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

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).

Study Overview

• Status: Completed
• Conditions: Distal Radius Fractures; Poor Bone Quality; Treatment Complications

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.

• Study Type: Observational
• Enrollment (Actual): 244

Contacts and Locations

Study Locations

• Austria
  • Steiermark
    • Graz, Steiermark, Austria, 8036
      • Universitätsklinik für Unfallchirurgie
• Germany
  • Berlin, Germany, 13353
    • Campus Virchow-Klinikum, Charité
  • Bayern
    • Muenchen, Bayern, Germany, 81675
      • Klinikum rechts der Isar der TU Muenchen
  • Niedersachsen
    • Hannover, Niedersachsen, Germany, 30169
      • Ev. Diakoniewerk Friederikenstift
• Italy
  • Tuscany
    • Firenze, Tuscany, Italy, 50139
      • C.T.O. Azienda Ospedaliera Careggi
• Singapore
  • Singapore, Singapore, 169608
    • Singapore General Hospital
• Switzerland
  • Basel, Switzerland, 4031
    • Universitätsspital Basel
  • Luzern, Switzerland, 6000
    • Kantonsspital
  • Zuerich, Switzerland, 8063
    • Stadtspital Triemli
  • Zuerich
    • Winterthur, Zuerich, Switzerland, 8401
      • Kantonsspital Winterthur
• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

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

Description

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)

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Bone mineral density at contralateral distal radius by DXA	Local bone status will comprise BMD and BMC of the contralateral side. The absolute values for BMD and BMC will be provided as well as the deviations to the T-score according to the manufacturer's reference collective.	until 6 weeks postoperative
Occurence of any complication	To capture any complication that occured. A complication is defined as any occurrence or deviation from the normal treatment or outcome, regardless of whether it has any relationship with the treatment or product under investigation.	Baseline
Occurence of any complication	To capture any complication that occured. A complication is defined as any occurrence or deviation from the normal treatment or outcome, regardless of whether it has any relationship with the treatment or product under investigation.	6 weeks
Occurence of any complication	To capture any complication that occured. A complication is defined as any occurrence or deviation from the normal treatment or outcome, regardless of whether it has any relationship with the treatment or product under investigation.	3 months
Occurence of any complication	To capture any complication that occured. A complication is defined as any occurrence or deviation from the normal treatment or outcome, regardless of whether it has any relationship with the treatment or product under investigation.	12 months
Range of motion	The bilateral range of motion will be measured by clinical examination as follows: Dorsal extension / palmar flexion; Wrist ulnar abduction / radial abduction; Forearm supination / pronation	6 weeks
Range of motion	The bilateral range of motion will be measured by clinical examination as follows: Dorsal extension / palmar flexion; Wrist ulnar abduction / radial abduction; Forearm supination / pronation	3 months
Range of motion	The bilateral range of motion will be measured by clinical examination as follows: Dorsal extension / palmar flexion; Wrist ulnar abduction / radial abduction; Forearm supination / pronation	12 months
Grip strength	For the grip strength, the average value of three successive measurements with a Jamar dynamometer will be calculated as percentage of the contralateral, healthy side.	6 weeks
Grip strength	For the grip strength, the average value of three successive measurements with a Jamar dynamometer will be calculated as percentage of the contralateral, healthy side.	3 months
Grip strength	For the grip strength, the average value of three successive measurements with a Jamar dynamometer will be calculated as percentage of the contralateral, healthy side.	12 months
Patient self-assessment of wrist function questionnaire (PRWE)	PRWE was developed to rate wrist-related pain and disability in functional activities. This provides a score from 0-100, where higher scores indicate greater pain and disability.	Baseline
Patient self-assessment of hand function with the PRWE	PRWE was developed to rate wrist-related pain and disability in functional activities. This provides a score from 0-100, where higher scores indicate greater pain and disability.	6 weeks
Patient self-assessment of hand function with the PRWE	PRWE was developed to rate wrist-related pain and disability in functional activities. This provides a score from 0-100, where higher scores indicate greater pain and disability.	3 months
Patient self-assessment of hand function with the PRWE	PRWE was developed to rate wrist-related pain and disability in functional activities. This provides a score from 0-100, where higher scores indicate greater pain and disability.	6 months
Patient self-assessment of hand function with the PRWE	PRWE was developed to rate wrist-related pain and disability in functional activities. This provides a score from 0-100, where higher scores indicate greater pain and disability.	12 months
Disabilities of the arm, shoulder and hand questionnaire (DASH)	The disability of the arm, shoulder and hand (DASH) questionnaire is an upper extremity specific outcome measure. The main part of the DASH is a 30-item disability/symptom scale concerning the patient's health status during the preceding week. The scores for all items are then used to calculate a scale score ranging from 0 (no disability) to 100 (most severe disability).	Baseline
Disabilities of the arm, shoulder and hand questionnaire (DASH)	The disability of the arm, shoulder and hand (DASH) questionnaire is an upper extremity specific outcome measure. The main part of the DASH is a 30-item disability/symptom scale concerning the patient's health status during the preceding week. The scores for all items are then used to calculate a scale score ranging from 0 (no disability) to 100 (most severe disability).	6 weeks
Disabilities of the arm, shoulder and hand questionnaire (DASH)	The disability of the arm, shoulder and hand (DASH) questionnaire is an upper extremity specific outcome measure. The main part of the DASH is a 30-item disability/symptom scale concerning the patient's health status during the preceding week. The scores for all items are then used to calculate a scale score ranging from 0 (no disability) to 100 (most severe disability).	3 months
Disabilities of the arm, shoulder and hand questionnaire (DASH)	The disability of the arm, shoulder and hand (DASH) questionnaire is an upper extremity specific outcome measure. The main part of the DASH is a 30-item disability/symptom scale concerning the patient's health status during the preceding week. The scores for all items are then used to calculate a scale score ranging from 0 (no disability) to 100 (most severe disability).	12 months
Health-related quality of life (EQ-5D)	EQ-5D is a standardised instrument for use as a measure of health outcome.It has five items with a three-point categorical response scale (no problems, some/moderate problems, extreme problems. A unique EQ-5D health state is defined by combining 1 level from each of the 5 dimensions.	Baseline
Health-related quality of life (EQ-5D)	EQ-5D is a standardised instrument for use as a measure of health outcome.It has five items with a three-point categorical response scale (no problems, some/moderate problems, extreme problems. A unique EQ-5D health state is defined by combining 1 level from each of the 5 dimensions.	6 weeks
Health-related quality of life (EQ-5D)	EQ-5D is a standardised instrument for use as a measure of health outcome.It has five items with a three-point categorical response scale (no problems, some/moderate problems, extreme problems. A unique EQ-5D health state is defined by combining 1 level from each of the 5 dimensions.	3 months
Health-related quality of life (EQ-5D)	EQ-5D is a standardised instrument for use as a measure of health outcome.It has five items with a three-point categorical response scale (no problems, some/moderate problems, extreme problems. A unique EQ-5D health state is defined by combining 1 level from each of the 5 dimensions.	6 months
Health-related quality of life (EQ-5D)	EQ-5D is a standardised instrument for use as a measure of health outcome.It has five items with a three-point categorical response scale (no problems, some/moderate problems, extreme problems. A unique EQ-5D health state is defined by combining 1 level from each of the 5 dimensions.	12 months
High resolution pQCT of contralateral distal radius	High-resolution pQCT of the contralateral side with an XTremeCT will be performed in a subset of patients in Zürich. To obtain the bone mineral content the CT values will be calibrated with the help of a phantom in hydoxyapatite (HA) densities in mg HA/cm3. The relation of bone volume to tissue volume will be calculated as BV/TV. These values will be analyzed separately.	within 6 weeks after surgery

Collaborators and Investigators

• Sponsor: AO Clinical Investigation and Publishing Documentation
• Investigators: Principal Investigator: Daniel A Rikli, PD, Universitätsspital Basel

Publications and helpful links

General Publications

• 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.

Helpful 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.

Study record dates

Study Major Dates

• Study Start: February 1, 2007
• Primary Completion (Actual): April 1, 2010
• Study Completion (Actual): April 1, 2010

Study Registration Dates

• First Submitted: June 14, 2010
• First Submitted That Met QC Criteria: June 14, 2010
• First Posted (Estimate): June 15, 2010

Study Record Updates

• Last Update Posted (Estimate): June 16, 2010
• Last Update Submitted That Met QC Criteria: June 15, 2010
• Last Verified: June 1, 2010

More Information

Terms related to this study

• Keywords: Postoperative complications; Osteoporosis; Adverse effects; Radius fracture; Wrist; Colles' fracture; Intraoperative complications; Dual-energy x-ray absorptiometry (DXA); Bone Density
• Additional Relevant MeSH Terms: Wounds and Injuries; Arm Injuries; Forearm Injuries; Fractures, Bone; Radius Fractures
• Other Study ID Numbers: FFOB-Rad