3DOOM III STUDY
Inclusion ongoing
Background:
Forearm fractures involving the radius and/or ulna are among the most common pediatric fractures. Despite reduction and stabilization with pins and/or cast immobilization, secondary displacement occurs in up to 30% of patients treated with casting alone, potentially resulting in malunion. Malunion may lead to pain, cosmetic deformity, and functional impairment, most notably restricted forearm rotation, which can substantially affect daily activities.
Rationale:
The current standard treatment for symptomatic forearm malunion is corrective osteotomy of both the radius and ulna using three-dimensional (3D)-printed patient-specific guides. Although effective, this approach is invasive and associated with prolonged rehabilitation and significant scarring. Advances in four-dimensional (4D) simulation now allow improved identification of the underlying cause of rotational impairment, distinguishing between soft-tissue constraints and bony impingement. In selected cases, isolated soft-tissue release or correction of a single bone may suffice, obviating the need for bilateral osteotomy. As functional recovery is prioritized over restoration of exact pre-traumatic anatomy, a patient-specific, minimally invasive stepwise treatment strategy may offer a less invasive alternative while preserving the option to convert to standard corrective osteotomy if required.
Objective:
To evaluate whether a minimally invasive stepwise treatment strategy results in sufficient restoration of forearm rotation in patients with malunion following a fracture of the radius and/or ulna.
Methods:
This prospective pilot study includes children and adults with restricted forearm rotation due to malunion after a radius and/or ulna fracture. Patients will undergo a minimally invasive stepwise treatment approach, with intraoperative conversion to standard corrective osteotomy using patient-specific guides as an escape option when necessary. Follow-up duration is 1 year.
Outcomes:
The primary outcome is postoperative improvement in forearm pronation and supination, measured in degrees. Secondary outcomes include patient-reported functional limitations, pain, cosmetic satisfaction, overall patient satisfaction, and comparison with a matched historical cohort.
