SAIDs INFLUENCE ON HEAL OF COLLES FRACTURE - NSAID's study

Phase 1

• Conditions: Ivestigations hypotheses: 1. NSAIDs provide a significant postoperative pain relief that can make mobilization / rehabilitation faster and easier oedema prophylaxis. 2. NSAIDs do not affect bone healing or affect so little that it will not lead to consequences (delayed or absent healing, osteoporosis, instability) of clinical significance. 3. Radiological assessment of secondary dislocation of fractures, DEXA - scanning and bone marker tests are equally sensitive to detect bone effects.; MedDRA version: 12.1Level: LLTClassification code 10009924Term: Colles' fracture

• Registration Number: EUCTR2010-018543-34-DK
• Lead Sponsor: Orthopaedic Syrgery Unit Northern Jytland

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-03-22
• Last Update Posted: 17 October 2016

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 192

Inclusion Criteria

Written acceptance to participate in the study, reposition and / or surgery demanding Colles fracture, which needs to be fixed with external fixation.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Age - younger than 50 years or older than 80 years; treatment with prednisolon; NSAIDs - treatment; previous fracture or surgery at the wrist; lack of mental and physical capacity to follow studies’ instructions; lack of informed consent; other diseases can affect bone substance (oncology, endocrine diseases), medical contraindications to NSAIDs use, smoking, alcohol consumption more than 14 drinks per week, secondary dislocation of fracture also apply as exclusion criterion.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified