Outcome measures
PROM
COMPLICATIONS
The primary outcome in this trial was DASH score at 2-year follow-up. The DASH is a patient-reported outcome measure (PROM), which measures self-reported disability and symptoms with 36 questions regarding different daily tasks [The patient data acquired were stored in paper portfolios from where they were extracted after the final patient’s 2-year follow-up was completed in December 2021. The portfolios contained the patients’ baseline characteristics, questionnaires, and case report files in which the allocation, collected radiographs, crossovers, complications, AEs, and SAEs were recorded.In order to avoid the wide interobserver variation reported with the CS, we arranged pretraining sessions for the assessors to standardize the measurements [