Distal Radius FracturesNCT01144208
The Influence of Local Bone Status on Complications After Surgical Treatment of Distal Radius Fractures
An observational study of Distal Radius Fractures and Poor Bone Quality, run by AO Clinical Investigation and Publishing Documentation at 11 sites in 6 countries.
Trial 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). Read more about this study
- Who is it for?
- Ages 50 to 90 years
- Conditions the study is for
- Distal Radius Fractures, Poor Bone Quality, Treatment Complications
- How many people
- 244 participants
- Where
- 11 sitesin 6 countries
- Study dates
- Feb 2007to Apr 2010
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: participating clinics will identify all eligible patients who meet the inclusion and exclusion
Who may be able to join
- 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
Who cannot join
- 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
Show all 14Show fewer
- 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)
Trial locations and contacts
11 sites in 6 countries.
11 sites in 6 countries
Switzerland4 sites
Universitätsspital Basel
Basel, Basel, 4031
Kantonsspital
Lucerne, Canton of Lucerne, 6000
Kantonsspital Winterthur
Winterthur, Canton of Zurich, 8401
Stadtspital Triemli
Zurich, Canton of Zurich, 8063
Germany3 sites
Campus Virchow-Klinikum, Charité
Berlin, State of Berlin, 13353
Ev. Diakoniewerk Friederikenstift
Hanover, Lower Saxony, 30169
Klinikum rechts der Isar der TU Muenchen
Munich, Bavaria, 81675
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
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).
Read the 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.
- Keywords
- Radius fracture, Adverse effects, Wrist, Postoperative complications, Colles' fracture, Intraoperative complications, Osteoporosis, Dual-energy x-ray absorptiometry (DXA), Bone Density
- Medical subject headings
- Wrist Fractures, Radius Fractures, Postoperative Complications, Colles' Fracture, Intraoperative Complications, Osteoporosis
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From enrollment to 12 months postoperative
Secondary outcomes (26)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: within 6 weeks after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2010 (estimated)
- Study startFeb 2007
- Primary completionApr 2010
- Study completionApr 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Distal Radius FracturesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 244 participants (actual)
Sponsor and investigators
- Lead sponsor
- AO Clinical Investigation and Publishing Documentation
- Sponsor type
- University, hospital or other
- Investigators
- Daniel A Rikli, PD, Principal investigator, Universitätsspital Basel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01144208
- Sponsor's protocol ID
- FFOB-Rad
- Status last verified
- Jun 2010
- First submitted
- 14 Jun 2010
- Last updated
- 16 Jun 2010
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 21062463
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Influence of Local Bone Status on Complications After Surgical Treatment of Distal Radius Fractures
- ClinicalTrials.gov ID
- NCT01144208
- Acronym / sponsor ID
- FFOB-Rad
- Keywords
- Radius fracture, Adverse effects, Wrist, Postoperative complications, Colles' fracture, Intraoperative complications, Osteoporosis, Dual-energy x-ray absorptiometry (DXA)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 244 participants (actual)
- Lead sponsor
- AO Clinical Investigation and Publishing DocumentationUniversity, hospital or other
- Study start
- Feb 2007
- Primary completion
- Apr 2010 (actual)
- Study completion
- Apr 2010 (actual)
- First posted
- 15 Jun 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 50 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- participating clinics will identify all eligible patients who meet the inclusion and exclusion
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Local bone quality-related complication
Time frame: From enrollment to 12 months postoperative
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.
26 secondary outcomes
Bone mineral density at contralateral distal radius by DXA
Time frame: until 6 weeks postoperative
Occurence of any complication
Time frame: Baseline
Occurence of any complication
Time frame: 6 weeks
Occurence of any complication
Time frame: 3 months
Occurence of any complication
Time frame: 12 months
Range of motion
Time frame: 6 weeks
Range of motion
Time frame: 3 months
Range of motion
Time frame: 12 months
Grip strength
Time frame: 6 weeks
Grip strength
Time frame: 3 months
Grip strength
Time frame: 12 months
Patient self-assessment of wrist function questionnaire (PRWE)
Time frame: Baseline
Patient self-assessment of hand function with the PRWE
Time frame: 6 weeks
Patient self-assessment of hand function with the PRWE
Time frame: 3 months
Patient self-assessment of hand function with the PRWE
Time frame: 6 months
Patient self-assessment of hand function with the PRWE
Time frame: 12 months
Disabilities of the arm, shoulder and hand questionnaire (DASH)
Time frame: Baseline
Disabilities of the arm, shoulder and hand questionnaire (DASH)
Time frame: 6 weeks
Disabilities of the arm, shoulder and hand questionnaire (DASH)
Time frame: 3 months
Disabilities of the arm, shoulder and hand questionnaire (DASH)
Time frame: 12 months
Health-related quality of life (EQ-5D)
Time frame: Baseline
Health-related quality of life (EQ-5D)
Time frame: 6 weeks
Health-related quality of life (EQ-5D)
Time frame: 3 months
Health-related quality of life (EQ-5D)
Time frame: 6 months
Health-related quality of life (EQ-5D)
Time frame: 12 months
High resolution pQCT of contralateral distal radius
Time frame: within 6 weeks after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2010.
- Derived from this study: PubMed 21062463Goldhahn 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.
- 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.Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Daniel A Rikli, PD principal investigator
Universitätsspital Basel
11 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Distal Radius Fractures and Poor Bone Quality, run by AO Clinical Investigation and Publishing Documentation at 11 sites in 6 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jun 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in Switzerland, Germany, United States, Austria, Italy and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Local bone quality-related complication (time frame: From enrollment to 12 months postoperative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01144208, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jun 2010.