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).
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
244
Massachusetts General Hospital
Boston, Massachusetts, United States
Universitätsklinik für Unfallchirurgie
Graz, Styria, Austria
Klinikum rechts der Isar der TU Muenchen
Munich, Bavaria, Germany
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.
Time frame: From enrollment to 12 months postoperative
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
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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
...and 1 more locations
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: within 6 weeks after surgery