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

NCT ID: NCT01144208

Last Updated: 2010-06-16

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 244 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2007-02-28
• Study Completion Date: 2010-04-30

Brief Summary

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).

Detailed 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.

Conditions

Distal Radius Fractures; Poor Bone Quality; Treatment Complications

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

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)

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

AO Clinical Investigation and Publishing Documentation

OTHER

Sponsor Role: lead

Responsible Party

Universitätsspital Basel, Behandlungszentrum Bewegungsapparat BZB, Spitalstrasse 21, CH-4031 Basel, Switzerland

Principal Investigators

Daniel A Rikli, PD

Role: PRINCIPAL_INVESTIGATOR

Universitätsspital Basel

Locations

Massachusetts General Hospital

Boston, Massachusetts, United States

Universitätsklinik für Unfallchirurgie

Graz, Styria, Austria

Klinikum rechts der Isar der TU Muenchen

Munich, Bavaria, Germany

Ev. Diakoniewerk Friederikenstift

Hanover, Lower Saxony, Germany

Campus Virchow-Klinikum, Charité

Berlin, State of Berlin, Germany

C.T.O. Azienda Ospedaliera Careggi

Florence, Tuscany, Italy

Singapore General Hospital

Singapore, Singapore, Singapore

Universitätsspital Basel

Basel, Basel, Switzerland

Kantonsspital

Lucerne, Canton of Lucerne, Switzerland

Kantonsspital Winterthur

Winterthur, Canton of Zurich, Switzerland

Stadtspital Triemli

Zurich, Canton of Zurich, Switzerland

Countries

United States; Austria; Germany; Italy; Singapore; Switzerland

References

Goldhahn S, Kralinger F, Rikli D, Marent M, Goldhahn J. Does osteoporosis increase complication risk in surgical fracture treatment? A protocol combining new endpoints for two prospective multicentre open cohort studies. BMC Musculoskelet Disord. 2010 Nov 9;11:256. doi: 10.1186/1471-2474-11-256.

Reference Type: DERIVED

PMID: 21062463 (View on PubMed)

Related Links

http://www.aofoundation.org

Non profit organization dedicated to improving the care of patients with musculoskeletal injuries and their sequelae through research, development, education and quality assurance in the principles, practice, and result of fracture treatment.

Other Identifiers

FFOB-Rad

Identifier Type: -

Identifier Source: org_study_id