Non-steroid Antiinflammatory Drugs to Heal Colles Fracture

Sponsor

Northern Orthopaedic Division, Denmark (Other)

Overall Status

Completed

CT.gov ID

NCT01606540

Collaborator

Aarhus University Hospital (Other)

192

Enrollment

Location

Arms

105.5

Duration (Months)

1.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Colles Fracture	Drug: Tablets Ibumetin and placebo Drug: Tablets Ibumetin and placebo	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

192 participants

Allocation:

Randomized

Intervention Model:

Single Group Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Jun 1, 2012

Actual Primary Completion Date :

Mar 20, 2020

Actual Study Completion Date :

Mar 18, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Reposition and immobilism 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.	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. Other Names: No other names.
Active Comparator: Surgery 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.	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. Other Names: No other names.

Arm

Intervention/Treatment

Experimental: Reposition and immobilism

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.

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.

Other Names:

No other names.

Active Comparator: Surgery

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.

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.

Other Names:

No other names.

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

50 Years to 80 Years

Sexes Eligible for Study:

All

Accepts 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.