Clinical trial NCT01144208: The Influence of Local Bone Status on Complications After Surgical Treatment of Distal Radius Fractures
Official title: The Influence of Local Bone Status on Complications After Surgical Treatment of Distal Radius Fractures
Study type: OBSERVATIONAL
Overall status: COMPLETED
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
Lead sponsor: AO Innovation Translation Center
Sponsor class: OTHER
First posted: 2010-06-15
Enrollment: 244
Sex: ALL
Minimum age (years): 50
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: participating clinics will identify all eligible patients who meet the inclusion and exclusion

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.

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)

Primary outcomes:
measure: Local bone quality-related complication
timeFrame: From enrollment to 12 months postoperative
Secondary outcomes:
measure: Bone mineral density at contralateral distal radius by DXA
timeFrame: until 6 weeks postoperative
measure: Occurence of any complication
timeFrame: Baseline
measure: Occurence of any complication
timeFrame: 6 weeks
measure: Occurence of any complication
timeFrame: 3 months
measure: Occurence of any complication
timeFrame: 12 months
measure: Range of motion
timeFrame: 6 weeks
measure: Range of motion
timeFrame: 3 months
measure: Range of motion
timeFrame: 12 months
measure: Grip strength
timeFrame: 6 weeks
measure: Grip strength
timeFrame: 3 months
measure: Grip strength
timeFrame: 12 months
measure: Patient self-assessment of wrist function questionnaire (PRWE)
timeFrame: Baseline
measure: Patient self-assessment of hand function with the PRWE
timeFrame: 6 weeks
measure: Patient self-assessment of hand function with the PRWE
timeFrame: 3 months
measure: Patient self-assessment of hand function with the PRWE
timeFrame: 6 months
measure: Patient self-assessment of hand function with the PRWE
timeFrame: 12 months
measure: Disabilities of the arm, shoulder and hand questionnaire (DASH)
timeFrame: Baseline
measure: Disabilities of the arm, shoulder and hand questionnaire (DASH)
timeFrame: 6 weeks
measure: Disabilities of the arm, shoulder and hand questionnaire (DASH)
timeFrame: 3 months
measure: Disabilities of the arm, shoulder and hand questionnaire (DASH)
timeFrame: 12 months
measure: Health-related quality of life (EQ-5D)
timeFrame: Baseline
measure: Health-related quality of life (EQ-5D)
timeFrame: 6 weeks
measure: Health-related quality of life (EQ-5D)
timeFrame: 3 months
measure: Health-related quality of life (EQ-5D)
timeFrame: 6 months
measure: Health-related quality of life (EQ-5D)
timeFrame: 12 months
measure: High resolution pQCT of contralateral distal radius
timeFrame: within 6 weeks after surgery
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Graz
country: Austria
facility: Universitätsklinik für Unfallchirurgie
state: Steiermark
city: Muenchen
country: Germany
facility: Klinikum rechts der Isar der TU Muenchen
state: Bayern
city: Hannover
country: Germany
facility: Ev. Diakoniewerk Friederikenstift
state: Niedersachsen
city: Berlin
country: Germany
facility: Campus Virchow-Klinikum, Charité
city: Firenze
country: Italy
facility: C.T.O. Azienda Ospedaliera Careggi
state: Tuscany
city: Singapore
country: Singapore
facility: Singapore General Hospital
city: Winterthur
country: Switzerland
facility: Kantonsspital Winterthur
state: Zuerich
city: Basel
country: Switzerland
facility: Universitätsspital Basel
city: Luzern
country: Switzerland
facility: Kantonsspital
city: Zuerich
country: Switzerland
facility: Stadtspital Triemli
Study officials:
affiliation: Universitätsspital Basel
name: Daniel A Rikli, PD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.