The Influence of Local Bone Status on Complications After Surgical Treatment of Distal Radius Fractures

AO Clinical Investigation and Publishing Documentation

Status: Completed

Conditions: Treatment Complications; Poor Bone Quality; Distal Radius Fractures

Study type: Observational

Funder types: Other

Identifiers

NCT01144208

FFOB-Rad

Details and patient eligibility

About

The purpose of this study is to evaluate if poor bone quality increases the risk of specific types of treatment complications in patients with distal radius fractures treated with open reduction and Locking Compression Plates(LCP).

Full description

Despite fractures of the wrist being widely regarded as "fragility fractures", there is good evidence that they are caused by diminished Bone Mineral Density (BMD) and that a low BMD value predicts a higher fracture risk at the distal radius. Both measurements of areal BMD with DXA and volumetric BMD with peripheral Quantitative Computer Tomography (pQCT)showed a lower BMD in women with Colles' fractures. Thus, Colles' fractures can be recognized as a good indication of underlying osteoporosis. High resolution peripheral Quantitative Computer Tomography at the distal radius will be evaluated in a subset of patients.

Clinical experts are concerned that osteoporosis increases the risk for poor outcomes and complication rates in surgical patients with osteoporosis. However, this has not yet been confirmed in clinical studies. It is important to investigate this question in order to correctly advise clinicians and patients and possibly develop tailored approaches for treatment of osteoporotic patients with distal radius fractures.

Enrollment: 244 patients

Sex: All

Ages: 50 to 90 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Radiologically confirmed closed fracture (within 7 days) of the distal radius
• Primary fracture treatment with a volar LCP 2.4 mm
• Age equal greater 50 and equal younger 90 years
• Willing and able to give written informed consent to participate in the study
• Willing and able to participate in the study follow-ups according to the CIP
• Willing and able to comply with the post-operative management program
• Able to understand and read country national language at an elementary level

Exclusion criteria

• Fracture of ulna (except an associated fracture of the ulnar styloid process)
• Open distal radius fracture
• Concomitant contralateral radius fracture
• Previous distal radius fracture on either side after the age of 25 years
• Time to operation > 7 days
• Polytrauma
• Regular systemic therapy with corticosteroids due to chronic disease
• Legal incompetence
• Patient received radio- or chemotherapy prior to, during, or within the last year
• Currently active cancer
• Recent history of substance abuse (i.e recreational drugs, alcohol)
• Prisoner
• Currently involved in a pharmaceutical study
• Has a disease process that would preclude accurate evaluation (e.g. neuromuscular or rheumatic disease, significant psychiatric or metabolic disorders)