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Non-steroid Antiinflammatory Drugs to Heal Colles Fracture

Primary Purpose

Colles Fracture

Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Tablets Ibumetin and placebo
Tablets Ibumetin and placebo
Sponsored by
Northern Orthopaedic Division, Denmark
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Colles Fracture focused on measuring Colles fracture, Non-steroid antiinflammatory drugs, Bone healing

Eligibility Criteria

50 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Orthopaedic Surgery Research Unit, Aalborg University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Reposition and immobilism

Surgery

Arm 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.

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.

Outcomes

Primary Outcome Measures

Evaluation of dislocation.
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.
Every patient keeps a pain log 2 weeks after surgery.
Bone Mineral Density.
By means of DEXA scanning the bone mineral density will be evaluated.
Movement deflections.
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.
To determine the predictors for bone healing in cooperation with Immunodiagnostic Systems.
Determine ossification.
To perform a core biopsi in order to determinating ossification of callus.

Full Information

First Posted
May 15, 2012
Last Updated
March 19, 2021
Sponsor
Northern Orthopaedic Division, Denmark
Collaborators
Aarhus University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01606540
Brief Title
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

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
June 2012 (undefined)
Primary Completion Date
March 20, 2020 (Actual)
Study Completion Date
March 18, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Northern Orthopaedic Division, Denmark
Collaborators
Aarhus University Hospital

4. Oversight

Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colles Fracture
Keywords
Colles fracture, Non-steroid antiinflammatory drugs, Bone healing

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
192 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Reposition and immobilism
Arm Type
Experimental
Arm 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.
Arm Title
Surgery
Arm Type
Active Comparator
Arm 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.
Intervention Type
Drug
Intervention Name(s)
Tablets Ibumetin and placebo
Other Intervention Name(s)
No other names.
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Tablets Ibumetin and placebo
Other Intervention Name(s)
No other names.
Intervention Description
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.
Primary Outcome Measure Information:
Title
Evaluation of dislocation.
Description
By means of new radiographic technology the investigator is able to determine the difference between any migration of fragments precisely.
Time Frame
An expected average of 5 weeks
Secondary Outcome Measure Information:
Title
Pain score by VAS scale.
Description
Every patient keeps a pain log 2 weeks after surgery.
Time Frame
An expected average of 2 weeks.
Title
Bone Mineral Density.
Description
By means of DEXA scanning the bone mineral density will be evaluated.
Time Frame
An expected average of 3 months
Title
Movement deflections.
Description
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.
Time Frame
An expected average of 5 weeks
Title
Predictors for bone healing.
Description
To determine the predictors for bone healing in cooperation with Immunodiagnostic Systems.
Time Frame
An expected average of 3 months
Title
Determine ossification.
Description
To perform a core biopsi in order to determinating ossification of callus.
Time Frame
An expected average of 3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marius Aliuskevicius, M.D.
Organizational Affiliation
Orthopaedic Research Unit, Aalborg University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Orthopaedic Surgery Research Unit, Aalborg University Hospital
City
Aalborg
Country
Denmark

12. IPD Sharing Statement

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Non-steroid Antiinflammatory Drugs to Heal Colles Fracture

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