NCT01606540

Non-steroid Antiinflammatory Drugs to Heal Colles Fracture

The Influence of Non-steroid Antiinflammatory Drugs (NSAID) to Heal Colles Fracture.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 192 (actual)
• Sponsor: Northern Orthopaedic Division, Denmark · Academic / Other
• Sex: All
• Age: 50 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Colles Fracture

Interventions

Type	Name	Description
DRUG	Tablets 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.
DRUG	Tablets Ibumetin and placebo	Group A: Daily tablets Ibumetin, 600 mg x 3, 7 days after surgery. Group B: Daily tablets Ibumetin, 600 mg x 3, 3 days after surgery. The following days placebo tablets. Group C: Placebo tablets for 1 week after surgery.

Timeline

• Start date: 2012-06-01
• Primary completion: 2020-03-20
• Completion: 2021-03-18
• First posted: 2012-05-25
• Last updated: 2021-03-22

Locations

1 site across 1 country: Denmark