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
Conditions
Interventions
Trade Name: Ibumetin
Product Name: Ibumetin
Pharmaceutical Form: Tablet
INN or Proposed INN: IBUPROFEN
CAS Number: 15687-27-1
Current Sponsor code: 12153599
Other descriptive name: Ibumetin
Concentrat
Sponsors
Orthopaedic Syrgery Unit Northern Jytland
Eligibility
Sex/Gender
All
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Primary point: assessment of radiological secondary dislocation: any migration larger than in the other group will be an expression of instability and thus slower or absent healing. It is possible to determine the migration of approx. 0.5 mm and 1 ° accuracy. Incidence of secondary dislocations and those, which need an operation, will be manufactured in absolute and percentage figures. ;Secondary Objective: Secondary points: movements of the wrist joint, DASH (function) score; pain measured by VAS-score (patients complete pain diary in the first 2 weeks postoperatively); noted consumption of painkillers, which is prescribed ‘as needed’; Bone mineral density measured by DEXA scanner: it will be examined whether there are significant differences between density measurement of healthy radius at the beginning of treatment and 3 months later, is there a significant difference between broken and healthy bone mineralization; bone markers: Serum Cross Laps ELISA ®, N-Mid ® Osteocalcin ELISA; bone biopsy from callus zone: assessed ossification and maturity of the callus , which are presented in histomorphometric numbers: bone and fibrous tissue volume fraction, osteoid thickness. ;Primary end point(s): Primary point: assessment of radiological secondary dislocation: any migration larger than in the other group will be an expression of instability and thus slower or absent healing. It is possible to determine the migration of approx. 0.5 mm and 1 ° accuracy. Incidence of secondary dislocations and those, which need an operation, will be manufactured in absolute and percentage figures. Secondary points: movements of the wrist joint, DASH (function) score; pain measured by VAS-score (patients complete pain diary in the first 2 weeks postoperatively); noted consumption of painkillers, which is prescribed ‘as needed’; Bone mineral density measured by DEXA scanner: it will be examined whether there are significant differences between density measurement of | — |
Countries
Denmark
Outcome results
None listed