Non-steroid Antiinflammatory Drugs to Heal Colles Fracture

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.

Study Overview

• Status: Completed
• Conditions: Colles Fracture
• Intervention / Treatment: Drug: Tablets Ibumetin and placebo; Drug: Tablets Ibumetin and placebo

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 Type: Interventional
• Enrollment (Actual): 192
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Aalborg, Denmark
    • Orthopaedic Surgery Research Unit, Aalborg University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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 Names: No other names.; 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 Names: 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 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 Names: No other names.; 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 Names: No other names.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: Northern Orthopaedic Division, Denmark
• Collaborators: Aarhus University Hospital
• Investigators: Principal Investigator: Marius Aliuskevicius, M.D., Orthopaedic Research Unit, Aalborg University Hospital

Study record dates

Study Major Dates

• Study Start: June 1, 2012
• Primary Completion (Actual): March 20, 2020
• Study Completion (Actual): March 18, 2021

Study Registration Dates

• First Submitted: May 15, 2012
• First Submitted That Met QC Criteria: May 23, 2012
• First Posted (Estimate): May 25, 2012

Study Record Updates

• Last Update Posted (Actual): March 22, 2021
• Last Update Submitted That Met QC Criteria: March 19, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Keywords: Bone healing; Colles fracture; Non-steroid antiinflammatory drugs
• Additional Relevant MeSH Terms: Wounds and Injuries; Joint Diseases; Musculoskeletal Diseases; Joint Dislocations; Fracture Dislocation; Radius Fractures; Fractures, Bone; Colles' Fracture; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Ibuprofen
• Other Study ID Numbers: N-20120015