Abstract / Summary
This prospective, multicenter clinical study evaluated patient-reported outcomes, functional recovery, and quality of life following orbital floor reconstruction using ultra-high-molecular-weight-polyethylene (UHMWPE) implants. The study emphasized both subjective recovery and the clinical performance of the implant material. Between June 2022 and July 2023, 46 adult patients (≥ 18 years of age) with radiologically confirmed orbital floor fractures requiring surgical reconstruction were enrolled and completed the full follow-up protocol. Surgical reconstruction was performed according to standardized procedures using UHMWPE implants. Pre- and postoperative CT or CBCT imaging was obtained when clinically indicated; radiological outcomes of this cohort have been reported separately. Pre- and postoperative evaluations included an assessment of pain, swelling, ocular motility, diplopia, sensory function, foreign body sensation, overall satisfaction and orbital volume, which was measured using three-dimensional imaging. Intraoperative parameters were also recorded. Patient-reported outcomes were collected through validated questionnaires and visual analogue scales, repeated at each visit, follow-up examinations were performed approximately one day, ten weeks, six months, and twelve months after surgery. Overall, clinical and patient-reported outcomes improved over the follow-up period. Pain intensity declined markedly within the first week after surgery and remained consistently low thereafter. Swelling, numbness, and the sensation of a foreign body gradually subsided, with almost complete resolution after one year. Furthermore, imaging confirmed stable anatomical reconstruction without implant displacement or volume loss. In general patient satisfaction increased steadily throughout the observation period, reaching near-maximal levels after twelve months. No cases of infection, inflammatory reaction or implant-related complication were recorded. In this prospective cohort, orbital floor reconstruction using UHMWPE was associated with favorable functional, aesthetic and patient-reported recovery over 12 months. These findings support the value of incorporating patient-centered outcomes into the assessment of recovery after orbital trauma, while comparative effectiveness and long-term safety require further controlled studies.