Clinical trial NCT01606540: Non-steroid Antiinflammatory Drugs to Heal Colles Fracture
Official title: The Influence of Non-steroid Antiinflammatory Drugs (NSAID) to Heal Colles Fracture.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colles Fracture
Keywords: Colles fracture
Non-steroid antiinflammatory drugs
Bone healing
Lead sponsor: Northern Orthopaedic Division, Denmark
Sponsor class: OTHER
Collaborators: name: Aarhus University Hospital
First posted: 2012-05-25
Enrollment: 192
Sex: ALL
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Evaluation of dislocation.
timeFrame: An expected average of 5 weeks
Secondary outcomes:
measure: Pain score by VAS scale.
timeFrame: An expected average of 2 weeks.
measure: Bone Mineral Density.
timeFrame: An expected average of 3 months
measure: Movement deflections.
timeFrame: An expected average of 5 weeks
measure: Predictors for bone healing.
timeFrame: An expected average of 3 months
measure: Determine ossification.
timeFrame: An expected average of 3 months
Other outcomes:
Locations:
city: Aalborg
country: Denmark
facility: Orthopaedic Surgery Research Unit, Aalborg University Hospital
Study officials:
affiliation: Orthopaedic Research Unit, Aalborg University Hospital
name: Marius Aliuskevicius, M.D.
role: PRINCIPAL_INVESTIGATOR
References: