Forearm Fracture
Conditions
Keywords
NSAID, bone fracture, heal
Brief summary
It is believed, that Non Steroidal Antiinflammatory Drug (NSAID) drugs slows bone healing, but the knowledge is based only on animal studies, and the results are automatically raised for the people. Many patients with bone fracture must therefore avoid the formerly so popular and good painkillers, although no clinical trial evidence is, that this medicine is really harmful for patients with fractures. The purpose of this study is to investigate whether these drugs slows bone healing, and what the relationship is between various bone studies - DEXA scanning, biochemical bone marker tests, radiographic controls and tissue examination of newly formed bone under a microscope. How sensitive and specific, each of the above study methods? If they are just as sensitive, the cheapest of them recommended as a routine investigation on suspicion of bone effects. Furthermore, to compare the benefit (pain-relieving effect, influence on rehabilitation) of these drugs and their possible harmful side effects (affected and delayed bone healing). The expectation is that the study may contribute to increased knowledge about NSAIDs effect do pain management, rehabilitation and the entire treatment process significantly easier and safer, so that patients recover faster and return to usual activities.
Interventions
DRUGIbuprofen
Treatment with Ibuprofen 600mg 3times a day in 7 days after Colles fracture diagnosis
DRUGPlacebo
Only placebo treatment instead of NSAID painkillers
Sponsors
University of Aarhus
Marius Aliuskevicius
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
50 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* written acceptance to participate in the study * immobilisation or reposition or surgery demanding Colles fracture (which needs to be fixed with external fixation).
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 of more than 14 drinks per week * secondary dislocation of fracture also apply as exclusion criterion.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Evaluation of changes of fractures position by X rays investigation | 1 week, 2 weeks, 6 weeks | Measurement of possible secondary dislocation |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| DEXA - scanning | 12 weeks | Evaluation of bone density |
| Bone Biochemical markers | 1 week, 2 weeks, 5 weeks, 3 months, 1 year | Se CrossLaps ELISA, N/Mid Osteocalcin Elisa |
| Histomorfometrical evaluation of bone biopsy from callus area | 6 weeks | qualitative evaluation of bone ossification |
Other
| Measure | Time frame | Description |
|---|---|---|
| Repeated measurements of pain in 14 days | 2 weeks | subjective pain registration in 10 points scala 3 times dayly in 14 days |
Countries
Denmark
Outcome results
None listed