Non-steroid Antiinflammatory Drugs to Heal Colles Fracture
- Conditions
- Colles Fracture
- Interventions
- Drug: Tablets Ibumetin and placebo
- Registration Number
- NCT01606540
- Lead Sponsor
- Northern Orthopaedic Division, Denmark
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 192
- 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.
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Reposition and immobilism Tablets Ibumetin and placebo 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. Surgery Tablets Ibumetin and placebo 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.
- Primary Outcome Measures
Name Time Method Evaluation of dislocation. 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 Outcome Measures
Name Time Method Pain score by VAS scale. An expected average of 2 weeks. Every patient keeps a pain log 2 weeks after surgery.
Bone Mineral Density. An expected average of 3 months By means of DEXA scanning the bone mineral density will be evaluated.
Movement deflections. 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.Predictors for bone healing. An expected average of 3 months To determine the predictors for bone healing in cooperation with Immunodiagnostic Systems.
Determine ossification. An expected average of 3 months To perform a core biopsi in order to determinating ossification of callus.
Trial Locations
- Locations (1)
Orthopaedic Surgery Research Unit, Aalborg University Hospital
🇩🇰Aalborg, Denmark