The Influence of Local Bone Status on Complications After Surgical Treatment of Distal Radius Fractures
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 244
- Locations
- 11
- Primary Endpoint
- Local bone quality-related complication
Study Overview
Brief 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).
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
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 50 Years to 90 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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)
- •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)
Outcomes
Primary Outcomes
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
- Bone mineral density at contralateral distal radius by DXA(until 6 weeks postoperative)
- Occurence of any complication(12 months)
- Range of motion(12 months)
- Grip strength(12 months)
- Patient self-assessment of wrist function questionnaire (PRWE)(Baseline)
- Patient self-assessment of hand function with the PRWE(12 months)
- Disabilities of the arm, shoulder and hand questionnaire (DASH)(12 months)
- Health-related quality of life (EQ-5D)(12 months)
- High resolution pQCT of contralateral distal radius(within 6 weeks after surgery)