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Completed

NCT Number: NCT01144208

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

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).

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Key information

Conditions

Distal Radius Fractures Arm Injuries Bone Diseases Bone Diseases, Metabolic Colles' Fracture Forearm Injuries Fracture Dislocation Fractures, Bone Intraoperative Complications Joint Diseases Joint Dislocations Metabolic Diseases Musculoskeletal Diseases Nutritional and Metabolic Diseases Osteoporosis Pathologic Processes Pathological Conditions, Signs and Symptoms Poor Bone Quality Postoperative Complications Radius Fractures Treatment Complications Wounds and Injuries Wrist Fractures Wrist Injuries

Age range

50 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Universitätsklinik für Unfallchirurgie, Graz, Styria, Austria

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Primary outcomes

  1. 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.

Secondary outcomes

  1. Bone mineral density at contralateral distal radius by DXA

    Time frame: until 6 weeks postoperative

    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.

  2. Occurence of any complication

    Time frame: Baseline

    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. Occurence of any complication

    Time frame: 6 weeks

    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.

  4. Occurence of any complication

    Time frame: 3 months

    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.

  5. Occurence of any complication

    Time frame: 12 months

    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. Range of motion

    Time frame: 6 weeks

    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

  7. Range of motion

    Time frame: 3 months

    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

  8. Range of motion

    Time frame: 12 months

    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

  9. Grip strength

    Time frame: 6 weeks

    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.

  10. Grip strength

    Time frame: 3 months

    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.

  11. Grip strength

    Time frame: 12 months

    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. Patient self-assessment of wrist function questionnaire (PRWE)

    Time frame: Baseline

    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.

  13. Patient self-assessment of hand function with the PRWE

    Time frame: 6 weeks

    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.

  14. Patient self-assessment of hand function with the PRWE

    Time frame: 3 months

    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.

  15. Patient self-assessment of hand function with the PRWE

    Time frame: 6 months

    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.

  16. Patient self-assessment of hand function with the PRWE

    Time frame: 12 months

    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.

  17. Disabilities of the arm, shoulder and hand questionnaire (DASH)

    Time frame: Baseline

    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).

  18. Disabilities of the arm, shoulder and hand questionnaire (DASH)

    Time frame: 6 weeks

    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).

  19. Disabilities of the arm, shoulder and hand questionnaire (DASH)

    Time frame: 3 months

    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).

  20. Disabilities of the arm, shoulder and hand questionnaire (DASH)

    Time frame: 12 months

    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).

  21. Health-related quality of life (EQ-5D)

    Time frame: Baseline

    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.

  22. Health-related quality of life (EQ-5D)

    Time frame: 6 weeks

    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.

  23. Health-related quality of life (EQ-5D)

    Time frame: 3 months

    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.

  24. Health-related quality of life (EQ-5D)

    Time frame: 6 months

    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.

  25. Health-related quality of life (EQ-5D)

    Time frame: 12 months

    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.

  26. High resolution pQCT of contralateral distal radius

    Time frame: within 6 weeks after surgery

    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.

Sponsors and collaborators

Lead sponsor

AO Clinical Investigation and Publishing Documentation

Other

Registry information

Important dates

Study start
2007
Primary completion
2010
Study completion
2010
First posted
Jun 15, 2010
Registry last updated
Jun 16, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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