study will estimate model coefficients and determine discrimination, calibration, internal validity, and clinical utility before the SpinePROTECT Score is considered for outcome prediction or treatment guidance.