Colles FractureNCT01606540
Non-steroid Antiinflammatory Drugs to Heal Colles Fracture
A study of Colles Fracture, run by Northern Orthopaedic Division, Denmark at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 80 years
- Conditions the study is for
- Colles Fracture
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 192 participants
- Where
- 1 siteDenmark
- Study dates
- Jun 2012to 18 Mar 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Denmark1 site
Orthopaedic Surgery Research Unit, Aalborg University Hospital
Aalborg
About this study
Official title: The Influence of Non-steroid Antiinflammatory Drugs (NSAID) to Heal Colles Fracture.
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.
Read the 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.
- Conditions
- Colles Fracture
- Being tested
- Tablets Ibumetin and placebo
- Keywords
- Colles fracture, Non-steroid antiinflammatory drugs, Bone healing
- Medical subject headings
- Colles' Fracture
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tablets Ibumetin and placeboDrug
Also called No other names.
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.
Tablets Ibumetin and placeboDrug
Also called No other names.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Tablets Ibumetin and placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of dislocation.
By means of new radiographic technology the investigator is able to determine the difference between any migration of fragments precisely.
Measured: An expected average of 5 weeks
Secondary outcomes (5)
Pain score by VAS scale.
Every patient keeps a pain log 2 weeks after surgery.
Measured: An expected average of 2 weeks.
Bone Mineral Density.
By means of DEXA scanning the bone mineral density will be evaluated.
Measured: An expected average of 3 months
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.
Measured: An expected average of 5 weeks
Predictors for bone healing.
To determine the predictors for bone healing in cooperation with Immunodiagnostic Systems.
Measured: An expected average of 3 months
Determine ossification.
To perform a core biopsi in order to determinating ossification of callus.
Measured: An expected average of 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2012 (estimated)
- Study startJun 2012
- Primary completion20 Mar 2020
- Study completion18 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colles FractureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 192 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northern Orthopaedic Division, Denmark
- Sponsor type
- University, hospital or other
- Collaborators
- Aarhus University Hospital
- Responsible party
- Sponsor
- Investigators
- Marius Aliuskevicius, M.D., Principal investigator, Orthopaedic Research Unit, Aalborg University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01606540
- Sponsor's protocol ID
- N-20120015
- Status last verified
- Mar 2021
- First submitted
- 15 May 2012
- Last updated
- 22 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Influence of Non-steroid Antiinflammatory Drugs (NSAID) to Heal Colles Fracture.
- ClinicalTrials.gov ID
- NCT01606540
- Acronym / sponsor ID
- N-20120015
- Conditions
- Colles Fracture
- Keywords
- Colles fracture, Non-steroid antiinflammatory drugs, Bone healing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 192 participants (actual)
- Lead sponsor
- Northern Orthopaedic Division, DenmarkUniversity, hospital or other
- Collaborators
- Aarhus University Hospital
- Study start
- Jun 2012
- Primary completion
- 20 Mar 2020 (actual)
- Study completion
- 18 Mar 2021 (actual)
- First posted
- 25 May 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Reposition and immobilism | Experimental | Drug: Tablets Ibumetin and placeboThe 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. |
| Surgery | Active comparator | Drug: Tablets Ibumetin and placeboThe 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. |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tablets Ibumetin and placeboAlso: No other names.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. | Drug | Reposition and immobilism |
| Tablets Ibumetin and placeboAlso: No other names.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. | Drug | Surgery |
Primary outcome
Evaluation of dislocation.
Time frame: 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.
5 secondary outcomes
Pain score by VAS scale.
Time frame: An expected average of 2 weeks.
Bone Mineral Density.
Time frame: An expected average of 3 months
Movement deflections.
Time frame: An expected average of 5 weeks
Predictors for bone healing.
Time frame: An expected average of 3 months
Determine ossification.
Time frame: An expected average of 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2021.
Related trials for Colles Fracture
Recruiting
Wrist Injury Strengthening Exercise (WISE) Versus Usual Care Advice for Improving Pain and Function
Distal Radius Fracture, Colles Fracture
Active, not recruitingPhase 4
Brachial Plexus Nerve Block Versus Haematoma Block for Closed Reduction of Distal Radius Fracture in Adults - The BLOCK Trial. A Multicentre Randomised Controlled Trial.
Distal Radius Fractures, Fracture Dislocation
Recruiting
Comparative Study Between Cannulated Screws and K-wires in the Fixation of Distal Radius Fractures
Distal Radius Fractures
Not yet recruiting
Comparison of Functional Outcomes of Closed Reduction With Cast Versus Closed Reduction With K-Wire Fixation in Colles' Fracture
Colles' Fracture
Recruiting
Comparison of Kaltenborn Mobilization and Mobilization With Movement (MWM) in Wrist Hypomobility After Colle's Fracture
Colles Fracture, Hypomobility
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marius Aliuskevicius, M.D. principal investigator
Orthopaedic Research Unit, Aalborg University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Colles Fracture, run by Northern Orthopaedic Division, Denmark at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of dislocation. (time frame: An expected average of 5 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Mar 2021.