Colles Fracture
Conditions
Keywords
Colles fracture, Non-steroid antiinflammatory drugs, Bone healing
Brief summary
It is believed that some painkillers (NSAID drugs) slow bone healing but the knowledge is based only on experimental studies with animals whose results are automatically translated for humans. The purpose is to examine whether these drugs slow bone healing and what relationship there is between different bone examinations, scan for osteoporosis, bone marker laboratory tests, radiological controls and histology of newly formed bone under a microscope.
Detailed description
One of the most popular painkillers in the world is known as NSAID (non-steroidal anti-inflammatory drugs). Many studies with animals have been made which show a clear tendency for delayed bone healing by taking NSAIDs. It is known that an early intake of NSAIDs prevents ectopic ossification in patients, receiving total hip prosthesis. However, cases of prosthetic loosening and instability after 10 years were almost exclusively observed in the group of patients who received NSAIDs postoperatively. However, very few clinical studies still show this tendency. In this study we include patients with fresh fracture in the wrist; Colles fracture. The fracture may seem unstable when there is a lack of bone healing. These fractures are very common in the orthopaedic clinic. Although there is no dislocation of the fragments, newly formed bone can be weaker as demonstrated by DEXA scanning (bone mineral density measurement). Histological examination of the healing bone can give a definitive answer whether the bone was affected or not. Thus, the possibilities of studying NSAIDs affect on bone healing in humans and the clinical significance are very positive.
Interventions
DRUGTablets Ibumetin and placebo
Group A: Daily tablets Ibumetin, 600 mg x 3, 7 days after reposition. Group B: Daily tablets Ibumetin, 600 mg x 3, 3 days after reposition. The following days placebo tablets. Group C: Placebo tablets 1 week after reposition.
Sponsors
Aarhus University Hospital
Northern Orthopaedic Division, Denmark
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
50 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Patients giving written informed consent and authority * Patients with Colles fracture who require surgery by means of an external fixation or type bridging with or without suture. * Patients who clinically and radiographically are diagnosed for reposition and therefore require external fixation or type bridging with or without suture.
Exclusion criteria
* Patients who have been given adrenal cortex hormone. * Patients who have been given non-steroid antiinflammatory drugs (NSAID). * Patients who have not been giving written informed consent and authority. * Patients who smoke more than 20 cigarettes daily. * Patients who consume more than 14 drinks weekly. * Lack of mental and physical ability to follow the directions according to the protocol. * Medical contraindication to non-steroid antiinflammatory drugs.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Evaluation of dislocation. | An expected average of 5 weeks | By means of new radiographic technology the investigator is able to determine the difference between any migration of fragments precisely. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain score by VAS scale. | An expected average of 2 weeks. | Every patient keeps a pain log 2 weeks after surgery. |
| Bone Mineral Density. | An expected average of 3 months | By means of DEXA scanning the bone mineral density will be evaluated. |
| Movement deflections. | An expected average of 5 weeks | Evaluation of flexion, extension, pronation and supination after 1 week, 2 weeks, 6 weeks and 3 months. DASH score after 3 months and 1 year. |
| Predictors for bone healing. | An expected average of 3 months | To determine the predictors for bone healing in cooperation with Immunodiagnostic Systems. |
| Determine ossification. | An expected average of 3 months | To perform a core biopsi in order to determinating ossification of callus. |
Countries
Denmark
Outcome results
None listed