COBRA I STUDY
RCT: dynamic or static progressive splinting in impaired forearm rotation 
Inclusion finished 

Background 

Forearm fractures are among the most common fractures in both children and adults. Displaced fractures are reduced and stabilized using osteosynthesis and/or casting to promote fracture healing. When malalignment is not recognized or corrected in time, a malunion may occur, potentially causing significant limitations in forearm rotation. Rotational restrictions may also develop due to soft-tissue scarring after trauma or, in some cases, without a clear underlying cause. 

 

Rationale 

Forearms with rotational deformities present a therapeutic challenge. Although corrective osteotomy has shown good outcomes for malunited forearm fractures, conservative treatment remains an important first-line option. Conservative management consists of specialized exercise therapy, sometimes combined with patient-specific rotational splinting. Splinting can be dynamic or static progressive. In this study, the type of brace is determined by randomization rather than therapist preference. All interventions are part of standard clinical care, and this study aims to prospectively evaluate their effectiveness. 
 

Study Objective 

The primary aim of this study is to evaluate the clinical outcome of conservative treatment for forearm rotational limitations. 
 

Primary Outcome 

• Improvement in forearm pronation and supination measured in degrees. 

 
 

Secondary Outcomes 

• Additional gain in pronation and supination with the use of a splint 

• Comparison between dynamic and static progressive splinting 

• Reduction in pain 

• Patient satisfaction 

 

Study Design 

This is a randomized controlled study with a maximum follow-up of one year. 

 

Study Population 

60 children (≥ 6 years) and adults with disabling symptoms due to limited forearm rotation are eligible for inclusion. 

 

Conclusion 

This study aims to provide insight into the effectiveness of conservative treatment for forearm rotational impairments and to determine whether different splinting strategies result in differences in functional outcomes, pain reduction, and patient satisfaction.