Non-steroid Antiinflammatory Drugs to Heal Colles Fracture

NCT01606540 | Completed

• 1 other identifier: N-20120015
• Study Type: interventional
• Target: 192
• Locations: 1 country
• Sites: 1

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.

Conditions

Colles Fracture

Keywords

Colles fracture; Non-steroid antiinflammatory drugs; Bone healing

Outcome Measures

Primary Outcomes (1)

• Evaluation of dislocation.

  By means of new radiographic technology the investigator is able to determine the difference between any migration of fragments precisely.

  An expected average of 5 weeks

Secondary Outcomes (5)

• Pain score by VAS scale.

  An expected average of 2 weeks.

• Bone Mineral Density.

  An expected average of 3 months

• Movement deflections.

  An expected average of 5 weeks

• Predictors for bone healing.

  An expected average of 3 months

• Determine ossification.

  An expected average of 3 months

Study Arms (2)

Reposition and immobilism

EXPERIMENTAL

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

Surgery

ACTIVE COMPARATOR

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

Interventions

Tablets Ibumetin and placebo DRUG

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.

Also known as: No other names.

Reposition and immobilism

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Northern Orthopaedic Division, Denmark: lead
• Aarhus University Hospital: collaborator

Study Sites (1)

Orthopaedic Surgery Research Unit, Aalborg University Hospital

Aalborg, Denmark

Location

MeSH Terms

Conditions

Colles' Fracture

Interventions

Ibuprofen

Condition Hierarchy (Ancestors)

Fracture Dislocation; Joint Dislocations; Joint Diseases; Musculoskeletal Diseases; Wounds and Injuries; Radius Fractures; Fractures, Bone

Intervention Hierarchy (Ancestors)

Phenylpropionates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals

Study Officials

• Marius Aliuskevicius, M.D.

  Orthopaedic Research Unit, Aalborg University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 15, 2012
• First Posted: May 25, 2012
• Study Start: June 1, 2012
• Primary Completion: March 20, 2020
• Study Completion: March 18, 2021
• Last Updated: March 22, 2021

Record last verified: 2021-03

Locations

DK (1)