Non-steroid Antiinflammatory Drugs to Heal Colles Fracture

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by Northern Orthopaedic Division, Denmark
Sponsor:
Collaborator:
Aarhus University Hospital
Information provided by (Responsible Party):
Northern Orthopaedic Division, Denmark
ClinicalTrials.gov Identifier:
NCT01606540
First received: May 15, 2012
Last updated: March 28, 2014
Last verified: March 2014
  Purpose

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 Intervention
Colles Fracture
Drug: Tablets Ibumetin and placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: The Influence of Non-steroid Antiinflammatory Drugs (NSAID) to Heal Colles Fracture.

Resource links provided by NLM:


Further study details as provided by Northern Orthopaedic Division, Denmark:

Primary Outcome Measures:
  • Evaluation of dislocation. [ Time Frame: An expected average of 5 weeks ] [ Designated as safety issue: No ]
    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. [ Time Frame: An expected average of 2 weeks. ] [ Designated as safety issue: No ]
    Every patient keeps a pain log 2 weeks after surgery.

  • Bone Mineral Density. [ Time Frame: An expected average of 3 months ] [ Designated as safety issue: No ]
    By means of DEXA scanning the bone mineral density will be evaluated.

  • Movement deflections. [ Time Frame: An expected average of 5 weeks ] [ Designated as safety issue: No ]

    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. [ Time Frame: An expected average of 3 months ] [ Designated as safety issue: No ]
    To determine the predictors for bone healing in cooperation with Immunodiagnostic Systems.

  • Determine ossification. [ Time Frame: An expected average of 3 months ] [ Designated as safety issue: No ]
    To perform a core biopsi in order to determinating ossification of callus.


Estimated Enrollment: 192
Study Start Date: June 2012
Estimated Study Completion Date: June 2017
Estimated Primary Completion Date: June 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: No other names.

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. But there are still very few clinical studies which show this tendency. In this study it is decided to include patients with fresh fracture in the wrist; Colles fracture. The fracture may seem unstable when there is a lack of bone healing. These patients are very regular in 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. Therefore, the possibilities of studying NSAIDs affect on bone healing in humans and the clinical significance are very positive.

  Eligibility

Ages Eligible for Study:   50 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01606540

Contacts
Contact: Marius Aliuskevicius, M.D. 99 32 51 95 ext +45 marius.aliuskevicius@rn.dk
Contact: Sten Rasmussen, M.D. 99 32 23 67 ext +45 sten.rasmussen@rn.dk

Locations
Denmark
Orthopaedic Surgery Research Unit, Aalborg University Hospital Recruiting
Aalborg, Denmark
Contact: Marius Aliuskevicius, M.D.       marius.aliuskevicius@rn.dk   
Sponsors and Collaborators
Northern Orthopaedic Division, Denmark
Aarhus University Hospital
Investigators
Principal Investigator: Marius Aliuskevicius, M.D. Orthopaedic Research Unit, Aalborg University Hospital
  More Information

No publications provided

Responsible Party: Northern Orthopaedic Division, Denmark
ClinicalTrials.gov Identifier: NCT01606540     History of Changes
Other Study ID Numbers: N-20120015
Study First Received: May 15, 2012
Last Updated: March 28, 2014
Health Authority: Denmark: The Danish National Committee on Biomedical Research Ethics
Denmark: Danish Dataprotection Agency

Keywords provided by Northern Orthopaedic Division, Denmark:
Colles fracture
Non-steroid antiinflammatory drugs
Bone healing

Additional relevant MeSH terms:
Colles' Fracture
Fractures, Bone
Radius Fractures
Wounds and Injuries
Anti-Inflammatory Agents
Ibuprofen
Therapeutic Uses
Pharmacologic Actions
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Central Nervous System Agents

ClinicalTrials.gov processed this record on August 20, 2014