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

This study has been completed.
Sponsor:
Information provided by:
AO Clinical Investigation and Documentation
ClinicalTrials.gov Identifier:
NCT01144208
First received: June 14, 2010
Last updated: June 15, 2010
Last verified: June 2010
  Purpose

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).


Condition Phase
Distal Radius Fractures
Poor Bone Quality
Treatment Complications
Phase 4

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Influence of Local Bone Status on Complications After Surgical Treatment of Distal Radius Fractures

Resource links provided by NLM:


Further study details as provided by AO Clinical Investigation and Documentation:

Primary Outcome Measures:
  • Local bone quality-related complication [ Time Frame: From enrollment to 12 months postoperative ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Bone mineral density at contralateral distal radius by DXA [ Time Frame: until 6 weeks postoperative ] [ Designated as safety issue: No ]
    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.

  • Occurence of any complication [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    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.

  • Occurence of any complication [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    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.

  • Occurence of any complication [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    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.

  • Occurence of any complication [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    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.

  • Range of motion [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]

    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

  • Range of motion [ Time Frame: 3 months ] [ Designated as safety issue: No ]

    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

  • Range of motion [ Time Frame: 12 months ] [ Designated as safety issue: No ]

    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

  • Grip strength [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    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.

  • Grip strength [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    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.

  • Grip strength [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    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.

  • Patient self-assessment of wrist function questionnaire (PRWE) [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    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.

  • Patient self-assessment of hand function with the PRWE [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    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.

  • Patient self-assessment of hand function with the PRWE [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    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.

  • Patient self-assessment of hand function with the PRWE [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    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.

  • Patient self-assessment of hand function with the PRWE [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    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.

  • Disabilities of the arm, shoulder and hand questionnaire (DASH) [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    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).

  • Disabilities of the arm, shoulder and hand questionnaire (DASH) [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    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).

  • Disabilities of the arm, shoulder and hand questionnaire (DASH) [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    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).

  • Disabilities of the arm, shoulder and hand questionnaire (DASH) [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    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).

  • Health-related quality of life (EQ-5D) [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    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.

  • Health-related quality of life (EQ-5D) [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    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.

  • Health-related quality of life (EQ-5D) [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    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.

  • Health-related quality of life (EQ-5D) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    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.

  • Health-related quality of life (EQ-5D) [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    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.

  • High resolution pQCT of contralateral distal radius [ Time Frame: within 6 weeks after surgery ] [ Designated as safety issue: No ]
    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.


Enrollment: 244
Study Start Date: February 2007
Study Completion Date: April 2010
Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
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

Ages Eligible for Study:   50 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

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

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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01144208

Locations
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Austria
Universitätsklinik für Unfallchirurgie
Graz, Steiermark, Austria, 8036
Germany
Klinikum rechts der Isar der TU Muenchen
Muenchen, Bayern, Germany, 81675
Ev. Diakoniewerk Friederikenstift
Hannover, Niedersachsen, Germany, 30169
Campus Virchow-Klinikum, Charité
Berlin, Germany, 13353
Italy
C.T.O. Azienda Ospedaliera Careggi
Firenze, Tuscany, Italy, 50139
Singapore
Singapore General Hospital
Singapore, Singapore, 169608
Switzerland
Kantonsspital Winterthur
Winterthur, Zuerich, Switzerland, 8401
Universitätsspital Basel
Basel, Switzerland, 4031
Kantonsspital
Luzern, Switzerland, 6000
Stadtspital Triemli
Zuerich, Switzerland, 8063
Sponsors and Collaborators
AO Clinical Investigation and Documentation
Investigators
Principal Investigator: Daniel A Rikli, PD Universitätsspital Basel
  More Information

Additional Information:
No publications provided by AO Clinical Investigation and Documentation

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Dr D. Rikli, Universitätsspital Basel, Behandlungszentrum Bewegungsapparat BZB, Spitalstrasse 21, CH-4031 Basel, Switzerland
ClinicalTrials.gov Identifier: NCT01144208     History of Changes
Other Study ID Numbers: FFOB-Rad
Study First Received: June 14, 2010
Last Updated: June 15, 2010
Health Authority: Switzerland: Ethikkommission
Germany: Ethics Commission
Austria: Ethikkommission
Hong Kong: Ethics Committee
Italy: Ethics Committee
United States: Institutional Review Board
Singapore: Domain Specific Review Boards

Keywords provided by AO Clinical Investigation and Documentation:
Radius fracture
Adverse effects
Wrist
Postoperative complications
Colles' fracture
Intraoperative complications
Osteoporosis
Dual-energy x-ray absorptiometry (DXA)
Bone Density

Additional relevant MeSH terms:
Fractures, Bone
Radius Fractures
Wounds and Injuries
Forearm Injuries
Arm Injuries

ClinicalTrials.gov processed this record on April 17, 2014