The Scandinavian Displaced Lateral Clavicle trial (ScanDiLaC): a study protocol for a randomized clinical trial

Area of Science:

• Orthopedic surgery
• Traumatology
• Clinical research

Background:

• Displaced, extraarticular lateral clavicle fractures lack sufficient evidence for optimal treatment.
• Previous studies have been limited by small sample sizes, hindering definitive comparisons between surgical and nonsurgical approaches.

Purpose of the Study:

• To compare outcomes between surgical and nonsurgical treatment for displaced lateral clavicle fractures.
• To provide evidence-based guidance for the orthopedic community on managing these fractures.

Main Methods:

• A pragmatic, multicenter, preference-tolerant randomized controlled trial (RCT) involving 100 patients.
• Patients aged 18-65 with displaced lateral clavicle fractures were randomized 1:1 to surgical or nonsurgical treatment, with an option for early crossover.
• Primary outcome: Disabilities of the Arm, Shoulder and Hand (DASH) score at 1 year. Secondary outcomes include EQ-5D-5L, UCLA activity score, NCS, VAS pain, and PGIC.

Main Results:

• Data collection is ongoing, with follow-up at 6 weeks, 3 months, 6 months, and 1 year.
• Radiographic healing, complications, and return to work are also reported.
• No results are available at this time.

Conclusions:

• The optimal treatment for displaced Neer type II and V lateral clavicle fractures remains debated.
• This RCT aims to elucidate differences in outcomes between treatment strategies in real-world clinical practice.
• Findings are expected to guide the development of a treatment algorithm for lateral clavicle fractures.