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

Distal Radius Fractures Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01144208
• Other study ID #: FFOB-Rad
• Status: Completed
• Phase: Phase 4
• First received: June 14, 2010
• Last updated: June 15, 2010
• Start date: February 2007
• Est. completion date: April 2010

Study information

• Verified date: June 2010
• Source: AO Clinical Investigation and Documentation
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: EthikkommissionGermany: Ethics CommissionAustria: EthikkommissionHong Kong: Ethics CommitteeItaly: Ethics CommitteeUnited States: Institutional Review BoardSingapore: Domain Specific Review Boards
• Study type: Observational

Clinical 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 244
• Est. completion date: April 2010
• Est. primary completion date: April 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years to 90 Years

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Distal Radius Fractures
• Fractures, Bone
• Poor Bone Quality
• Radius Fractures
• Treatment Complications

Locations

Country	Name	City	State
Austria	Universitätsklinik für Unfallchirurgie	Graz	Steiermark
Germany	Campus Virchow-Klinikum, Charité	Berlin
Germany	Ev. Diakoniewerk Friederikenstift	Hannover	Niedersachsen
Germany	Klinikum rechts der Isar der TU Muenchen	Muenchen	Bayern
Italy	C.T.O. Azienda Ospedaliera Careggi	Firenze	Tuscany
Singapore	Singapore General Hospital	Singapore
Switzerland	Universitätsspital Basel	Basel
Switzerland	Kantonsspital	Luzern
Switzerland	Kantonsspital Winterthur	Winterthur	Zuerich
Switzerland	Stadtspital Triemli	Zuerich
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
AO Clinical Investigation and Documentation

Countries where clinical trial is conducted

United States,  Austria,  Germany,  Italy,  Singapore,  Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No

External Links

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