Non-steroid Antiinflammatory Drugs to Heal Colles Fracture

Colles Fracture Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01606540
• Other study ID #: N-20120015
• Status: Completed
• Phase: N/A
• Start date: June 2012
• Est. completion date: March 18, 2021

Study information

• Verified date: March 2021
• Source: Northern Orthopaedic Division, Denmark
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 192
• Est. completion date: March 18, 2021
• Est. primary completion date: March 20, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Colles Fracture
• Colles' Fracture
• Fractures, Bone

Intervention

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.
• 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.

Locations

Country	Name	City	State
Denmark	Orthopaedic Surgery Research Unit, Aalborg University Hospital	Aalborg

Sponsors (2)

Lead Sponsor	Collaborator
Northern Orthopaedic Division, Denmark	Aarhus University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Pain score by VAS scale.	Every patient keeps a pain log 2 weeks after surgery.	An expected average of 2 weeks.
Secondary	Bone Mineral Density.	By means of DEXA scanning the bone mineral density will be evaluated.	An expected average of 3 months
Secondary	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.	An expected average of 5 weeks
Secondary	Predictors for bone healing.	To determine the predictors for bone healing in cooperation with Immunodiagnostic Systems.	An expected average of 3 months
Secondary	Determine ossification.	To perform a core biopsi in order to determinating ossification of callus.	An expected average of 3 months