Clinical Trial: Non-steroid Antiinflammatory Drugs to Heal Colles Fracture

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

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

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 Summary:

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.

Sponsor: Northern Orthopaedic Division, Denmark

Current Primary Outcome: Evaluation of dislocation. [ Time Frame: An expected average of 5 weeks ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

• Pain score by VAS scale. [ Time Frame: An expected average of 2 weeks. ]
  Every patient keeps a pain log 2 weeks after surgery.
• Bone Mineral Density. [ Time Frame: An expected average of 3 months ]
  By means of DEXA scanning the bone mineral density will be evaluated.
• 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.

• Predictors for bone healing. [ Time Frame: An expected average of 3 months ]
  To determine the predictors for bone healing in cooperation with Immunodiagnostic Systems.
• Determine ossification. [ Time Frame: An expected average of 3 months ]
  To perform a core biopsi in order to determinating ossification of callus.

Original Secondary Outcome:

• Pain score by VAS scale. [ Time Frame: 2 weeks ]
  Every patient keeps a pain log 2 weeks after surgery.
• Bone Mineral Density. [ Time Frame: 3 months ]
  By means of DEXA scanning the bone mineral density will be evaluated.
• 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.

• Predictors for bone healing. [ Time Frame: An expected average of 3 months ]
  To determine the predictors for bone healing in cooperation with Immunodiagnostic Systems.
• Determine ossification. [ Time Frame: An expected average of 3 months ]
  To perform a core biopsi in order to determinating ossification of callus.

Information By: Northern Orthopaedic Division, Denmark

Dates:
Date Received: May 15, 2012
Date Started: June 2012
Date Completion: June 2017
Last Updated: April 11, 2017
Last Verified: April 2017