Operative Treatment of Intra-Articular Distal Radius Fractures With versus Without Arthroscopy a Randomized Controlled Trial

Operative Treatment of Intra-Articular Distal Radius Fractures With versus Without Arthroscopy a Randomized Controlled Trial - RADAR

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON42637

Enrollment

Registered

2015-10-28

Start date

2016-02-02

Completion date

Unknown

Last updated

2024-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

intra-articular distal radius fracture wrist fracture

Interventions

This study will randomize between a conventional fluoroscopic open reduction and internal volar plate fixation (control group) and the conventional procedure with an additional wrist arthroscopy (in

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Patient from 18 years or older with a displaced complete articular distal radius fracture (AO type C), requiring open reduction and internal fixation with a volar locking plate

Exclusion criteria

Exclusion criteria: • Patients with impaired wrist function prior to injury due to arthrosis/neurological disorders of the upper limb • Open distal radius fractures • Multiple trauma patients (Injury Severity Score (ISS) >=16) • Other injuries in the ipsilateral extremity (except ulnar styloid process) • Fracture of contralateral wrist • Insufficient comprehension of the Dutch language to understand a rehabilitation program and other treatment information as judged by the attending physician • Patient suffering from disorders of bone metabolism other than osteoporosis (i.e. Paget*s disease, renal osteodystrophy, osteomalacia) • Patients suffering from connective tissue disease or (joint) hyperflexibility disorders such as Marfan*s, Ehler Danlos or other related disorders

Design outcomes

Primary

Measure	Time frame
Patient-Rated Wrist Evaluation (PRWE) score	—

Secondary

Measure	Time frame
Disability of the Arm, Shoulder and Hand (DASH) score Pain, as indicated on a Visual Analogue Scale (VAS) Range of Motion (ROM) Grip strength (measured with a grip strength meter) Complications Costs and absence from work (economic evaluation)	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)