Non-steroid Antiinflammatory Drugs to Heal Colles Fracture

Northern Orthopaedic Division, Denmark

Status: Completed

Conditions: Colles Fracture

Treatments: Drug: Tablets Ibumetin and placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT01606540

N-20120015

Details and patient eligibility

About

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.

Full 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.

Enrollment: 192 patients

Sex: All

Ages: 50 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Double Blind

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192 participants in 2 patient groups

Reposition and immobilism

Experimental group

Description:

The patient are under sedation before reposition. The patient will be injected with 8-10 ml 1% Lidocain. After reposition the patient is asked to fill in a questionnaire with information of experienced pain based on VAS score. The patient note down the experience of pain each day 14 days after reposition.

Treatment:

Drug: Tablets Ibumetin and placebo

Drug: Tablets Ibumetin and placebo

Surgery

Active Comparator group

Description:

The method of surgery is type bridging. After surgery the patient is asked to fill in a questionnaire with information of experienced pain based on VAS score. The patient note down the experience of pain each day 14 days after operation.

Treatment:

Drug: Tablets Ibumetin and placebo

Drug: Tablets Ibumetin and placebo