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

NCT01144208 | Completed

• 1 other identifier: FFOB-Rad
• Study Type: observational
• Target: 244
• Locations: 6 countries
• Sites: 11

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).

Conditions

Distal Radius Fractures; Poor Bone Quality; Treatment Complications

Keywords

Radius fracture; Adverse effects; Wrist; Postoperative complications; Colles' fracture; Intraoperative complications; Osteoporosis; Dual-energy x-ray absorptiometry (DXA); Bone Density

Outcome Measures

Primary Outcomes (1)

• Local bone quality-related complication

  The qualifying events are those involving either directly the local bone and fracture or the implant and its surgical application whether they are anticipated or not.

  From enrollment to 12 months postoperative

Secondary Outcomes (26)

• Bone mineral density at contralateral distal radius by DXA

  until 6 weeks postoperative

• Occurence of any complication

  Baseline

• Occurence of any complication

  6 weeks

• Occurence of any complication

  3 months

• Occurence of any complication

  12 months

Eligibility Criteria

• Age: 50 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

participating clinics will identify all eligible patients who meet the inclusion and exclusion

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• AO Clinical Investigation and Publishing Documentation: lead

Study Sites (11)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Universitätsklinik für Unfallchirurgie

Graz, Styria, 8036, Austria

Location

Klinikum rechts der Isar der TU Muenchen

Munich, Bavaria, 81675, Germany

Location

Ev. Diakoniewerk Friederikenstift

Hanover, Lower Saxony, 30169, Germany

Location

Campus Virchow-Klinikum, Charité

Berlin, State of Berlin, 13353, Germany

Location

C.T.O. Azienda Ospedaliera Careggi

Florence, Tuscany, 50139, Italy

Location

Singapore General Hospital

Singapore, Singapore, 169608, Singapore

Location

Universitätsspital Basel

Basel, Basel, 4031, Switzerland

Location

Kantonsspital

Lucerne, Canton of Lucerne, 6000, Switzerland

Location

Kantonsspital Winterthur

Winterthur, Canton of Zurich, 8401, Switzerland

Location

Stadtspital Triemli

Zurich, Canton of Zurich, 8063, Switzerland

Location

Related Publications (1)

• 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.

  PMID: 21062463 DERIVED

Related Links

• 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.

MeSH Terms

Conditions

Wrist Fractures; Radius Fractures; Postoperative Complications; Colles' Fracture; Intraoperative Complications; Osteoporosis

Condition Hierarchy (Ancestors)

Wrist Injuries; Arm Injuries; Wounds and Injuries; Fractures, Bone; Forearm Injuries; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Fracture Dislocation; Joint Dislocations; Joint Diseases; Musculoskeletal Diseases; Bone Diseases, Metabolic; Bone Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Daniel A Rikli, PD

  Universitätsspital Basel

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: June 14, 2010
• First Posted: June 15, 2010
• Study Start: February 1, 2007
• Primary Completion: April 1, 2010
• Study Completion: April 1, 2010
• Last Updated: June 16, 2010

Record last verified: 2010-06

Locations

IT (1); CH (4); AU (1); SG (1); DE (3); US (1)