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NCT Number: NCT01606540

Non-steroid Antiinflammatory Drugs 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.

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Key information

Conditions

Colles Fracture Colles' Fracture Fracture Dislocation Fractures, Bone Joint Diseases Joint Dislocations Musculoskeletal Diseases Radius Fractures Wounds and Injuries

Age range

50 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Orthopaedic Surgery Research Unit, Aalborg University Hospital

Aalborg, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Tablets Ibumetin and placebo

Drug

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. Pain score by VAS scale.

    Time frame: An expected average of 2 weeks.

    Every patient keeps a pain log 2 weeks after surgery.

  2. Bone Mineral Density.

    Time frame: An expected average of 3 months

    By means of DEXA scanning the bone mineral density will be evaluated.

  3. Movement deflections.

    Time frame: An expected average of 5 weeks

    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.

  4. Predictors for bone healing.

    Time frame: An expected average of 3 months

    To determine the predictors for bone healing in cooperation with Immunodiagnostic Systems.

  5. Determine ossification.

    Time frame: An expected average of 3 months

    To perform a core biopsi in order to determinating ossification of callus.

Sponsors and collaborators

Lead sponsor

Northern Orthopaedic Division, Denmark

Other

Collaborators

  • Aarhus University Hospital

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2020
Study completion
2021
First posted
May 25, 2012
Registry last updated
Mar 22, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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