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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.
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| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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participating clinics will identify all eligible patients who meet the inclusion and exclusion
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| Name | Affiliation | Role |
|---|---|---|
| Daniel A Rikli, PD | Universitätsspital Basel | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States | ||
| Universitätsklinik für Unfallchirurgie |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21062463 | Derived | 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. |
| Label | URL |
|---|---|
| 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. | View source |
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| 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:
| 6 weeks |
| Range of motion | The bilateral range of motion will be measured by clinical examination as follows:
| 3 months |
| Range of motion | The bilateral range of motion will be measured by clinical examination as follows:
| 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 |
| Graz |
| Styria |
| 8036 |
| Austria |
| Klinikum rechts der Isar der TU Muenchen | Munich | Bavaria | 81675 | Germany |
| Ev. Diakoniewerk Friederikenstift | Hanover | Lower Saxony | 30169 | Germany |
| Campus Virchow-Klinikum, Charité | Berlin | State of Berlin | 13353 | Germany |
| C.T.O. Azienda Ospedaliera Careggi | Florence | Tuscany | 50139 | Italy |
| Singapore General Hospital | Singapore | Singapore | 169608 | Singapore |
| Universitätsspital Basel | Basel | Basel | 4031 | Switzerland |
| Kantonsspital | Lucerne | Canton of Lucerne | 6000 | Switzerland |
| Kantonsspital Winterthur | Winterthur | Canton of Zurich | 8401 | Switzerland |
| Stadtspital Triemli | Zurich | Canton of Zurich | 8063 | Switzerland |
| ID | Term |
|---|---|
| D000092503 | Wrist Fractures |
| D011885 | Radius Fractures |
| D011183 | Postoperative Complications |
| D003100 | Colles' Fracture |
| D007431 | Intraoperative Complications |
| D010024 | Osteoporosis |
| ID | Term |
|---|---|
| D014954 | Wrist Injuries |
| D001134 | Arm Injuries |
| D014947 | Wounds and Injuries |
| D050723 | Fractures, Bone |
| D005543 | Forearm Injuries |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D000072039 | Fracture Dislocation |
| D004204 | Joint Dislocations |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D001851 | Bone Diseases, Metabolic |
| D001847 | Bone Diseases |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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