The Influence of Local Bone Status on Complications After Surgical Treatment of Distal Radius Fra… (NCT01144208) | Clinical Trial Compass
CompletedNot Applicable
The Influence of Local Bone Status on Complications After Surgical Treatment of Distal Radius Fractures
United States, Austria, Germany244 participantsStarted 2007-02
Plain-language 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).
Who can participate
Age range50 Years – 90 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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)
What they're measuring
1
Local bone quality-related complication
Timeframe: From enrollment to 12 months postoperative
Trial details
NCT IDNCT01144208
SponsorAO Clinical Investigation and Publishing Documentation